HIV Infections
Conditions
Keywords
HIV, VRC01
Brief summary
The purpose of this study was to evaluate the safety, tolerability, and effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), in adults infected with HIV who were receiving antiretroviral therapy (ART).
Detailed description
Monoclonal antibodies (mAbs) have been developed as treatment for a variety of conditions including cancer, autoimmune disorders, and infections. mAbs may also be a potential treatment for people infected with HIV. The purpose of this study was to evaluate the safety and tolerability of an experimental human mAb, VRC-HIVMAB060-00-AB (VRC01), in HIV-infected adults receiving ART. Study researchers will also evaluate the effect of VRC01 on the number of infected cells containing unspliced HIV-1 transcripts in the blood in participants. This study enrolled HIV-infected people 18 to 65 years old, who had been receiving ART for at least 2 years and who had a CD4+ count of 200 cells/mm\^3 or greater. Participants were randomly assigned to Arm A or Arm B. Participants in Arm A received an intravenous (IV) infusion of VRC01 at Day 0 and Week 3 and an IV infusion of placebo (normal saline) at Weeks 6 and 9. Participants in Arm B received an IV infusion of placebo (normal saline) at Day 0 and Week 3 and an IV infusion of VRC01 at Weeks 6 and 9. Participants recorded their temperature and symptoms for 3 days after each infusion. Study visits occured at study entry (Day 0), and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, and 30. Study visits included physical examinations, clinical assessments, and blood collection. The primary safety outcome for this study was descriptive and assessed the occurrence of Grade ≥ 3 AEs including signs/symptoms, lab toxicities, and/or clinical events that are possibly, probably, or definitely related to study treatment (as judged by the core team, blinded to treatment arm) at any time from the initial dose of study treatment to the end of study follow-up. Since this outcome is descriptive, no statistical significance testing was performed.
Interventions
BIOLOGICALVRC01
40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
BIOLOGICALPlacebo
Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Sponsors
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* HIV-1 infection, documented by any FDA-approved rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV or E/CIA tests, or by HIV-1 antigen, or plasma HIV-1 RNA assay. More information on this criterion is available in the protocol. * Received continuous ART for at least 2 years (defined as no interruptions longer than 14 consecutive days) and with no changes in the components of the ART for at least 90 days prior to study entry * CD4+ cell count greater than or equal to 200 cells/mm\^3 obtained within 60 days prior to study entry in a clinical laboratory improvement amendments (CLIA)-certified laboratory * Plasma HIV-1 RNA below the limit of detection of the FDA-approved assays (limit of detection: 75, 50, 40 or 20 copies/mL) for greater than or equal to 2 years on ART. Participants must have had at least one documented HIV-1 RNA less than the limit of detection 12-24 months prior to study entry and at least one HIV-1 RNA less than the limit of detection within 12 months prior to study entry. All available HIV-1 RNA measurements must have been below the assay limit of detection during the 2 years prior to study entry except as allowed by the following note. NOTE: A single unconfirmed plasma HIV-1 RNA greater than the limit of detection but less than 200 copies/mL within 6-24 months was allowed if followed by a subsequent value below the limit of detection. * Plasma HIV-1 RNA level of less than 40 copies/mL obtained by the Abbott Real-time HIV assay (m2000) or less than 20 copies/mL obtained by the Roche COBAS Taqman HIV-1 v2.0 assay within 60 days prior to entry * The following laboratory values obtained within 60 days prior to entry by any U.S. laboratory that has a CLIA certification or its equivalent. * Absolute neutrophil count (ANC) greater than or equal to 750 cells/mm\^3 * Hemoglobin greater than or equal to 11.0 g/dL for men and greater than or equal to 10.0 g/dL for women * Platelet count greater than or equal to 100,000/mm\^3 * Creatinine clearance greater than or equal to 60 mL/min estimated by the Cockcroft-Gault equation. NOTE: A program for calculating creatinine clearance by the Cockcroft-Gault method is available on www.fstrf.org. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (SGPT) less than or equal to 2.0 times upper limit of normal (ULN) * Hepatitis C virus (HCV) antibody negative result within 60 days prior to study entry or, if the HCV antibody result is positive, a negative HCV RNA result within 60 days prior to study entry * Negative HBsAg result obtained within 60 days prior to study entry * Ability and willingness of participant to provide informed consent * Females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy, or bilateral oophorectomy and/or bilateral salpingectomy), needed a negative serum or urine pregnancy test within 48 hours prior to study entry. NOTE: Acceptable documentation of hysterectomy and bilateral oophorectomy, bilateral salpingectomy, tubal micro-inserts, partner who has undergone vasectomy, and menopause is participant-reported history. * All participants must have agreed not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the participant/partner must use at least one reliable form of contraception (condoms, with or without a spermicidal agent; a diaphragm or cervical cap with spermicide; an intrauterine device (IUD); or hormone-based contraceptive), while receiving study treatment and for 12 weeks after stopping study treatment * Documentation of the availability of the following stored samples from the screening visit: peripheral blood mononuclear cell (PBMC) for CD4+ T-cell associated HIV-1 RNA, DNA assay and plasma for HIV-1 SCA. Sites must receive confirmation from the processing lab via phone, email, or fax, that specimens have been entered into the AIDS Clinical Trials Group (ACTG) Laboratory Data Management System (LDMS).
Exclusion criteria
* Previous receipt of humanized or human monoclonal antibody (licensed or investigational) * Weight greater than 115 kg or less than 53 kg * Acute or ongoing AIDS-defining illness within 60 days prior to study entry * History of a severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis within 2 years of study entry * Currently breastfeeding or pregnant * Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements * Acute or serious illness that, in the opinion of the site investigator, requires systemic treatment and/or hospitalization within 60 days prior to entry * Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 60 days prior to study entry. NOTE: Participants receiving stable physiologic doses of glucocorticoids, defined as the equivalent of prednisone less than or equal to 10 mg/day, will not be excluded. Stable physiologic glucocorticoid doses should not be discontinued for the duration of the study. In addition, participants receiving inhaled or topical corticosteroids will not be excluded. * Treatment for hepatitis C within 24 weeks of study entry * Vaccinations within 7 days prior to the screening, pre-entry, or study entry visits. NOTE: Participants are encouraged to get routine vaccinations, such as seasonal influenza vaccine more than 7 days prior to screening or between screening and pre-entry visits (outside of the 7-day window above). * Initiation of ART during acute HIV-1 infection (as determined by the site investigator by history and/or available medical records)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Grade 3 or Greater, Treatment Related, Adverse Event (AE) | Measured from study treatment initiation to study discontinuation (study duration is 30 weeks) | Refer to detailed description in the protocol section. Includes signs/symptoms, lab toxicities, and/or clinical events that are possibly, probably, or definitely related to study treatment (as judged by the core team, blinded to treatment arm) at any time from the initial dose of VRC01 to end of study follow-up. This analysis was primarily descriptive and no significance testing was performed. |
| Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells | Screening, entry and week 6 | Change from baseline (geometric average of screening and entry results) to week 6 in log10 transformed cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Premature Treatment Discontinuation, for Reasons Related to Study Treatment | Measured from study treatment initiation to study treatment discontinuation (study treatment dispensed through week 12) | Study treatment was taken from entry through week 12 - this outcome assesses the number of participants who permanently and prematurely discontinued study treatment due to reasons related to the study treatment |
| Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Last Value Carried Forward (LVCF) | Screening, entry, week 3 and week 6 (week 3 used as LVCF if necessary) | Change from baseline (geometric average of screening and entry results) to week 6 in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells, using a last value carried forward approach if week 6 cell-associated HIV-1 RNA/DNA ratio was missing. In the event that the week 6 value was missing, the week 3 value was carried forward to be used. This comparison is the change from the average of screening and entry results to the week 6 value (if available), and if week 6 result was not available, the week 3 value was used instead of the week 6 value. |
| Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Across Arms | Screening, entry and weeks 6 and 12 | Summary of within-participant change across treatment arms from the pre-VRC01 time point to the post-VRC01 time point. For Arm A, the pre-VRC01 time point used was the baseline measure (geometric average of screening and entry results) and the post-VRC01 time point was the week 6 measure. For Arm B, the pre-VRC01 time point used was the week 6 measure and the post-VRC01 time point was the week 12 measure. Change in CA-RNA/DNA ratio was calculated on the log10 scale. |
| Cell-associated HIV-1 RNA in Total CD4+ Cells | Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30 | Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Baseline values are the geometric mean of screening and entry results. Testing of specimens at weeks 1, 4, 7, 10, 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes. |
| Cell-associated HIV-1 DNA in Total CD4+ Cells | Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30 | Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Baseline values are the geometric mean of screening and entry results. Testing of specimens at weeks 1, 4, 7, 10, 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes. |
| Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells | Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30 | Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Baseline values are the geometric mean of screening and entry results. Testing of specimens at weeks 1, 4, 7, 10, 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes. |
| Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30 | The analysis of HIV-1 RNA SCA assessed the number of participants below the assay lower limit (1 copy/mL) at each measurement week. Specific specimens and time points were targeted based on Arm. Samples were not tested for Arm A at the Week 7 and Week 10 time points. Samples were not tested for Arm B at the Week 1 and Week 4 time points. Testing of specimens at weeks 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes. |
| CD4+ T-cell Counts | Measured at screening, entry and weeks 6, 12, 18 and 30 | Baseline measure represents the average of screening and entry results |
| CD8+ T-cell Counts | Measured at screening, entry and weeks 6, 12, 18 and 30 | Baseline measure represents the average of screening and entry results |
| Total/Inducible Virus Recovery - Stimulated HIV-1 RNA | Measured at pre-entry, week 6 and week 12 | As part of the total virus recovery assay, results for stimulated HIV-1 RNA (copies/mL) are generated |
| Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA | Measured at pre-entry, week 6 and week 12 | As part of the total virus recovery assay, results for unstimulated HIV-1 RNA (copies/mL) are generated |
| Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio | Measured at pre-entry, week 6 and week 12 | As part of the total virus recovery assay, results for stimulated and unstimulated HIV-1 RNA (copies/mL) are generated. At each time point, the ratio of the stimulated to unstimulated HIV-1 RNA was calculated. |
| Total/Inducible Virus Recovery - Stimulated Cell Fluor | Measured at pre-entry, week 6 and week 12 | As part of the total virus recovery assay, results for stimulated cell fluor (light units) are generated. |
| Total/Inducible Virus Recovery - Unstimulated Cell Fluor | Measured at pre-entry, week 6 and week 12 | As part of the total virus recovery assay, results for unstimulated cell fluor (light units) are generated. |
| Change in Total/Inducible Virus Recovery - Stimulated HIV-1 RNA | Measured at pre-entry, week 6 | As part of the total virus recovery assay, results for stimulated HIV-1 RNA (copies/mL) are generated. The change from the pre-treatment time point to week 6 was assessed as a fold change (week 6 / pre-entry) |
| Change in Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA | Measured at pre-entry, week 6 | As part of the total virus recovery assay, results for unstimulated HIV-1 RNA (copies/mL) are generated. The change from the pre-treatment time point to week 6 was assessed as a fold change (week 6 / pre-entry) |
| Total/Inducible Virus Recovery - Percentage of Total CD4 Yield | Measured at pre-entry, week 6 and week 12 | As part of the total virus recovery assay, results for %tCD4 yield are generated. |
| Change in Total/Inducible Virus Recovery - Stimulated Cell Fluor | Measured at pre-entry, week 6 | As part of the total virus recovery assay, results for stimulated cell fluor (light units) are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry) |
| Change in Total/Inducible Virus Recovery - Unstimulated Cell Fluor | Measured at pre-entry, week 6 | As part of the total virus recovery assay, results for unstimulated cell fluor (light units) are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry) |
| Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio | Measured at pre-entry, week 6 | As part of the total virus recovery assay, results for stimulated and unstimulated cell fluor (light units) are generated. At each time point, the ratio of the stimulated to unstimulated cell fluor was calculated. The fold change of this ratio from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry) |
| Change in Total/Inducible Virus Recovery - Percentage of Total CD4 Yield | Measured at pre-entry, week 6 | As part of the total virus recovery assay, results for %tCD4 yield are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry) |
| VRC01 Antibody Level | Measured at entry and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18 and 30 | Summarize the pharmacokinetics (PK) of two infusions of VRC01 during study follow up Specific specimens and time points were targeted for testing based on Arm. Samples for Arm A were not tested for the Week 6 and Week 9 post-infusion time points. Samples for Arm B were not tested for the Week 0 and Week 3 post-infusion time points. |
| Detectability of Antibody to VRC01 as Measured in Serum | Measured at week 30 | Assess the detectability of antibody to VRC01 in samples collected during study follow-up. Intended to be result from specimen at week 30 time point. Due to specimen availability, four participants in Arm A had results from specimens from the week 18 time point. Counts provided are number of participants with detectable anti-VRC01 antibody result. |
| Levels of T-cell Activation | Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30 | % CD4+ and CD8+ T-cells co-expressing human leukocyte antigen (HLA)-DR and CD38 Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes. |
| Levels of NK Cell Activation | Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30 | % NK cells expressing CD69 or CD95 Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes. |
| Plasma Levels of sCD163 | Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30 | Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes. |
| Plasma Levels of sCD14 | Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30 | Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes. |
| Plasma Levels of Interleukin-6 (IL-6) | Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30 | Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes. |
| Plasma Levels of Human Soluble Tumor Necrosis Factor Alpha-receptor (sTNFαR) | Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30 | Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes. |
| Plasma Levels of Tumor Necrosis Factor Alpha (TNFα) | Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30 | Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes. |
| Plasma Levels of High-sensitivity C-reactive Protein (hsCRP) | Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30 | Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes. |
| VRC01 Antibody Level Relative to Infusion Timing | Measured immediately after first infusion (and 1, 2, and 3 weeks after), and immediately after second infusion (and 1, 2, 3, 6 and 9 weeks after) | Summarize the pharmacokinetics (PK) of two infusions of VRC01 during study follow up - aligning the timing of PK samples/results to the respective VRC01 infusions for each Arm |
| Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio | Measured at pre-entry and week 6 | As part of the total virus recovery assay, results for stimulated and unstimulated HIV-1 RNA (copies/mL) are generated. At each time point, the ratio of the stimulated to unstimulated HIV-1 RNA was calculated. The fold change of this ratio from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry) |
| Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio | Measured at pre-entry, week 6 and week 12 | As part of the total virus recovery assay, results for stimulated and unstimulated cell fluor (light units) are generated. At each time point, the ratio of the stimulated to unstimulated cell fluor was calculated. |
Countries
United States
Participant flow
Recruitment details
The first participant enrolled to the study on August 25th, 2015 and the last participant enrolled on March 4th, 2016. A total of 13 U.S. sites enrolled participants.
Participants by arm
| Arm | Count |
|---|---|
| Arm A: VRC01 Followed by Placebo Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump | 20 |
| Arm B: Placebo Followed by VRC01 Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Confounding medical condition | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Arm A: VRC01 Followed by Placebo | Arm B: Placebo Followed by VRC01 | Total |
|---|---|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 12 | 52 years STANDARD_DEVIATION 11 | 48 years STANDARD_DEVIATION 12 |
| Age, Customized 18-29 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Customized 30-39 years | 4 Participants | 1 Participants | 5 Participants |
| Age, Customized 40-49 years | 4 Participants | 2 Participants | 6 Participants |
| Age, Customized 50+ years | 9 Participants | 15 Participants | 24 Participants |
| BMI, categorical Normal (18 - <25 kg/m^2) | 4 Participants | 11 Participants | 15 Participants |
| BMI, categorical Obese (30+ kg/m^2) | 5 Participants | 3 Participants | 8 Participants |
| BMI, categorical Overweight (25 - <30 kg/m^2) | 10 Participants | 6 Participants | 16 Participants |
| BMI, categorical Underweight (<18 kg/m^2) | 1 Participants | 0 Participants | 1 Participants |
| CD4+ T-Cell Count, categorical 200 - <350 cells/mm^3 | 0 Participants | 2 Participants | 2 Participants |
| CD4+ T-Cell Count, categorical 350 - <500 cells/mm^3 | 3 Participants | 2 Participants | 5 Participants |
| CD4+ T-Cell Count, categorical >= 500 cells/mm^3 | 17 Participants | 16 Participants | 33 Participants |
| Cell-associated HIV-1 RNA/DNA Ratio | -1.35 log10 ratio | -1.51 log10 ratio | -1.45 log10 ratio |
| Creatinine clearance, categorical 50 - 90 mL/min | 4 Participants | 9 Participants | 13 Participants |
| Creatinine clearance, categorical > 90 mL/min | 16 Participants | 11 Participants | 27 Participants |
| IV drug history, categorical Never | 19 Participants | 18 Participants | 37 Participants |
| IV drug history, categorical Previously | 1 Participants | 2 Participants | 3 Participants |
| Plasma HIV-1 RNA, categorical < 40 copies/mL | 20 Participants | 20 Participants | 40 Participants |
| Plasma HIV-1 RNA, categorical >= 40 copies/mL | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black non-hispanic | 3 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Hispanic (regardless of race) | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized White non-hispanic | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 17 Participants | 20 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 16 / 20 | 17 / 20 |
| serious Total, serious adverse events | 0 / 20 | 1 / 20 |
Outcome results
Primary
Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells
Change from baseline (geometric average of screening and entry results) to week 6 in log10 transformed cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells
Time frame: Screening, entry and week 6
Population: Analysis of participants with available results for the change in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells. All participants received at least one dose of the randomized treatment assigned. No participants received the incorrect treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: VRC01 Followed by Placebo | Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells | 0.05 log10 ratio |
| Arm B: Placebo Followed by VRC01 | Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells | -0.08 log10 ratio |
Comparison: The primary efficacy analysis compared the change in cell-associated HIV-1 RNA/DNA ratio (log-transformed) from baseline to week 6 between the two randomized arms, testing the null hypothesis of no difference in changes in cell-associated HIV-1 RNA/DNA ratio between the two arms using a Wilcoxon rank sum test at 10% significance level.p-value: 0.16Wilcoxon (Mann-Whitney)
Primary
Number of Participants Who Experienced Grade 3 or Greater, Treatment Related, Adverse Event (AE)
Refer to detailed description in the protocol section. Includes signs/symptoms, lab toxicities, and/or clinical events that are possibly, probably, or definitely related to study treatment (as judged by the core team, blinded to treatment arm) at any time from the initial dose of VRC01 to end of study follow-up. This analysis was primarily descriptive and no significance testing was performed.
Time frame: Measured from study treatment initiation to study discontinuation (study duration is 30 weeks)
Population: Includes all available follow-up for all participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: VRC01 Followed by Placebo | Number of Participants Who Experienced Grade 3 or Greater, Treatment Related, Adverse Event (AE) | 0 Participants |
| Arm B: Placebo Followed by VRC01 | Number of Participants Who Experienced Grade 3 or Greater, Treatment Related, Adverse Event (AE) | 0 Participants |
Secondary
CD4+ T-cell Counts
Baseline measure represents the average of screening and entry results
Time frame: Measured at screening, entry and weeks 6, 12, 18 and 30
Population: Analysis of all participants with available CD4+ results
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: VRC01 Followed by Placebo | CD4+ T-cell Counts | Week 30 | 750 cells/mm^3 |
| Arm A: VRC01 Followed by Placebo | CD4+ T-cell Counts | Week 6 | 709 cells/mm^3 |
| Arm A: VRC01 Followed by Placebo | CD4+ T-cell Counts | Week 12 | 734 cells/mm^3 |
| Arm A: VRC01 Followed by Placebo | CD4+ T-cell Counts | Week 18 | 709 cells/mm^3 |
| Arm A: VRC01 Followed by Placebo | CD4+ T-cell Counts | Baseline | 701 cells/mm^3 |
| Arm B: Placebo Followed by VRC01 | CD4+ T-cell Counts | Week 18 | 672 cells/mm^3 |
| Arm B: Placebo Followed by VRC01 | CD4+ T-cell Counts | Week 30 | 712 cells/mm^3 |
| Arm B: Placebo Followed by VRC01 | CD4+ T-cell Counts | Baseline | 685 cells/mm^3 |
| Arm B: Placebo Followed by VRC01 | CD4+ T-cell Counts | Week 12 | 671 cells/mm^3 |
| Arm B: Placebo Followed by VRC01 | CD4+ T-cell Counts | Week 6 | 697 cells/mm^3 |
Secondary
CD8+ T-cell Counts
Baseline measure represents the average of screening and entry results
Time frame: Measured at screening, entry and weeks 6, 12, 18 and 30
Population: Analysis of all participants with available CD8+ results
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: VRC01 Followed by Placebo | CD8+ T-cell Counts | Week 6 | 688 cells/mm^3 |
| Arm A: VRC01 Followed by Placebo | CD8+ T-cell Counts | Week 18 | 766 cells/mm^3 |
| Arm A: VRC01 Followed by Placebo | CD8+ T-cell Counts | Week 12 | 649 cells/mm^3 |
| Arm A: VRC01 Followed by Placebo | CD8+ T-cell Counts | Week 30 | 731 cells/mm^3 |
| Arm A: VRC01 Followed by Placebo | CD8+ T-cell Counts | Baseline | 801 cells/mm^3 |
| Arm B: Placebo Followed by VRC01 | CD8+ T-cell Counts | Week 30 | 655 cells/mm^3 |
| Arm B: Placebo Followed by VRC01 | CD8+ T-cell Counts | Baseline | 617 cells/mm^3 |
| Arm B: Placebo Followed by VRC01 | CD8+ T-cell Counts | Week 6 | 614 cells/mm^3 |
| Arm B: Placebo Followed by VRC01 | CD8+ T-cell Counts | Week 12 | 620 cells/mm^3 |
| Arm B: Placebo Followed by VRC01 | CD8+ T-cell Counts | Week 18 | 665 cells/mm^3 |
Secondary
Cell-associated HIV-1 DNA in Total CD4+ Cells
Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Baseline values are the geometric mean of screening and entry results. Testing of specimens at weeks 1, 4, 7, 10, 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes.
Time frame: Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Population: Analysis of participants with available cell-associated HIV-1 DNA results
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: VRC01 Followed by Placebo | Cell-associated HIV-1 DNA in Total CD4+ Cells | Baseline | 3.05 log10 copies/million CD4 |
| Arm A: VRC01 Followed by Placebo | Cell-associated HIV-1 DNA in Total CD4+ Cells | Week 9 | 2.96 log10 copies/million CD4 |
| Arm A: VRC01 Followed by Placebo | Cell-associated HIV-1 DNA in Total CD4+ Cells | Week 3 | 2.99 log10 copies/million CD4 |
| Arm A: VRC01 Followed by Placebo | Cell-associated HIV-1 DNA in Total CD4+ Cells | Week 12 | 3.01 log10 copies/million CD4 |
| Arm A: VRC01 Followed by Placebo | Cell-associated HIV-1 DNA in Total CD4+ Cells | Week 6 | 2.99 log10 copies/million CD4 |
| Arm B: Placebo Followed by VRC01 | Cell-associated HIV-1 DNA in Total CD4+ Cells | Week 12 | 2.90 log10 copies/million CD4 |
| Arm B: Placebo Followed by VRC01 | Cell-associated HIV-1 DNA in Total CD4+ Cells | Week 6 | 2.92 log10 copies/million CD4 |
| Arm B: Placebo Followed by VRC01 | Cell-associated HIV-1 DNA in Total CD4+ Cells | Baseline | 3.00 log10 copies/million CD4 |
| Arm B: Placebo Followed by VRC01 | Cell-associated HIV-1 DNA in Total CD4+ Cells | Week 3 | 2.89 log10 copies/million CD4 |
| Arm B: Placebo Followed by VRC01 | Cell-associated HIV-1 DNA in Total CD4+ Cells | Week 9 | 2.91 log10 copies/million CD4 |
Secondary
Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells
Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Baseline values are the geometric mean of screening and entry results. Testing of specimens at weeks 1, 4, 7, 10, 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes.
Time frame: Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Population: Analysis of participants with available cell-associated HIV-1 RNA/DNA ratio
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: VRC01 Followed by Placebo | Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells | Baseline | -1.35 log10 ratio |
| Arm A: VRC01 Followed by Placebo | Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells | Week 9 | -1.37 log10 ratio |
| Arm A: VRC01 Followed by Placebo | Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells | Week 3 | -1.29 log10 ratio |
| Arm A: VRC01 Followed by Placebo | Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells | Week 6 | -1.28 log10 ratio |
| Arm A: VRC01 Followed by Placebo | Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells | Week 12 | -1.42 log10 ratio |
| Arm B: Placebo Followed by VRC01 | Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells | Week 9 | -1.40 log10 ratio |
| Arm B: Placebo Followed by VRC01 | Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells | Week 3 | -1.38 log10 ratio |
| Arm B: Placebo Followed by VRC01 | Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells | Week 6 | -1.44 log10 ratio |
| Arm B: Placebo Followed by VRC01 | Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells | Week 12 | -1.33 log10 ratio |
| Arm B: Placebo Followed by VRC01 | Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells | Baseline | -1.51 log10 ratio |
Secondary
Cell-associated HIV-1 RNA in Total CD4+ Cells
Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Baseline values are the geometric mean of screening and entry results. Testing of specimens at weeks 1, 4, 7, 10, 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes.
Time frame: Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Population: Analysis of participants with available cell-associated HIV-1 RNA results
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: VRC01 Followed by Placebo | Cell-associated HIV-1 RNA in Total CD4+ Cells | Week 3 | 1.62 log10 copies/million CD4 |
| Arm A: VRC01 Followed by Placebo | Cell-associated HIV-1 RNA in Total CD4+ Cells | Week 9 | 1.56 log10 copies/million CD4 |
| Arm A: VRC01 Followed by Placebo | Cell-associated HIV-1 RNA in Total CD4+ Cells | Week 6 | 1.48 log10 copies/million CD4 |
| Arm A: VRC01 Followed by Placebo | Cell-associated HIV-1 RNA in Total CD4+ Cells | Week 12 | 1.62 log10 copies/million CD4 |
| Arm A: VRC01 Followed by Placebo | Cell-associated HIV-1 RNA in Total CD4+ Cells | Baseline | 1.60 log10 copies/million CD4 |
| Arm B: Placebo Followed by VRC01 | Cell-associated HIV-1 RNA in Total CD4+ Cells | Week 12 | 1.51 log10 copies/million CD4 |
| Arm B: Placebo Followed by VRC01 | Cell-associated HIV-1 RNA in Total CD4+ Cells | Baseline | 1.38 log10 copies/million CD4 |
| Arm B: Placebo Followed by VRC01 | Cell-associated HIV-1 RNA in Total CD4+ Cells | Week 3 | 1.56 log10 copies/million CD4 |
| Arm B: Placebo Followed by VRC01 | Cell-associated HIV-1 RNA in Total CD4+ Cells | Week 6 | 1.41 log10 copies/million CD4 |
| Arm B: Placebo Followed by VRC01 | Cell-associated HIV-1 RNA in Total CD4+ Cells | Week 9 | 1.56 log10 copies/million CD4 |
Secondary
Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Across Arms
Summary of within-participant change across treatment arms from the pre-VRC01 time point to the post-VRC01 time point. For Arm A, the pre-VRC01 time point used was the baseline measure (geometric average of screening and entry results) and the post-VRC01 time point was the week 6 measure. For Arm B, the pre-VRC01 time point used was the week 6 measure and the post-VRC01 time point was the week 12 measure. Change in CA-RNA/DNA ratio was calculated on the log10 scale.
Time frame: Screening, entry and weeks 6 and 12
Population: Analysis of all participants with available pre- and post-VRC01 cell-associated RNA/DNA ratio results available. Participants from Arm A must have had results at entry and week 6. Participants from Arm B must have had results from week 6 and week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: VRC01 Followed by Placebo | Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Across Arms | 0.09 log10 ratio |
Secondary
Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Last Value Carried Forward (LVCF)
Change from baseline (geometric average of screening and entry results) to week 6 in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells, using a last value carried forward approach if week 6 cell-associated HIV-1 RNA/DNA ratio was missing. In the event that the week 6 value was missing, the week 3 value was carried forward to be used. This comparison is the change from the average of screening and entry results to the week 6 value (if available), and if week 6 result was not available, the week 3 value was used instead of the week 6 value.
Time frame: Screening, entry, week 3 and week 6 (week 3 used as LVCF if necessary)
Population: Analysis of participants with available results for the change in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells, carrying last available result forward if missing at week 6
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: VRC01 Followed by Placebo | Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Last Value Carried Forward (LVCF) | 0.06 log10 ratio |
| Arm B: Placebo Followed by VRC01 | Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Last Value Carried Forward (LVCF) | -0.08 log10 ratio |
Secondary
Change in Total/Inducible Virus Recovery - Percentage of Total CD4 Yield
As part of the total virus recovery assay, results for %tCD4 yield are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)
Time frame: Measured at pre-entry, week 6
Population: Includes all participants with available %tCD4 yield results from virus recovery assay at pre-entry and week 6 time points
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: VRC01 Followed by Placebo | Change in Total/Inducible Virus Recovery - Percentage of Total CD4 Yield | 1.00 fold change |
| Arm B: Placebo Followed by VRC01 | Change in Total/Inducible Virus Recovery - Percentage of Total CD4 Yield | 1.06 fold change |
Secondary
Change in Total/Inducible Virus Recovery - Stimulated Cell Fluor
As part of the total virus recovery assay, results for stimulated cell fluor (light units) are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)
Time frame: Measured at pre-entry, week 6
Population: Includes all participants with available stimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: VRC01 Followed by Placebo | Change in Total/Inducible Virus Recovery - Stimulated Cell Fluor | 0.97 fold change |
| Arm B: Placebo Followed by VRC01 | Change in Total/Inducible Virus Recovery - Stimulated Cell Fluor | 0.97 fold change |
Secondary
Change in Total/Inducible Virus Recovery - Stimulated HIV-1 RNA
As part of the total virus recovery assay, results for stimulated HIV-1 RNA (copies/mL) are generated. The change from the pre-treatment time point to week 6 was assessed as a fold change (week 6 / pre-entry)
Time frame: Measured at pre-entry, week 6
Population: Includes all participants with available stimulated HIV-1 RNA results from virus recovery assay at pre-entry and week 6 time points
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: VRC01 Followed by Placebo | Change in Total/Inducible Virus Recovery - Stimulated HIV-1 RNA | 0.74 fold change |
| Arm B: Placebo Followed by VRC01 | Change in Total/Inducible Virus Recovery - Stimulated HIV-1 RNA | 1.32 fold change |
Secondary
Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio
As part of the total virus recovery assay, results for stimulated and unstimulated cell fluor (light units) are generated. At each time point, the ratio of the stimulated to unstimulated cell fluor was calculated. The fold change of this ratio from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)
Time frame: Measured at pre-entry, week 6
Population: Includes all participants with available stimulated/unstimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: VRC01 Followed by Placebo | Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio | 1.08 fold change |
| Arm B: Placebo Followed by VRC01 | Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio | 0.85 fold change |
Secondary
Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio
As part of the total virus recovery assay, results for stimulated and unstimulated HIV-1 RNA (copies/mL) are generated. At each time point, the ratio of the stimulated to unstimulated HIV-1 RNA was calculated. The fold change of this ratio from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)
Time frame: Measured at pre-entry and week 6
Population: Includes all participants with available stimulated/unstimulated HIV-1 RNA results from virus recovery assay
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: VRC01 Followed by Placebo | Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio | 0.69 fold change |
| Arm B: Placebo Followed by VRC01 | Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio | 0.85 fold change |
Secondary
Change in Total/Inducible Virus Recovery - Unstimulated Cell Fluor
As part of the total virus recovery assay, results for unstimulated cell fluor (light units) are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)
Time frame: Measured at pre-entry, week 6
Population: Includes all participants with available unstimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: VRC01 Followed by Placebo | Change in Total/Inducible Virus Recovery - Unstimulated Cell Fluor | 0.93 fold change |
| Arm B: Placebo Followed by VRC01 | Change in Total/Inducible Virus Recovery - Unstimulated Cell Fluor | 1.12 fold change |
Secondary
Change in Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA
As part of the total virus recovery assay, results for unstimulated HIV-1 RNA (copies/mL) are generated. The change from the pre-treatment time point to week 6 was assessed as a fold change (week 6 / pre-entry)
Time frame: Measured at pre-entry, week 6
Population: Includes all participants with available unstimulated HIV-1 RNA results from virus recovery assay at pre-entry and week 6 time points
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: VRC01 Followed by Placebo | Change in Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA | 1.37 fold change |
| Arm B: Placebo Followed by VRC01 | Change in Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA | 1.00 fold change |
Secondary
Detectability of Antibody to VRC01 as Measured in Serum
Assess the detectability of antibody to VRC01 in samples collected during study follow-up. Intended to be result from specimen at week 30 time point. Due to specimen availability, four participants in Arm A had results from specimens from the week 18 time point. Counts provided are number of participants with detectable anti-VRC01 antibody result.
Time frame: Measured at week 30
Population: All participants with results for anti-VRC01 antibody. Two participants did not have results (one from each arm) due to being lost to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: VRC01 Followed by Placebo | Detectability of Antibody to VRC01 as Measured in Serum | 0 Participants |
| Arm B: Placebo Followed by VRC01 | Detectability of Antibody to VRC01 as Measured in Serum | 0 Participants |
Secondary
Levels of NK Cell Activation
% NK cells expressing CD69 or CD95 Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.
Time frame: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Population: Analysis not performed. See outcome measure description for reasoning.
Secondary
Levels of T-cell Activation
% CD4+ and CD8+ T-cells co-expressing human leukocyte antigen (HLA)-DR and CD38 Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.
Time frame: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Population: Analysis not performed. See outcome measure description for reasoning.
Secondary
Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit
The analysis of HIV-1 RNA SCA assessed the number of participants below the assay lower limit (1 copy/mL) at each measurement week. Specific specimens and time points were targeted based on Arm. Samples were not tested for Arm A at the Week 7 and Week 10 time points. Samples were not tested for Arm B at the Week 1 and Week 4 time points. Testing of specimens at weeks 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes.
Time frame: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Population: Analysis of participants with available SCA results
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: VRC01 Followed by Placebo | Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Entry | 8 Participants |
| Arm A: VRC01 Followed by Placebo | Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Week 1 | 9 Participants |
| Arm A: VRC01 Followed by Placebo | Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Week 3 | 9 Participants |
| Arm A: VRC01 Followed by Placebo | Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Week 6 | 11 Participants |
| Arm A: VRC01 Followed by Placebo | Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Week 9 | 13 Participants |
| Arm A: VRC01 Followed by Placebo | Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Week 12 | 11 Participants |
| Arm A: VRC01 Followed by Placebo | Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Screening | 13 Participants |
| Arm A: VRC01 Followed by Placebo | Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Week 4 | 11 Participants |
| Arm B: Placebo Followed by VRC01 | Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Week 7 | 11 Participants |
| Arm B: Placebo Followed by VRC01 | Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Week 12 | 13 Participants |
| Arm B: Placebo Followed by VRC01 | Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Week 6 | 12 Participants |
| Arm B: Placebo Followed by VRC01 | Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Week 3 | 11 Participants |
| Arm B: Placebo Followed by VRC01 | Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Screening | 12 Participants |
| Arm B: Placebo Followed by VRC01 | Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Entry | 10 Participants |
| Arm B: Placebo Followed by VRC01 | Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Week 9 | 9 Participants |
| Arm B: Placebo Followed by VRC01 | Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit | Week 10 | 11 Participants |
Secondary
Number of Participants With Premature Treatment Discontinuation, for Reasons Related to Study Treatment
Study treatment was taken from entry through week 12 - this outcome assesses the number of participants who permanently and prematurely discontinued study treatment due to reasons related to the study treatment
Time frame: Measured from study treatment initiation to study treatment discontinuation (study treatment dispensed through week 12)
Population: All participants who received at least one infusion of study treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: VRC01 Followed by Placebo | Number of Participants With Premature Treatment Discontinuation, for Reasons Related to Study Treatment | 0 Participants |
| Arm B: Placebo Followed by VRC01 | Number of Participants With Premature Treatment Discontinuation, for Reasons Related to Study Treatment | 0 Participants |
Secondary
Plasma Levels of High-sensitivity C-reactive Protein (hsCRP)
Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.
Time frame: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Population: Analysis not performed. See outcome measure description for reasoning.
Secondary
Plasma Levels of Human Soluble Tumor Necrosis Factor Alpha-receptor (sTNFαR)
Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.
Time frame: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Population: Analysis not performed. See outcome measure description for reasoning.
Secondary
Plasma Levels of Interleukin-6 (IL-6)
Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.
Time frame: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Population: Analysis not performed. See outcome measure description for reasoning.
Secondary
Plasma Levels of sCD14
Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.
Time frame: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Population: Analysis not performed. See outcome measure description for reasoning.
Secondary
Plasma Levels of sCD163
Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.
Time frame: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Population: Analysis not performed. See outcome measure description for reasoning.
Secondary
Plasma Levels of Tumor Necrosis Factor Alpha (TNFα)
Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.
Time frame: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Population: Analysis not performed. See outcome measure description for reasoning.
Secondary
Total/Inducible Virus Recovery - Percentage of Total CD4 Yield
As part of the total virus recovery assay, results for %tCD4 yield are generated.
Time frame: Measured at pre-entry, week 6 and week 12
Population: Includes all participants with available %tCD4 yield results from virus recovery assay
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Percentage of Total CD4 Yield | Pre-entry | 25.35 percentage of Total CD4 Yield |
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Percentage of Total CD4 Yield | Week 6 | 25.00 percentage of Total CD4 Yield |
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Percentage of Total CD4 Yield | Week 12 | 25.00 percentage of Total CD4 Yield |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Percentage of Total CD4 Yield | Pre-entry | 22.00 percentage of Total CD4 Yield |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Percentage of Total CD4 Yield | Week 6 | 22.38 percentage of Total CD4 Yield |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Percentage of Total CD4 Yield | Week 12 | 22.58 percentage of Total CD4 Yield |
Secondary
Total/Inducible Virus Recovery - Stimulated Cell Fluor
As part of the total virus recovery assay, results for stimulated cell fluor (light units) are generated.
Time frame: Measured at pre-entry, week 6 and week 12
Population: Includes all participants with available stimulated cell fluor results from virus recovery assay
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Stimulated Cell Fluor | Week 6 | 24.68 million light units |
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Stimulated Cell Fluor | Pre-entry | 25.86 million light units |
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Stimulated Cell Fluor | Week 12 | 27.38 million light units |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Stimulated Cell Fluor | Pre-entry | 26.05 million light units |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Stimulated Cell Fluor | Week 6 | 26.13 million light units |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Stimulated Cell Fluor | Week 12 | 26.97 million light units |
Secondary
Total/Inducible Virus Recovery - Stimulated HIV-1 RNA
As part of the total virus recovery assay, results for stimulated HIV-1 RNA (copies/mL) are generated
Time frame: Measured at pre-entry, week 6 and week 12
Population: Includes all participants with available stimulated HIV-1 RNA results from virus recovery assay
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Stimulated HIV-1 RNA | Pre-entry | 2.83 log10 copies/mL |
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Stimulated HIV-1 RNA | Week 6 | 2.74 log10 copies/mL |
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Stimulated HIV-1 RNA | Week 12 | 2.74 log10 copies/mL |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Stimulated HIV-1 RNA | Pre-entry | 2.85 log10 copies/mL |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Stimulated HIV-1 RNA | Week 6 | 3.12 log10 copies/mL |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Stimulated HIV-1 RNA | Week 12 | 2.63 log10 copies/mL |
Secondary
Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio
As part of the total virus recovery assay, results for stimulated and unstimulated cell fluor (light units) are generated. At each time point, the ratio of the stimulated to unstimulated cell fluor was calculated.
Time frame: Measured at pre-entry, week 6 and week 12
Population: Includes all participants with available stimulated/unstimulated cell fluor results from virus recovery assay
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio | Pre-entry | 2.91 ratio |
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio | Week 6 | 4.20 ratio |
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio | Week 12 | 3.33 ratio |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio | Week 6 | 3.87 ratio |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio | Pre-entry | 4.32 ratio |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio | Week 12 | 3.76 ratio |
Secondary
Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio
As part of the total virus recovery assay, results for stimulated and unstimulated HIV-1 RNA (copies/mL) are generated. At each time point, the ratio of the stimulated to unstimulated HIV-1 RNA was calculated.
Time frame: Measured at pre-entry, week 6 and week 12
Population: Includes all participants with available stimulated/unstimulated HIV-1 RNA results from virus recovery assay
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio | Pre-entry | 16.73 ratio |
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio | Week 6 | 21.03 ratio |
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio | Week 12 | 34.12 ratio |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio | Pre-entry | 25.49 ratio |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio | Week 6 | 40.50 ratio |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio | Week 12 | 16.09 ratio |
Secondary
Total/Inducible Virus Recovery - Unstimulated Cell Fluor
As part of the total virus recovery assay, results for unstimulated cell fluor (light units) are generated.
Time frame: Measured at pre-entry, week 6 and week 12
Population: Includes all participants with available unstimulated cell fluor results from virus recovery assay
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Unstimulated Cell Fluor | Pre-entry | 6.86 million light units |
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Unstimulated Cell Fluor | Week 6 | 6.39 million light units |
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Unstimulated Cell Fluor | Week 12 | 8.53 million light units |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Unstimulated Cell Fluor | Pre-entry | 5.87 million light units |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Unstimulated Cell Fluor | Week 6 | 6.22 million light units |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Unstimulated Cell Fluor | Week 12 | 6.27 million light units |
Secondary
Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA
As part of the total virus recovery assay, results for unstimulated HIV-1 RNA (copies/mL) are generated
Time frame: Measured at pre-entry, week 6 and week 12
Population: Includes all participants with available unstimulated HIV-1 RNA results from virus recovery assay
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA | Pre-entry | 1.00 log10 copies/mL |
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA | Week 6 | 1.44 log10 copies/mL |
| Arm A: VRC01 Followed by Placebo | Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA | Week 12 | 1.25 log10 copies/mL |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA | Pre-entry | 1.00 log10 copies/mL |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA | Week 6 | 0.92 log10 copies/mL |
| Arm B: Placebo Followed by VRC01 | Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA | Week 12 | 1.53 log10 copies/mL |
Secondary
VRC01 Antibody Level
Summarize the pharmacokinetics (PK) of two infusions of VRC01 during study follow up Specific specimens and time points were targeted for testing based on Arm. Samples for Arm A were not tested for the Week 6 and Week 9 post-infusion time points. Samples for Arm B were not tested for the Week 0 and Week 3 post-infusion time points.
Time frame: Measured at entry and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18 and 30
Population: Analysis of all participants with available results.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 3 - Pre-Infusion | 113.6 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 10 | 37.8 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 3 - Post-Infusion | 1807.7 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 5 | 216.9 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 18 | 2.1 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 0 - Post-Infusion | 1726.2 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 30 | 0.1 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 6 - Pre-Infusion | 135.8 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 9 - Pre-Infusion | 42.1 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 1 | 259.9 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 4 | 361.9 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 0 - Pre-Infusion | 0.1 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 7 | 95.9 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 11 | 19.3 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 2 | 147.4 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 12 | 13.4 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 8 | 56.2 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level | Week 15 | 5.0 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 8 | 158.0 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 0 - Pre-Infusion | 0.1 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 1 | 0.1 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 3 - Pre-Infusion | 0.1 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 5 | 0.1 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 6 - Pre-Infusion | 0.1 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 6 - Post-Infusion | 1643.5 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 7 | 277.7 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 9 - Post-Infusion | 1717.8 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 9 - Pre-Infusion | 98.7 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 10 | 373.8 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 15 | 42.1 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 18 | 18.3 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 30 | 0.1 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 2 | 0.1 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 4 | 0.1 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 11 | 217.2 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level | Week 12 | 131.1 ug/mL |
Secondary
VRC01 Antibody Level Relative to Infusion Timing
Summarize the pharmacokinetics (PK) of two infusions of VRC01 during study follow up - aligning the timing of PK samples/results to the respective VRC01 infusions for each Arm
Time frame: Measured immediately after first infusion (and 1, 2, and 3 weeks after), and immediately after second infusion (and 1, 2, 3, 6 and 9 weeks after)
Population: Analysis of all participants with available results.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level Relative to Infusion Timing | Second dose - Post-infusion | 1807.7 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level Relative to Infusion Timing | One week after second infusion | 361.9 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level Relative to Infusion Timing | Six weeks after second infusion | 42.1 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level Relative to Infusion Timing | First dose - Post-Infusion | 1726.2 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level Relative to Infusion Timing | One week after first infusion | 259.9 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level Relative to Infusion Timing | Two weeks after first infusion | 147.4 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level Relative to Infusion Timing | Three weeks after first infusion | 113.6 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level Relative to Infusion Timing | Two weeks after second infusion | 216.9 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level Relative to Infusion Timing | Three weeks after second infusion | 135.8 ug/mL |
| Arm A: VRC01 Followed by Placebo | VRC01 Antibody Level Relative to Infusion Timing | Nine weeks after second infusion | 13.4 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level Relative to Infusion Timing | One week after first infusion | 277.7 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level Relative to Infusion Timing | Second dose - Post-infusion | 1717.8 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level Relative to Infusion Timing | Three weeks after second infusion | 131.1 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level Relative to Infusion Timing | One week after second infusion | 373.8 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level Relative to Infusion Timing | Two weeks after first infusion | 158.0 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level Relative to Infusion Timing | Six weeks after second infusion | 42.1 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level Relative to Infusion Timing | Nine weeks after second infusion | 18.3 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level Relative to Infusion Timing | Two weeks after second infusion | 217.2 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level Relative to Infusion Timing | First dose - Post-Infusion | 1643.5 ug/mL |
| Arm B: Placebo Followed by VRC01 | VRC01 Antibody Level Relative to Infusion Timing | Three weeks after first infusion | 98.7 ug/mL |