Department of Psychiatry

Penn Behavioral Health

Previous and Closed Studies

HVTN 502

A Multi-center, Double-Blind, Randomized, Placebo-Controlled Phase II Proof-of-Concept Study to Evaluate the Safety and Efficacy of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 Vaccine gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) in Adults at High Risk of HIV-1 Infection

Primary Safety: To demonstrate that intramuscular injection of the Merck Adenovirus Serotype 5 HIV-1 gag/pol/nef Vaccine (MRKAd5 HIV-1 gag/pol/nef) is generally safe and well tolerated in 18 to 45 year old HIV-1 seronegative adults with baseline Ad5 titers < 200.

Primary Efficacy: To demonstrate that intramuscular injection of the MRKAd5 HIV-1 gag/pol/nef vaccine (a) reduces the proportion of subjects who acquire HIV-1 infection and/or (b) results in a decrease in the HIV-1 viral load set-point (HIV-1 RNA at ~ 3 months post-diagnosis), in subjects who become HIV-1 infected, relative to placebo recipients.

HVTN 070

A Phase I clinical trial to evaluate the safety and immunogenicity of PENNVAX-B (gag, pol, env) given alone, with IL-12 DNA, or with a dose escalation of IL-15 DNA, in healthy, HIV-1 - uninfected adult participants.

Primary objectives: 
To assess the safety and tolerability of a multigene HIV DNA vaccine (gag, pol, env) with or without co-administration of IL-12 DNA or IL-15 DNA in a cohort of HIV-uninfected healthy adults.

To evaluate the safety and tolerability of IL-15 DNA (escalating doses of 0.8 mg and 2 mg) with co-administration of 6 mg of a multigene HIV DNA vaccine (gag, pol, env).


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