Status:
COMPLETED
Safety and Immunogenicity Study of HIV-MAG Vaccine +/- IL-12 and Ad35-GRIN/ENV in HIV-uninfected Volunteers
Lead Sponsor:
International AIDS Vaccine Initiative
Collaborating Sponsors:
Auro Vaccines LLC
Ichor Medical Systems Incorporated
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and immunogenicity of multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human IL-12 pDNA (GENEVAX...
Detailed Description
The study is a randomized, double-blind placebo-controlled trial assessing the safety and tolerability of HIV-MAG with or without co-administered GENEVAX® IL-12 given intramuscularly by in vivo electr...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- healthy male or female adults,
- 18 to 50 years of age (21 to 50 years of age for volunteers in Rwanda),
- who do not report high-risk behaviour for HIV infection,
- who are available for the duration of the trial,
- who are willing to undergo HIV testing,
- use an effective method of contraception, and
- who, in the opinion of the principal investigator or designee, understand the study and who provide written informed consent.
- Principal exclusion criteria:
- confirmed HIV infection,
- pregnancy and lactation,
- significant acute or chronic disease,
- clinically significant laboratory abnormalities,
- recent vaccination or receipt of a blood product,
- previous receipt of an HIV vaccine, and
- previous severe local or systemic reactions to vaccination or history of severe allergic reactions.
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01496989
Start Date
December 1 2011
Last Update
September 2 2013
Active Locations (3)
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1
Kenya AIDS Vaccine Initiative, Kangemi
Nairobi, Kenya
2
Projet San Francisco
Kigali, Rwanda
3
Uganda Virus Research Institute-IAVI
Entebbe, Uganda