Safety and Effectiveness of an HIV DNA Vaccine Followed by an HIV Adenoviral Vector Vaccine for Prevention of HIV Infection in the Americas and Africa
A Phase IIB Test-of-Concept, Randomized, Double-Blind, Placebo-Controlled, International Clinical Trial to Evaluate the Efficacy, Safety, and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in HIV Uninfected Persons
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
The development of a safe and effective vaccine is the best strategy for preventing the spread of HIV-1. The purpose of this study is to determine the safety and effectiveness of and immune responses to an HIV vaccine regimen in healthy adults at risk for HIV infection.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2007
CompletedFirst Posted
Study publicly available on registry
July 9, 2007
CompletedNovember 1, 2021
October 1, 2021
July 5, 2007
October 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Acquisition of HIV infection, reduction in viral load in those who become infected, and adverse events (AEs)
At 26 weeks or later from study entry and from first study injection for AEs
Seroconversion with HIV RNA or HIV DNA detection, average of two viral load measurements, and AEs graded on the DAIDS AE Grading Table
Early after diagnosis of HIV infection and throughout the study for AEs
Study Arms (2)
1
EXPERIMENTALParticipants will receive a total of three injections of the DNA vaccine VRC-HIVDNA016-00-VP followed by one injection of the adenovirus vaccine VRC-HIVADV014-00-VP. Injections will occur at study entry and Weeks 4, 8, and 24.
2
PLACEBO COMPARATORParticipants will receive a total of three injections of the DNA vaccine VRC-HIVDNA016-00-VP placebo followed by one injection of the adenovirus vaccine VRC-HIVADV014-00-VP placebo. Injections will occur at study entry and Weeks 4, 8, and 24.
Interventions
Eligibility Criteria
You may qualify if:
- At risk for HIV-1 sexual exposure within 24 weeks prior to study entry. More information about this criterion is available in the protocol.
- HIV uninfected within 6 weeks prior to study entry
- Willing to undergo HIV testing and counseling
- Willing to receive HIV test results
- Willing to use highly reliable method for contraception for at least the first 6 months of study
You may not qualify if:
- Participation in a clinical trial of another investigational product within 12 weeks prior to study entry
- Contraindication to intramuscular injections, history of bleeding disorder, or use of anticoagulant therapy in the 4 weeks prior to study entry
- Previously received an investigational HIV vaccine
- History of severe local or systemic reactogenicity to vaccines or severe allergic reactions or recurrent rash for unknown reasons in the 5 years prior to study entry
- Received an inactivated vaccine within the 2 weeks prior to study entry or of live attenuated within 4 weeks of study entry
- Received any blood products or any immunomodulatory agents within 12 weeks of study entry
- History of cancer. Participants with a history of localized squamous cell or basal cell carcinoma of the skin are not excluded.
- History of clinically significant autoimmune disease or immune deficiency syndrome
- Use of immunosuppressive medications within 24 weeks of study entry. Participants who have completed a short course of steroids more than 2 weeks prior to study entry, or using inhaled or topical steroids are not excluded.
- Seizure disorder. Participants who have had seizures with fever under the age of 2, seizures secondary to alcohol withdrawal more than 3 years prior to study entry, or a singular seizure more than 3 years ago that has not recurred or required treatment within the last 3 years are not excluded.
- Any medical condition or acute medical illness that, in the opinion of the investigator, would interfere with the study
- Pregnancy, plan to become pregnant, or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Centers for Disease Control and Preventioncollaborator
- HIV Vaccine Trials Networkcollaborator
- International AIDS Vaccine Initiativecollaborator
- US Military HIV Research Programcollaborator
- Vaccine Research Centercollaborator
Related Publications (4)
Esparza J, Osmanov S. HIV vaccines: a global perspective. Curr Mol Med. 2003 May;3(3):183-93. doi: 10.2174/1566524033479825.
PMID: 12699356BACKGROUNDGaschen B, Taylor J, Yusim K, Foley B, Gao F, Lang D, Novitsky V, Haynes B, Hahn BH, Bhattacharya T, Korber B. Diversity considerations in HIV-1 vaccine selection. Science. 2002 Jun 28;296(5577):2354-60. doi: 10.1126/science.1070441.
PMID: 12089434BACKGROUNDJohnston MI, Fauci AS. An HIV vaccine--evolving concepts. N Engl J Med. 2007 May 17;356(20):2073-81. doi: 10.1056/NEJMra066267. No abstract available.
PMID: 17507706BACKGROUNDStratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. doi: 10.2174/1389450043490686.
PMID: 14738219BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Scott M. Hammer, MD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2007
First Posted
July 9, 2007
Last Updated
November 1, 2021
Record last verified: 2021-10