Who is sponsoring NCT03783130?

NCT03783130 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What condition does NCT03783130 study?

NCT03783130 studies Human Immunodeficiency Virus Prevention, Human Immunodeficiency Virus (HIV).

What drugs are being tested in NCT03783130?

Interventions: VRC-HIVRGP096-00-VP, Alum Adjuvant.

What is the status of NCT03783130?

NCT03783130 is currently COMPLETED.

Last reviewed 2021-08-12 · How we verify

Dose, Safety, Tolerability, and Immunogenicity of an HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults

NCT03783130 PHASE1 COMPLETED Results posted

Background: HIV stands for human immunodeficiency virus, which is the virus that causes AIDS. There is currently no licensed vaccine to prevent HIV infection. Researchers want to test a vaccine called Trimer 4571 for the first time. It was made at the National Institutes of Health (NIH) and contains no HIV. The vaccine is mixed with a substance called alum and injected in the arm. Alum is included to boost the body's immune response to the vaccine. It has been used in licensed vaccines for over 60 years and has been found to be safe. Objectives: To see if the vaccine Trimer 4571 is safe, well-tolerated, and to study immune responses to it. Eligibility: Healthy adults ages 18-50 years Design: Participants were screened with a physical exam and blood tests. They agreed to not become pregnant and to avoid behavior that would put them at high-risk for HIV infection during the study. Participants had about 15 study visits over about 9 months. The first 6 participants received a low dose of the vaccine mixed with alum. Once the low dose was deemed safe, 10 new participants were allocated to receive a higher dose. All participants were randomly assigned to get the vaccine by injection in a muscle or under the skin. All participants received a total of 3 vaccine injections over 20 weeks. Each visit where participants received the vaccine lasted about 5 hours. Participants were watched after each injection. Participants who were able to get pregnant would have a pregnancy test before each injection. Participants received a thermometer and recorded their temperature and symptoms every day for 1 week after each injection. The injection site was checked for redness, swelling, or bruising. At follow-up visits, participants had blood drawn and checked for health changes or problems. Follow up visits lasted about 1-2 hours.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	PHASE1
Status	COMPLETED
Enrolment	16
Start date	Thu Mar 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Jun 24 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Human Immunodeficiency Virus Prevention
Human Immunodeficiency Virus (HIV)

Interventions

VRC-HIVRGP096-00-VP
Alum Adjuvant

Countries

United States