Recruiting

Testing a new nasal HIV vaccine in healthy volunteers

Plain-English translation of NCT03878121 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 2026 · How we translate trials

What is this trial?

This is a Phase 1 study testing a new HIV vaccine called Ad4-HIV envelope vaccine, which is sprayed into your nose rather than injected. Researchers want to see if it is safe for people to receive and whether it helps your body develop immune responses against HIV. You would receive two nasal spray doses two months apart, followed by a booster injection at six months.

HIV remains a major health threat, and current prevention methods are limited. This trial is exploring a new vaccine approach that might help prevent HIV infection by training your immune system to recognize and fight the virus.

Do you qualify?

You likely qualify if…

you are between 18 and 49 years old (or 18–65 if you are a household or intimate contact)
you are HIV-negative and willing to have an HIV test
you are in good general health without significant medical conditions
you agree to practice safe behaviors and HIV prevention counseling throughout the study
you are willing to attend follow-up visits and provide blood samples for up to 12 months

You likely don't qualify if…

you are HIV-positive or have an unknown HIV status
you have a history of severe allergies or serious medical conditions that affect your immune system
you are pregnant, breastfeeding, or unwilling to use birth control for 21 days before and after each vaccination
you have previously received another HIV vaccine or have immunity to the adenovirus serotype 4
you are unable or unwilling to commit to the full study schedule and follow-up visits

What participation looks like

You would receive two nasal spray doses of the vaccine two months apart, then return for a booster injection at six months. Throughout the study (12 months total), you would have multiple clinic visits for blood draws and immune system testing to see how your body responds to the vaccine. Your household members and intimate partners may also be asked to participate in safety monitoring to check if the vaccine virus spreads to them.

Testing a new nasal HIV vaccine in healthy volunteers

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)