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Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT02256631
Collaborator
(none)
83
Enrollment
14
Locations
7
Arms
77.6
Actual Duration (Months)
5.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.

Condition or Disease Intervention/Treatment Phase
  • Biological: VRC01
  • Biological: VRC01LS
  • Biological: VRC07-523LS
 Phase 1

Detailed Description

VRC01, VRC01LS, and VRC07-523LS are anti-HIV neutralizing monoclonal antibodies that may help prevent mother-to-child transmission of HIV. This study enrolled HIV-infected mothers who were at increased risk of passing HIV on to their children. The purpose of this study was to assess the safety and PK of VRC01, VRC01LS, and VRC07-523LS in HIV-exposed infants.

This study enrolled mother-infant pairs into five dose groups. Infants enrolled in Dose Group 1 and Dose Group 2 received a single VRC01 injection less than 72 hours after birth. Infants in Dose Group 3 received a VRC01 injection less than 5 days after birth, followed by VRC01 injections monthly for at least 6 months and no more than 18 months, while breastfeeding.

Dose Groups 4 and 5 each enrolled infants into two cohorts: Cohort 1 (non-breastfeeding) or Cohort 2 (breastfeeding). Infants in Dose Group 4, Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Infants in Dose Group 4, Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth, and a second VRC01LS injection at Week 12 if they were still breastfeeding. Infants in Dose Group 5, Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Infants in Dose Group 5, Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth, and a second VRC07-523LS injection at Week 12 if they were still breastfeeding.

The mothers did not receive any VRC01, VRC01LS, or VRC07-523LS injections. At study entry, all mothers underwent a medical history review and a blood collection, and then the study ended for the mothers.

Infants in Dose Groups 1 and 2 attended study visits at days 0, 1, 3, 7, 14, 28 and at weeks 8, 16, 24, and 48. Infants in Dose Group 3 attended study visits at days 0, 1, 14, 28 and at weeks 8, 12, 16, 20, 24, and every 4 weeks until cessation of breastfeeding or week 72, then at weeks 84 and 96. Infants in Dose Group 4 attended study visits at days 0, 1, 14, 28 and at weeks 8, 12, 24, 36, 48, 60, 72, 84 and 96, with additional visits at weeks 14 and 16 for Cohort 2 participants. Infants in Dose Group 5 attended study visits at days 0, 1, 3, 7, 14, 28 and at weeks 8, 12, 24, 36, 48, 60, 72, 84 and 96, with additional visits at weeks 14 and 16 for Cohort 2 participants. Visits included a medical history review, physical examination, blood collection, and oral fluid collection.

Study Design

Study Type:
Interventional
Actual Enrollment :
83 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Open-Label, Dose-Escalating, Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous (SC) VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
Actual Study Start Date :
Jun 30, 2015
Actual Primary Completion Date :
Jun 17, 2020
Actual Study Completion Date :
Dec 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose Group 1

Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.

Biological: VRC01
Administered by subcutaneous injection in the thigh
Other Names:
  • VRC-HIVMAB-060-00-AB
  • VRC01 mAb

    		•
    Experimental: Dose Group 2

    Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.

    Biological: VRC01
    Administered by subcutaneous injection in the thigh
    Other Names:
  • VRC-HIVMAB-060-00-AB
  • VRC01 mAb

    		•
    Experimental: Dose Group 3

    Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.

    Biological: VRC01
    Administered by subcutaneous injection in the thigh
    Other Names:
  • VRC-HIVMAB-060-00-AB
  • VRC01 mAb

    		•
    Experimental: Dose Group 4, Cohort 1

    Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.

    Biological: VRC01LS
    Administered by subcutaneous injection in the thigh
    Other Names:
  • VRC-HIVMAB080-00-AB

    		•
    Experimental: Dose Group 4, Cohort 2

    Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.

    Biological: VRC01LS
    Administered by subcutaneous injection in the thigh
    Other Names:
  • VRC-HIVMAB080-00-AB

    		•
    Experimental: Dose Group 5, Cohort 1

    Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.

    Biological: VRC07-523LS
    Administered by subcutaneous injection in the thigh
    Other Names:
  • VRC-HIVMAB075-00-AB

    		•
    Experimental: Dose Group 5, Cohort 2

    Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.

    Biological: VRC07-523LS
    Administered by subcutaneous injection in the thigh
    Other Names:
  • VRC-HIVMAB075-00-AB

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Who Died [From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)]

      The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Deaths from day 0 to 4 weeks after the participants' last immunization were included.

    2. Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) [From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)]

      The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included.

    3. Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) [From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)]

      The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed and determined if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included.

    4. Percentage of Participants Diagnosed With HIV Infection [From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)]

      The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. HIV diagnoses from day 0 to 4 weeks after the participants' last immunization were included.

    5. Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Groups 1, 2, 3 and 4 [Dose Groups (DG) 1, 2: at days 0, 1, 3, 7, 14, 28; DG 3: at days 0, 1, 14, 28, weeks 16, 20, 24; DG 4-Cohort 1: at days 0, 1, 14, 28; Cohort 2: at days 0, 1, 14, 28, 84.]

      The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-28 days (area-under-the-curve from 0 to 28 days) for Dose Groups 1, 2 and 3 and AUC0-84 days for Dose Group 4, were determined using the linear trapezoidal rule. Median and range were summarized.

    6. Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Group 5 [Dose Group 5 - Cohort 1: at days 0, 1, 3, 7, 14, 28; Cohort 2: at days 0, 1, 3, 7, 14, 28, 84.]

      The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-84 days (area-under-the-curve from 0 to 84 days) were determined using the linear trapezoidal rule. Median and range were summarized. The data collection is complete but data for Dose Group 5 are not available yet due to delays caused by export permits and by COVID-19. The results will be added when available, before December 2022.

    7. Pharmacokinetics (PK) Parameter: Concentration for Dose Groups 1, 2, 3 and 4 [Dose Groups (DG) 1, 2: at days 0, 1, 3, 7, 14, 28; DG 3: at days 0, 1, 14, 28, weeks 16, 20, 24; DG 4-Cohort 1: at days 0, 1, 14, 28; Cohort 2: at days 0, 1, 14, 28, 84.]

      The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C28 days (concentration at 28 days) for Dose Groups 1, 2 and 3 and C84 days for Dose Group 4.

    8. Pharmacokinetics (PK) Parameter: Concentration for Dose Group 5 [Dose Group 5 - Cohort 1: at days 0, 1, 3, 7, 14, 28; Cohort 2: at days 0, 1, 3, 7, 14, 28, 84.]

      The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C84 days (concentration at 84 days). The data collection is complete but data for Dose Group 5 are not available yet due to delays caused by export permits and by COVID-19. The results will be added when available, before December 2022.

    Secondary Outcome Measures

    1. Percentage of Participants Who Died After Last Immunization for Dose Groups 1, 2, 3 and 4 [From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Group 3 and 4).]

      The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here. Study is ongoing. Some participants in Dose group 5 are still in follow-up (post-PCD). The data for Dose Group 5 will be added at end of study follow up in a separate outcome measure.

    2. Percentage of Participants Who Died After Last Immunization for Dose Group 5 [From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).]

      The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Study is ongoing. Some participants in Dose Group 5 are still in follow-up (post-PCD). The data for Dose Group 5 will be added at end of study follow up. Data collection for all other arms is complete and reported separately.

    3. Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Groups 1, 2, 3 and 4 [From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).]

      The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here. Study is ongoing. Some participants in Dose group 5 are still in follow-up (post-PCD). The data for Dose Group 5 will be added at end of study follow up in a separate outcome measure.

    4. Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Group 5 [From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).]

      The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Study is ongoing. Some participants in Dose Group 5 are still in follow-up (post-PCD). The data for Dose Group 5 will be added at end of study follow up. Data collection for all other arms is complete and reported separately.

    5. Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Groups 1, 2, 3, and 4 [From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).]

      The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here. Study is ongoing. Some participants in Dose group 5 are still in follow-up (post-PCD). The data for Dose Group 5 will be added at end of study follow up in a separate outcome measure.

    6. Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Group 5 [From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).]

      The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Study is ongoing. Some participants in Dose group 5 are still in follow-up (post-PCD). The data for Dose Group 5 will be added at end of study follow up. Data collection for all other arms is complete and reported separately.

    7. Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Groups 1, 2, 3, and 4 [From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).]

      The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here. Study is ongoing. Some participants in Dose group 5 are still in follow-up (post-PCD). The data for Dose Group 5 will be added at end of study follow up in a separate outcome measure.

    8. Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Group 5 [From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).]

      The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Study is ongoing. Some participants are still in follow-up (post-PCD). The data for Dose Group 5 will be added at end of study follow up. Data collection for all other arms is complete and reported separately.

    9. Number of Participants Who Developed Anti-VRC Antibodies [At weeks 24 and 48.]

      The Overall Number of Participants Analyzed represents infants who developed anti antibodies to the study products. For Dose Groups 1, 2, and 3, these are anti-VRC01 antibodies. For Dose Group 4, these are anti-VCR07 antibodies and for Dose Group 5, these are anti-VRC07-523LS antibodies. These assays will be run at the end of the study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Days to 5 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Maternal Inclusion Criteria:

    • HIV infection

    • Greater than or equal to 18 years of age

    • Able and willing to provide signed informed consent for herself and her infant

    Maternal Exclusion Criteria:

    • Prior participation in any HIV-1 vaccine trial

    • Receipt of any other active or passive HIV immunotherapy or investigational product during this pregnancy. (Note that administration of Food and Drug Administration [FDA]-approved antiretroviral (ARV) drugs when used to treat disease or prevent mother-to-child transmission were not considered investigational.)

    • Documented or suspected serious medical illness or immediate life-threatening condition (other than HIV infection) in the mother that may have interfered with the ability to complete study requirements, as judged by the examining clinician

    Infant Inclusion Criteria:

    • Born to an HIV-1-infected woman who met all maternal inclusion/exclusion criteria listed above

    • Gestational age, by best obstetrical, ultrasound, or infant exam, greater than or equal to 36 weeks

    • Birth weight greater than or equal to 2.0 kg

    • Allowable infant age at the time of enrollment was dependent on the Dose Group and

    Cohort:

    • Dose Groups 1, 2, 4 and 5 (Cohort 1): Less than 72 hours of age, and anticipated availability to receive VRC immunization at less than 72 hours after birth.

    • Dose Groups 3, 4 and 5 (Cohort 2): Less than or equal to 5 days of age, and anticipated availability to receive VRC immunization no more than 5 days after birth.

    • At increased risk of HIV acquisition defined as documentation of one or more of the following risk factors:

    • Dose Groups 1, 2, 4 and 5 (Cohort 1), only:

    • Mother received no antiretroviral therapy (ART) during pregnancy or mother began or reinitiated ART (after an interruption of greater than 14 days), during the third trimester of pregnancy; or

    • Mother with any detectable viral replication (HIV RNA above the limit of detection) at last measurement prior to delivery determined within 30 days of delivery; or

    • Prolonged rupture of membranes (greater than 12 hours); or

    • Mother with documented 2-class resistant HIV infection, which may have included historical documentation of lack of response

    • Women who had a documented history of virologic failure while on non-nucleoside reverse transcriptase inhibitors (NNRTIs) but who had no resistance testing at the time of viral failure were considered to have NNRTI-documented resistance.

    • Dose Groups 3, 4 and 5 (Cohort 2), only (African sites):

    • Mother intended to breastfeed

    Infant Exclusion Criteria:

    • Receipt of any other active or passive HIV immunotherapy or investigational product other than the study vaccine (Note: Infant prophylaxis with any licensed ARV drugs clinically prescribed to prevent mother-to-child HIV transmission were not considered investigational.)

    • Receipt of or anticipated need for blood products, immunoglobulin, or immunosuppressive therapy. This included infants who required hepatitis B immunoglobulin (HBIG) but did not require exclusion of infants who received hepatitis B vaccine in the newborn period.

    • Documented or suspected serious medical illness, serious congenital anomaly, or immediate life-threatening condition in the infant that may have interfered with the ability to complete study requirements, as judged by the examining clinician

    • Any requirement for supplemental oxygen beyond 24 hours of life or requiring supplemental oxygen at the time of the VRC01, VRC01LS, or VRC07-523LS dose

    • Baseline laboratory results:

    • Hemoglobin less than 12.0 g/dL

    • Platelet count less than 100,000 cells/mm^3

    • Absolute neutrophil count: for infants less than or equal to 24 hours old, less than 4,000 cells/mm3; for infants greater than 24 hours old, less than 1,250 cells/mm3

    • Serum glutamic pyruvic transaminase (SGPT) greater than or equal to 1.25 times upper limit of age adjusted normal

    • Dose Groups 1, 2, 4 and 5 (Cohort 1), only: Infant was breastfeeding at time of enrollment or mother had indicated an intention to initiate breastfeeding. Note: if a child was breastfed prior to known maternal diagnosis (in the case of a woman diagnosed in the intrapartum period), the child was still eligible as long as breastfeeding was stopped by the time the child was enrolled and there was no plan to resume breast milk feeding.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 David Geffen School of Medicine at UCLA NICHD CRS Los Angeles California United States 90095-1752
    2 Univ. of Colorado Denver NICHD CRS Aurora Colorado United States 80045
    3 South Florida CDTC Ft Lauderdale NICHD CRS Fort Lauderdale Florida United States 33316
    4 Univ. of Florida Jacksonville NICHD CRS Jacksonville Florida United States 32209
    5 Pediatric Perinatal HIV Clinical Trials Unit CRS Miami Florida United States 33136
    6 Emory University School of Medicine NICHD CRS Atlanta Georgia United States 30322
    7 Johns Hopkins Univ. Baltimore NICHD CRS Baltimore Maryland United States 21287
    8 Bronx-Lebanon Hospital Center NICHD CRS Bronx New York United States 10457
    9 Jacobi Med. Ctr. Bronx NICHD CRS Bronx New York United States 10461
    10 Texas Children's Hospital CRS Houston Texas United States 77030-2399
    11 University of Puerto Rico Pediatric HIV/AIDS Research Program CRS San Juan Puerto Rico 00935
    12 San Juan City Hosp. PR NICHD CRS San Juan Puerto Rico 00936
    13 Famcru Crs Tygerberg Western Cape Province South Africa 7505
    14 Harare Family Care CRS Harare Zimbabwe

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Study Chair: Coleen Cunningham, MD, Duke University

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT02256631
    Other Study ID Numbers:
    • IMPAACT P1112
    • 11903
    First Posted:
    Oct 3, 2014
    Last Update Posted:
    Apr 22, 2022
    Last Verified:
    Apr 1, 2022
    Additional relevant MeSH terms:
    HIV Infections

    Study Results

    Participant Flow

    Recruitment Details 83 mother-infant pairs were enrolled in the study. Since the mothers did not receive any treatment on study and were taken off study immediately after enrollment, the number of participants shown in all tables is the number of infants (83). Participants were enrolled from June 2015 to February 2020, at 14 medical clinics in the United States, Puerto Rico, South Africa and Zimbabwe.
    Pre-assignment Detail Dose groups enrolled sequentially. There was no randomization.
    Arm/Group Title Dose Group 1 Dose Group 2 Dose Group 3 Dose Group 4, Cohort 1 Dose Group 4, Cohort 2 Dose Group 5, Cohort 1 Dose Group 5, Cohort 2
    Arm/Group Description Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. VRC01: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC07-523LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding. VRC07-523LS: Administered by subcutaneous injection in the thigh
    Period Title: Overall Study
    STARTED 13 14 13 10 11 11 11
    COMPLETED 12 11 13 6 10 9 7
    NOT COMPLETED 1 3 0 4 1 2 4

    Baseline Characteristics

    Arm/Group Title Dose Group 1 Dose Group 2 Dose Group 3 Dose Group 4, Cohort 1 Dose Group 4, Cohort 2 Dose Group 5, Cohort 1 Dose Group 5, Cohort 2 Total
    Arm/Group Description Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. VRC01: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC07-523LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding. VRC07-523LS: Administered by subcutaneous injection in the thigh Total of all reporting groups
    Overall Participants 13 14 13 10 11 11 11 83
    Age, Customized (days) [Median (Full Range) ]
    Age at first dose
    2
    2
    2
    2
    2
    1
    4
    2
    Sex: Female, Male (Count of Participants)
    Female
    5
    38.5%
    8
    57.1%
    5
    38.5%
    4
    40%
    6
    54.5%
    6
    54.5%
    3
    27.3%
    37
    44.6%
    Male
    8
    61.5%
    6
    42.9%
    8
    61.5%
    6
    60%
    5
    45.5%
    5
    45.5%
    8
    72.7%
    46
    55.4%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    5
    38.5%
    4
    28.6%
    0
    0%
    1
    10%
    0
    0%
    2
    18.2%
    0
    0%
    12
    14.5%
    Not Hispanic or Latino
    8
    61.5%
    10
    71.4%
    13
    100%
    9
    90%
    11
    100%
    8
    72.7%
    11
    100%
    70
    84.3%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    9.1%
    0
    0%
    1
    1.2%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    6
    46.2%
    11
    78.6%
    13
    100%
    8
    80%
    11
    100%
    8
    72.7%
    11
    100%
    68
    81.9%
    White
    6
    46.2%
    2
    14.3%
    0
    0%
    2
    20%
    0
    0%
    1
    9.1%
    0
    0%
    11
    13.3%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    9.1%
    0
    0%
    1
    1.2%
    Unknown or Not Reported
    1
    7.7%
    1
    7.1%
    0
    0%
    0
    0%
    0
    0%
    1
    9.1%
    0
    0%
    3
    3.6%
    Region of Enrollment (participants) [Number]
    Puerto Rico
    2
    15.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    2.4%
    United States
    10
    76.9%
    9
    64.3%
    0
    0%
    7
    70%
    0
    0%
    11
    100%
    0
    0%
    37
    44.6%
    South Africa
    1
    7.7%
    5
    35.7%
    10
    76.9%
    3
    30%
    5
    45.5%
    0
    0%
    7
    63.6%
    31
    37.3%
    Zimbabwe
    0
    0%
    0
    0%
    3
    23.1%
    0
    0%
    6
    54.5%
    0
    0%
    4
    36.4%
    13
    15.7%
    Birth Weight (grams) [Median (Full Range) ]
    Median (Full Range) [grams]
    3045
    3160
    2860
    2865
    2920
    2810
    3235
    2920

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Who Died
    Description The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Deaths from day 0 to 4 weeks after the participants' last immunization were included.
    Time Frame From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)

    Outcome Measure Data

    Analysis Population Description
    All infant study participants.
    Arm/Group Title Dose Group 1 Dose Group 2 Dose Group 3 Dose Group 4, Cohort 1 Dose Group 4, Cohort 2 Dose Group 5, Cohort 1 Dose Group 5, Cohort 2
    Arm/Group Description Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. VRC01: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC07-523LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding. VRC07-523LS: Administered by subcutaneous injection in the thigh
    Measure Participants 13 14 13 10 11 11 11
    Number (90% Confidence Interval) [percentage of participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2. Primary Outcome
    Title Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE)
    Description The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included.
    Time Frame From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)

    Outcome Measure Data

    Analysis Population Description
    All infant study participants.
    Arm/Group Title Dose Group 1 Dose Group 2 Dose Group 3 Dose Group 4, Cohort 1 Dose Group 4, Cohort 2 Dose Group 5, Cohort 1 Dose Group 5, Cohort 2
    Arm/Group Description Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. VRC01: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC07-523LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding. VRC07-523LS: Administered by subcutaneous injection in the thigh
    Measure Participants 13 14 13 10 11 11 11
    Number (90% Confidence Interval) [percentage of participants]
    31
    238.5%
    14
    100%
    31
    238.5%
    10
    100%
    27
    245.5%
    36
    327.3%
    9
    81.8%
    3. Primary Outcome
    Title Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE)
    Description The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed and determined if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included.
    Time Frame From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)

    Outcome Measure Data

    Analysis Population Description
    All infant study participants.
    Arm/Group Title Dose Group 1 Dose Group 2 Dose Group 3 Dose Group 4, Cohort 1 Dose Group 4, Cohort 2 Dose Group 5, Cohort 1 Dose Group 5, Cohort 2
    Arm/Group Description Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. VRC01: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC07-523LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding. VRC07-523LS: Administered by subcutaneous injection in the thigh
    Measure Participants 13 14 13 10 11 11 11
    Number (90% Confidence Interval) [percentage of participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    4. Primary Outcome
    Title Percentage of Participants Diagnosed With HIV Infection
    Description The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. HIV diagnoses from day 0 to 4 weeks after the participants' last immunization were included.
    Time Frame From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)

    Outcome Measure Data

    Analysis Population Description
    All infant study participants.
    Arm/Group Title Dose Group 1 Dose Group 2 Dose Group 3 Dose Group 4, Cohort 1 Dose Group 4, Cohort 2 Dose Group 5, Cohort 1 Dose Group 5, Cohort 2
    Arm/Group Description Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. VRC01: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC07-523LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding. VRC07-523LS: Administered by subcutaneous injection in the thigh
    Measure Participants 13 14 13 10 11 11 11
    Number (90% Confidence Interval) [percentage of participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    5. Primary Outcome
    Title Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Groups 1, 2, 3 and 4
    Description The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-28 days (area-under-the-curve from 0 to 28 days) for Dose Groups 1, 2 and 3 and AUC0-84 days for Dose Group 4, were determined using the linear trapezoidal rule. Median and range were summarized.
    Time Frame Dose Groups (DG) 1, 2: at days 0, 1, 3, 7, 14, 28; DG 3: at days 0, 1, 14, 28, weeks 16, 20, 24; DG 4-Cohort 1: at days 0, 1, 14, 28; Cohort 2: at days 0, 1, 14, 28, 84.

    Outcome Measure Data

    Analysis Population Description
    Infants who received the correct dose and were evaluated for PK at the designated timepoints.
    Arm/Group Title Dose Group 1 Dose Group 2 Dose Group 3 Dose Group 4, Cohort 1 Dose Group 4, Cohort 2
    Arm/Group Description Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. VRC01: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh
    Measure Participants 12 13 13 9 9
    Median (Full Range) [mcg*d/mL]
    2672
    4435
    6654
    9825
    8639
    6. Primary Outcome
    Title Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Group 5
    Description The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-84 days (area-under-the-curve from 0 to 84 days) were determined using the linear trapezoidal rule. Median and range were summarized. The data collection is complete but data for Dose Group 5 are not available yet due to delays caused by export permits and by COVID-19. The results will be added when available, before December 2022.
    Time Frame Dose Group 5 - Cohort 1: at days 0, 1, 3, 7, 14, 28; Cohort 2: at days 0, 1, 3, 7, 14, 28, 84.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    7. Primary Outcome
    Title Pharmacokinetics (PK) Parameter: Concentration for Dose Groups 1, 2, 3 and 4
    Description The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C28 days (concentration at 28 days) for Dose Groups 1, 2 and 3 and C84 days for Dose Group 4.
    Time Frame Dose Groups (DG) 1, 2: at days 0, 1, 3, 7, 14, 28; DG 3: at days 0, 1, 14, 28, weeks 16, 20, 24; DG 4-Cohort 1: at days 0, 1, 14, 28; Cohort 2: at days 0, 1, 14, 28, 84.

    Outcome Measure Data

    Analysis Population Description
    Infants who received the correct dose and were evaluated for PK at the designated timepoints.
    Arm/Group Title Dose Group 1 Dose Group 2 Dose Group 3 Dose Group 4, Cohort 1 Dose Group 4, Cohort 2
    Arm/Group Description Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. VRC01: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh
    Measure Participants 12 13 13 9 9
    Median (Full Range) [mcg/mL]
    39.19
    75.25
    124.24
    44.64
    49.60
    8. Primary Outcome
    Title Pharmacokinetics (PK) Parameter: Concentration for Dose Group 5
    Description The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C84 days (concentration at 84 days). The data collection is complete but data for Dose Group 5 are not available yet due to delays caused by export permits and by COVID-19. The results will be added when available, before December 2022.
    Time Frame Dose Group 5 - Cohort 1: at days 0, 1, 3, 7, 14, 28; Cohort 2: at days 0, 1, 3, 7, 14, 28, 84.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    9. Secondary Outcome
    Title Percentage of Participants Who Died After Last Immunization for Dose Groups 1, 2, 3 and 4
    Description The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here. Study is ongoing. Some participants in Dose group 5 are still in follow-up (post-PCD). The data for Dose Group 5 will be added at end of study follow up in a separate outcome measure.
    Time Frame From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Group 3 and 4).

    Outcome Measure Data

    Analysis Population Description
    All infants enrolled in these Dose Groups.
    Arm/Group Title Dose Group 1 Dose Group 2 Dose Group 3 Dose Group 4, Cohort 1 Dose Group 4, Cohort 2
    Arm/Group Description Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. VRC01: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh
    Measure Participants 13 14 13 10 11
    Number (90% Confidence Interval) [percentage of participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    10. Secondary Outcome
    Title Percentage of Participants Who Died After Last Immunization for Dose Group 5
    Description The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Study is ongoing. Some participants in Dose Group 5 are still in follow-up (post-PCD). The data for Dose Group 5 will be added at end of study follow up. Data collection for all other arms is complete and reported separately.
    Time Frame From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    11. Secondary Outcome
    Title Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Groups 1, 2, 3 and 4
    Description The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here. Study is ongoing. Some participants in Dose group 5 are still in follow-up (post-PCD). The data for Dose Group 5 will be added at end of study follow up in a separate outcome measure.
    Time Frame From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).

    Outcome Measure Data

    Analysis Population Description
    All infants enrolled in these Dose Groups.
    Arm/Group Title Dose Group 1 Dose Group 2 Dose Group 3 Dose Group 4, Cohort 1 Dose Group 4, Cohort 2
    Arm/Group Description Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. VRC01: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh
    Measure Participants 13 14 13 10 11
    Number (90% Confidence Interval) [percentage of participants]
    23
    176.9%
    0
    0%
    0
    0%
    20
    200%
    18
    163.6%
    12. Secondary Outcome
    Title Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Group 5
    Description The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Study is ongoing. Some participants in Dose Group 5 are still in follow-up (post-PCD). The data for Dose Group 5 will be added at end of study follow up. Data collection for all other arms is complete and reported separately.
    Time Frame From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    13. Secondary Outcome
    Title Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Groups 1, 2, 3, and 4
    Description The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here. Study is ongoing. Some participants in Dose group 5 are still in follow-up (post-PCD). The data for Dose Group 5 will be added at end of study follow up in a separate outcome measure.
    Time Frame From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).

    Outcome Measure Data

    Analysis Population Description
    All infants enrolled in these Dose Groups.
    Arm/Group Title Dose Group 1 Dose Group 2 Dose Group 3 Dose Group 4, Cohort 1 Dose Group 4, Cohort 2
    Arm/Group Description Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. VRC01: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh
    Measure Participants 13 14 13 10 11
    Number (90% Confidence Interval) [percentage of participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    14. Secondary Outcome
    Title Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Group 5
    Description The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Study is ongoing. Some participants in Dose group 5 are still in follow-up (post-PCD). The data for Dose Group 5 will be added at end of study follow up. Data collection for all other arms is complete and reported separately.
    Time Frame From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    15. Secondary Outcome
    Title Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Groups 1, 2, 3, and 4
    Description The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here. Study is ongoing. Some participants in Dose group 5 are still in follow-up (post-PCD). The data for Dose Group 5 will be added at end of study follow up in a separate outcome measure.
    Time Frame From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).

    Outcome Measure Data

    Analysis Population Description
    All infants enrolled in these Dose Groups.
    Arm/Group Title Dose Group 1 Dose Group 2 Dose Group 3 Dose Group 4, Cohort 1 Dose Group 4, Cohort 2
    Arm/Group Description Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. VRC01: Administered by subcutaneous injection in the thigh Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh
    Measure Participants 13 14 10 11 11
    Number (90% Confidence Interval) [percentage of participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    16. Secondary Outcome
    Title Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Group 5
    Description The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Study is ongoing. Some participants are still in follow-up (post-PCD). The data for Dose Group 5 will be added at end of study follow up. Data collection for all other arms is complete and reported separately.
    Time Frame From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    17. Secondary Outcome
    Title Number of Participants Who Developed Anti-VRC Antibodies
    Description The Overall Number of Participants Analyzed represents infants who developed anti antibodies to the study products. For Dose Groups 1, 2, and 3, these are anti-VRC01 antibodies. For Dose Group 4, these are anti-VCR07 antibodies and for Dose Group 5, these are anti-VRC07-523LS antibodies. These assays will be run at the end of the study.
    Time Frame At weeks 24 and 48.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5. Study is ongoing. Some participants are still in follow-up (post-PCD). AE summaries will be updated at end of study follow up.
    Adverse Event Reporting Description Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
    Arm/Group Title Dose Group 1 Dose Group 2 Dose Group 3 Dose Group 4, Cohort 1 Dose Group 4, Cohort 2 Dose Group 5, Cohort 1 Dose Group 5, Cohort 2
    Arm/Group Description Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth. Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
    All Cause Mortality
    Dose Group 1 Dose Group 2 Dose Group 3 Dose Group 4, Cohort 1 Dose Group 4, Cohort 2 Dose Group 5, Cohort 1 Dose Group 5, Cohort 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Serious Adverse Events
    Dose Group 1 Dose Group 2 Dose Group 3 Dose Group 4, Cohort 1 Dose Group 4, Cohort 2 Dose Group 5, Cohort 1 Dose Group 5, Cohort 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/13 (30.8%) 1/14 (7.1%) 0/13 (0%) 2/10 (20%) 0/11 (0%) 6/11 (54.5%) 1/11 (9.1%)
    Blood and lymphatic system disorders
    Neutropenia 2/13 (15.4%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Congenital, familial and genetic disorders
    ABO haemolytic disease of newborn 0/13 (0%) 0/14 (0%) 0/13 (0%) 1/10 (10%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Gastrointestinal disorders
    Abdominal distension 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Infantile spitting up 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 2/11 (18.2%) 0/11 (0%)
    Vomiting 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Infections and infestations
    Bronchiolitis 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 1/10 (10%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Pneumonia bacterial 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Pneumonia parainfluenzae viral 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Respiratory syncytial virus bronchiolitis 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Sepsis neonatal 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 1/11 (9.1%)
    Investigations
    Weight decreased 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Other (Not Including Serious) Adverse Events
    Dose Group 1 Dose Group 2 Dose Group 3 Dose Group 4, Cohort 1 Dose Group 4, Cohort 2 Dose Group 5, Cohort 1 Dose Group 5, Cohort 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 13/13 (100%) 13/14 (92.9%) 13/13 (100%) 9/10 (90%) 11/11 (100%) 11/11 (100%) 10/11 (90.9%)
    Blood and lymphatic system disorders
    Anaemia 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Iron deficiency anaemia 0/13 (0%) 0/14 (0%) 2/13 (15.4%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Lymphadenopathy 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Neutropenia neonatal 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Cardiac disorders
    Neonatal tachycardia 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Congenital, familial and genetic disorders
    Atrial septal defect 1/13 (7.7%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Congenital pigmentation disorder 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 1/11 (9.1%) 0/11 (0%) 0/11 (0%)
    Congenital umbilical hernia 1/13 (7.7%) 3/14 (21.4%) 5/13 (38.5%) 1/10 (10%) 0/11 (0%) 0/11 (0%) 4/11 (36.4%)
    Naevus flammeus 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Phimosis 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Pulmonary artery stenosis congenital 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 1/11 (9.1%) 0/11 (0%) 0/11 (0%)
    Sickle cell trait 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Strabismus congenital 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Eye disorders
    Dacryostenosis acquired 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Eye discharge 3/13 (23.1%) 4/14 (28.6%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 1/11 (9.1%)
    Lacrimation increased 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Ocular hyperaemia 2/13 (15.4%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Periorbital oedema 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Gastrointestinal disorders
    Abdominal pain 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Coating in mouth 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Constipation 2/13 (15.4%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Diarrhoea 3/13 (23.1%) 4/14 (28.6%) 2/13 (15.4%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Eructation 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Flatulence 2/13 (15.4%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Frequent bowel movements 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Functional gastrointestinal disorder 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Gastrointestinal sounds abnormal 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Gastrooesophageal reflux disease 2/13 (15.4%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Infantile colic 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Infantile spitting up 1/13 (7.7%) 1/14 (7.1%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Infantile vomiting 1/13 (7.7%) 1/14 (7.1%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Regurgitation 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Umbilical hernia 2/13 (15.4%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Vomiting 1/13 (7.7%) 2/14 (14.3%) 2/13 (15.4%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    General disorders
    Crying 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Drug withdrawal syndrome neonatal 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Generalised oedema 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Peripheral swelling 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Pyrexia 6/13 (46.2%) 2/14 (14.3%) 1/13 (7.7%) 1/10 (10%) 0/11 (0%) 2/11 (18.2%) 0/11 (0%)
    Vessel puncture site bruise 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 1/11 (9.1%) 0/11 (0%) 0/11 (0%)
    Withdrawal syndrome 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Hepatobiliary disorders
    Hepatomegaly 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Ocular icterus 0/13 (0%) 0/14 (0%) 0/13 (0%) 1/10 (10%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Infections and infestations
    Acarodermatitis 0/13 (0%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Body tinea 2/13 (15.4%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Bronchiolitis 2/13 (15.4%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Candida nappy rash 2/13 (15.4%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Cellulitis 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Conjunctivitis 2/13 (15.4%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 1/11 (9.1%)
    Gastroenteritis 0/13 (0%) 2/14 (14.3%) 2/13 (15.4%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Gastroenteritis viral 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Gastrointestinal viral infection 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Neonatal candida infection 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 1/11 (9.1%)
    Ophthalmia neonatorum 0/13 (0%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Oral candidiasis 3/13 (23.1%) 2/14 (14.3%) 1/13 (7.7%) 3/10 (30%) 0/11 (0%) 2/11 (18.2%) 3/11 (27.3%)
    Otitis media 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Otitis media acute 2/13 (15.4%) 1/14 (7.1%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Pharyngitis 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Pneumonia bacterial 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Pustule 0/13 (0%) 0/14 (0%) 0/13 (0%) 1/10 (10%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Respiratory tract infection bacterial 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Septic rash 0/13 (0%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Septic shock 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Tinea capitis 0/13 (0%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Upper respiratory tract infection 1/13 (7.7%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Varicella 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Viral infection 1/13 (7.7%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Viral upper respiratory tract infection 1/13 (7.7%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Injury, poisoning and procedural complications
    Exposure to communicable disease 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Eyelid abrasion 0/13 (0%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Procedural pain 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Investigations
    Alanine aminotransferase increased 0/13 (0%) 0/14 (0%) 1/13 (7.7%) 2/10 (20%) 0/11 (0%) 0/11 (0%) 1/11 (9.1%)
    Aspartate aminotransferase increased 3/13 (23.1%) 3/14 (21.4%) 0/13 (0%) 4/10 (40%) 0/11 (0%) 4/11 (36.4%) 2/11 (18.2%)
    Blood albumin decreased 3/13 (23.1%) 2/14 (14.3%) 1/13 (7.7%) 1/10 (10%) 0/11 (0%) 1/11 (9.1%) 2/11 (18.2%)
    Blood alkaline phosphatase increased 0/13 (0%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 2/11 (18.2%)
    Blood bicarbonate 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Blood bicarbonate decreased 4/13 (30.8%) 5/14 (35.7%) 0/13 (0%) 1/10 (10%) 0/11 (0%) 3/11 (27.3%) 0/11 (0%)
    Blood bilirubin increased 2/13 (15.4%) 1/14 (7.1%) 3/13 (23.1%) 3/10 (30%) 2/11 (18.2%) 0/11 (0%) 0/11 (0%)
    Blood calcium increased 3/13 (23.1%) 4/14 (28.6%) 0/13 (0%) 2/10 (20%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Blood creatinine increased 2/13 (15.4%) 3/14 (21.4%) 2/13 (15.4%) 1/10 (10%) 2/11 (18.2%) 1/11 (9.1%) 1/11 (9.1%)
    Blood glucose decreased 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 1/10 (10%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Blood lactate dehydrogenase increased 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Blood potassium increased 5/13 (38.5%) 6/14 (42.9%) 0/13 (0%) 2/10 (20%) 0/11 (0%) 3/11 (27.3%) 0/11 (0%)
    Blood sodium decreased 3/13 (23.1%) 5/14 (35.7%) 0/13 (0%) 1/10 (10%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Breath sounds abnormal 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    C-reactive protein increased 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Capillary nail refill test abnormal 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Carbon dioxide decreased 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Cardiac murmur 0/13 (0%) 3/14 (21.4%) 1/13 (7.7%) 1/10 (10%) 1/11 (9.1%) 1/11 (9.1%) 0/11 (0%)
    Faecal volume decreased 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Haemoglobin decreased 3/13 (23.1%) 3/14 (21.4%) 11/13 (84.6%) 7/10 (70%) 11/11 (100%) 6/11 (54.5%) 6/11 (54.5%)
    Liver palpable 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Neutrophil count decreased 4/13 (30.8%) 3/14 (21.4%) 6/13 (46.2%) 4/10 (40%) 7/11 (63.6%) 2/11 (18.2%) 1/11 (9.1%)
    Platelet count decreased 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 1/11 (9.1%)
    Urine output decreased 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Weight decreased 1/13 (7.7%) 2/14 (14.3%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 2/13 (15.4%) 0/14 (0%) 2/13 (15.4%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Dehydration 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Failure to thrive 0/13 (0%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Feeding disorder 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Hypoglycaemia neonatal 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Hypophagia 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Poor feeding infant 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 1/11 (9.1%)
    Musculoskeletal and connective tissue disorders
    Acquired plagiocephaly 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Growth failure 0/13 (0%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Nervous system disorders
    Agitation neonatal 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 1/10 (10%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Fontanelle bulging 0/13 (0%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Infant irritability 2/13 (15.4%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Somnolence 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Tremor 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Tremor neonatal 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Pregnancy, puerperium and perinatal conditions
    Caput succedaneum 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Jaundice neonatal 0/13 (0%) 1/14 (7.1%) 2/13 (15.4%) 2/10 (20%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Neonatal disorder 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Poor weight gain neonatal 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Umbilical granuloma 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Weight decrease neonatal 0/13 (0%) 0/14 (0%) 2/13 (15.4%) 1/10 (10%) 4/11 (36.4%) 0/11 (0%) 4/11 (36.4%)
    Psychiatric disorders
    Insomnia 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Irritability 0/13 (0%) 0/14 (0%) 2/13 (15.4%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Mental status changes 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Selective eating disorder 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Renal and urinary disorders
    Polyuria 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Reproductive system and breast disorders
    Galactorrhoea 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Genital macule 0/13 (0%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Genital swelling 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Gynaecomastia 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Penile rash 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Perineal erythema 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Scrotal dermatitis 0/13 (0%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Vulvovaginal erythema 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Vulvovaginal rash 0/13 (0%) 0/14 (0%) 2/13 (15.4%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Cough 8/13 (61.5%) 3/14 (21.4%) 9/13 (69.2%) 0/10 (0%) 3/11 (27.3%) 1/11 (9.1%) 1/11 (9.1%)
    Dyspnoea 3/13 (23.1%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Grunting 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 1/11 (9.1%)
    Hypoxia 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 1/10 (10%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Irregular breathing 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Nasal congestion 7/13 (53.8%) 8/14 (57.1%) 6/13 (46.2%) 1/10 (10%) 2/11 (18.2%) 1/11 (9.1%) 3/11 (27.3%)
    Oropharyngeal plaque 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Pneumonitis 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Pneumothorax 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Productive cough 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Rales 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Respiratory distress 0/13 (0%) 0/14 (0%) 0/13 (0%) 1/10 (10%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Respiratory tract congestion 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Rhinorrhoea 3/13 (23.1%) 2/14 (14.3%) 4/13 (30.8%) 0/10 (0%) 2/11 (18.2%) 0/11 (0%) 0/11 (0%)
    Rhonchi 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 1/10 (10%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Sneezing 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Stridor 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Tachypnoea 2/13 (15.4%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Use of accessory respiratory muscles 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Wheezing 3/13 (23.1%) 0/14 (0%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Skin and subcutaneous tissue disorders
    Dermatitis atopic 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Dermatitis diaper 1/13 (7.7%) 2/14 (14.3%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Dry skin 3/13 (23.1%) 0/14 (0%) 0/13 (0%) 1/10 (10%) 0/11 (0%) 0/11 (0%) 1/11 (9.1%)
    Eczema 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Eczema infantile 1/13 (7.7%) 2/14 (14.3%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Erythema 2/13 (15.4%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 1/11 (9.1%) 0/11 (0%) 0/11 (0%)
    Erythema toxicum neonatorum 2/13 (15.4%) 1/14 (7.1%) 1/13 (7.7%) 2/10 (20%) 0/11 (0%) 1/11 (9.1%) 1/11 (9.1%)
    Exfoliative rash 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Hyperhidrosis 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Macule 0/13 (0%) 0/14 (0%) 1/13 (7.7%) 2/10 (20%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Milia 0/13 (0%) 0/14 (0%) 0/13 (0%) 1/10 (10%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Miliaria 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Papule 0/13 (0%) 0/14 (0%) 1/13 (7.7%) 1/10 (10%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Pruritus 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Rash 4/13 (30.8%) 1/14 (7.1%) 6/13 (46.2%) 0/10 (0%) 2/11 (18.2%) 0/11 (0%) 0/11 (0%)
    Rash maculo-papular 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Rash neonatal 1/13 (7.7%) 3/14 (21.4%) 2/13 (15.4%) 1/10 (10%) 4/11 (36.4%) 0/11 (0%) 2/11 (18.2%)
    Rash vesicular 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Seborrhoeic dermatitis 3/13 (23.1%) 1/14 (7.1%) 1/13 (7.7%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Skin exfoliation 1/13 (7.7%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Skin mass 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Transient neonatal pustular melanosis 0/13 (0%) 0/14 (0%) 0/13 (0%) 1/10 (10%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Umbilical haemorrhage 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 1/11 (9.1%) 0/11 (0%) 0/11 (0%)
    Urticaria 1/13 (7.7%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)
    Vascular disorders
    Hypotension 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 1/11 (9.1%) 0/11 (0%)
    Pallor 0/13 (0%) 1/14 (7.1%) 0/13 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Melissa Allen, Director, IMPAACT Operations Center
    Organization Family Health International (FHI 360)
    Phone (919) 405-1429
    Email mallen@fhi360.org
    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT02256631
    Other Study ID Numbers:
    • IMPAACT P1112
    • 11903
    First Posted:
    Oct 3, 2014
    Last Update Posted:
    Apr 22, 2022
    Last Verified:
    Apr 1, 2022