Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), Administered Intravenously or Subcutaneously to Healthy Adults
- 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.
- To see if VRC01 and placebo are safe and well tolerated.
- Healthy adults 18 to 50 years old.
- 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.
Monoclonal Antibody, Human
VRC01 Monoclonal Antibody
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||VRC 602: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIV MAB060-00-AB (VRC01),Administered Intravenously or Subcutaneously to Healthy Adults|
- This is a Phase 1 study with primary outcomes of safety and pharmacokinetics [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
VRC 602 is the first study of the VRC-HIVMAB060-00-AB (VRC01) monoclonal antibody (MAb) in healthy adults. It is a dose-escalation study to examine safety, tolerability, and pharmacokinetics of VRC01. The hypothesis is that VRC01 will be safe for administration to healthy adults by the intravenous (IV) and subcutaneous (SC) routes and will not elicit hypersensitivity reactions. The SC route evaluation will be placebo-controlled and conducted double-blinded to evaluate safety and tolerability of VRC01 and placebo (VRC-PLAMAB068-00-AB).
Healthy adults 18-50 years of age will be enrolled. There are 3 dose escalation groups for IV administration and 1 blinded, placebo-controlled group for SC administration. The doses are 5 mg/kg, 20 mg/kg, and 40 mg/kg for the IV administration, and 5 mg/kg of VRC01 or placebo for the SC administration.
Each group is expected to include 3-5 participants. Each participant will receive two infusions of VRC01 or placebo. The infusions are administered in an inpatient unit and an overnight stay at the NIH Clinical Center is required. No more than one subject per day in each group will receive the first IV infusion of the study product, and no more than one subject per week will receive the first SC administration for the first 6 subjects in Group 4. For each subject the study participation will last about 16 weeks. Blood and mucosal samples will be collected and stored for research purposes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01993706
|Contact: Jamie G Saunders, R.N.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Julie E Ledgerwood, D.O.||National Institute of Allergy and Infectious Diseases (NIAID)|