Status:
COMPLETED
Safety and Efficacy of a Three-Dose Regimen of an Adenoviral HIV Vaccine (MRKAd5 HIV-1 Gag/Pol/Nef) in HIV Uninfected South African Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
HIV Vaccine Trials Network
Conditions:
HIV Infections
Eligibility:
All Genders
18-35 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety, efficacy, and tolerability of a three-dose regimen of an adenovirus-based HIV-1 vaccine in healthy South African adults.
Detailed Description
The HIV epidemic is a major global health challenge. The Joint United Nations Program on HIV/AIDS (UNAIDS) reported that in 2004, 3 million people worldwide died of AIDS and an estimated 5 million peo...
Eligibility Criteria
Inclusion
- As of 9/19/07, clinical research sites were notified that HVTN 503 has been suspended; therefore, enrollment is discontinued and all participants will be unblinded and encouraged to continue follow-up visits.
- HIV-1 and -2 negative
- Good general health
- ALT less than 2.6 times the upper limit of normal (ULN)
- Sexually active within the 6 months prior to study entry
- Have access to a participating HIV Vaccine Trials Unit (HVTU) and are willing to be followed during the study
- Demonstrate understanding of the study
- Willing to receive HIV test results
- Female participants must be willing to use acceptable forms of contraception, or not be of reproductive potential. More information about this criterion can be found in the protocol.
Exclusion
- Adenovirus 5 titer greater than 200, once enrollment of participants in this stratum has been completed
- HIV vaccines in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
- Immunosuppressive medications within 168 days prior to first study vaccination. Participants who have used corticosteroid nasal sprays for allergic rhinitis or topical corticosteroids for mild, uncomplicated dermatitis are not excluded.
- Blood products within 90 days prior to first study vaccination
- Immunoglobulin within 90 days prior to first study vaccination
- Live attenuated vaccines within 30 days prior to first study vaccination
- Investigational research agents within 30 days prior to first study vaccination
- Medically indicated subunit or killed vaccines within 5 days prior to first study vaccination OR scheduled to receive such vaccines within 14 days after first study vaccination
- Allergy treatment with antigen injections within 30 days prior to first study vaccination
- Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health. More information about this criterion can be found in the protocol.
- Any medical, psychiatric, or job-related responsibility that would interfere with the study. More information about this criterion can be found in the protocol.
- Any concern that, in the opinion of the investigator, may interfere with a participant's completion of the post-vaccination symptom log
- History of anaphylaxis or allergy to any of the vaccine's components
- Autoimmune disease
- Immunodeficiency
- Bleeding disorder
- Cancer
- Seizure disorder
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
801 Patients enrolled
Trial Details
Trial ID
NCT00413725
Start Date
January 1 2007
End Date
August 1 2012
Last Update
October 15 2021
Active Locations (5)
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1
Soweto HVTN CRS
Johannesburg, Gauteng, South Africa, 1862
2
MedCRU CRS
Pretoria, Gauteng, South Africa, 0204
3
eThekwini CRS
Durban, KwaZulu-Natal, South Africa, 4001
4
Emavundleni CRS
Cape Town, Western Cape, South Africa, 7750