NCT01993706

Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), Administered Intravenously or Subcutaneously to Healthy Adults

Completed Phase 1 Last updated 17 December 2019

What this trial tests

Phase 1 trial testing VRC-HIVMAB060-00-AB in HIV Infection in 29 participants. Completed in 27 February 2015.

Timeline

19 November 2013

Primary endpoint
27 February 2015

27 February 2015

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Primary purpose	prevention
Enrollment	29
Start date	19 November 2013
Primary completion	27 February 2015
Estimated completion	27 February 2015
Sites	1 location across United States

Drugs / interventions tested

• VRC-HIVMAB060-00-AB — full drug profile →

Conditions studied

• HIV Infection — all drugs for HIV Infection →
• Monoclonal Antibody, Human — all drugs for Monoclonal Antibody, Human →
• HIV Antibodies — all drugs for HIV Antibodies →
• VRC01 Monoclonal Antibody — all drugs for VRC01 Monoclonal Antibody →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 50, any sex, with HIV Infection or Monoclonal Antibody, Human. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- VRC01 is a manmade antibody directed against the human immunodeficiency virus (HIV). Antibodies fight infection. Researchers eventually want to know if VRC01 helps prevent or treat HIV infection. In this study they want to know if the study drug is safe if taken in a vein or under the skin. Taking VRC01 in this study will not protect against HIV infection.

Objectives:

\- To see if VRC01 and placebo are safe and well tolerated.

Eligibility:

\- Healthy adults 18 to 50 years old.

Design:

* Participants will be screened with medical history, physical exam, and lab tests.
* Participants will be randomly divided into 4 groups. VRC01 or the placebo will be given in weeks 1 and 4. Blood samples will be taken several times after each VRC01 or placebo dose.
* Three groups will receive VRC01 by needle into a vein with an IV pump. It will take about 1 hour and it is done in the hospital.
* One group will receive either VRC01 or the placebo by needle into the fatty tissue under the skin, usually the belly. It will take up to 20 minutes and it is done in the hospital.
* Participants will stay in the hospital overnight after receiving the medication and have about 14 clinic visits over 4 months. Most clinic visits last about 2 hours.
* Participants will keep a symptom diary after receiving the medicatino.
* Participants can volunteer to have mouth, rectal, and genital samples taken throughout the study.
* The study will last 8 months.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Trials of Broadly Neutralizing Monoclonal Antibodies for Human Immunodeficiency Virus Prevention: A Review.
   Mahomed S, Garrett N, Baxter C, Abdool Karim Q, et al · · 2021 · cited 77× · PMID 32604408 · DOI 10.1093/infdis/jiaa377
2. Broadly Neutralizing Antibodies for HIV-1 Prevention.
   Walsh SR, Seaman MS. · · 2021 · cited 73× · PMID 34354713 · DOI 10.3389/fimmu.2021.712122
3. Broadly neutralizing monoclonal antibodies for HIV prevention.
   Miner MD, Corey L, Montefiori D. · · 2021 · cited 34× · PMID 34806308 · DOI 10.1002/jia2.25829
4. The Use of Broadly Neutralizing Antibodies (bNAbs) in HIV-1 Treatment and Prevention.
   Thavarajah JJ, Hønge BL, Wejse CM. · · 2024 · cited 31× · PMID 38932203 · DOI 10.3390/v16060911
5. Vectored antibody gene delivery for the prevention or treatment of HIV infection.
   Deal CE, Balazs AB. · · 2015 · cited 27× · PMID 25700206 · DOI 10.1097/coh.0000000000000145
6. Impact of LS Mutation on Pharmacokinetics of Preventive HIV Broadly Neutralizing Monoclonal Antibodies: A Cross-Protocol Analysis of 16 Clinical Trials in People without HIV.
   Mayer BT, Zhang L, deCamp AC, Yu C, et al · · 2024 · cited 18× · PMID 38794258 · DOI 10.3390/pharmaceutics16050594
7. Strategies for preventing mucosal cell-associated HIV transmission.
   Whaley KJ, Mayer KH. · · 2014 · cited 9× · PMID 25414423 · DOI 10.1093/infdis/jiu398
8. The potential of broadly neutralizing antibodies for HIV prevention.
   Gelderblom HC, Corey L, Barouch DH. · · 2024 · cited 8× · PMID 38757844 · DOI 10.1002/jia2.26257