Phase I Open-Label Study of Safety and Immunogenicity of AD4-HIV Envelope Vaccine Vectors in Healthy Volunteers
National Institute of Allergy and Infectious Diseases (NIAID)
Summary
Background: Researchers want see if three new HIV (human immunodeficiency virus) vaccines are safe. Two vaccines are carried by live adenoviruses, which are natural and typically cause cold symptoms or an eye infection. Researchers want to see if all the vaccines help fight HIV and if the adenoviruses are contagious. Objectives: To test the safety and effects of three new HIV vaccines. Eligibility: Healthy adults 18-49 years old (vaccinees) Their household and intimate contacts 18-65 years old Design: Vaccinees will be screened with: Physical exam Medical history Blood and urine tests Questions about HIV risk Vaccinees will learn how to prevent spreading the viruses and about required contraception during the study. Vaccinees will get consent forms for their household and intimate contacts. All contacts must be age 18-65. All intimate contacts must sign a consent form. Contacts will have 4 visits over 8 months for blood tests and a physical exam. All applicable participants will have a pregnancy test at every visit. Vaccinees will have about 9 visits over 12 months. They will repeat screening tests and get: 1 of the 2 adenovirus vaccines sprayed in the nose at 2 visits The booster vaccine by needle in an arm at 1 visit Nasal swabs taken at some visits Vaccinees will note their temperature and symptoms for at least 1-4 weeks after each vaccine. Vaccinees may choose to have: Leukapheresis. Blood will be removed by needle in a vein in one arm. A machine will remove white blood cells. The rest of the blood will be returned into the other arm. Small pieces of the tonsil removed Sponsoring Institute: National Institute of Allergy and Infectious Diseases ...
Description
This is a Phase 1 study to evaluate the immunogenicity and safety of adenovirus serotype 4 (Ad4)-based HIV vaccines when administered via the intranasal route to healthy human volunteers. It is hypothesized that the vaccines will be safe for human administration and will elicit immune responses to the HIV components. All study activities will be carried out at the NIH. Each study vaccinee will receive 5x10\^8 viral particles of either Ad4-Env150KN or Ad4-Env145NFL, administered as an intranasal spray at months 0 and 2. An intramuscular protein booster vaccination with the heterologous soluble…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
* INCLUSION CRITERIA: All participants (vaccinees, household contacts, and intimate contacts) must meet all of the following criteria: 1. Age 18 to 49 years for vaccinees. Age 18 to 65 years for household and intimate contacts. 2. Negative FDA-approved HIV test. 3. Available and willing to participate in follow-up visits and tests for the duration of the study. 4. Willing to have samples stored for future research. The following inclusion criteria apply to vaccinees and intimate contacts, but not to household contacts: 1. In good general health without clinically significant medical histor…
Interventions
- BiologicalAd4-Env145NFL
10\^8 vp doses of Ad4-Env145NFL formulated as a liquid for intranasal administration.
- BiologicalAd4-Env150KN
10\^8 vp doses of Ad4-Env150KN formulated as a liquid for intranasal administration.
- BiologicalVRC-HIVRGP096-00-VP (Trimer 4571) with alum
500-mcg dose of protein boost vaccine formulated for intramuscular administration.
Location
- National Institutes of Health Clinical CenterBethesda, Maryland