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| ID | Type | Description | Link |
|---|---|---|---|
| 17-I-0030 | Other Identifier | NIH |
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Background:
Human immunodeficiency virus (HIV) is a global health threat. The body uses antibodies to fight infection. VRC07-523LS is an antibody directed against HIV. It may be used to prevent mother-to-child transmission of HIV. It may also prevent sexual transmission of HIV and treat HIV-1 infected people.
Objective:
To test the safety, tolerability, dose, and pharmacokinetics of VRC07-523LS in healthy adults.
Eligibility:
Healthy people ages 18-50
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
Participants will be assigned to 1 of 7 groups:
Groups 1-5 will get the drug at 1 visit and then be observed for 24 weeks.
Groups 6 and 7 will get the drug at 1 visit every 12 weeks, for a total of 3 doses over 48 weeks.
Participants will get the drug in 1 of 2 ways:
Infusion into a vein over at least 30 minutes. Participants will have blood tests 1, 3, and 6 hours after the infusion. They will have 1-3 visits during that week. Those in Group 7 will have 4-5 visits in the week after their second and third doses.
Injection into the fatty tissue under the skin. Participants will have blood tests before the injection. They will have 1-3 visits during that week. Those in Group 6 will have 4-5 visits after the second and third doses.
Visits include:
Physical exam
Blood and urine tests
Optional oral swabs to collect saliva
Participants will keep a diary of their temperature and symptoms for 3 days after each dose.
This is the first study of the VRC-HIVMAB075-00-AB (VRC07-523LS) monoclonal antibody (MAb) in healthy adults. It is a phase 1, dose-escalation study to examine safety, tolerability, dose, and pharmacokinetics of VRC07-523LS. The hypothesis is that VRC07-523LS will be safe for administration to healthy adults by the intravenous (IV) and subcutaneous (SC) routes.
Healthy adults 18-50 years of age will be enrolled. There are 4 open-label, dose escalations of VRC07-523LS from 1 mg/kg IV to 40 mg/kg IV, 1 route escalation from IV to SC, and 2 open-label groups to assess repeat dosing. Groups 1-5 are expected to include 3 subjects and Groups 6-7 are expected to enroll 5 subjects. Subjects will be followed for 24 weeks after the last study product administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 1 mg/kg IV Single Dose | Experimental | Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. |
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| Group 2: 5 mg/kg IV Single Dose | Experimental | Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. |
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| Group 3: 5 mg/kg SC Single Dose | Experimental | Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. |
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| Group 4: 20 mg/kg IV Single Dose | Experimental | Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. |
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| Group 5: 40 mg/kg IV Single Dose | Experimental | Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VRC-HIVMAB075-00-AB | Biological | VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration | Subjects recorded 3-day systemic symptoms in a diary after each study product administration. Solicited systemic symptoms include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea, temperature and joint pain. Subjects recorded highest measured temperature daily. Clinicians reviewed the diary with the subject and collected resolution information for any symptoms that were not resolved within 3 days. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0. | 3 days after each product administration |
| Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration | Local symptoms assessed and recorded by the clinicians. Solicited local symptoms include pain/tenderness, swelling, redness, bruising, and pruritus (itchiness) at the product administration site. Clinicians assessed the study product administration site for local symptoms on the day of product administration after completion of the administration and on Days 1, 2 and 7 post administration. Subjects were counted once for each symptom at the worst severity if they experienced the symptom at any severity during the reporting period. If symptoms were experienced, clinicians collected resolution information for any symptom that was not resolved within 7 days. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Solicited reactogenicity recorded without an attribution assessment. If symptoms were reported, grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0. | 7 days after each product administration |
| Number of Subjects Reporting 1 or More Unsolicited Non-Serious Adverse Events |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Single Dose Groups | Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group. Serum was collected at the following time points: Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection |
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A volunteer must meet all of the following criteria:
Able and willing to complete the informed consent process.
18 to 50 years of age.
Based on history and examination, must be in good general health and without history of any of the conditions listed in the exclusion criteria.
Willing to have blood samples collected, stored indefinitely, and used for research purposes.
Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
Willing to adhere to reduced risk sexual behavior during study participation.
Screening laboratory values within 84 days prior to enrollment must meet the following criteria:
Negative for HIV infection by the FDA approved method of detection.
Female-Specific Criteria:
EXCLUSION CRITERIA:
A volunteer will be excluded if one or more of the following conditions apply:
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| Name | Affiliation | Role |
|---|---|---|
| Martin R Gaudinski, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25142607 | Background | Rudicell RS, Kwon YD, Ko SY, Pegu A, Louder MK, Georgiev IS, Wu X, Zhu J, Boyington JC, Chen X, Shi W, Yang ZY, Doria-Rose NA, McKee K, O'Dell S, Schmidt SD, Chuang GY, Druz A, Soto C, Yang Y, Zhang B, Zhou T, Todd JP, Lloyd KE, Eudailey J, Roberts KE, Donald BR, Bailer RT, Ledgerwood J; NISC Comparative Sequencing Program; Mullikin JC, Shapiro L, Koup RA, Graham BS, Nason MC, Connors M, Haynes BF, Rao SS, Roederer M, Kwong PD, Mascola JR, Nabel GJ. Enhanced potency of a broadly neutralizing HIV-1 antibody in vitro improves protection against lentiviral infection in vivo. J Virol. 2014 Nov;88(21):12669-82. doi: 10.1128/JVI.02213-14. Epub 2014 Aug 20. | |
| 20616233 |
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Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: 1 mg/kg IV Single Dose | Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| FG001 | Group 2: 5 mg/kg IV Single Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 11, 2017 |
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| Group 6: 5 mg/kg SC Multiple Doses | Experimental | Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg. |
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| Group 7: 20 mg/kg IV Multiple Doses | Experimental | Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg. |
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Unsolicited adverse events (AEs) collected during the period from study product administration at Day 0 through 56 days after the last product administration. After the indicated time period through the last expected study visit at 24 weeks after the last product administration, only new chronic medical conditions collected as unsolicited AEs. The number reported is the number of subjects who experienced at least one AE in the reporting period. A subject with multiple experiences of the same event is counted once using the event of worst severity.
| Through 24 weeks after the last product administration |
| Number of Subjects Reporting Serious Adverse Events | Serious adverse events (SAEs) collected during the period from study product administration at Day 0 through 24 weeks after the last product administration. | Through 24 weeks after the last product administration |
| Up to 24 weeks post product administration |
| Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Multiple Dose Groups | Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group. Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3: Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion | Through 24 weeks after the last product administration |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of VRC07-523LS | Tmax is the time it takes to reach Cmax of VRC07-523LS after it has been administered; it is determined based on the summary PK curve for each study group Serum was collected at the following time points: Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion | Through 24 weeks after the last product administration for Groups 1-5 and through 8 weeks after the last product administration for Groups 6 and 7 |
| 4 Week Mean Serum Concentration of VRC07-523LS | The mean of individual subject VRC07-523LS serum concentrations by administered dose group | Week 4 post product administration |
| 12 Week Mean Serum Concentration of VRC07-523LS: Single Dose Groups | The mean of individual subject VRC07-523LS serum concentrations by administered dose group | Week 12 post product administration |
| 12 Week Mean Serum Concentration of VRC07-523LS: Multiple Dose Groups | The mean of individual subject VRC07-523LS serum concentrations by administered dose group | Up to 12 weeks after each product administration |
| Area Under the Curve (AUC(0-inf)): Single Dose Groups | The total area under the curve (AUC(inf)) was taken as the sum of the observed AUC up to the final concentration (AUC(obs)) plus the AUC after the final concentration (AUC(Clast-inf)) where AUC(Clast-inf) was estimated as Clast/lz. Serum was collected at the following time points: Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection | Administration (0h) to 24 weeks post product administration |
| Area Under the Curve (AUC0-84D): Multiple Dose Groups | The AUC0-84D represents the total drug exposure in 84 days after VRC07-523LS administration; it is determined based on the summary PK curve for each group. Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3: Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion | Administration (0h) up to 84 days after each product administration |
| VRC07-523LS Clearance Rate | Rate of VRC07-523LS elimination divided by the plasma VRC07-523LS concentration; determined based on the summary PK curve for each study group. Serum was collected at the following time points: Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2 and 4 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2 and 4 post infusion | Administration (0h) to 28 days post product administration |
| Overall IV Half-life (T1/2) of VRC07-523LS | Half-life (T1/2) is the time required for half of the drug to be eliminated from the serum. Serum was collected at the following time points: Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 and 8 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 and 8 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion | Administration (0h) to 56 days post product administration |
| Number of Single Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS | Serum samples collected 4 weeks and 8 weeks after VRC07-523LS administration | Weeks 4 and 8 post product administration |
| Number of Multiple Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS | Serum samples collected 4 weeks, 28 weeks and 32 weeks after VRC07-523LS administration | Weeks 4, 28 and 32 after the first product administration |
| Background |
| Wu X, Yang ZY, Li Y, Hogerkorp CM, Schief WR, Seaman MS, Zhou T, Schmidt SD, Wu L, Xu L, Longo NS, McKee K, O'Dell S, Louder MK, Wycuff DL, Feng Y, Nason M, Doria-Rose N, Connors M, Kwong PD, Roederer M, Wyatt RT, Nabel GJ, Mascola JR. Rational design of envelope identifies broadly neutralizing human monoclonal antibodies to HIV-1. Science. 2010 Aug 13;329(5993):856-61. doi: 10.1126/science.1187659. Epub 2010 Jul 8. |
| 31473167 | Result | Gaudinski MR, Houser KV, Doria-Rose NA, Chen GL, Rothwell RSS, Berkowitz N, Costner P, Holman LA, Gordon IJ, Hendel CS, Kaltovich F, Conan-Cibotti M, Gomez Lorenzo M, Carter C, Sitar S, Carlton K, Gall J, Laurencot C, Lin BC, Bailer RT, McDermott AB, Ko SY, Pegu A, Kwon YD, Kwong PD, Namboodiri AM, Pandey JP, Schwartz R, Arnold F, Hu Z, Zhang L, Huang Y, Koup RA, Capparelli EV, Graham BS, Mascola JR, Ledgerwood JE; VRC 605 study team. Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial. Lancet HIV. 2019 Oct;6(10):e667-e679. doi: 10.1016/S2352-3018(19)30181-X. Epub 2019 Aug 28. |
Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| FG002 | Group 3: 5 mg/kg SC Single Dose | Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| FG003 | Group 4: 20 mg/kg IV Single Dose | Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| FG004 | Group 5: 40 mg/kg IV Single Dose | Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| FG005 | Group 6: 5 mg/kg SC Multiple Doses | Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| FG006 | Group 7: 20 mg/kg IV Multiple Doses | Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| Received VRC07-523LS Per Protocol |
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| Discontinued VRC07-523LS Administrations |
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| COMPLETED |
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| NOT COMPLETED |
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Population includes all enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: 1 mg/kg IV Single Dose | Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| BG001 | Group 2: 5 mg/kg IV Single Dose | Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| BG002 | Group 3: 5 mg/kg SC Single Dose | Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| BG003 | Group 4: 20 mg/kg IV Single Dose | Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| BG004 | Group 5: 40 mg/kg IV Single Dose | Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| BG005 | Group 6: 5 mg/kg SC Multiple Doses | Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| BG006 | Group 7: 20 mg/kg IV Multiple Doses | Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kg |
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| Education | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
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| Primary | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration | Subjects recorded 3-day systemic symptoms in a diary after each study product administration. Solicited systemic symptoms include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea, temperature and joint pain. Subjects recorded highest measured temperature daily. Clinicians reviewed the diary with the subject and collected resolution information for any symptoms that were not resolved within 3 days. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0. | Subjects who received VRC07-523LS (N=25), where "N" signifies number of subjects analyzed for this outcome measure. Groups 1, 2, 4, 5 and 7 are IV administration groups and Groups 3 and 6 are SC administration groups, with Groups 6 and 7 receiving multiple doses. | Posted | Count of Participants | Participants | 3 days after each product administration |
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| Primary | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration | Local symptoms assessed and recorded by the clinicians. Solicited local symptoms include pain/tenderness, swelling, redness, bruising, and pruritus (itchiness) at the product administration site. Clinicians assessed the study product administration site for local symptoms on the day of product administration after completion of the administration and on Days 1, 2 and 7 post administration. Subjects were counted once for each symptom at the worst severity if they experienced the symptom at any severity during the reporting period. If symptoms were experienced, clinicians collected resolution information for any symptom that was not resolved within 7 days. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Solicited reactogenicity recorded without an attribution assessment. If symptoms were reported, grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0. | Subjects who received VRC07-523LS (N=25), where "N" signifies number of subjects analyzed for this outcome measure. Groups 1, 2, 4, 5 and 7 are IV administration groups and Groups 3 and 6 are SC administration groups, with Groups 6 and 7 receiving multiple doses. | Posted | Count of Participants | Participants | 7 days after each product administration |
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| Primary | Number of Subjects Reporting 1 or More Unsolicited Non-Serious Adverse Events | Unsolicited adverse events (AEs) collected during the period from study product administration at Day 0 through 56 days after the last product administration. After the indicated time period through the last expected study visit at 24 weeks after the last product administration, only new chronic medical conditions collected as unsolicited AEs. The number reported is the number of subjects who experienced at least one AE in the reporting period. A subject with multiple experiences of the same event is counted once using the event of worst severity. | Subjects who received VRC07-523LS (N=25), where "N" signifies number of subjects analyzed for this outcome measure. | Posted | Count of Participants | Participants | Through 24 weeks after the last product administration |
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| Primary | Number of Subjects Reporting Serious Adverse Events | Serious adverse events (SAEs) collected during the period from study product administration at Day 0 through 24 weeks after the last product administration. | Subjects who received VRC07-523LS (N=25), where "N" signifies number of subjects analyzed for this outcome measure. | Posted | Count of Participants | Participants | Through 24 weeks after the last product administration |
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| Secondary | Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Single Dose Groups | Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group. Serum was collected at the following time points: Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection | Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). | Posted | Mean | Standard Deviation | µg/mL | Up to 24 weeks post product administration |
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| Secondary | Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Multiple Dose Groups | Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group. Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3: Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion | Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). For Dose 3, values calculated from 4 subjects per group. | Posted | Mean | Standard Deviation | µg/mL | Through 24 weeks after the last product administration |
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| Secondary | Time to Reach Maximum Observed Serum Concentration (Tmax) of VRC07-523LS | Tmax is the time it takes to reach Cmax of VRC07-523LS after it has been administered; it is determined based on the summary PK curve for each study group Serum was collected at the following time points: Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion | Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). | Posted | Mean | Standard Deviation | days | Through 24 weeks after the last product administration for Groups 1-5 and through 8 weeks after the last product administration for Groups 6 and 7 |
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| Secondary | 4 Week Mean Serum Concentration of VRC07-523LS | The mean of individual subject VRC07-523LS serum concentrations by administered dose group | Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). | Posted | Mean | Standard Deviation | µg/mL | Week 4 post product administration |
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| Secondary | 12 Week Mean Serum Concentration of VRC07-523LS: Single Dose Groups | The mean of individual subject VRC07-523LS serum concentrations by administered dose group | Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). | Posted | Mean | Standard Deviation | µg/mL | Week 12 post product administration |
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| Secondary | 12 Week Mean Serum Concentration of VRC07-523LS: Multiple Dose Groups | The mean of individual subject VRC07-523LS serum concentrations by administered dose group | Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). For Dose 3, values calculated from 4 subjects per group. | Posted | Mean | Standard Deviation | µg/mL | Up to 12 weeks after each product administration |
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| Secondary | Area Under the Curve (AUC(0-inf)): Single Dose Groups | The total area under the curve (AUC(inf)) was taken as the sum of the observed AUC up to the final concentration (AUC(obs)) plus the AUC after the final concentration (AUC(Clast-inf)) where AUC(Clast-inf) was estimated as Clast/lz. Serum was collected at the following time points: Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection | Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). | Posted | Mean | Standard Deviation | µg*d/mL | Administration (0h) to 24 weeks post product administration |
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| Secondary | Area Under the Curve (AUC0-84D): Multiple Dose Groups | The AUC0-84D represents the total drug exposure in 84 days after VRC07-523LS administration; it is determined based on the summary PK curve for each group. Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3: Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion | Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). For Dose 3, value calculated from 4 subjects per group. | Posted | Mean | Standard Deviation | µg*d/mL | Administration (0h) up to 84 days after each product administration |
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| Secondary | VRC07-523LS Clearance Rate | Rate of VRC07-523LS elimination divided by the plasma VRC07-523LS concentration; determined based on the summary PK curve for each study group. Serum was collected at the following time points: Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2 and 4 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2 and 4 post infusion | Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). Value following SC administration represents CL/F (apparent clearance). | Posted | Mean | Standard Deviation | mL/day | Administration (0h) to 28 days post product administration |
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| Secondary | Overall IV Half-life (T1/2) of VRC07-523LS | Half-life (T1/2) is the time required for half of the drug to be eliminated from the serum. Serum was collected at the following time points: Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 and 8 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 and 8 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion | Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). | Posted | Mean | Standard Deviation | days | Administration (0h) to 56 days post product administration |
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| Secondary | Number of Single Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS | Serum samples collected 4 weeks and 8 weeks after VRC07-523LS administration | Subjects who received a single dose of VRC07-523LS via SC or IV administration. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4. | Posted | Count of Participants | Participants | Weeks 4 and 8 post product administration |
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| Secondary | Number of Multiple Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS | Serum samples collected 4 weeks, 28 weeks and 32 weeks after VRC07-523LS administration | Subjects who received multiple doses of VRC07-523LS via SC or IV administration. One subject in Group 7 who only received a single dose was not included in this analysis but was analyzed with Group 4 (single dose at 20 mg/kg IV). | Posted | Count of Participants | Participants | Weeks 4, 28 and 32 after the first product administration |
|
|
Solicited adverse events (AEs) included systemic AEs reported by subjects at the worst severity through 3 days post any product administration; and local administration site AEs reported for subjects at the worst severity through 7 days post any product administration. Unsolicited AEs were reported from the date of product administration through 56 days thereafter, and new chronic medical conditions and SAEs with onset any time following the date of last product administration through 24 weeks.
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: 1 mg/kg IV Single Dose | Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG001 | Group 2: 5 mg/kg IV Single Dose | Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG002 | Group 4: 20 mg/kg IV Single Dose | Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG003 | Group 5: 40 mg/kg IV Single Dose | Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG004 | Group 7: 20 mg/kg IV Multiple Doses | Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG005 | Group 3: 5 mg/kg SC Single Dose | Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG006 | Group 6: 5 mg/kg SC Multiple Doses | Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. | 0 | 5 | 0 | 5 | 5 | 5 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 21.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 21.1 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 21.1 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 21.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 21.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 21.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Femoroacetabular impingement | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Administration site pain/tenderness | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Administration site bruise | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Administration site erythema | General disorders | MedDRA 21.1 | Systematic Assessment | Redness |
|
| Malaise | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment | Temperature (Fever) |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment | Joint Pain |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martin Gaudinski, MD | Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health | 301-451-8715 | martin.gaudinski@nih.gov |
| Feb 4, 2020 |
| Prot_SAP_ICF_001.pdf |
| 31-40 years |
|
| 41-50 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| White |
|
| Multiracial |
|
| College/University |
|
| Advanced degree |
|
Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg.
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.
| OG006 | Group 7: 20 mg/kg IV Multiple Doses: Dose 3 | Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG007 | Overall IV Groups | Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups |
| OG008 | Group 3: 5 mg/kg SC Single Dose | Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG009 | Group 6: 5 mg/kg SC Multiple Doses: Dose 1 | Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG010 | Group 6: 5 mg/kg SC Multiple Doses: Dose 2 | Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG011 | Group 6: 5 mg/kg SC Multiple Doses: Dose 3 | Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG012 | Overall SC Groups | Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups |
| Mild |
|
| Moderate |
|
| Myalgia |
|
| Headache |
|
| Chills |
|
| Nausea |
|
| Temperature |
|
| Joint Pain |
|
| Any Systemic Symptom Reported |
|
| OG001 | Group 2: 5 mg/kg IV Single Dose | Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG002 | Group 4: 20 mg/kg IV Single Dose | Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG003 | Group 5: 40 mg/kg IV Single Dose | Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG004 | Group 7: 20 mg/kg IV Multiple Doses: Dose 1 | Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG005 | Group 7: 20 mg/kg IV Multiple Doses: Dose 2 | Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG006 | Group 7: 20 mg/kg IV Multiple Doses: Dose 3 | Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG007 | Overall IV Groups | Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups |
| OG008 | Group 3: 5 mg/kg SC Single Dose | Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG009 | Group 6: 5 mg/kg SC Multiple Doses: Dose 1 | Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG010 | Group 6: 5 mg/kg SC Multiple Doses: Dose 2 | Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG011 | Group 6: 5 mg/kg SC Multiple Doses: Dose 3 | Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG012 | Overall SC Groups | Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups |
|
|
| OG002 | Group 3: 5 mg/kg SC Single Dose | Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG003 | Group 4: 20 mg/kg IV Single Dose | Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG004 | Group 5: 40 mg/kg IV Single Dose | Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG005 | Group 6: 5 mg/kg SC Multiple Doses | Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG006 | Group 7: 20 mg/kg IV Multiple Doses | Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG007 | Overall | Total number of subjects who received VRC07-523LS (VRC-HIVMAB075-00-AB) |
|
|
| OG003 | Group 4: 20 mg/kg IV Single Dose | Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG004 | Group 5: 40 mg/kg IV Single Dose | Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG005 | Group 6: 5 mg/kg SC Multiple Doses | Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG006 | Group 7: 20 mg/kg IV Multiple Doses | Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG007 | Overall | Total number of subjects who received VRC07-523LS (VRC-HIVMAB075-00-AB) |
|
|
| OG002 | Group 3: 5 mg/kg SC Single Dose | Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG003 | Group 4: 20 mg/kg IV Single Dose | Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG004 | Group 5: 40 mg/kg IV Single Dose | Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
|
|
| OG001 | Group 7: 20 mg/kg IV Multiple Doses | Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
|
|
| OG001 |
| Group 2: 5 mg/kg IV Single Dose |
Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG002 | Group 3: 5 mg/kg SC Single Dose | Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG003 | Group 4: 20 mg/kg IV Single Dose | Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG004 | Group 5: 40 mg/kg IV Single Dose | Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG005 | Group 6: 5 mg/kg SC Multiple Doses | Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG006 | Group 7: 20 mg/kg IV Multiple Doses | Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
|
|
| OG003 | Group 4: 20 mg/kg IV Single Dose | Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG004 | Group 5: 40 mg/kg IV Single Dose | Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG005 | Group 6: 5 mg/kg SC Multiple Doses | Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG006 | Group 7: 20 mg/kg IV Multiple Doses | Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
|
|
| OG003 | Group 4: 20 mg/kg IV Single Dose | Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG004 | Group 5: 40 mg/kg IV Single Dose | Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| OG002 | Group 3: 5 mg/kg SC Single Dose | Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG003 | Group 4: 20 mg/kg IV Single Dose | Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG004 | Group 5: 40 mg/kg IV Single Dose | Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
|
|
| OG001 | Group 7: 20 mg/kg IV Multiple Doses | Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
|
|
Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG002 | Group 4: 20 mg/kg IV Single Dose | Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG003 | Group 5: 40 mg/kg IV Single Dose | Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG004 | Group 7: 20 mg/kg IV Multiple Doses | Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG005 | Overall IV Groups | Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups |
| OG006 | Group 3: 5 mg/kg SC Single Dose | Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG007 | Group 6: 5 mg/kg SC Multiple Doses | Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG008 | Overall SC Groups | Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups |
|
|
| OG002 | Group 4: 20 mg/kg IV Single Dose | Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG003 | Group 5: 40 mg/kg IV Single Dose | Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG004 | Group 7: 20 mg/kg IV Multiple Doses | Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG005 | Overall IV Groups | Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups |
| OG006 | Group 3: 5 mg/kg SC Single Dose | Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG007 | Group 6: 5 mg/kg SC Multiple Doses | Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG008 | Overall SC Groups | Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups |
|
|
| OG003 | Group 4: 20 mg/kg IV Single Dose | Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
| OG004 | Group 5: 40 mg/kg IV Single Dose | Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1. |
|
|
| Participants |
|
|
| Mild |
|
| Moderate |
|
| Mild |
|
| Moderate |
|
| Mild |
|
| Moderate |
|
| Mild |
|
| Moderate |
|
| Mild |
|
| Moderate |
|