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Monoclonal Antibodies

VRC-HIVMAB0102-00-AB for HIV/AIDS (VRC 611 Trial)

Phase 1

Waitlist Available

Led By Alicia T Widge, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days after cap256v2ls product administration, at approximately week 1

Awards & highlights

VRC 611 Trial Summary

This trial is testing an experimental antibody to see if it is safe and if it can prevent HIV infection.

VRC 611 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days after cap256v2ls product administration, at approximately week 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days after cap256v2ls product administration, at approximately week 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after cap256v2ls product administration, at approximately week 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CAP256V2LS Product Administration

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CAP256V2LS Product Administration

Number of Participants With Abnormal Laboratory Measures of Safety Following CAP256V2LS Product Administration

+3 more

Secondary outcome measures

Pharmacokinetic (PK) Parameters of CAP256V2LS: Beta Half-life (T1/2b)

Pharmacokinetic (PK) Parameters of CAP256V2LS: Clearance Rate

Pharmacokinetic (PK) Parameters of CAP256V2LS: Maximum Observed Serum Concentration (Cmax)

+2 more

Side effects data

From 2022 Phase 1 trial • 10 Patients • NCT04408963

100%

Lymphopenia

100%

Malaise

100%

Headache

100%

Chills

100%

Myalgia

80%

Pyrexia

80%

Arthralgia

40%

Nausea

40%

Hypertension

20%

Transaminases Increased

20%

Abdominal Pain

20%

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Group 1: CAP256V2LS (5 mg/kg IV)

Group 2: CAP256V2LS (5 mg/kg SC)

VRC 611 Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2: CAP256V2LS (5 mg/kg SC)Experimental Treatment1 Intervention

CAP256V2LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)

Group II: Group 1: CAP256V2LS (5 mg/kg IV)Experimental Treatment1 Intervention

CAP256V2LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VRC-HIVMAB0102-00-AB

2022

Completed Phase 1

~10

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,485,227 Total Patients Enrolled

Alicia T Widge, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)

3 Previous Clinical Trials

137 Total Patients Enrolled

Seemal F Awan, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)

1 Previous Clinical Trials

33 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned VRC-HIVMAB0102-00-AB for medicinal purposes?

"Due to its Phase 1 nature, our team at Power only gave VRC-HIVMAB0102-00-AB a score of one for safety. This is because there are minimal data points in regards to the drug's efficacy and security measures."

Answered by AI

Is this medical trial admitting participants younger than 55?

"The prerequisites for this medical trial necessitate that participants are aged between 18 to 60. In contrast, there are 57 trials specifically targeting minors and 176 studies suitable for patients over 65 years old."

Answered by AI

Is there a current recruitment process for this trial?

"Contrary to clinicaltrials.gov's records, this medical trial is not actively recruiting participants. Although the first posting date was March 22nd 2022 and it last received an update on November 18th 2022, there are 238 other trials which currently require new enrollees."

Answered by AI

What criteria must be met for participation in this clinical study?

"This clinical trial is looking for 20 individuals living with HIV aged between 18 and 60. To qualify, potential participants must meet the following standards: be willing to provide informed consent, present legal identification documents, commit to medical follow-up until completion of the study, weigh no more than 115 kilograms (255 pounds), allow indefinite storage and use of blood samples in research purposes; display a WBC differential within institutional normal range or obtain approval from principal investigator/designee; have platelet values ranging from 125k - 500k/mm3; possess white blood cell counts between 2.5-12K/mm3."

Answered by AI

Recent research and studies

NatureJournal

Enhanced Neonatal Fc Receptor Function Improves Protection Against Primate SHIV Infection

Ko, Sung-Youl, Amarendra Pegu, Rebecca S. Rudicell, Zhi-yong Yang, M. Gordon Joyce, Xuejun Chen, Keyun Wang, et al.. 2014. “Enhanced Neonatal Fc Receptor Function Improves Protection Against Primate SHIV Infection”. Nature. Springer Science and Business Media LLC. doi:10.1038/nature13612.

NatureJournal

Developmental Pathway for Potent V1v2-directed Hiv-neutralizing Antibodies

Doria-Rose, Nicole A., NISC Comparative Sequencing, Chaim A. Schramm, Jason Gorman, Penny L. Moore, Jinal N. Bhiman, Brandon J. DeKosky, et al.. 2014. “Developmental Pathway for Potent V1v2-directed Hiv-neutralizing Antibodies”. Nature. Springer Science and Business Media LLC. doi:10.1038/nature13036.

Journal of VirologyJournal

New Member of the V1v2-directed CAP256-VRC26 Lineage That Shows Increased Breadth and Exceptional Potency

Doria-Rose, Nicole A., Jinal N. Bhiman, Ryan S. Roark, Chaim A. Schramm, Jason Gorman, Gwo-Yu Chuang, Marie Pancera, et al.. 2016. “New Member of the V1v2-directed CAP256-VRC26 Lineage That Shows Increased Breadth and Exceptional Potency”. Edited by G. Silvestri. Journal of Virology. American Society for Microbiology. doi:10.1128/jvi.01791-15.

clinicaltrials.govStudy