HIVPhase 1VRC 611NCT04408963
A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults
A Phase 1 study testing VRC-HIVMAB0102-00-AB in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs. Researchers want to test an antibody, CAP256V2LS. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- VRC-HIVMAB0102-00-AB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2022to 28 Nov 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A volunteer must have met all of the following criteria to be included:
- Able and willing to complete the informed consent process
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
- Available for clinical follow-up through the last study visit
- 18 to 60 years of age
- Based on medical history and physical examination, in good health and without clinically significant findings within 84 days prior to enrollment.
Show all 19Show fewer
- Weight less than or equal to 115 kg
- Willing to have blood samples collected, stored indefinitely, and used for research purposes
- Laboratory Criteria within 84 days prior to enrollment:
- White Blood Cell (WBC) 2,500-12,000/mm^3
- WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval
- Platelets = 125,000-500,000/mm^3
- Hemoglobin within institutional normal range or accompanied by the PI or designee approval
- Creatinine less than or equal to 1.1 x upper limit of normal (ULN) based on the institutional normal range
- Alanine aminotransferase (ALT) less than or equal to 1.25 x ULN based on the institutional normal range
- Negative for HIV infection by an FDA approved method of detection
- Criteria Specific to Women of Childbearing Potential:
- Negative beta-human chorionic gonadotropin (HCG) pregnancy test (urine or serum) on day of enrollment, and prior to product administration
- Agrees to use an effective means of birth control from at least 21 days prior to enrollment through the duration of study participation
Who cannot join
- A volunteer was excluded if one or more of the following conditions applied:
- Woman who is breast-feeding or planning to become pregnant during study participation
- Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the study
- Hypertension that is not well controlled
- Receipt of any investigational study product within 28 days prior to enrollment. Note: SARS-CoV-2 vaccines approved by emergency use authorization are not exclusionary.
- Receipt of any live attenuated vaccines within 28 days prior to enrollment.
Show all 10Show fewer
- Receipt of any vaccine within 2 weeks prior to enrollment/product administration
- Prior receipt of a licensed or investigational monoclonal antibody
- Prior receipt of an HIV vaccine
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a participant's ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: VRC 611: A Phase 1 Safety and Pharmacokinetic Study to Evaluate a Human Monoclonal Antibody (mAb) VRC-HIVMAB0102-00-AB (CAP256V2LS) Administered Via Subcutaneous and Intravenous Injection in Healthy Adults
Background:
HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs. Researchers want to test an antibody, CAP256V2LS.
Read more
Objective:
To test CAP256V2LS to see if it is safe and how the body responds to it.
Eligibility:
Healthy people, ages 18-60
Design:
Participants were screened with a medical history, physical exam, and blood tests. Some females had a pregnancy test.
Participants were assigned to one of two groups. Based on their group, they got 1 dose of CAP256V2LS in 1 of 2 ways:
- Some participants got CAP256V2LS as an infusion. A thin tube was placed in an arm vein and CAP256V2LS was given into the vein using a pump.
- Some participants got CAP256V2LS injected under the skin. A small needle was used to inject CAP256V2LS into the fatty tissue of the belly, arm, or thigh. They got 1 to 4 injections.
On the day they got CAP256V2LS, participants gave blood samples at different time points.
Participants were asked to check their temperature every day for 7 days after receiving CAP256V2LS. They used a tool to measure any redness, swelling, or bruising they may have at the site where they received the study drug.
Participants had visits at least 2-3 times during the first week after they got CAP256V2LS. Then they had about 9 more visits over the next 6 months. Visits included blood tests.
Read the detailed description
Design:
This open-label study evaluated CAP256V2LS (VRC-HIVMAB0102-00-AB) in healthy adults. The primary hypothesis was that subcutaneous (SC) and intravenous (IV) administrations of CAP256V2LS will be safe and well-tolerated in healthy adults. A secondary hypothesis was that CAP256V2LS will be detectable in human sera with a definable half-life.
Study Product:
The CAP256V2LS broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo. This bNAb was developed by the VRC/NIAID/NIH in collaboration with The Centre for the AIDS Programme of Research in South Africa (CAPRISA) and is manufactured under current Good Manufacturing Practice (cGMP) regulations at the VRC Pilot Plant operated under contract by the Vaccine Clinical Materials Program (VCMP), Leidos Biomedical Research, Inc., Frederick. MD. The CAP256V2LS drug product is supplied at a concentration of 100 mg/mL in a sterile, aqueous, buffered solution of 6.25 mL in single-use 10 mL glass vials. R-Gene10 was added as a stabilizing agent to IV doses of CAP256V2LS. R-Gene10 (Arginine Hydrochloride Injection, USP) for intravenous infusion contains L-Arginine Hydrochloride, USP in Water for Injection (equivalent to a 10% solution).
Participants:
Healthy participants, 18-60 years of age
Study Plan:
This open-label study included 2 dosing regimens with CAP256V2LS administered at 5 mg/kg IV and 5 mg/kg SC. A single dose of the study product was administered on Day 0 as shown below.
VRC 611 Study Design
- Group 1
- Study Product: CAP256V2LS
- Participants per Group: 5
- Dose (mg/kg) and Route Administered on Day 0: 5 mg/kg IV
- Group 2
- Study Product: CAP256V2LS
- Participants per Group: 5
- Dose (mg/kg) and Route Administered on Day 0: 5 mg/kg SC
Total Participants: 10
Duration:
Study participation was approximately 24 weeks from the Day 0 product administration.
- Conditions
- HIV
- Being tested
- VRC-HIVMAB0102-00-AB
- Keywords
- HIV Prevention, Broadly-Neutralizing Human Monoclonal Antibodies, First in Human, Anti-Drug Antibody Response, Antibodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRC-HIVMAB0102-00-ABBiological
Also called CAP256V2LS
The VRC-HIVMAB0102-00-AB (CAP256V2LS) broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: CAP256V2LS (5 mg/kg IV) | Experimental | CAP256V2LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0) Receives: Biological: VRC-HIVMAB0102-00-AB |
| Group 2: CAP256V2LS (5 mg/kg SC) | Experimental | CAP256V2LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) Receives: Biological: VRC-HIVMAB0102-00-AB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CAP256V2LS Product Administration
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
Measured: 7 days after CAP256V2LS product administration, at approximately Week 1
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CAP256V2LS Product Administration
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
Measured: 7 days after CAP256V2LS product administration, at approximately Week 1
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following CAP256V2LS Product Administration
Unsolicited adverse event (AE) data collection included AEs of all severities from the date of product administration through the Day 28 post-product administration visit. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that required ongoing medical management (reported as a separate outcome) were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Measured: Day 0 through 4 weeks after CAP256V2LS Product Administration
Number of Participants With Serious Adverse Events (SAEs) Following CAP256V2LS Product Administration
SAEs were recorded from receipt of study product administration through the last expected study visit at Week 24. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Measured: Day 0 after CAP256V2LS product administration through the study participation, up to Week 24
Number of Participants With New Chronic Medical Conditions Following CAP256V2LS Product Administration
New chronic medical conditions that required ongoing medical management were recorded from receipt of first study product administration through the last expected study visit at Week 24. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Measured: Day 0 after CAP256V2LS product administration through the study participation, up to Week 24
Number of Participants With Abnormal Laboratory Measures of Safety Following CAP256V2LS Product Administration
Abnormal laboratory results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV) platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete Blood Count (CBC) with differential and Chemistry (ALT and creatinine) results were collected at different timepoints throughout the study per the protocol's schedule of evaluations. Comprehensive metabolic panel (CMP) was collected at baseline, and 2 weeks after product administration and as needed at additional timepoints. Institutional laboratory normal ranges as well as the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 were used.
Measured: Day 0 through 4 weeks after CAP256V2LS Product Administration
Secondary outcomes (5)
Pharmacokinetic (PK) Parameters of CAP256V2LS: Maximum Observed Serum Concentration (Cmax)
Cmax is the peak serum concentration that CAP256V2LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.
Measured: Baseline through 24 weeks after CAP256V2LS product administration
Pharmacokinetic (PK) Parameters of CAP256V2LS: Time to Reach Maximum Observed Serum Concentration (Tmax)
Tmax is the time it takes to reach Cmax of CAP256V2LS after it has been administered; it is determined based on the summary PK curve for each dose group.
Measured: Baseline through 24 weeks after CAP256V2LS product administration
Pharmacokinetic (PK) Parameters of CAP256V2LS: Beta Half-life (T1/2b)
Beta half-life (T1/2b) is the time required for half of the CAP256V2LS product to be eliminated from the serum.
Measured: Baseline through 24 weeks after CAP256V2LS product administration
Pharmacokinetic (PK) Parameters of CAP256V2LS: Clearance Rate
Clearance is the rate of CAP256V2LS elimination divided by the plasma CAP256V2LS concentration; determined based on the summary pharmacokinetic (PK) curve for each study group. Clearance following a SC administration is calculated as Clearance (CL)/Bioavailability (F).
Measured: Baseline through 24 weeks after CAP256V2LS product administration
Pharmacokinetic (PK) Parameters of CAP256V2LS: Volume of Distribution
Theoretical volume that would be necessary to contain the total amount of administered drug at the same concentration as observed in plasma. It represents the degree to which a drug is distributed in body tissue rather than the plasma and calculated based in the PK curve for each study group. Volume of distribution following a SC administration is calculated as Volume of distribution (V)/Bioavailability (F).
Measured: Baseline through 24 weeks after CAP256V2LS product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start22 Mar 2022
- Primary completion28 Nov 2022
- Study completion28 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Richard L Wu, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408963
- Sponsor's protocol ID
- 200096
- Other IDs
- 20-I-0096
- Acronym
- VRC 611
- Status last verified
- Dec 2023
- First submitted
- 29 May 2020
- Last updated
- 11 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ko SY, Pegu A, Rudicell RS, Yang ZY, Joyce MG, Chen X, Wang K, Bao S, Kraemer TD, Rath T, Zeng M, Schmidt SD, Todd JP, Penzak SR, Saunders KO, Nason MC, Haase AT, Rao SS, Blumberg RS, Mascola JR, Nabel GJ. Enhanced neonatal Fc receptor function improves protection against primate SHIV infection. Nature. 2014 Oct 30;514(7524):642-5. doi: 10.1038/nature13612. Epub 2014 Aug 13.
PubMed 25119033Doria-Rose NA, Schramm CA, Gorman J, Moore PL, Bhiman JN, DeKosky BJ, Ernandes MJ, Georgiev IS, Kim HJ, Pancera M, Staupe RP, Altae-Tran HR, Bailer RT, Crooks ET, Cupo A, Druz A, Garrett NJ, Hoi KH, Kong R, Louder MK, Longo NS, McKee K, Nonyane M, O'Dell S, Roark RS, Rudicell RS, Schmidt SD, Sheward DJ, Soto C, Wibmer CK, Yang Y, Zhang Z; NISC Comparative Sequencing Program; Mullikin JC, Binley JM, Sanders RW, Wilson IA, Moore JP, Ward AB, Georgiou G, Williamson C, Abdool Karim SS, Morris L, Kwong PD, Shapiro L, Mascola JR. Developmental pathway for potent V1V2-directed HIV-neutralizing antibodies. Nature. 2014 May 1;509(7498):55-62. doi: 10.1038/nature13036. Epub 2014 Mar 2.
PubMed 24590074Doria-Rose NA, Bhiman JN, Roark RS, Schramm CA, Gorman J, Chuang GY, Pancera M, Cale EM, Ernandes MJ, Louder MK, Asokan M, Bailer RT, Druz A, Fraschilla IR, Garrett NJ, Jarosinski M, Lynch RM, McKee K, O'Dell S, Pegu A, Schmidt SD, Staupe RP, Sutton MS, Wang K, Wibmer CK, Haynes BF, Abdool-Karim S, Shapiro L, Kwong PD, Moore PL, Morris L, Mascola JR. New Member of the V1V2-Directed CAP256-VRC26 Lineage That Shows Increased Breadth and Exceptional Potency. J Virol. 2015 Oct 14;90(1):76-91. doi: 10.1128/JVI.01791-15. Print 2016 Jan 1.
PubMed 26468542
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VRC 611: A Phase 1 Safety and Pharmacokinetic Study to Evaluate a Human Monoclonal Antibody (mAb) VRC-HIVMAB0102-00-AB (CAP256V2LS) Administered Via Subcutaneous and Intravenous Injection in Healthy Adults
- ClinicalTrials.gov ID
- NCT04408963
- Acronym / sponsor ID
- VRC 611 / 200096
- Conditions
- HIV
- Keywords
- HIV Prevention, Broadly-Neutralizing Human Monoclonal Antibodies, First in Human, Anti-Drug Antibody Response, Antibodies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Posted 18 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs. Researchers want to test an antibody, CAP256V2LS.
Objective:
To test CAP256V2LS to see if it is safe and how the body responds to it.
Eligibility:
Healthy people, ages 18-60
Design:
Participants were screened with a medical history, physical exam, and blood tests. Some females had a pregnancy test.
Participants were assigned to one of two groups. Based on their group, they got 1 dose of CAP256V2LS in 1 of 2 ways:
- Some participants got CAP256V2LS as an infusion. A thin tube was placed in an arm vein and CAP256V2LS was given into the vein using a pump.
- Some participants got CAP256V2LS injected under the skin. A small needle was used to inject CAP256V2LS into the fatty tissue of the belly, arm, or thigh. They got 1 to 4 injections.
On the day they got CAP256V2LS, participants gave blood samples at different time points.
Participants were asked to check their temperature every day for 7 days after receiving CAP256V2LS. They used a tool to measure any redness, swelling, or bruising they may have at the site where they received the study drug.
Participants had visits at least 2-3 times during the first week after they got CAP256V2LS. Then they had about 9 more visits over the next 6 months. Visits included blood tests.
Detailed description
Design:
This open-label study evaluated CAP256V2LS (VRC-HIVMAB0102-00-AB) in healthy adults. The primary hypothesis was that subcutaneous (SC) and intravenous (IV) administrations of CAP256V2LS will be safe and well-tolerated in healthy adults. A secondary hypothesis was that CAP256V2LS will be detectable in human sera with a definable half-life.
Study Product:
The CAP256V2LS broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo. This bNAb was developed by the VRC/NIAID/NIH in collaboration with The Centre for the AIDS Programme of Research in South Africa (CAPRISA) and is manufactured under current Good Manufacturing Practice (cGMP) regulations at the VRC Pilot Plant operated under contract by the Vaccine Clinical Materials Program (VCMP), Leidos Biomedical Research, Inc., Frederick. MD. The CAP256V2LS drug product is supplied at a concentration of 100 mg/mL in a sterile, aqueous, buffered solution of 6.25 mL in single-use 10 mL glass vials. R-Gene10 was added as a stabilizing agent to IV doses of CAP256V2LS. R-Gene10 (Arginine Hydrochloride Injection, USP) for intravenous infusion contains L-Arginine Hydrochloride, USP in Water for Injection (equivalent to a 10% solution).
Participants:
Healthy participants, 18-60 years of age
Study Plan:
This open-label study included 2 dosing regimens with CAP256V2LS administered at 5 mg/kg IV and 5 mg/kg SC. A single dose of the study product was administered on Day 0 as shown below.
VRC 611 Study Design
- Group 1
- Study Product: CAP256V2LS
- Participants per Group: 5
- Dose (mg/kg) and Route Administered on Day 0: 5 mg/kg IV
- Group 2
- Study Product: CAP256V2LS
- Participants per Group: 5
- Dose (mg/kg) and Route Administered on Day 0: 5 mg/kg SC
Total Participants: 10
Duration:
Study participation was approximately 24 weeks from the Day 0 product administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: CAP256V2LS (5 mg/kg IV) | Experimental | Biological: VRC-HIVMAB0102-00-ABCAP256V2LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0) |
| Group 2: CAP256V2LS (5 mg/kg SC) | Experimental | Biological: VRC-HIVMAB0102-00-ABCAP256V2LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Able and willing to complete the informed consent process
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
- Available for clinical follow-up through the last study visit
- 18 to 60 years of age
- Based on medical history and physical examination, in good health and without clinically significant findings within 84 days prior to enrollment.
Key exclusion criteria (10 listed)
- Woman who is breast-feeding or planning to become pregnant during study participation
- Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the study
- Hypertension that is not well controlled
- Receipt of any investigational study product within 28 days prior to enrollment. Note: SARS-CoV-2 vaccines approved by emergency use authorization are not exclusionary.
- Receipt of any live attenuated vaccines within 28 days prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRC-HIVMAB0102-00-ABAlso: CAP256V2LSThe VRC-HIVMAB0102-00-AB (CAP256V2LS) broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo. | Biological | Group 1: CAP256V2LS (5 mg/kg IV), Group 2: CAP256V2LS (5 mg/kg SC) |
Primary outcome
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CAP256V2LS Product Administration
Time frame: 7 days after CAP256V2LS product administration, at approximately Week 1
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CAP256V2LS Product Administration
Time frame: 7 days after CAP256V2LS product administration, at approximately Week 1
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following CAP256V2LS Product Administration
Time frame: Day 0 through 4 weeks after CAP256V2LS Product Administration
Unsolicited adverse event (AE) data collection included AEs of all severities from the date of product administration through the Day 28 post-product administration visit. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that required ongoing medical management (reported as a separate outcome) were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Number of Participants With Serious Adverse Events (SAEs) Following CAP256V2LS Product Administration
Time frame: Day 0 after CAP256V2LS product administration through the study participation, up to Week 24
SAEs were recorded from receipt of study product administration through the last expected study visit at Week 24. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Number of Participants With New Chronic Medical Conditions Following CAP256V2LS Product Administration
Time frame: Day 0 after CAP256V2LS product administration through the study participation, up to Week 24
New chronic medical conditions that required ongoing medical management were recorded from receipt of first study product administration through the last expected study visit at Week 24. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Number of Participants With Abnormal Laboratory Measures of Safety Following CAP256V2LS Product Administration
Time frame: Day 0 through 4 weeks after CAP256V2LS Product Administration
Abnormal laboratory results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV) platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete Blood Count (CBC) with differential and Chemistry (ALT and creatinine) results were collected at different timepoints throughout the study per the protocol's schedule of evaluations. Comprehensive metabolic panel (CMP) was collected at baseline, and 2 weeks after product administration and as needed at additional timepoints. Institutional laboratory normal ranges as well as the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 were used.
5 secondary outcomes
Pharmacokinetic (PK) Parameters of CAP256V2LS: Maximum Observed Serum Concentration (Cmax)
Time frame: Baseline through 24 weeks after CAP256V2LS product administration
Pharmacokinetic (PK) Parameters of CAP256V2LS: Time to Reach Maximum Observed Serum Concentration (Tmax)
Time frame: Baseline through 24 weeks after CAP256V2LS product administration
Pharmacokinetic (PK) Parameters of CAP256V2LS: Beta Half-life (T1/2b)
Time frame: Baseline through 24 weeks after CAP256V2LS product administration
Pharmacokinetic (PK) Parameters of CAP256V2LS: Clearance Rate
Time frame: Baseline through 24 weeks after CAP256V2LS product administration
Pharmacokinetic (PK) Parameters of CAP256V2LS: Volume of Distribution
Time frame: Baseline through 24 weeks after CAP256V2LS product administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25119033Ko SY, Pegu A, Rudicell RS, Yang ZY, Joyce MG, Chen X, Wang K, Bao S, Kraemer TD, Rath T, Zeng M, Schmidt SD, Todd JP, Penzak SR, Saunders KO, Nason MC, Haase AT, Rao SS, Blumberg RS, Mascola JR, Nabel GJ. Enhanced neonatal Fc receptor function improves protection against primate SHIV infection. Nature. 2014 Oct 30;514(7524):642-5. doi: 10.1038/nature13612. Epub 2014 Aug 13.
- Background: PubMed 24590074Doria-Rose NA, Schramm CA, Gorman J, Moore PL, Bhiman JN, DeKosky BJ, Ernandes MJ, Georgiev IS, Kim HJ, Pancera M, Staupe RP, Altae-Tran HR, Bailer RT, Crooks ET, Cupo A, Druz A, Garrett NJ, Hoi KH, Kong R, Louder MK, Longo NS, McKee K, Nonyane M, O'Dell S, Roark RS, Rudicell RS, Schmidt SD, Sheward DJ, Soto C, Wibmer CK, Yang Y, Zhang Z; NISC Comparative Sequencing Program; Mullikin JC, Binley JM, Sanders RW, Wilson IA, Moore JP, Ward AB, Georgiou G, Williamson C, Abdool Karim SS, Morris L, Kwong PD, Shapiro L, Mascola JR. Developmental pathway for potent V1V2-directed HIV-neutralizing antibodies. Nature. 2014 May 1;509(7498):55-62. doi: 10.1038/nature13036. Epub 2014 Mar 2.
- Background: PubMed 26468542Doria-Rose NA, Bhiman JN, Roark RS, Schramm CA, Gorman J, Chuang GY, Pancera M, Cale EM, Ernandes MJ, Louder MK, Asokan M, Bailer RT, Druz A, Fraschilla IR, Garrett NJ, Jarosinski M, Lynch RM, McKee K, O'Dell S, Pegu A, Schmidt SD, Staupe RP, Sutton MS, Wang K, Wibmer CK, Haynes BF, Abdool-Karim S, Shapiro L, Kwong PD, Moore PL, Morris L, Mascola JR. New Member of the V1V2-Directed CAP256-VRC26 Lineage That Shows Increased Breadth and Exceptional Potency. J Virol. 2015 Oct 14;90(1):76-91. doi: 10.1128/JVI.01791-15. Print 2016 Jan 1.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard L Wu, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VRC-HIVMAB0102-00-AB in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CAP256V2LS Product Administration (time frame: 7 days after CAP256V2LS product administration, at approximately Week 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04408963, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.