Evaluating the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC01 and VRC01LS in the Serum and Mucosa of Healthy, HIV-Uninfected Adults

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT02797171
• Collaborator: (none)
• Enrollment: 80
• Locations: 4
• Arms: 5
• Actual Duration (Months): 27.1
• Patients Per Site: 20
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This study will evaluate the safety, pharmacokinetics, and antiviral activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the serum and mucosa of healthy, HIV-uninfected adults.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Biological: VRC01; Biological: VRC01LS	Phase 1

Detailed Description

This study will evaluate two experimental human monoclonal antibodies (mAbs):

VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS). VRC01LS is designed to have a longer half-life than VRC01. The purpose of this study is to evaluate the safety, pharmacokinetics, and antiviral activity of VRC01 and VRC01LS in the serum and mucosa of healthy, HIV-uninfected adults.

This study will enroll healthy, HIV-uninfected adults into five groups. At various time points during the study, participants in Groups 1, 2, and 4 will receive intravenous (IV) infusions of VRC01, and participants in Groups 3 and 5 will receive IV infusions of VRC01LS. Participants in Groups 1, 2, and 3 will attend 13 to 14 study visits over about 1 to 1 ½ years; participants in Groups 4 and 5 will attend 7 to 9 study visits over about 6 months to 1 year. At certain time points, study visits will include physical examinations, blood collection, urine collection, and interviews and questionnaires. At other time points, depending on group assignment and gender, visits will also include collection of cervicovaginal secretions, rectal secretions, and semen; and cervical, vaginal, and rectal biopsies.

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the Serum and Mucosa of Healthy, HIV-Uninfected Adult Participants
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: Jun 5, 2019
• Actual Study Completion Date: Jun 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Participants will receive 10 mg/kg of VRC01 at Months 0, 2, 4, and 6.	Biological: VRC01; Administered by intravenous (IV) infusion; Other Names: VRC-HIVMAB060-00-AB
Experimental: Group 2 Participants will receive 30 mg/kg of VRC01 at Months 0, 2, 4, and 6.	Biological: VRC01; Administered by intravenous (IV) infusion; Other Names: VRC-HIVMAB060-00-AB
Experimental: Group 3 Participants will receive 30 mg/kg of VRC01LS at Months 0, 3, and 6.	Biological: VRC01LS; Administered by intravenous (IV) infusion; Other Names: VRC-HIVMAB080-00-AB
Experimental: Group 4 Participants will receive 30 mg/kg of VRC01 at Month 0.	Biological: VRC01; Administered by intravenous (IV) infusion; Other Names: VRC-HIVMAB060-00-AB
Experimental: Group 5 Participants will receive 30 mg/kg of VRC01LS at Month 0.	Biological: VRC01LS; Administered by intravenous (IV) infusion; Other Names: VRC-HIVMAB080-00-AB

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reporting Local Reactogenicity Signs and Symptoms [Measured through 3 days after each infusion at months 0, 2, 3, 4 or 6 (infusion visits depending on which group participants are in)]

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

2. Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms [Measured through 3 days after each infusion at months 0, 2, 3, 4 or 6 (infusion visits depending on which group participants are in)]

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

3. Chemistry and Hematology Laboratory Measures [Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in)]

   alkaline phosphate (ALP) (U/L), aspartate aminotransferase (AST) (U/L), alanine aminotransferase (ALT) (U/L) (Doesn't mention about lab grade > 1 )

4. Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin [Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in)]

   Chemistry and Hematology Laboratory Measures - creatinine (g/dl), hemoglobin (g/dl)

5. Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) [Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in)]

   Chemistry and Hematology Laboratory Measures - lymphocyte count (1000/mm3), neutrophil count (1000/mm3), platelets (1000/mm3), white blood cells (WBC) (1000/mm3)

6. Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 [Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in)]

   Number of Participants with Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 for alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC).

7. Number of Participants Reporting Adverse Events (AEs) [Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)]

   For participants reporting multiple AEs over the time frame, the maximum severity is counted

8. Number of Participants Reporting Serious Adverse Events (SAEs) [Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)]

   For participants reporting multiple AEs over the time frame, the maximum severity is counted

9. Rates of Participant Discontinuation [Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)]

   Tabulated by reason for discontinuation and treatment arm

10. Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) [Measured through 6 months after the last infusion]

    Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the estimated concentration of VRC01/VRC01LS.

11. IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) [Measured through 6 months after the last infusion]

    Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total IgG levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the IgG-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total IgG concentrations (ng/mL)

12. Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4) [Measured through 6 months after the last infusion]

    Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total protein levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the protein-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total protein concentrations (ng/mL)

13. Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) [Measured through 6 months after the last infusion]

    Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the estimated concentration of VRC01/VRC01LS.

14. IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) [Measured through 6 months after the last infusion]

    Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total IgG levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the IgG-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total IgG concentrations (ng/mL)

15. Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4) [Measured through 6 months after the last infusion]

    Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total protein levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the protein-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total protein concentrations (ng/mL)

Secondary Outcome Measures

1. Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3) [Cervical biopsies collected at visits 2 and 14; Rectal biopsies collected at visits 2, 14, 15, 16, 17, 18, 19 (19 not apply for Du422.1); Vaginal biopsies collected at visits 2 and 14, 15, 16, 17. RLU measured every 3 days, during culture days 3-21.]

   Magnitudes of ex vivo HIV-1 infection were measured by the tissue luminescence assay (TLA). Susceptibility to viral infection in the ex vivo challenge assay is summarized by the area under the viral infectivity curve (AUC) based on log-transformed RLU values between 3-21 days of culture, indicated as AUCday3-21.

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

• Weight less than or equal to 115 kg

• Access to a participating HIV Vaccine Trials Network (HVTN) 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; completes a questionnaire prior to enrollment 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 study 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 [low risk guidelines are found on the protocol home page on the HVTN Members' site (https://members.hvtn.org/protocols/hvtn116)] and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit

Laboratory Inclusion Values:

Hemogram/CBC

• Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male

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

• Total lymphocyte count greater than or equal to 800 cells/mm^3

• Remaining 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), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal

Virology

• Negative HIV-1 and -2 blood test: U.S. volunteers must have a negative Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA). Non-U.S. sites may use locally available assays that have been approved by HVTN 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

• Normal urine:

• Negative urine glucose, and

• Negative or trace urine protein, and

• Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range)

Reproductive Status:

• Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to initial biopsy for groups 1-3 and prior to initial infusion for groups 4-5 on the day of enrollment. Persons who are NOT of reproductive potential due to having undergone bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.

Reproductive Status:

United States:

A volunteer who was born female must:

• Agree to consistently use effective contraception (see the 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 116 Protocol Safety Review Team (PSRT)

• Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner 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 had a bilateral oophorectomy, or tubal ligation;

• Or be sexually abstinent.

South Africa:

A volunteer who was born female must:

• Agree to consistently use effective contraception (see the 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 for participants in South Africa is defined as using 2 methods of birth control.

ONE barrier contraceptive method:

• Condoms (male or female)

• Diaphragm or cervical cap

PLUS ONE of the following methods:

• Intrauterine device (IUD),

• Hormonal contraception, or

• Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner 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

• Any other contraceptive method approved by the HVTN 116 PSRT

Or not be of reproductive potential, such as having had a bilateral oophorectomy, or tubal ligation;

Or be sexually abstinent.

• Volunteers who were born female 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

Mucosal Specimen Collection

• Volunteers 21 years of age and older who were born female: Pap smear (verified by medical records) is required within:

• the 3 years prior to enrollment with the latest result reported as normal or ASCUS (atypical squamous cells of undetermined significance), OR

• the 5 years prior to enrollment, with the latest result reported as normal, or ASCUS with no evidence of high risk HPV.

• If no Pap smear was done within the last 3 years (or within the last 5 years, if high risk HPV testing was performed), the volunteer must be willing to undergo a Pap smear with the result reported (verified by medical records) as normal or ASCUS prior to sample collection.

• Willing to have mucosal secretions and tissue biopsies collected

• Willing to abstain from sexual intercourse for the required period after each biopsy collection

Exclusion Criteria:

General

• Blood products received within 120 days before first infusion, unless eligibility for earlier enrollment is determined by the HVTN 116 PSRT

• Investigational research agents received within 30 days before first infusion

• Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 116 study

• Pregnant or breastfeeding

• Active duty U.S. military personnel with the potential of being deployed during the study

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 116 PSRT will determine eligibility on a case-by-case basis.

• Non-HIV experimental vaccine(s) received within the last 6 months in a prior vaccine trial. Exceptions may be made for some vaccines and vaccine trials. For volunteers who have received an experimental vaccine(s) less than 6 months ago, eligibility for enrollment will be determined by the HVTN 116 PSRT on a case-by-case basis.

• Live attenuated vaccines other than influenza vaccine received within 10 days before first infusion or scheduled within 10 days after first infusion (e.g., measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)

• Previous receipt of humanized or human mAbs whether licensed or investigational

Immune System

• Immunosuppressive medications received within 30 days before first infusion. (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; or [3] topical corticosteroids for mild, uncomplicated dermatitis)

• Serious adverse reactions to VRC01 and VRC01LS formulation components such as sodium citrate, sodium chloride, and L-arginine hydrochloride, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain

• Autoimmune disease (Not exclusionary: mild, well-controlled psoriasis)

• Immunodeficiency

Clinically Significant Medical Conditions

• Untreated or incompletely treated syphilis infection

• 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 infusions or blood draws, including perceived inability to establish venous access

• A condition that requires regular use of any anticoagulant medications (not including aspirin or NSAIDs),

• 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 for which signs or symptoms could be confused with reactions to study product, or

• Any condition specifically listed among the exclusion criteria below.

• 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 reactogenicity, 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) prophylaxis or therapy

• Asthma other than mild, 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 moderate/high dose inhaled corticosteroids, or

• In the past year has 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, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)

• Thyroidectomy, or thyroid disease unless well controlled (normal T3/T4/TSH) with medication

• 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 (e.g., 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

• For those undergoing rectal biopsies, a rectal condition, such as an active infection or inflammation of the colorectal area (e.g., an HSV-2 outbreak or inflamed hemorrhoids or colitis/diarrhea), internal hemorrhoids, or any other condition noted during screening rectal exam via anoscope or in medical history that in the opinion of the clinician represents a contraindication to mucosal sampling

• For those undergoing vaginal and cervical biopsies, any condition noted during pelvic exam via speculum or in medical history that in the opinion of the clinician represents a contraindication to mucosal sampling

• An active genital tract condition, such as an active infection or inflammation of the genital tract (e.g., genital sores or ulcers, penile or abnormal vaginal discharge, genital warts that are symptomatic or requiring treatment) or any other condition that in the opinion of the clinician represents a contraindication to mucosal sampling

• Hysterectomy

• Menopause

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Case Clinical Research Site	Cleveland	Ohio	United States	44106
2	Penn Prevention CRS	Philadelphia	Pennsylvania	United States	19104
3	Seattle Vaccine and Prevention CRS	Seattle	Washington	United States	98109-1024
4	Groote Schuur HIV CRS	Cape Town	Western Cape Province	South Africa	7925

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: Julie McElrath, Seattle Vaccine Trials Unit
• Study Chair: Linda-Gail Bekker, Desmond Tutu HIV Centre

Study Documents (Full-Text)

• Study Protocol - Aug 3, 2018
• Statistical Analysis Plan - Dec 17, 2019

More Information

Publications

None provided.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT02797171
• Other Study ID Numbers: HVTN 116; 20733
• First Posted: Jun 13, 2016
• Last Update Posted: Oct 8, 2021
• Last Verified: Oct 1, 2021

• 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: Pre-treatment
Arm/Group Description	VRC01 10 mg/kg mo(0,2,4,6)	VRC01 30 mg/kg mo(0,2,4,6)	VRC01LS 30 mg/kg mo(0,3,6)	VRC01 30 mg/kg mo(0)	VRC01LS 30 mg/kg mo(0)	Biopsy collected but was not randomized to any treatment group
Period Title: Overall Study
STARTED	23	23	7	16	10	1
Safety Population	23	23	7	16	10	1
COMPLETED	19	21	5	15	8	0
NOT COMPLETED	4	2	2	1	2	1

Baseline Characteristics

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Pre-treatment	Total
Arm/Group Description	VRC01 10 mg/kg mo(0,2,4,6)	VRC01 30 mg/kg mo(0,2,4,6)	VRC01LS 30 mg/kg mo(0,3,6)	VRC01 30 mg/kg mo(0)	VRC01LS 30 mg/kg mo(0)	Biopsy collected but was not randomized to any treatment group	Total of all reporting groups
Overall Participants	23	23	7	16	10	1	80
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	31	27	33	30	30	34	29
Age, Customized (Count of Participants)
Less than 18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
18 - 20 years	0 0%	0 0%	0 0%	2 12.5%	0 0%	0 0%	2 2.5%
21 - 30 years	11 47.8%	16 69.6%	3 42.9%	7 43.8%	5 50%	0 0%	42 52.5%
31 - 40 years	7 30.4%	5 21.7%	3 42.9%	7 43.8%	4 40%	1 100%	27 33.8%
41 - 50 years	5 21.7%	2 8.7%	1 14.3%	0 0%	1 10%	0 0%	9 11.3%
Above 50 years	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%
Sex: Female, Male (Count of Participants)
Female	13 56.5%	13 56.5%	3 42.9%	8 50%	6 60%	0 0%	43 53.8%
Male	10 43.5%	10 43.5%	4 57.1%	8 50%	4 40%	1 100%	37 46.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 4.3%	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.3%
Not Hispanic or Latino	22 95.7%	23 100%	7 100%	16 100%	10 100%	1 100%	79 98.8%
Unknown or Not Reported	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%
Asian	0 0%	2 8.7%	0 0%	0 0%	0 0%	0 0%	2 2.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	12 52.2%	12 52.2%	5 71.4%	4 25%	1 10%	1 100%	35 43.8%
White	9 39.1%	6 26.1%	2 28.6%	11 68.8%	8 80%	0 0%	36 45%
More than one race	1 4.3%	3 13%	0 0%	1 6.3%	1 10%	0 0%	6 7.5%
Unknown or Not Reported	1 4.3%	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.3%
Region of Enrollment (Count of Participants)
USA	13 56.5%	12 52.2%	3 42.9%	16 100%	10 100%	0 0%	54 67.5%
South Africa	10 43.5%	11 47.8%	4 57.1%	0 0%	0 0%	1 100%	26 32.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reporting Local 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 [March 2017] The maximum grade observed for each symptom over the time frame is presented.
Time Frame	Measured through 3 days after each infusion at months 0, 2, 3, 4 or 6 (infusion visits depending on which group participants are in)

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
Arm/Group Description	VRC01 10 mg/kg mo(0,2,4,6)	VRC01 30 mg/kg mo(0,2,4,6)	VRC01LS 30 mg/kg mo(0,3,6)	VRC01 30 mg/kg mo(0)	VRC01LS 30 mg/kg mo(0)
Measure Participants	23	23	7	16	10
None	19 82.6%	18 78.3%	7 100%	15 93.8%	10 100%
Mild	4 17.4%	5 21.7%	0 0%	1 6.3%	0 0%
Moderate	0 0%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%
None	19 82.6%	16 69.6%	7 100%	13 81.3%	9 90%
Mild	4 17.4%	6 26.1%	0 0%	3 18.8%	1 10%
Moderate	0 0%	1 4.3%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%
None	18 78.3%	15 65.2%	7 100%	13 81.3%	9 90%
Mild	5 21.7%	7 30.4%	0 0%	3 18.8%	1 10%
Moderate	0 0%	1 4.3%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%
None	22 95.7%	21 91.3%	7 100%	16 100%	10 100%
Mild	0 0%	2 8.7%	0 0%	0 0%	0 0%
Moderate	1 4.3%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%
None	22 95.7%	23 100%	7 100%	16 100%	10 100%
Mild	1 4.3%	0 0%	0 0%	0 0%	0 0%
Moderate	0 0%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%
None	22 95.7%	21 91.3%	7 100%	16 100%	10 100%
Mild	0 0%	2 8.7%	0 0%	0 0%	0 0%
Moderate	1 4.3%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%

2. 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 [March 2017] The maximum grade observed for each symptom over the time frame is presented.
Time Frame	Measured through 3 days after each infusion at months 0, 2, 3, 4 or 6 (infusion visits depending on which group participants are in)

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
Arm/Group Description	VRC01 10 mg/kg mo(0,2,4,6)	VRC01 30 mg/kg mo(0,2,4,6)	VRC01LS 30 mg/kg mo(0,3,6)	VRC01 30 mg/kg mo(0)	VRC01LS 30 mg/kg mo(0)
Measure Participants	23	23	7	16	10
None	14 60.9%	18 78.3%	6 85.7%	12 75%	9 90%
Mild	7 30.4%	3 13%	1 14.3%	3 18.8%	1 10%
Moderate	2 8.7%	2 8.7%	0 0%	1 6.3%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%
None	21 91.3%	19 82.6%	7 100%	15 93.8%	9 90%
Mild	2 8.7%	4 17.4%	0 0%	1 6.3%	1 10%
Moderate	0 0%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%
None	13 56.5%	17 73.9%	7 100%	15 93.8%	10 100%
Mild	9 39.1%	4 17.4%	0 0%	0 0%	0 0%
Moderate	1 4.3%	2 8.7%	0 0%	1 6.3%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%
None	20 87%	19 82.6%	5 71.4%	14 87.5%	10 100%
Mild	3 13%	4 17.4%	1 14.3%	2 12.5%	0 0%
Moderate	0 0%	0 0%	1 14.3%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%
None	22 95.7%	22 95.7%	5 71.4%	16 100%	10 100%
Mild	1 4.3%	1 4.3%	2 28.6%	0 0%	0 0%
Moderate	0 0%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%
None	21 91.3%	23 100%	7 100%	16 100%	10 100%
Mild	1 4.3%	0 0%	0 0%	0 0%	0 0%
Moderate	1 4.3%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%
None	22 95.7%	22 95.7%	7 100%	15 93.8%	10 100%
Mild	1 4.3%	1 4.3%	0 0%	1 6.3%	0 0%
Moderate	0 0%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%
None	20 87%	17 73.9%	7 100%	15 93.8%	10 100%
Mild	2 8.7%	6 26.1%	0 0%	1 6.3%	0 0%
Moderate	1 4.3%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%
None	10 43.5%	14 60.9%	3 42.9%	11 68.8%	8 80%
Mild	11 47.8%	7 30.4%	3 42.9%	4 25%	2 20%
Moderate	2 8.7%	2 8.7%	1 14.3%	1 6.3%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%
None	21 91.3%	22 95.7%	7 100%	16 100%	10 100%
Mild	2 8.7%	1 4.3%	0 0%	0 0%	0 0%
Moderate	0 0%	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%	0 0%
Potentially Life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%

3. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures
Description	alkaline phosphate (ALP) (U/L), aspartate aminotransferase (AST) (U/L), alanine aminotransferase (ALT) (U/L) (Doesn't mention about lab grade > 1 )
Time Frame	Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in)

Outcome Measure Data

Analysis Population Description

Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Pre-treatment
Arm/Group Description	VRC01 10 mg/kg mo(0,2,4,6)	VRC01 30 mg/kg mo(0,2,4,6)	VRC01LS 30 mg/kg mo(0,3,6)	VRC01 30 mg/kg mo(0)	VRC01LS 30 mg/kg mo(0)	Biopsy collected but was not randomized to any treatment group
Measure Participants	23	23	7	16	10	1
ALT (SGPT) (U/L)- Screening	16	16	17	15.5	13	33
ALT (SGPT) (U/L)- Day 1 - 15	15	15	21	13	13.5
ALT (SGPT) (U/L)- Day 57 - 71	15	16
ALT (SGPT) (U/L)- Day 99 - 113	22
ALT (SGPT) (U/L)- Day 127 - 141	15.5	18.5	13
ALT (SGPT) (U/L)- Day 169 - 183	16	15.5	17
ALT (SGPT) (U/L)- Day 252 - 267	15.5	19	25	18.5
ALT (SGPT) (U/L)- Day 442 - 456	19
AST (U/L)- Screening	20	20	22	19	15.5	32
AST (U/L)- Day 1 - 15	19	20	22	18	19.5
AST (U/L)- Day 57 - 71	18	19
AST (U/L)- Day 99 - 113	25
AST (U/L)- Day 127 - 141	19.5	21	17
AST (U/L)- Day 169 - 183	19	20.5	20
AST (U/L)- Day 252 - 267	18.5	20	19
AST (U/L)- Day 442 - 456	17
Alkaline Phosphatase (U/L)- Screening	65	61	71	52.5	55.5	97
Alkaline Phosphatase (U/L)- Day 1 - 15	65	60	69	54	60.5
Alkaline Phosphatase (U/L)- Day 57 - 71	67	67
Alkaline Phosphatase (U/L)- Day 99 - 113	72
Alkaline Phosphatase (U/L)- Day 127 - 141	68	67.5	52
Alkaline Phosphatase (U/L)- Day 169 - 183	68.5	63	79.5
Alkaline Phosphatase (U/L)- Day 252 - 267	68	59	70.5
Alkaline Phosphatase (U/L)- Day 442 - 456	70

4. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Description	Chemistry and Hematology Laboratory Measures - creatinine (g/dl), hemoglobin (g/dl)
Time Frame	Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in)

Outcome Measure Data

Analysis Population Description

Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Pre-treatment
Arm/Group Description	VRC01 10 mg/kg mo(0,2,4,6)	VRC01 30 mg/kg mo(0,2,4,6)	VRC01LS 30 mg/kg mo(0,3,6)	VRC01 30 mg/kg mo(0)	VRC01LS 30 mg/kg mo(0)	Biopsy collected but was not randomized to any treatment group
Measure Participants	23	23	7	16	10	1
Hemoglobin (g/dL)- Screening	14.5	14	13.7	14.75	13.3	14.9
Hemoglobin (g/dL)- Day 1 - 15	13.8	13.3	13.7	14	12.95
Hemoglobin (g/dL)- Day 57 - 71	14.1	14
Hemoglobin (g/dL)- Day 99 - 113	14.6
Hemoglobin (g/dL)- Day 127 - 141	13.7	13.25	14.3
Hemoglobin (g/dL)- Day 169 - 183	14	13	13.7
Hemoglobin (g/dL)- Day 252 - 267	14.05	13.4	14.25
Hemoglobin (g/dL)- Day 442 - 456	14.6
Creatinine (g/dL)- Screening	0.00073	0.00074	0.00071	0.00085	0.00074	0.00086
Creatinine (g/dL)- Day 1 - 15	0.00076	0.00076	0.00071	0.0008	0.000735
Creatinine (g/dL)- Day 57 - 71	0.00076	0.00076
Creatinine (g/dL)- Day 99 - 113	0.00078
Creatinine (g/dL)- Day 127 - 141	0.00074	0.000735	0.00081
Creatinine (g/dL)- Day 169 - 183	0.00073	0.0008	0.000765
Creatinine (g/dL)- Day 252 - 267	0.000715	0.00072	0.00077
Creatinine (g/dL)- Day 442 - 456	0.00082

5. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Description	Chemistry and Hematology Laboratory Measures - lymphocyte count (1000/mm3), neutrophil count (1000/mm3), platelets (1000/mm3), white blood cells (WBC) (1000/mm3)
Time Frame	Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in)

Outcome Measure Data

Analysis Population Description

Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Pre-treatment
Arm/Group Description	VRC01 10 mg/kg mo(0,2,4,6)	VRC01 30 mg/kg mo(0,2,4,6)	VRC01LS 30 mg/kg mo(0,3,6)	VRC01 30 mg/kg mo(0)	VRC01LS 30 mg/kg mo(0)	Biopsy collected but was not randomized to any treatment group
Measure Participants	23	23	7	16	10	1
WBC (1000/cubic mm)- Screening	6.37	7.14	8.31	5.85	6.45	9.02
WBC (1000/cubic mm)- Day 1 - 15	5.9	5.86	6.53	5.2	6.35
WBC (1000/cubic mm)- Day 57 - 71	6.21	7.26
WBC (1000/cubic mm)- Day 99 - 113	5.5
WBC (1000/cubic mm)- Day 127 - 141	6.395	6.475	5.5
WBC (1000/cubic mm)- Day 169 - 183	5.83	6.2	6.5
WBC (1000/cubic mm)- Day 252 - 267	6.21	6.92	6.45
WBC (1000/cubic mm)- Day 442 - 456	5.67
Neutrophils (1000/cubic mm)- Screening	3.709	4.185	4.958	3.494	3.4345	6.747
Neutrophils (1000/cubic mm)- Day 1 - 15	3.336	3.54	3.853	3.124	3.733
Neutrophils (1000/cubic mm)- Day 57 - 71	3.3	4
Neutrophils (1000/cubic mm)- Day 99 - 113	3.27
Neutrophils (1000/cubic mm)- Day 127 - 141	3.8025	3.4375	3.26
Neutrophils (1000/cubic mm)- Day 169 - 183	3.63	3.14	3.775
Neutrophils (1000/cubic mm)- Day 252 - 267	4.0245	3.599	3.301
Neutrophils (1000/cubic mm)- Day 442 - 456	3.02
Lymphocytes (1000/cubic mm)- Screening	2.033	2.198	2.255	1.875	2.161	1.741
Lymphocytes (1000/cubic mm)- Day 1 - 15	1.93	1.872	2.21	1.68	2.0345
Lymphocytes (1000/cubic mm)- Day 57 - 71	1.7	2.27
Lymphocytes (1000/cubic mm)- Day 99 - 113	1.743
Lymphocytes (1000/cubic mm)- Day 127 - 141	1.843	2.09	1.72
Lymphocytes (1000/cubic mm)- Day 169 - 183	1.7685	1.966	1.7765
Lymphocytes (1000/cubic mm)- Day 252 - 267	1.8045	1.95	2.251
Lymphocytes (1000/cubic mm)- Day 442 - 456	2.156
Platelets (1000/cubic mm)- Screening	256	275	281	258	270.5	334
Platelets (1000/cubic mm)- Day 1 - 15	255	274	285	258.5	278
Platelets (1000/cubic mm)- Day 57 - 71	247	285
Platelets (1000/cubic mm)- Day 99 - 113	290
Platelets (1000/cubic mm)- Day 127 - 141	258	294	274
Platelets (1000/cubic mm)- Day 169 - 183	249	261	278
Platelets (1000/cubic mm)- Day 252 - 267	253	266.5	259.5
Platelets (1000/cubic mm)- Day 442 - 456	269

6. Primary Outcome

Title	Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Description	Number of Participants with Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 for alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC).
Time Frame	Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in)

Outcome Measure Data

Analysis Population Description

Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine	Group 4: Vaccine	Group 5: Vaccine	Group 6: Pre-treatment
Arm/Group Description	VRC01 10 mg/kg mo(0,2,4,6)	VRC01 30 mg/kg mo(0,2,4,6)	VRC01LS 30 mg/kg mo(0,3,6)	VRC01 30 mg/kg mo(0)	VRC01LS 30 mg/kg mo(0)	Biopsy collected but was not randomized to any treatment group
Measure Participants	23	23	7	16	10	1
WBC (1000/cubic mm)- DayScreening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- Day 1 - 15	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- Day 57 - 71	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- Day 99 - 113	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- Day 127 - 141	0 0%	0 0%	0 0%	1 6.3%	0 0%	0 0%
WBC (1000/cubic mm)- Day 169 - 183	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- Day 252 - 267	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC (1000/cubic mm)- Day 442 - 456	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- DayScreening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- Day 1 - 15	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- Day 57 - 71	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- Day 99 - 113	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- Day 127 - 141	0 0%	0 0%	0 0%	1 6.3%	0 0%	0 0%
Neutrophils (1000/cubic mm)- Day 169 - 183	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- Day 252 - 267	1 4.3%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000/cubic mm)- Day 442 - 456	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- DayScreening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Day 1 - 15	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Day 57 - 71	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Day 99 - 113	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Day 127 - 141	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Day 169 - 183	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Day 252 - 267	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)- Day 442 - 456	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- DayScreening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- Day 1 - 15	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- Day 57 - 71	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- Day 99 - 113	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- Day 127 - 141	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- Day 169 - 183	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- Day 252 - 267	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000/cubic mm)- Day 442 - 456	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- DayScreening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- Day 1 - 15	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- Day 57 - 71	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- Day 99 - 113	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- Day 127 - 141	0 0%	0 0%	0 0%	1 6.3%	0 0%	0 0%
Platelets (1000/cubic mm)- Day 169 - 183	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- Day 252 - 267	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets (1000/cubic mm)- Day 442 - 456	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)- DayScreening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)- Day 1 - 15	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)- Day 57 - 71	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)- Day 99 - 113	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)- Day 127 - 141	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)- Day 169 - 183	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)- Day 252 - 267	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
ALT (SGPT) (U/L)- Day 442 - 456	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
AST (U/L)- DayScreening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
AST (U/L)- Day 1 - 15	0 0%	0 0%	0 0%	1 6.3%	0 0%	0 0%
AST (U/L)- Day 57 - 71	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
AST (U/L)- Day 99 - 113	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
AST (U/L)- Day 127 - 141	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
AST (U/L)- Day 169 - 183	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
AST (U/L)- Day 252 - 267	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
AST (U/L)- Day 442 - 456	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Alkaline Phosphatase (U/L)- DayScreening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Alkaline Phosphatase (U/L)- Day 1 - 15	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Alkaline Phosphatase (U/L)- Day 57 - 71	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Alkaline Phosphatase (U/L)- Day 99 - 113	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Alkaline Phosphatase (U/L)- Day 127 - 141	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Alkaline Phosphatase (U/L)- Day 169 - 183	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Alkaline Phosphatase (U/L)- Day 252 - 267	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Alkaline Phosphatase (U/L)- Day 442 - 456	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Creatinine (g/dL)- DayScreening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Creatinine (g/dL)- Day 1 - 15	1 4.3%	1 4.3%	1 14.3%	0 0%	0 0%	0 0%
Creatinine (g/dL)- Day 57 - 71	0 0%	1 4.3%	0 0%	0 0%	0 0%	0 0%
Creatinine (g/dL)- Day 99 - 113	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Creatinine (g/dL)- Day 127 - 141	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Creatinine (g/dL)- Day 169 - 183	0 0%	3 13%	0 0%	0 0%	0 0%	0 0%
Creatinine (g/dL)- Day 252 - 267	1 4.3%	1 4.3%	0 0%	0 0%	0 0%	0 0%
Creatinine (g/dL)- Day 442 - 456	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

7. Primary Outcome

Title	Number of Participants Reporting Adverse Events (AEs)
Description	For participants reporting multiple AEs over the time frame, the maximum severity is counted
Time Frame	Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)

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: Pre-treatment
Arm/Group Description	VRC01 10 mg/kg mo(0,2,4,6)	VRC01 30 mg/kg mo(0,2,4,6)	VRC01LS 30 mg/kg mo(0,3,6)	VRC01 30 mg/kg mo(0)	VRC01LS 30 mg/kg mo(0)	Biopsy collected but was not randomized to any treatment group
Measure Participants	23	23	7	16	10	1
Mild	5 21.7%	3 13%	0 0%	2 12.5%	1 10%	1 100%
Moderate	16 69.6%	11 47.8%	6 85.7%	5 31.3%	1 10%	0 0%
Severe	1 4.3%	4 17.4%	1 14.3%	0 0%	1 10%	0 0%
Potentially life-threatening	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No AE reported	1 4.3%	5 21.7%	0 0%	9 56.3%	7 70%	0 0%

8. Primary Outcome

Title	Number of Participants Reporting Serious Adverse Events (SAEs)
Description	For participants reporting multiple AEs over the time frame, the maximum severity is counted
Time Frame	Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)

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: Pre-treatment
Arm/Group Description	VRC01 10 mg/kg mo(0,2,4,6)	VRC01 30 mg/kg mo(0,2,4,6)	VRC01LS 30 mg/kg mo(0,3,6)	VRC01 30 mg/kg mo(0)	VRC01LS 30 mg/kg mo(0)	Biopsy collected but was not randomized to any treatment group
Measure Participants	23	23	7	16	10	1
SAE	0 0%	1 4.3%	1 14.3%	0 0%	1 10%	0 0%
No SAE reported	23 100%	22 95.7%	6 85.7%	16 100%	9 90%	1 100%

9. Primary Outcome

Title	Rates of Participant Discontinuation
Description	Tabulated by reason for discontinuation and treatment arm
Time Frame	Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)

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
Arm/Group Description	VRC01 10 mg/kg mo(0,2,4,6)	VRC01 30 mg/kg mo(0,2,4,6)	VRC01LS 30 mg/kg mo(0,3,6)	VRC01 30 mg/kg mo(0)	VRC01LS 30 mg/kg mo(0)
Measure Participants	23	23	7	16	10
Coenrolled with an investigational agent	1 4.3%	0 0%	0 0%	0 0%	0 0%
Terminated to donate bone marrow	0 0%	1 4.3%	0 0%	0 0%	0 0%
Refused study product administration	1 4.3%	0 0%	0 0%	0 0%	0 0%
Clinical event (not reacto, HIV, death)	1 4.3%	0 0%	1 14.3%	0 0%	0 0%
Unable to contact participant for visits	1 4.3%	0 0%	0 0%	0 0%	0 0%
Did not discontinue SPA	19 82.6%	22 95.7%	6 85.7%	16 100%	10 100%

10. Primary Outcome

Title	Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Description	Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the estimated concentration of VRC01/VRC01LS.
Time Frame	Measured through 6 months after the last infusion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Primary Outcome

Title	IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Description	Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total IgG levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the IgG-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total IgG concentrations (ng/mL)
Time Frame	Measured through 6 months after the last infusion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Primary Outcome

Title	Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Description	Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total protein levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the protein-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total protein concentrations (ng/mL)
Time Frame	Measured through 6 months after the last infusion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Primary Outcome

Title	Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Description	Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the estimated concentration of VRC01/VRC01LS.
Time Frame	Measured through 6 months after the last infusion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

14. Primary Outcome

Title	IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Description	Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total IgG levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the IgG-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total IgG concentrations (ng/mL)
Time Frame	Measured through 6 months after the last infusion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

15. Primary Outcome

Title	Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Description	Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total protein levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the protein-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total protein concentrations (ng/mL)
Time Frame	Measured through 6 months after the last infusion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

16. Secondary Outcome

Title	Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Description	Magnitudes of ex vivo HIV-1 infection were measured by the tissue luminescence assay (TLA). Susceptibility to viral infection in the ex vivo challenge assay is summarized by the area under the viral infectivity curve (AUC) based on log-transformed RLU values between 3-21 days of culture, indicated as AUCday3-21.
Time Frame	Cervical biopsies collected at visits 2 and 14; Rectal biopsies collected at visits 2, 14, 15, 16, 17, 18, 19 (19 not apply for Du422.1); Vaginal biopsies collected at visits 2 and 14, 15, 16, 17. RLU measured every 3 days, during culture days 3-21.

Outcome Measure Data

Analysis Population Description

Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.

Arm/Group Title	Group 1: Vaccine	Group 2: Vaccine	Group 3: Vaccine
Arm/Group Description	VRC01 10 mg/kg mo(0,2,4,6)	VRC01 30 mg/kg mo(0,2,4,6)	VRC01LS 30 mg/kg mo(0,3,6)
Measure Participants	23	23	7
Cervical Biopsy-Bal26-visit 2	134.61	128.69	125.66
Cervical Biopsy-Bal26-visit 14	81.74	80.03	82.33
Rectal Biopsy-1086-visit 2	149.47	151.28	145.97
Rectal Biopsy-1086-visit 14	147.95	147.69	152.22
Rectal Biopsy-1086-visit 15	150.66	148.86	145.42
Rectal Biopsy-1086-visit 16	147.24	145.82	153.31
Rectal Biopsy-1086-visit 17	147.56	148.37	148.82
Rectal Biopsy-1086-visit 18	139.29
Rectal Biopsy-1086-visit 19	148.87
Rectal Biopsy-Bal26-visit 2	142.83	139.99	140.62
Rectal Biopsy-Bal26-visit 14	93.17	97.41	90.31
Rectal Biopsy-Bal26-visit 15	136.16	117.51	89.36
Rectal Biopsy-Bal26-visit 16	136.69	135.71	92.33
Rectal Biopsy-Bal26-visit 17	138.8	140.59	129.17
Rectal Biopsy-Bal26-visit 18	115.21
Rectal Biopsy-Bal26-visit 19	106.05
Rectal Biopsy-Du422.1-visit 2	141.44	142.74	151.14
Rectal Biopsy-Du422.1-visit 14	145.48	138.99	143.46
Rectal Biopsy-Du422.1-visit 15	141.14	139.5	145.45
Rectal Biopsy-Du422.1-visit 16	143.53	142	144.16
Rectal Biopsy-Du422.1-visit 17	145.72	139.58	150.64
Rectal Biopsy-Du422.1-visit 18	130.75
Vaginal Biopsy-Bal26-visit 2	128.69	130.33	116.62
Vaginal Biopsy-Bal26-visit 14	80.78	82.89	80.88
Vaginal Biopsy-Bal26-visit 15	94.41	89.85	82.26
Vaginal Biopsy-Bal26-visit 16	128.28	104.97	82.76
Vaginal Biopsy-Bal26-visit 17	131.37	137.49

Adverse Events

Time Frame	Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
Arm/Group Title	Group 1: Vaccine		Group 2: Vaccine		Group 3: Vaccine		Group 4: Vaccine		Group 5: Vaccine		Group 6: Pre-treatment
Arm/Group Description	VRC01 10 mg/kg mo(0,2,4,6)		VRC01 30 mg/kg mo(0,2,4,6)		VRC01LS 30 mg/kg mo(0,3,6)		VRC01 30 mg/kg mo(0)		VRC01LS 30 mg/kg mo(0)		Biopsy collected but was not randomized to any treatment group
All Cause Mortality
	Group 1: Vaccine		Group 2: Vaccine		Group 3: Vaccine		Group 4: Vaccine		Group 5: Vaccine		Group 6: Pre-treatment
	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	0/23 (0%)		0/23 (0%)		0/7 (0%)		0/16 (0%)		0/10 (0%)		0/1 (0%)
Serious Adverse Events
	Group 1: Vaccine		Group 2: Vaccine		Group 3: Vaccine		Group 4: Vaccine		Group 5: Vaccine		Group 6: Pre-treatment
	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	0/23 (0%)		1/23 (4.3%)		1/7 (14.3%)		0/16 (0%)		1/10 (10%)		0/1 (0%)
Blood and lymphatic system disorders
Any Event in SOC	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Blood loss anaemia	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Infections and infestations
Any Event in SOC	0/23 (0%)	0	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	1/10 (10%)	1	0/1 (0%)	0
Appendicitis	0/23 (0%)	0	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	1/10 (10%)	1	0/1 (0%)	0
Nervous system disorders
Any Event in SOC	0/23 (0%)	0	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Transient ischaemic attack	0/23 (0%)	0	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Reproductive system and breast disorders
Any Event in SOC	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Adenomyosis	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (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: Pre-treatment
	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	22/23 (95.7%)		18/23 (78.3%)		7/7 (100%)		7/16 (43.8%)		3/10 (30%)		1/1 (100%)
Ear and labyrinth disorders
Any Event in SOC	0/23 (0%)	0	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Tinnitus	0/23 (0%)	0	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Eye disorders
Any Event in SOC	0/23 (0%)	0	0/23 (0%)	0	0/7 (0%)	0	1/16 (6.3%)	1	0/10 (0%)	0	0/1 (0%)	0
Vitreous floaters	0/23 (0%)	0	0/23 (0%)	0	0/7 (0%)	0	1/16 (6.3%)	1	0/10 (0%)	0	0/1 (0%)	0
Gastrointestinal disorders
Any Event in SOC	7/23 (30.4%)	10	6/23 (26.1%)	13	2/7 (28.6%)	6	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Abdominal pain	2/23 (8.7%)	2	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Abdominal pain upper	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Anal haemorrhage	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Anal pruritus	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Anorectal discomfort	1/23 (4.3%)	2	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Constipation	1/23 (4.3%)	1	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Dental caries	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Diarrhoea	0/23 (0%)	0	3/23 (13%)	3	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Dyschezia	0/23 (0%)	0	0/23 (0%)	0	1/7 (14.3%)	2	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Dyspepsia	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Food poisoning	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Gastritis	1/23 (4.3%)	1	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Haemorrhoids	0/23 (0%)	0	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Irritable bowel syndrome	0/23 (0%)	0	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Nausea	0/23 (0%)	0	2/23 (8.7%)	2	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Proctalgia	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Rectal haemorrhage	0/23 (0%)	0	1/23 (4.3%)	1	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Toothache	0/23 (0%)	0	2/23 (8.7%)	2	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
General disorders
Any Event in SOC	2/23 (8.7%)	3	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	1/10 (10%)	1	0/1 (0%)	0
Chest discomfort	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Fatigue	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Influenza like illness	2/23 (8.7%)	2	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Injury associated with device	0/23 (0%)	0	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	1/10 (10%)	1	0/1 (0%)	0
Infections and infestations
Any Event in SOC	16/23 (69.6%)	37	17/23 (73.9%)	31	7/7 (100%)	12	2/16 (12.5%)	2	0/10 (0%)	0	0/1 (0%)	0
Abscess limb	0/23 (0%)	0	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Acarodermatitis	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Bacterial vaginosis	2/23 (8.7%)	2	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Body tinea	0/23 (0%)	0	0/23 (0%)	0	1/7 (14.3%)	2	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Bronchitis	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Candida cervicitis	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Candida infection	0/23 (0%)	0	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Cellulitis	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Conjunctivitis	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Dysentery	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Folliculitis	1/23 (4.3%)	1	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Gastroenteritis	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Gastroenteritis norovirus	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Genitourinary chlamydia infection	1/23 (4.3%)	1	1/23 (4.3%)	1	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Gingivitis	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Haemorrhoid infection	0/23 (0%)	0	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Impetigo	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Laryngitis	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Localised infection	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Lower respiratory tract infection	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Oral herpes	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Pharyngitis	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Post procedural infection	0/23 (0%)	0	0/23 (0%)	0	0/7 (0%)	0	1/16 (6.3%)	1	0/10 (0%)	0	0/1 (0%)	0
Rhinitis	2/23 (8.7%)	2	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Sinusitis	1/23 (4.3%)	1	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Subcutaneous abscess	0/23 (0%)	0	2/23 (8.7%)	2	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Tinea capitis	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Tinea pedis	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Tinea versicolour	0/23 (0%)	0	1/23 (4.3%)	1	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Upper respiratory tract infection	9/23 (39.1%)	13	9/23 (39.1%)	15	3/7 (42.9%)	3	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Urinary tract infection	1/23 (4.3%)	1	1/23 (4.3%)	1	0/7 (0%)	0	1/16 (6.3%)	1	0/10 (0%)	0	0/1 (0%)	0
Viral upper respiratory tract infection	1/23 (4.3%)	1	3/23 (13%)	3	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Vulvovaginal candidiasis	2/23 (8.7%)	2	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Vulvovaginal mycotic infection	2/23 (8.7%)	2	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Injury, poisoning and procedural complications
Any Event in SOC	7/23 (30.4%)	8	3/23 (13%)	6	1/7 (14.3%)	1	2/16 (12.5%)	4	0/10 (0%)	0	0/1 (0%)	0
Ankle fracture	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Arthropod bite	2/23 (8.7%)	2	1/23 (4.3%)	2	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Arthropod sting	1/23 (4.3%)	1	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Infusion related reaction	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	1/16 (6.3%)	1	0/10 (0%)	0	0/1 (0%)	0
Muscle strain	0/23 (0%)	0	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Neck injury	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Procedural dizziness	0/23 (0%)	0	0/23 (0%)	0	0/7 (0%)	0	1/16 (6.3%)	3	0/10 (0%)	0	0/1 (0%)	0
Procedural nausea	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Procedural pain	0/23 (0%)	0	2/23 (8.7%)	3	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Skin laceration	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Investigations
Any Event in SOC	9/23 (39.1%)	22	10/23 (43.5%)	16	3/7 (42.9%)	8	2/16 (12.5%)	5	1/10 (10%)	1	0/1 (0%)	0
Alanine aminotransferase increased	1/23 (4.3%)	1	3/23 (13%)	3	1/7 (14.3%)	3	1/16 (6.3%)	1	1/10 (10%)	1	0/1 (0%)	0
Aspartate aminotransferase increased	1/23 (4.3%)	1	1/23 (4.3%)	1	1/7 (14.3%)	2	1/16 (6.3%)	1	0/10 (0%)	0	0/1 (0%)	0
Blood alkaline phosphatase increased	1/23 (4.3%)	1	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Blood creatinine increased	3/23 (13%)	3	5/23 (21.7%)	6	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Blood pressure increased	6/23 (26.1%)	11	3/23 (13%)	3	2/7 (28.6%)	2	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Haemoglobin decreased	2/23 (8.7%)	2	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Neutrophil count decreased	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	1/16 (6.3%)	1	0/10 (0%)	0	0/1 (0%)	0
Platelet count decreased	0/23 (0%)	0	1/23 (4.3%)	2	0/7 (0%)	0	1/16 (6.3%)	1	0/10 (0%)	0	0/1 (0%)	0
Vitamin D decreased	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
White blood cell count decreased	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	1/16 (6.3%)	1	0/10 (0%)	0	0/1 (0%)	0
Metabolism and nutrition disorders
Any Event in SOC	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Decreased appetite	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Musculoskeletal and connective tissue disorders
Any Event in SOC	6/23 (26.1%)	7	3/23 (13%)	4	3/7 (42.9%)	3	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Arthralgia	0/23 (0%)	0	2/23 (8.7%)	2	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Back pain	2/23 (8.7%)	2	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Flank pain	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Musculoskeletal pain	2/23 (8.7%)	2	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Myalgia	1/23 (4.3%)	1	1/23 (4.3%)	1	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Neck pain	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Pain in extremity	0/23 (0%)	0	0/23 (0%)	0	2/7 (28.6%)	2	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Tendonitis	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any Event in SOC	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Cystadenofibroma of fallopian tube	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Nervous system disorders
Any Event in SOC	5/23 (21.7%)	5	5/23 (21.7%)	7	1/7 (14.3%)	1	1/16 (6.3%)	1	0/10 (0%)	0	0/1 (0%)	0
Dizziness	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Headache	3/23 (13%)	3	2/23 (8.7%)	2	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Presyncope	1/23 (4.3%)	1	1/23 (4.3%)	2	1/7 (14.3%)	1	1/16 (6.3%)	1	0/10 (0%)	0	0/1 (0%)	0
Restless legs syndrome	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Tension headache	0/23 (0%)	0	2/23 (8.7%)	2	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Pregnancy, puerperium and perinatal conditions
Any Event in SOC	0/23 (0%)	0	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	1/10 (10%)	1	0/1 (0%)	0
Ectopic pregnancy	0/23 (0%)	0	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	1/10 (10%)	1	0/1 (0%)	0
Psychiatric disorders
Any Event in SOC	3/23 (13%)	3	2/23 (8.7%)	2	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Anxiety	1/23 (4.3%)	1	2/23 (8.7%)	2	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Insomnia	1/23 (4.3%)	1	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Post-traumatic stress disorder	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Renal and urinary disorders
Any Event in SOC	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Glycosuria	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Reproductive system and breast disorders
Any Event in SOC	6/23 (26.1%)	13	2/23 (8.7%)	2	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Adenomyosis	0/23 (0%)	0	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Breast mass	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Menstruation irregular	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Vaginal haemorrhage	2/23 (8.7%)	2	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Vulva cyst	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Vulvovaginal discomfort	2/23 (8.7%)	7	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Vulvovaginal pruritus	1/23 (4.3%)	1	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Respiratory, thoracic and mediastinal disorders
Any Event in SOC	1/23 (4.3%)	1	0/23 (0%)	0	1/7 (14.3%)	1	1/16 (6.3%)	1	0/10 (0%)	0	0/1 (0%)	0
Cough	0/23 (0%)	0	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Epistaxis	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Paranasal sinus discomfort	0/23 (0%)	0	0/23 (0%)	0	0/7 (0%)	0	1/16 (6.3%)	1	0/10 (0%)	0	0/1 (0%)	0
Skin and subcutaneous tissue disorders
Any Event in SOC	6/23 (26.1%)	9	4/23 (17.4%)	5	2/7 (28.6%)	2	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Dermatitis	0/23 (0%)	0	2/23 (8.7%)	3	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Dry skin	0/23 (0%)	0	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Eczema	1/23 (4.3%)	1	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Macule	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Miliaria	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Night sweats	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Papule	1/23 (4.3%)	1	1/23 (4.3%)	1	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Rash papular	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Rash pruritic	2/23 (8.7%)	2	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Skin ulcer	1/23 (4.3%)	1	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Urticaria	0/23 (0%)	0	0/23 (0%)	0	1/7 (14.3%)	1	0/16 (0%)	0	0/10 (0%)	0	0/1 (0%)	0
Vascular disorders
Any Event in SOC	0/23 (0%)	0	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	1/10 (10%)	1	1/1 (100%)	1
Hot flush	0/23 (0%)	0	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	1/10 (10%)	1	0/1 (0%)	0
Thrombophlebitis	0/23 (0%)	0	0/23 (0%)	0	0/7 (0%)	0	0/16 (0%)	0	0/10 (0%)	0	1/1 (100%)	1

Limitations/Caveats

[Not Specified]

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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.