Actively Recruiting
Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors in Healthy Volunteers
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-21
300
Participants Needed
1
Research Sites
502 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 ...
CONDITIONS
Official Title
Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 49 years for vaccine recipients; age 18 to 65 years for household and intimate contacts
- Negative FDA-approved HIV test
- Willing and able to participate in all follow-up visits and tests
- Agree to have samples stored for future research
- Good general health with no significant medical history (for vaccinees and intimate contacts)
- Low risk for HIV infection and agree to risk reduction counseling (for vaccinees and intimate contacts)
- Negative pregnancy test for females who can become pregnant
- Female vaccinees without reproductive potential or practicing effective contraception with male contacts
- Male vaccinees and female contacts agree to abstinence or effective birth control during the study
- Willing to receive HIV test results and follow NIH partner notification guidelines (vaccinees only)
- Physical exam and labs showing no significant findings within 8 weeks before study
- Willing to avoid other investigational or HIV vaccines during the study
- Laboratory safety tests within normal or acceptable limits
- Willing to follow precautions to prevent adenovirus spread
- Males agree not to donate sperm for 21 days after vaccination
You will not qualify if you...
- Any condition that increases risk from participation according to investigator
- History of disease or therapy affecting immune or lung function (vaccinees and intimate contacts)
- Prior cancer except certain skin or cervical cancers
- History of radiation or chemotherapy
- Uncontrolled diabetes; some controlled diabetes cases considered individually
- Immunodeficiency or autoimmune disease
- Recent or ongoing infections suggesting immunodeficiency
- Use of glucocorticoids or immunosuppressive drugs
- Asthma with recent severe exacerbations or high medication use
- Other chronic respiratory diseases or recent respiratory infections
- Females breastfeeding or planning pregnancy during study
- Medical, psychiatric, or social conditions that interfere with participation (vaccinees only)
- Psychiatric disorders affecting compliance
- Living with individuals under 18, over 65, immunocompromised, or with chronic respiratory disease (vaccinees only)
- Providing hands-on care to vulnerable individuals within 21 days after vaccinations
- Recent antiviral, blood product, immunoglobulin, investigational drug, or allergy treatment use
- Active hepatitis B or C infection
- History of Guillain-Barre syndrome
- Indeterminate HIV Western blot
- Prior receipt of Merck Ad5-based HIV vaccine
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
M
Mark Connors, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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