Evaluating the Safety and Serum Concentrations of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered in Multiple Doses and Routes to Healthy, HIV-uninfected Adults

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT03387150
• Collaborator: (none)
• Enrollment: 124
• Locations: 7
• Arms: 7
• Actual Duration (Months): 33.3
• Patients Per Site: 17.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected adults.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Biological: VRC07-523LS; Biological: Placebo	Phase 1

Detailed Description

This study will evaluate the safety, tolerability, and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected adults.

Participants will be randomly assigned to one of six groups. Participants in Group 1 will receive 2.5 mg/kg of VRC07-523LS by intravenous (IV) infusion at Weeks 0, 16, 32, 48, and 64. Participants in Group 2 will receive 5 mg/kg of VRC07-523LS by IV infusion at Weeks 0, 16, 32, 48, and 64. Participants in Group 3 will receive 20 mg/kg of VRC07-523LS by IV infusion at Weeks 0, 16, 32, 48, and 64. Participants in Group 4 will receive 2.5 mg/kg of VRC07-523LS by subcutaneous (SC) injection at Weeks 0, 16, 32, 48, and 64. Participants in Group 5 will receive 5 mg/kg of VRC07-523LS by SC injection at Weeks 0, 16, 32, 48, and 64. Participants in Group 6 will receive 2.5 mg/kg of VRC07-523LS or placebo by intramuscular (IM) injection at Weeks 0, 16, 32, 48, and 64.

Participants will attend numerous study visits throughout the course of the study, beginning at Week 0 through Week 112. Visits may include physical examinations, blood and urine collection, HIV testing, risk reduction counseling, and questionnaires.

Study Design

• Study Type: Interventional
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Multicenter, Randomized, Partially Blinded Phase 1 Clinical Trial to Evaluate the Safety and Serum Concentrations of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered in Multiple Doses and Routes to Healthy, HIV-uninfected Adults
• Actual Study Start Date: Feb 28, 2018
• Actual Primary Completion Date: Dec 7, 2020
• Actual Study Completion Date: Dec 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: VRC07-523LS Participants in Group 1 will receive 2.5 mg/kg of VRC07-523LS by IV infusion at Weeks 0, 16, 32, 48, and 64.	Biological: VRC07-523LS; Administered by intravenous (IV) infusion, subcutaneous (SC) injection, or intramuscular (IM) injection, depending on which group participants are in; Other Names: VRC-HIVMAB075-00-AB
Experimental: Group 2: VRC07-523LS Participants in Group 2 will receive 5 mg/kg of VRC07-523LS by IV infusion at Weeks 0, 16, 32, 48, and 64.	Biological: VRC07-523LS; Administered by intravenous (IV) infusion, subcutaneous (SC) injection, or intramuscular (IM) injection, depending on which group participants are in; Other Names: VRC-HIVMAB075-00-AB
Experimental: Group 3: VRC07-523LS Participants in Group 3 will receive 20 mg/kg of VRC07-523LS by IV infusion at Weeks 0, 16, 32, 48, and 64.	Biological: VRC07-523LS; Administered by intravenous (IV) infusion, subcutaneous (SC) injection, or intramuscular (IM) injection, depending on which group participants are in; Other Names: VRC-HIVMAB075-00-AB
Experimental: Group 4: VRC07-523LS Participants in Group 4 will receive 2.5 mg/kg of VRC07-523LS by SC injection at Weeks 0, 16, 32, 48, and 64.	Biological: VRC07-523LS; Administered by intravenous (IV) infusion, subcutaneous (SC) injection, or intramuscular (IM) injection, depending on which group participants are in; Other Names: VRC-HIVMAB075-00-AB
Experimental: Group 5: VRC07-523LS Participants in Group 5 will receive 5 mg/kg of VRC07-523LS by SC injection at Weeks 0, 16, 32, 48, and 64.	Biological: VRC07-523LS; Administered by intravenous (IV) infusion, subcutaneous (SC) injection, or intramuscular (IM) injection, depending on which group participants are in; Other Names: VRC-HIVMAB075-00-AB
Experimental: Group T6 VRC07-523LS Participants in Group T6 will receive 2.5 mg/kg of VRC07-523LS by IM injection at Weeks 0, 16, 32, 48, and 64.	Biological: VRC07-523LS; Administered by intravenous (IV) infusion, subcutaneous (SC) injection, or intramuscular (IM) injection, depending on which group participants are in; Other Names: VRC-HIVMAB075-00-AB
Placebo Comparator: Group P6: Placebo Participants in Group P6 will receive 2.5 mg/kg of placebo by IM injection at Weeks 0, 16, 32, 48, and 64.	Biological: Placebo; Sodium Chloride for Injection USP, 0.9%; administered by IM injection

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness [Measured through 3 days after each vaccine dose at Weeks 0, 16, 32, 48, 64]

   Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented

2. Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration [Measured through 3 days after each vaccine dose at Weeks 0, 16, 32, 48, 64]

   Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented

3. Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms [Measured through 3 days after each vaccine dose at Weeks 0, 16, 32, 48, 64]

   Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.

4. Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) [Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728]

   For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

5. Chemistry and Hematology Laboratory Measures - Creatinine [Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728]

   For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

6. Chemistry and Hematology Laboratory Measures - Hemoglobin [Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728]

   For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

7. Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count [Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728]

   For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

8. Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) [Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728]

   For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

9. Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). [Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728]

   The number (percentage) of participants with lab grade >= 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm

10. Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation [Measured through Month 18]

    The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

General and Demographic Criteria

• Age of 18 to 50 years

• Access to a participating clinical research site (CRS) and willingness to be followed for the planned duration of the study

• Ability and willingness to provide informed consent

• Assessment of understanding: volunteer demonstrates understanding of this study and completes a questionnaire prior to first study product administration with verbal demonstration of understanding of all questionnaire items answered incorrectly

• Agrees not to enroll in another study of an investigational research agent until completion of the last required protocol clinic visit

• Good general health as shown by medical history, physical exam, and screening laboratory tests

HIV-Related Criteria:

• Willingness to receive HIV test results

• Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.

• Assessed by the clinic staff as being at 'low risk' for HIV infection and committed to maintaining behavior consistent with those criteria through the last required protocol clinic visit (see the protocol for more information).

Laboratory Inclusion Values

Hemogram/Complete Blood Count (CBC)

• Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth, greater than or equal to 13.0 g/dL for volunteers who were assigned male sex at birth. For transgender participants who have been on hormone therapy for more than 6 consecutive months, determine hemoglobin eligibility based on the gender with which they identify (ie, a transgender female who has been on hormone therapy for more than 6 consecutive months should be assessed for eligibility using the hemoglobin parameters for volunteers assigned female sex at birth).

• White blood cell (WBC) count equal to 2,500 to 12,000 cells/mm^3

• WBC differential either within institutional normal range or with site physician approval

• Platelets equal to 125,000 to 550,000/mm^3

Chemistry

• Chemistry panel: Alanine aminotransferase (ALT) less than 1.25 times the institutional upper limit of normal and creatinine less than or equal to institutional upper limits of normal.

Virology

• Negative HIV-1 and -2 blood test: US volunteers must have a negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA). Non-US sites may use locally available assays that have been approved by HVTN and HIV Prevention Trials Network (HPTN) Laboratory Operations.

• Negative Hepatitis B surface antigen (HBsAg)

• Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive

Urine

• Negative or trace urine protein

Reproductive Status

• Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to study product administration on the day of initial study infusion/injection. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.

• Reproductive status: A volunteer who was assigned female sex at birth must:

• Agree to use effective contraception (see protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception is defined as using the following methods:

• Condoms (male or female) with or without a spermicide,

• Diaphragm or cervical cap with spermicide,

• Intrauterine device (IUD),

• Hormonal contraception, or

• Any other contraceptive method approved by the HVTN 127/HPTN 087 Protocol Safety Review Team (PSRT)

• Successful vasectomy in any partner assigned male sex at birth (considered successful if a volunteer reports that a partner assigned male sex at birth has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy);

• Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation;

• Or plan to be sexually abstinent until at least 6 months following the last study product administration.

• Volunteers who were assigned female sex at birth must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit

Exclusion Criteria:

General

• Weight greater than 115 kg

• Blood products received within 120 days before first study product administration, unless eligibility for earlier enrollment is determined by the HVTN 127/HPTN 087 PSRT

• Investigational research agents received within 30 days before first study product administration

• Intent to participate in another study of an investigational research agent or any other study that requires non-Network HIV antibody testing during the planned duration of the HVTN 127/HPTN 087 study

• Pregnant or breastfeeding

Vaccines and other Injections

• HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 127/HPTN 087 PSRT will determine eligibility on a case-by-case basis.

• Previous receipt of humanized or human mAbs, whether licensed or investigational; the HVTN 127/HPTN 087 PSRT will determine eligibility on a case-by-case basis.

• Previous receipt of monoclonal antibodies VRC01, VRC01LS, or VRC07-523LS

Immune System

• Immunosuppressive medications received within 30 days before first injection or infusion (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of oral/parenteral prednisone or equivalent at doses less than 2 mg/kg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment)

• Serious adverse reactions to VRC07-523LS formulation components, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain

• Immunoglobulin received within 90 days before first injection or infusion, unless eligibility for earlier enrollment is determined by the HVTN 127/HPTN 087 PSRT

• Autoimmune disease (Not excluded from participation: Volunteer with mild, stable and uncomplicated autoimmune disease that does not require immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate Solicited and Unsolicited adverse event (AE) assessments)

• Immunodeficiency

Clinically significant medical conditions

• Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:

• A process that would affect the immune response,

• A process that would require medication that affects the immune response,

• Any contraindication to repeated injections, infusions, or blood draws, including inability to establish venous access,

• A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period,

• A condition or process (eg, chronic urticaria or recent injection or infusion with evidence of residual inflammation) for which signs or symptoms could be confused with reactions to the study product, or

• Any condition specifically listed among the exclusion criteria.

• Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or Solicited AEs, or a volunteer's ability to give informed consent

• Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.

• Current anti-tuberculosis (TB) therapy

• Asthma other than mild or moderate, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention

Program (NAEPP) Expert Panel report). Exclude a volunteer who:

• Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or

• Uses high dose inhaled corticosteroids, or

• In the past year has had either of the following:

• Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids;

• Needed emergency care, urgent care, hospitalization, or intubation for asthma.

• Diabetes mellitus type 1 or type 2 (Not excluded: type 2 cases controlled with diet alone or a history of isolated gestational diabetes.)

• Hypertension:

• If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined as consistently less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be less than or equal to 150 mm Hg systolic and less than or equal to 100 mm Hg diastolic. For these volunteers, blood pressure must be less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic at enrollment.

• If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure greater than or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or equal to 100 mm Hg at enrollment.

• Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)

• Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study)

• Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.

• Asplenia: any condition resulting in the absence of a functional spleen

• History of hereditary angioedema, acquired angioedema, or idiopathic angioedema

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama CRS	Birmingham	Alabama	United States	35294
2	The Ponce de Leon Center CRS	Atlanta	Georgia	United States	30308-2012
3	Brigham and Women's Hospital Vaccine CRS (BWH VCRS)	Boston	Massachusetts	United States	02115-6110
4	Fenway Health (FH) CRS	Boston	Massachusetts	United States	02215-4302
5	Columbia P&S CRS	New York	New York	United States	10032-3732
6	Chapel Hill CRS	Chapel Hill	North Carolina	United States	27599
7	Lausanne Vaccine and Immunotherapy Center CRS	Lausanne	Vaud	Switzerland	1011

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: Stephen Walsh, Brigham and Women's Hospital
• Study Chair: Cynthia Gay, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 8, 2018

More Information

Publications

None provided.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT03387150
• Other Study ID Numbers: HVTN 127/HPTN 087; 38458
• First Posted: Dec 29, 2017
• Last Update Posted: Mar 21, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: HIV Infections

Study Results

Participant Flow

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Vaccine	Group 7: Placebo
Arm/Group Description	VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)	IM-0.9% Sodium Chloride wks(0,16,32,48,64)
Period Title: Overall Study
STARTED	19	19	21	21	20	21	3
Safety Population	19	19	21	21	20	21	3
COMPLETED	13	16	16	14	14	14	3
NOT COMPLETED	6	3	5	7	6	7	0

Baseline Characteristics

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Vaccine	Group 7: Placebo	Total
Arm/Group Description	VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)	IM-0.9% Sodium Chloride wks(0,16,32,48,64)	Total of all reporting groups
Overall Participants	19	19	21	21	20	21	3	124
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	30	30	23	29	27	27	31	28
Age, Customized (Count of Participants)
Less than 18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
18 - 20 years	4 21.1%	3 15.8%	4 19%	1 4.8%	0 0%	2 9.5%	0 0%	14 11.3%
21 - 30 years	6 31.6%	7 36.8%	11 52.4%	11 52.4%	17 85%	13 61.9%	1 33.3%	66 53.2%
31 - 40 years	6 31.6%	7 36.8%	4 19%	3 14.3%	3 15%	3 14.3%	2 66.7%	28 22.6%
41 - 50 years	3 15.8%	2 10.5%	2 9.5%	6 28.6%	0 0%	3 14.3%	0 0%	16 12.9%
Above 50 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	14 73.7%	8 42.1%	11 52.4%	15 71.4%	13 65%	11 52.4%	3 100%	75 60.5%
Male	5 26.3%	11 57.9%	10 47.6%	6 28.6%	7 35%	10 47.6%	0 0%	49 39.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	3 15.8%	5 23.8%	2 9.5%	0 0%	2 9.5%	0 0%	12 9.7%
Not Hispanic or Latino	19 100%	16 84.2%	16 76.2%	19 90.5%	20 100%	19 90.5%	3 100%	112 90.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
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%	1 5.3%	3 14.3%	0 0%	1 5%	1 4.8%	0 0%	6 4.8%
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	5 26.3%	4 21.1%	2 9.5%	5 23.8%	6 30%	6 28.6%	0 0%	28 22.6%
White	12 63.2%	10 52.6%	13 61.9%	10 47.6%	11 55%	12 57.1%	3 100%	71 57.3%
More than one race	2 10.5%	2 10.5%	1 4.8%	3 14.3%	2 10%	1 4.8%	0 0%	11 8.9%
Unknown or Not Reported	0 0%	2 10.5%	2 9.5%	3 14.3%	0 0%	1 4.8%	0 0%	8 6.5%
Region of Enrollment (Count of Participants)
USA	19 100%	19 100%	21 100%	21 100%	20 100%	21 100%	3 100%	124 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Description	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Time Frame	Measured through 3 days after each vaccine dose at Weeks 0, 16, 32, 48, 64

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Vaccine	Group 7: Placebo
Arm/Group Description	VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)	IM-0.9% Sodium Chloride wks(0,16,32,48,64)
Measure Participants	19	19	21	21	20	21	3
None	12 63.2%	11 57.9%	15 71.4%	8 38.1%	5 25%	7 33.3%	2 66.7%
Mild	6 31.6%	8 42.1%	5 23.8%	11 52.4%	15 75%	13 61.9%	1 33.3%
Moderate	1 5.3%	0 0%	1 4.8%	2 9.5%	0 0%	1 4.8%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

2. Primary Outcome

Title	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Description	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Time Frame	Measured through 3 days after each vaccine dose at Weeks 0, 16, 32, 48, 64

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Vaccine	Group 7: Placebo
Arm/Group Description	VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)	IM-0.9% Sodium Chloride wks(0,16,32,48,64)
Measure Participants	19	19	21	21	20	21	3
None	14 73.7%	15 78.9%	16 76.2%	7 33.3%	7 35%	19 90.5%	3 100%
Not gradable	3 15.8%	4 21.1%	3 14.3%	2 9.5%	3 15%	0 0%	0 0%
Gr 1: 2.5 - less than 5cm dim.	0 0%	0 0%	1 4.8%	2 9.5%	2 10%	0 0%	0 0%
Gr 1: 6.25 - less than 25cm^2 area	1 5.3%	0 0%	0 0%	4 19%	3 15%	2 9.5%	0 0%
Gr 2: 5 - less than 10cm dim.	0 0%	0 0%	1 4.8%	2 9.5%	5 25%	0 0%	0 0%
Gr 2: 25 - less than 100cm^2 area	1 5.3%	0 0%	0 0%	1 4.8%	0 0%	0 0%	0 0%
Gr 3: >= 10cm dim.	0 0%	0 0%	0 0%	1 4.8%	0 0%	0 0%	0 0%
Gr 3: >= 100cm^2 area	0 0%	0 0%	0 0%	2 9.5%	0 0%	0 0%	0 0%
Gr 3: complications AE	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Gr 4: complications AE	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Missing	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
None	19 100%	16 84.2%	20 95.2%	12 57.1%	12 60%	18 85.7%	3 100%
Not gradable	0 0%	3 15.8%	1 4.8%	2 9.5%	6 30%	2 9.5%	0 0%
Gr 1: 2.5 - less than 5cm dim.	0 0%	0 0%	0 0%	4 19%	0 0%	0 0%	0 0%
Gr 1: 6.25 - less than 25cm^2 area	0 0%	0 0%	0 0%	1 4.8%	0 0%	1 4.8%	0 0%
Gr 2: 5 - less than 10cm dim.	0 0%	0 0%	0 0%	0 0%	1 5%	0 0%	0 0%
Gr 2: 25 - less than 100cm^2 area	0 0%	0 0%	0 0%	1 4.8%	1 5%	0 0%	0 0%
Gr 3: >= 10cm dim.	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Gr 3: >= 100cm^2 area	0 0%	0 0%	0 0%	1 4.8%	0 0%	0 0%	0 0%
Gr 3: complications AE	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Gr 4: complications AE	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Missing	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
None	14 73.7%	15 78.9%	16 76.2%	6 28.6%	6 30%	17 81%	3 100%
Not gradable	3 15.8%	4 21.1%	3 14.3%	2 9.5%	4 20%	2 9.5%	0 0%
Gr 1: 2.5 - less than 5cm dim.	0 0%	0 0%	1 4.8%	3 14.3%	2 10%	0 0%	0 0%
Gr 1: 6.25 - less than 25cm^2 area	1 5.3%	0 0%	0 0%	4 19%	3 15%	2 9.5%	0 0%
Gr 2: 5 - less than 10cm dim.	0 0%	0 0%	1 4.8%	2 9.5%	4 20%	0 0%	0 0%
Gr 2: 25 - less than 100cm^2 area	1 5.3%	0 0%	0 0%	1 4.8%	1 5%	0 0%	0 0%
Gr 3: >= 10cm dim.	0 0%	0 0%	0 0%	1 4.8%	0 0%	0 0%	0 0%
Gr 3: >= 100cm^2 area	0 0%	0 0%	0 0%	2 9.5%	0 0%	0 0%	0 0%
Gr 3: complications AE	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Gr 4: complications AE	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Missing	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

3. Primary Outcome

Title	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Description	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.
Time Frame	Measured through 3 days after each vaccine dose at Weeks 0, 16, 32, 48, 64

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Vaccine	Group 7: Placebo
Arm/Group Description	VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)	IM-0.9% Sodium Chloride wks(0,16,32,48,64)
Measure Participants	19	19	21	21	20	21	3
None	10 52.6%	10 52.6%	7 33.3%	12 57.1%	13 65%	14 66.7%	1 33.3%
Mild	6 31.6%	5 26.3%	7 33.3%	6 28.6%	6 30%	4 19%	2 66.7%
Moderate	3 15.8%	4 21.1%	5 23.8%	3 14.3%	1 5%	3 14.3%	0 0%
Severe	0 0%	0 0%	2 9.5%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
None	18 94.7%	16 84.2%	14 66.7%	18 85.7%	17 85%	17 81%	3 100%
Mild	1 5.3%	3 15.8%	2 9.5%	2 9.5%	3 15%	4 19%	0 0%
Moderate	0 0%	0 0%	4 19%	1 4.8%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	1 4.8%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
None	13 68.4%	11 57.9%	4 19%	12 57.1%	16 80%	13 61.9%	2 66.7%
Mild	4 21.1%	6 31.6%	12 57.1%	6 28.6%	4 20%	7 33.3%	1 33.3%
Moderate	2 10.5%	2 10.5%	5 23.8%	3 14.3%	0 0%	1 4.8%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
None	15 78.9%	15 78.9%	17 81%	16 76.2%	18 90%	18 85.7%	2 66.7%
Mild	4 21.1%	2 10.5%	1 4.8%	5 23.8%	1 5%	3 14.3%	1 33.3%
Moderate	0 0%	2 10.5%	3 14.3%	0 0%	1 5%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
None	19 100%	17 89.5%	13 61.9%	20 95.2%	18 90%	20 95.2%	2 66.7%
Mild	0 0%	1 5.3%	5 23.8%	1 4.8%	2 10%	1 4.8%	1 33.3%
Moderate	0 0%	1 5.3%	3 14.3%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
None	19 100%	16 84.2%	14 66.7%	19 90.5%	19 95%	19 90.5%	3 100%
Mild	0 0%	3 15.8%	4 19%	1 4.8%	1 5%	2 9.5%	0 0%
Moderate	0 0%	0 0%	2 9.5%	1 4.8%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	1 4.8%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
None	19 100%	18 94.7%	17 81%	19 90.5%	19 95%	19 90.5%	3 100%
Mild	0 0%	1 5.3%	4 19%	2 9.5%	1 5%	2 9.5%	0 0%
Moderate	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
None	19 100%	18 94.7%	19 90.5%	21 100%	19 95%	21 100%	3 100%
Mild	0 0%	1 5.3%	2 9.5%	0 0%	1 5%	0 0%	0 0%
Moderate	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
None	19 100%	19 100%	21 100%	21 100%	20 100%	21 100%	3 100%
Mild	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Moderate	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
None	19 100%	19 100%	19 90.5%	20 95.2%	19 95%	21 100%	3 100%
Mild	0 0%	0 0%	2 9.5%	1 4.8%	1 5%	0 0%	0 0%
Moderate	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
None	19 100%	19 100%	21 100%	21 100%	19 95%	21 100%	3 100%
Mild	0 0%	0 0%	0 0%	0 0%	1 5%	0 0%	0 0%
Moderate	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
None	19 100%	19 100%	21 100%	21 100%	20 100%	21 100%	3 100%
Mild	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Moderate	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
None	8 42.1%	5 26.3%	4 19%	10 47.6%	11 55%	8 38.1%	1 33.3%
Mild	7 36.8%	9 47.4%	8 38.1%	5 23.8%	8 40%	10 47.6%	2 66.7%
Moderate	4 21.1%	5 26.3%	7 33.3%	6 28.6%	1 5%	3 14.3%	0 0%
Severe	0 0%	0 0%	2 9.5%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
None	17 89.5%	18 94.7%	18 85.7%	21 100%	20 100%	20 95.2%	3 100%
Mild	2 10.5%	1 5.3%	3 14.3%	0 0%	0 0%	0 0%	0 0%
Moderate	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.8%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

4. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
Description	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time Frame	Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728

Outcome Measure Data

Analysis Population Description

'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Vaccine	Group 7: Placebo
Arm/Group Description	VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)	IM-0.9% Sodium Chloride wks(0,16,32,48,64)
Measure Participants	19	19	21	21	20	21	3
ALT (SGPT) (U/L)- Screening	16	16	16	14	18	13	13
ALT (SGPT) (U/L)- 0/Enrollment	14	16	19	13.5	13	12	17
ALT (SGPT) (U/L)- 56	15	16	15	13	15	13	31
ALT (SGPT) (U/L)- 112	16	20	13	12	16	14	19
ALT (SGPT) (U/L)- 168	13.5	14.5	15	14	16.5	15	19
ALT (SGPT) (U/L)- 224	18	17	15.5	13	14	14.5	17
ALT (SGPT) (U/L)- 280	16	18	15	15	17	14	18
ALT (SGPT) (U/L)- 336	15	17	14.5	15	16	15	13
ALT (SGPT) (U/L)- 392	17	16	19	15	16	15	18
ALT (SGPT) (U/L)- 448	13	16.5	17.5	16	18	13	16
ALT (SGPT) (U/L)- 504	12	15	13.5	14.5	16.5	17	15
ALT (SGPT) (U/L)- 728	19	16	16	18.5	18	14	26

5. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Creatinine
Description	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time Frame	Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728

Outcome Measure Data

Analysis Population Description

'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Vaccine	Group 7: Placebo
Arm/Group Description	VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)	IM-0.9% Sodium Chloride wks(0,16,32,48,64)
Measure Participants	19	19	21	21	20	21	3
Creatinine (mg/dL)- Screening	0.85	0.92	0.84	0.79	0.84	0.86	0.74
Creatinine (mg/dL)- 0/Enrollment	0.8	0.93	0.83	0.83	0.8	0.83	0.77
Creatinine (mg/dL)- 56	0.84	0.9	0.94	0.82	0.82	0.8	0.7
Creatinine (mg/dL)- 112	0.8	0.88	0.88	0.86	0.79	0.84	0.72
Creatinine (mg/dL)- 168	0.86	0.91	0.81	0.83	0.81	0.9	0.7
Creatinine (mg/dL)- 224	0.79	0.86	0.81	0.81	0.83	0.82	0.72
Creatinine (mg/dL)- 280	0.81	0.89	0.78	0.81	0.85	0.89	0.72
Creatinine (mg/dL)- 336	0.84	0.85	0.85	0.84	0.87	0.87	0.78
Creatinine (mg/dL)- 392	0.88	0.95	0.82	0.85	0.89	0.89	0.75
Creatinine (mg/dL)- 448	0.82	0.9	0.8	0.81	0.9	0.84	0.75
Creatinine (mg/dL)- 504	0.87	0.92	0.78	0.85	0.8	0.88	0.81
Creatinine (mg/dL)- 728	1.1	1.1	0.77	0.87	0.81	0.89	0.66

6. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Hemoglobin
Description	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time Frame	Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728

Outcome Measure Data

Analysis Population Description

'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Vaccine	Group 7: Placebo
Arm/Group Description	VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)	IM-0.9% Sodium Chloride wks(0,16,32,48,64)
Measure Participants	19	19	21	21	20	21	3
Hemoglobin (g/dL)- Screening	13.3	14.2	13.8	13.1	13.8	14.4	13.4
Hemoglobin (g/dL)- 0/Enrollment	13.1	13.9	13.8	13	13.55	14.1	12.5
Hemoglobin (g/dL)- 56	13.35	14.25	13.4	12.9	13.8	14.4	12.6
Hemoglobin (g/dL)- 112	12.7	13.95	13.6	13.1	13.7	14.45	12.6
Hemoglobin (g/dL)- 168	13.7	14.1	13.65	13.25	13.5	14.5	12.8
Hemoglobin (g/dL)- 224	12.95	13.7	13.2	13.5	13.6	14.15	13.1
Hemoglobin (g/dL)- 280	13.3	13.7	13.1	13.3	13.6	14.2	13.3
Hemoglobin (g/dL)- 336	13.3	13.6	13.3	13.3	13.5	14.2	12.9
Hemoglobin (g/dL)- 392	13.3	14.2	13.5	13.4	13.5	14.3	12.6
Hemoglobin (g/dL)- 448	12.9	13.95	13.3	13.3	13.6	14.2	13
Hemoglobin (g/dL)- 504	13.25	14.35	13.4	13	13.9	14.4	12.9
Hemoglobin (g/dL)- 728	12.7	14.7	13.1	14.9	14.6	14	12.5

7. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Description	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time Frame	Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728

Outcome Measure Data

Analysis Population Description

'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Vaccine	Group 7: Placebo
Arm/Group Description	VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)	IM-0.9% Sodium Chloride wks(0,16,32,48,64)
Measure Participants	19	19	21	21	20	21	3
Neutrophils (1000/cubic mm)- Screening	3.84	3.7	3.72	3.24	3.76	2.82	3.37
Neutrophils (1000/cubic mm)- 0/Enrollment	2.95	4.01	3.92	2.98	3.31	3.16	5.82
Neutrophils (1000/cubic mm)- 56	3.12	3.83	4	2.78	3.47	3.28	7.27
Neutrophils (1000/cubic mm)- 112	3.65	3.87	3.89	3.03	3.02	3.17	5.9
Neutrophils (1000/cubic mm)- 168	3.35	3.1	3.61	3.17	3.19	2.84	6.19
Neutrophils (1000/cubic mm)- 224	2.94	3.55	3.53	2.89	3.02	2.75	4.96
Neutrophils (1000/cubic mm)- 280	2.69	3.64	3.57	3.12	3.15	2.94	5.27
Neutrophils (1000/cubic mm)- 336	3.06	3.55	4.17	3.04	3.08	2.83	6.51
Neutrophils (1000/cubic mm)- 392	3.13	3.61	3.69	2.86	3.53	2.84	6.13
Neutrophils (1000/cubic mm)- 448	3.11	3.76	3.74	3.05	2.97	3.04	6.24
Neutrophils (1000/cubic mm)- 504	3.38	3.86	3.91	2.81	3.39	3.02	6.42
Neutrophils (1000/cubic mm)- 728	4.56	4.25	4.02	2.3	2.93	3.63	4.8
Lymphocytes (1000/cubic mm)- Screening	2	1.98	2.04	1.6	1.92	1.86	3.06
Lymphocytes (1000/cubic mm)- 0/Enrollment	1.86	1.85	1.87	1.64	1.86	1.95	2.94
Lymphocytes (1000/cubic mm)- 56	1.98	1.94	1.99	1.86	2.12	1.87	2.97
Lymphocytes (1000/cubic mm)- 112	1.82	1.8	2.04	1.77	1.91	1.93	3.46
Lymphocytes (1000/cubic mm)- 168	1.76	1.8	1.86	1.61	1.97	1.89	3.27
Lymphocytes (1000/cubic mm)- 224	1.65	1.91	2.01	1.61	1.94	1.74	3.13
Lymphocytes (1000/cubic mm)- 280	1.93	1.71	1.73	1.7	2.1	1.92	2.86
Lymphocytes (1000/cubic mm)- 336	2	1.69	2.16	1.76	2.12	1.82	2.95
Lymphocytes (1000/cubic mm)- 392	1.79	1.8	2.01	1.58	1.91	1.82	2.82
Lymphocytes (1000/cubic mm)- 448	1.89	1.83	1.96	1.8	1.89	1.99	2.87
Lymphocytes (1000/cubic mm)- 504	1.92	1.89	1.84	1.79	1.94	1.76	2.96
Lymphocytes (1000/cubic mm)- 728	1.85	1.7	2.24	1.5	2.65	1.69	3.89

8. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Description	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time Frame	Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728

Outcome Measure Data

Analysis Population Description

'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Vaccine	Group 7: Placebo
Arm/Group Description	VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)	IM-0.9% Sodium Chloride wks(0,16,32,48,64)
Measure Participants	19	19	21	21	20	21	3
WBC (1000/cubic mm)- Screening	6.4	6.15	6.8	6.06	6.7	5.9	7.1
WBC (1000/cubic mm)- 0/Enrollment	6.2	6.9	6.51	5.65	6.1	5.9	9.8
WBC (1000/cubic mm)- 56	5.41	6.76	6.45	5.44	6.1	5.9	10.1
WBC (1000/cubic mm)- 112	6.23	6.39	6.67	5.4	5.85	6	9.7
WBC (1000/cubic mm)- 168	5.81	5.51	6.03	5.28	5.87	5.7	8.9
WBC (1000/cubic mm)- 224	6.5	5.93	6.35	5.3	6	5.4	8.8
WBC (1000/cubic mm)- 280	6.26	6.59	7	5.56	6.4	5.8	8.7
WBC (1000/cubic mm)- 336	5.39	6	7.04	5.43	5.76	5.49	8.8
WBC (1000/cubic mm)- 392	5.43	5.9	6.6	5.08	6.13	5.6	9.5
WBC (1000/cubic mm)- 448	5.66	6.26	6	5.45	6.7	5.7	8.6
WBC (1000/cubic mm)- 504	5.67	6.3	6.32	5.55	6.16	5.05	8.7
WBC (1000/cubic mm)- 728	7.12	6.6	7.02	4.8	6.6	6.18	9.3
Platelets (1000/cubic mm)- Screening	260	251	271	273	244.5	240.1	315
Platelets (1000/cubic mm)- 0/Enrollment	254.9	239	254	270	247	244.5	283
Platelets (1000/cubic mm)- 56	262.65	255	275.5	283	246	246	326
Platelets (1000/cubic mm)- 112	244.45	250	284.5	267	252.8	261.5	316
Platelets (1000/cubic mm)- 168	255.5	255.5	278.5	271	240.5	257	303
Platelets (1000/cubic mm)- 224	264	252	283	252	234	256.5	341
Platelets (1000/cubic mm)- 280	252.9	249	278	250	254.45	257	284.5
Platelets (1000/cubic mm)- 336	242	246	270.5	256	238.5	233	310
Platelets (1000/cubic mm)- 392	255.85	255.5	265	251	252	250	319
Platelets (1000/cubic mm)- 448	249	243.5	264	260	254.4	255	336
Platelets (1000/cubic mm)- 504	271.35	252.65	257.5	268.5	248.5	251	323
Platelets (1000/cubic mm)- 728	283.2	278	250	233	263.5	302	327

9. Primary Outcome

Title	Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
Description	The number (percentage) of participants with lab grade >= 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm
Time Frame	Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728

Outcome Measure Data

Analysis Population Description

'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Vaccine	Group 7: Placebo
Arm/Group Description	VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)	IM-0.9% Sodium Chloride wks(0,16,32,48,64)
Measure Participants	19	19	21	21	20	21	3
WBC (1000/cubic mm)- Screening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- 0/Enrollment	0 0%	1 5.3%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- 56	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- 112	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- 168	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- 224	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- 280	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- 336	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- 392	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- 448	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- 504	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- 728	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- Screening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- 0/Enrollment	0 0%	1 5.3%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- 56	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- 112	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- 168	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- 224	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- 280	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- 336	1 5.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- 392	1 5.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- 448	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- 504	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- 728	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Screening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- 0/Enrollment	1 5.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- 56	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- 112	1 5.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- 168	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- 224	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- 280	1 5.3%	0 0%	1 4.8%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- 336	1 5.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- 392	0 0%	0 0%	1 4.8%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- 448	1 5.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- 504	1 5.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- 728	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- Screening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- 0/Enrollment	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- 56	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- 112	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- 168	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- 224	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- 280	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- 336	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- 392	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- 448	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- 504	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- 728	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- Screening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- 0/Enrollment	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- 56	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- 112	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- 168	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- 224	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- 280	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- 336	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- 392	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- 448	0 0%	0 0%	0 0%	1 4.8%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- 504	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- 728	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)- Screening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)- 0/Enrollment	0 0%	0 0%	0 0%	0 0%	1 5%	1 4.8%	0 0%
ALT (SGPT) (U/L)- 56	0 0%	0 0%	2 9.5%	0 0%	0 0%	0 0%	1 33.3%
ALT (SGPT) (U/L)- 112	0 0%	0 0%	1 4.8%	0 0%	2 10%	1 4.8%	1 33.3%
ALT (SGPT) (U/L)- 168	1 5.3%	1 5.3%	1 4.8%	1 4.8%	1 5%	1 4.8%	1 33.3%
ALT (SGPT) (U/L)- 224	1 5.3%	0 0%	0 0%	0 0%	1 5%	0 0%	1 33.3%
ALT (SGPT) (U/L)- 280	1 5.3%	0 0%	0 0%	2 9.5%	1 5%	1 4.8%	0 0%
ALT (SGPT) (U/L)- 336	0 0%	0 0%	0 0%	1 4.8%	0 0%	1 4.8%	1 33.3%
ALT (SGPT) (U/L)- 392	3 15.8%	0 0%	0 0%	0 0%	0 0%	0 0%	1 33.3%
ALT (SGPT) (U/L)- 448	0 0%	0 0%	0 0%	0 0%	1 5%	0 0%	1 33.3%
ALT (SGPT) (U/L)- 504	0 0%	1 5.3%	0 0%	0 0%	0 0%	0 0%	1 33.3%
ALT (SGPT) (U/L)- 728	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Creatinine (mg/dL)- Screening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Creatinine (mg/dL)- 0/Enrollment	1 5.3%	0 0%	0 0%	1 4.8%	0 0%	0 0%	0 0%
Creatinine (mg/dL)- 56	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Creatinine (mg/dL)- 112	0 0%	0 0%	1 4.8%	1 4.8%	0 0%	0 0%	0 0%
Creatinine (mg/dL)- 168	0 0%	0 0%	0 0%	2 9.5%	0 0%	1 4.8%	0 0%
Creatinine (mg/dL)- 224	0 0%	0 0%	1 4.8%	1 4.8%	1 5%	0 0%	0 0%
Creatinine (mg/dL)- 280	0 0%	0 0%	1 4.8%	0 0%	1 5%	0 0%	0 0%
Creatinine (mg/dL)- 336	0 0%	0 0%	0 0%	2 9.5%	0 0%	0 0%	0 0%
Creatinine (mg/dL)- 392	0 0%	0 0%	0 0%	2 9.5%	3 15%	0 0%	0 0%
Creatinine (mg/dL)- 448	0 0%	0 0%	0 0%	1 4.8%	0 0%	0 0%	0 0%
Creatinine (mg/dL)- 504	0 0%	1 5.3%	0 0%	1 4.8%	0 0%	0 0%	0 0%
Creatinine (mg/dL)- 728	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

10. Primary Outcome

Title	Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Description	The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
Time Frame	Measured through Month 18

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Vaccine	Group 7: Placebo
Arm/Group Description	VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)	VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)	VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)	IM-0.9% Sodium Chloride wks(0,16,32,48,64)
Measure Participants	19	19	21	21	20	21	3
Refused study product administration	2 10.5%	0 0%	0 0%	0 0%	1 5%	1 4.8%	0 0%
Clinical event (not reacto, HIV, death)	0 0%	0 0%	1 4.8%	0 0%	0 0%	0 0%	0 0%
Unable to contact participant for visits	3 15.8%	1 5.3%	2 9.5%	2 9.5%	3 15%	3 14.3%	0 0%
Investigator decision	0 0%	1 5.3%	0 0%	0 0%	0 0%	0 0%	0 0%
Solicited adverse event symptom	0 0%	0 0%	1 4.8%	0 0%	0 0%	0 0%	0 0%
Did not discontinue SPA	14 73.7%	17 89.5%	17 81%	19 90.5%	16 80%	17 81%	3 100%

Adverse Events

Time Frame	The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) the Week 112 visit (v20.0). The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at weeks 0, 16, 32, 48 and 64).
Arm/Group Title	Group 1: Vaccine		Group 2: Vaccine		Group 3: Vaccine		Group 4: Vaccine		Group 5: Vaccine		Group 6: Vaccine		Group 7: Placebo
Arm/Group Description	VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64)		VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64)		VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64)		VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64)		VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64)		VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64)		IM-0.9% Sodium Chloride wks(0,16,32,48,64)
All Cause Mortality
	Group 1: Vaccine		Group 2: Vaccine		Group 3: Vaccine		Group 4: Vaccine		Group 5: Vaccine		Group 6: Vaccine		Group 7: Placebo
	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	0/19 (0%)		0/19 (0%)		0/21 (0%)		0/21 (0%)		0/20 (0%)		0/21 (0%)		0/3 (0%)
Serious Adverse Events
	Group 1: Vaccine		Group 2: Vaccine		Group 3: Vaccine		Group 4: Vaccine		Group 5: Vaccine		Group 6: Vaccine		Group 7: Placebo
	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	1/19 (5.3%)		1/19 (5.3%)		0/21 (0%)		1/21 (4.8%)		0/20 (0%)		0/21 (0%)		0/3 (0%)
General disorders
Any Event in SOC	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Pyrexia	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Infections and infestations
Any Event in SOC	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Staphylococcal infection	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Renal and urinary disorders
Any Event in SOC	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Calculus urinary	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Other (Not Including Serious) Adverse Events
	Group 1: Vaccine		Group 2: Vaccine		Group 3: Vaccine		Group 4: Vaccine		Group 5: Vaccine		Group 6: Vaccine		Group 7: Placebo
	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	14/19 (73.7%)		16/19 (84.2%)		14/21 (66.7%)		18/21 (85.7%)		16/20 (80%)		17/21 (81%)		3/3 (100%)
Blood and lymphatic system disorders
Any Event in SOC	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Lymphadenopathy	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Cardiac disorders
Any Event in SOC	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Mitral valve prolapse	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Endocrine disorders
Any Event in SOC	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Hypothyroidism	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Eye disorders
Any Event in SOC	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	1/3 (33.3%)	1
Eczema eyelids	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	1/3 (33.3%)	1
Eyelid rash	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Gastrointestinal disorders
Any Event in SOC	1/19 (5.3%)	1	7/19 (36.8%)	8	5/21 (23.8%)	5	2/21 (9.5%)	3	6/20 (30%)	7	3/21 (14.3%)	3	1/3 (33.3%)	1
Abdominal pain	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Abdominal pain lower	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Anal fissure	0/19 (0%)	0	1/19 (5.3%)	1	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Colitis	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Dental caries	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	2/20 (10%)	3	1/21 (4.8%)	1	0/3 (0%)	0
Diarrhoea	1/19 (5.3%)	1	1/19 (5.3%)	2	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	1/3 (33.3%)	1
Dyspepsia	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Food poisoning	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	2	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Gastritis	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Gastrooesophageal reflux disease	0/19 (0%)	0	1/19 (5.3%)	1	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Haemorrhoids	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Nausea	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Plicated tongue	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Rectal fissure	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Toothache	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Vomiting	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
General disorders
Any Event in SOC	3/19 (15.8%)	3	3/19 (15.8%)	4	1/21 (4.8%)	1	2/21 (9.5%)	3	1/20 (5%)	1	2/21 (9.5%)	2	0/3 (0%)	0
Chest discomfort	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Chest pain	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Fatigue	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Feeling hot	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Influenza like illness	2/19 (10.5%)	2	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Injection site erythema	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Injection site induration	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Injection site pruritus	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Malaise	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Non-cardiac chest pain	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Pain	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Hepatobiliary disorders
Any Event in SOC	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	2	0/21 (0%)	0	0/3 (0%)	0
Gallbladder polyp	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Hepatic steatosis	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Immune system disorders
Any Event in SOC	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Seasonal allergy	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Infections and infestations
Any Event in SOC	9/19 (47.4%)	12	10/19 (52.6%)	31	11/21 (52.4%)	27	9/21 (42.9%)	15	10/20 (50%)	14	12/21 (57.1%)	21	3/3 (100%)	9
Acute sinusitis	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	2	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Anorectal human papilloma virus infection	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Bacterial vulvovaginitis	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Bronchitis	0/19 (0%)	0	1/19 (5.3%)	1	2/21 (9.5%)	2	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
COVID-19	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Cellulitis	1/19 (5.3%)	1	1/19 (5.3%)	2	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Conjunctivitis	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Conjunctivitis bacterial	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Conjunctivitis viral	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Cystitis	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Diarrhoea infectious	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	2	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Epstein-Barr virus infection	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Fungal infection	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	1/3 (33.3%)	1
Gastroenteritis	2/19 (10.5%)	2	2/19 (10.5%)	2	2/21 (9.5%)	2	1/21 (4.8%)	1	1/20 (5%)	1	1/21 (4.8%)	1	1/3 (33.3%)	1
Gastroenteritis viral	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Helicobacter infection	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Impetigo	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	1/3 (33.3%)	2
Infectious mononucleosis	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Influenza	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Nasopharyngitis	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Otitis media	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Paronychia	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Pharyngitis	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Pharyngitis streptococcal	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	2/20 (10%)	2	0/21 (0%)	0	0/3 (0%)	0
Pilonidal cyst	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Pyuria	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Respiratory tract infection	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Sinusitis	2/19 (10.5%)	2	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	1/3 (33.3%)	1
Suspected COVID-19	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Tinea cruris	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Tinea infection	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Upper respiratory tract infection	1/19 (5.3%)	2	5/19 (26.3%)	9	7/21 (33.3%)	10	3/21 (14.3%)	4	4/20 (20%)	5	6/21 (28.6%)	7	3/3 (100%)	4
Urinary tract infection	0/19 (0%)	0	2/19 (10.5%)	5	0/21 (0%)	0	1/21 (4.8%)	1	1/20 (5%)	1	1/21 (4.8%)	1	0/3 (0%)	0
Viral infection	0/19 (0%)	0	2/19 (10.5%)	2	3/21 (14.3%)	7	0/21 (0%)	0	0/20 (0%)	0	3/21 (14.3%)	3	0/3 (0%)	0
Viral pharyngitis	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Viral upper respiratory tract infection	1/19 (5.3%)	1	2/19 (10.5%)	2	2/21 (9.5%)	2	0/21 (0%)	0	0/20 (0%)	0	3/21 (14.3%)	3	0/3 (0%)	0
Vulvovaginal candidiasis	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Vulvovaginal mycotic infection	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	3	0/3 (0%)	0
Injury, poisoning and procedural complications
Any Event in SOC	3/19 (15.8%)	4	4/19 (21.1%)	4	4/21 (19%)	7	4/21 (19%)	6	4/20 (20%)	4	4/21 (19%)	4	0/3 (0%)	0
Animal bite	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Burns second degree	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Concussion	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Corneal abrasion	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Fibula fracture	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Foot fracture	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Infusion related reaction	0/19 (0%)	0	0/19 (0%)	0	3/21 (14.3%)	3	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Joint dislocation	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Joint injury	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Ligament rupture	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	2/21 (9.5%)	2	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Ligament sprain	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	1/20 (5%)	1	3/21 (14.3%)	3	0/3 (0%)	0
Lip injury	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Post-traumatic pain	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Procedural pain	1/19 (5.3%)	1	1/19 (5.3%)	1	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Skin abrasion	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Skin laceration	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Sunburn	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Tendon rupture	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Tibia fracture	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Wrist fracture	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Investigations
Any Event in SOC	4/19 (21.1%)	7	3/19 (15.8%)	5	8/21 (38.1%)	15	9/21 (42.9%)	19	5/20 (25%)	11	5/21 (23.8%)	7	2/3 (66.7%)	6
Alanine aminotransferase abnormal	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Alanine aminotransferase increased	3/19 (15.8%)	5	1/19 (5.3%)	2	3/21 (14.3%)	4	3/21 (14.3%)	4	2/20 (10%)	4	2/21 (9.5%)	3	2/3 (66.7%)	3
Aspartate aminotransferase increased	0/19 (0%)	0	0/19 (0%)	0	2/21 (9.5%)	2	1/21 (4.8%)	1	1/20 (5%)	1	0/21 (0%)	0	1/3 (33.3%)	1
Blood creatine phosphokinase increased	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	1/3 (33.3%)	1
Blood creatinine increased	0/19 (0%)	0	1/19 (5.3%)	1	3/21 (14.3%)	3	5/21 (23.8%)	8	3/20 (15%)	4	1/21 (4.8%)	1	0/3 (0%)	0
Blood glucose increased	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Blood pressure increased	1/19 (5.3%)	1	1/19 (5.3%)	2	2/21 (9.5%)	3	1/21 (4.8%)	4	1/20 (5%)	1	2/21 (9.5%)	2	0/3 (0%)	0
Haemoglobin decreased	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	2	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Lymphocyte count decreased	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Neutrophil count decreased	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Platelet count decreased	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Red blood cells urine positive	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Smear cervix abnormal	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	1/3 (33.3%)	1
Metabolism and nutrition disorders
Any Event in SOC	0/19 (0%)	0	2/19 (10.5%)	2	1/21 (4.8%)	1	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Iron deficiency	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Vitamin D deficiency	0/19 (0%)	0	2/19 (10.5%)	2	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Musculoskeletal and connective tissue disorders
Any Event in SOC	1/19 (5.3%)	1	4/19 (21.1%)	6	1/21 (4.8%)	1	6/21 (28.6%)	9	4/20 (20%)	6	2/21 (9.5%)	2	2/3 (66.7%)	2
Arthralgia	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Back pain	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	1/21 (4.8%)	1	2/20 (10%)	3	0/21 (0%)	0	0/3 (0%)	0
Bursitis	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	1/3 (33.3%)	1
Coccydynia	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	1/3 (33.3%)	1
Costochondritis	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Joint stiffness	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Muscle spasms	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Muscle tightness	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Musculoskeletal chest pain	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Myalgia	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Neck pain	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Pain in extremity	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	2/21 (9.5%)	2	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Pain in jaw	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Rotator cuff syndrome	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Spinal osteoarthritis	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Synovial cyst	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Temporomandibular joint syndrome	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Tendonitis	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Tenosynovitis stenosans	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any Event in SOC	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Osteochondroma	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Nervous system disorders
Any Event in SOC	2/19 (10.5%)	2	2/19 (10.5%)	2	2/21 (9.5%)	2	1/21 (4.8%)	1	3/20 (15%)	4	2/21 (9.5%)	2	0/3 (0%)	0
Dizziness	0/19 (0%)	0	2/19 (10.5%)	2	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Headache	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Hemiparesis	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Hypoaesthesia	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Nerve compression	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Nystagmus	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Paraesthesia	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Post-traumatic headache	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Presyncope	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Sciatica	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Syncope	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Psychiatric disorders
Any Event in SOC	2/19 (10.5%)	2	1/19 (5.3%)	1	1/21 (4.8%)	2	0/21 (0%)	0	1/20 (5%)	1	1/21 (4.8%)	1	0/3 (0%)	0
Adjustment disorder with depressed mood	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Anxiety	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Bruxism	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Burnout syndrome	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Depression	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Insomnia	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Renal and urinary disorders
Any Event in SOC	0/19 (0%)	0	1/19 (5.3%)	1	1/21 (4.8%)	1	2/21 (9.5%)	2	0/20 (0%)	0	1/21 (4.8%)	2	0/3 (0%)	0
Haematuria	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Nephrolithiasis	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Proteinuria	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Reproductive system and breast disorders
Any Event in SOC	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Ovarian cyst	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Respiratory, thoracic and mediastinal disorders
Any Event in SOC	1/19 (5.3%)	2	2/19 (10.5%)	2	0/21 (0%)	0	3/21 (14.3%)	3	3/20 (15%)	5	0/21 (0%)	0	0/3 (0%)	0
Cough	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	1/20 (5%)	2	0/21 (0%)	0	0/3 (0%)	0
Nasal congestion	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	2/21 (9.5%)	2	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Oropharyngeal pain	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Rhinitis allergic	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Rhinorrhoea	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Sinus congestion	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Throat irritation	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Skin and subcutaneous tissue disorders
Any Event in SOC	2/19 (10.5%)	3	4/19 (21.1%)	4	0/21 (0%)	0	4/21 (19%)	4	3/20 (15%)	3	1/21 (4.8%)	2	1/3 (33.3%)	1
Dermal cyst	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Dermatitis allergic	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Dermatitis contact	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Dry skin	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Erythema	1/19 (5.3%)	2	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Exfoliative rash	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	1/3 (33.3%)	1
Miliaria	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Night sweats	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Pityriasis rosea	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Pruritus	0/19 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	0/21 (0%)	0	0/3 (0%)	0
Rash	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Skin mass	0/19 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1	0/3 (0%)	0
Vascular disorders
Any Event in SOC	1/19 (5.3%)	1	0/19 (0%)	0	1/21 (4.8%)	1	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Hot flush	1/19 (5.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	0
Hypertension	0/19 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0	0/3 (0%)	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.