Safety of and Immune Response to an HIV-1 Vaccine (VRC-HIVDNA016-00-VP) and a Vaccine Booster (VRC-HIVADV014-00-VP) in HIV Uninfected East African Adults
A Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Boosted by a Multiclade HIV-1 Recombinant Adenovirus-5 Vector Vaccine, VRC-HIVADV014-00-VP, in HIV Uninfected Adult Volunteers in East Africa
2 other identifiers
interventional
326
3 countries
3
Brief Summary
The purpose of the study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVDNA016-00-VP, and a vaccine booster, VRC-HIVADV014-00-VP, in HIV uninfected adults from Kenya, Tanzania, and Uganda.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
Started May 2006
Longer than P75 for phase_1 hiv-infections
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2005
CompletedFirst Posted
Study publicly available on registry
July 26, 2005
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedNovember 9, 2021
July 1, 2014
6.1 years
July 22, 2005
November 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Local reactogenicity signs and symptoms
Throughout study
Systemic reactogenicity signs and symptoms
Throughout study
Laboratory measures of safety
Throughout study
Adverse and serious adverse experiences
Throughout study
Unfractionated IFN-gamma ELISPOT responses to HIV-1
At Day 196
CD4+ and CD8+ T cell responses to HIV-1, as measured by flow cytometry-based intracellular cytokine staining (ICS) assay
At Day 196
Study Arms (6)
1A
EXPERIMENTALParticipants will receive a low dose of the adenovirus-vectored HIV vaccine or placebo at study entry
1B
EXPERIMENTALParticipants will receive a higher dose of the adenovirus-vectored HIV vaccine or placebo at study entry
1C
EXPERIMENTALParticipants will receive the DNA plasmid vaccine or placebo at study entry and Days 28 and 56. They will also receive either a low dose of the adenovirus-vectored HIV vaccine or placebo at Day 168.
1D
EXPERIMENTALParticipants will receive the DNA plasmid vaccine or placebo at study entry and Days 28 and 56. They will also receive either a higher dose of the adenovirus-vectored HIV vaccine or placebo at Day 168.
2A
EXPERIMENTALParticipants will receive the DNA plasmid vaccine at study entry and Days 28 and 56. They will also receive a low dose of the adenovirus-vectored HIV vaccine at Day 168.
2B
EXPERIMENTALParticipants will receive the DNA plasmid vaccine placebo at study entry and Days 28 and 56. They will also receive a the adenovirus-vectored HIV vaccine placebo at Day 168.
Interventions
1x10\^11 per unit vaccine administered intramuscularly via Bioinjector
Administered intramuscularly via Bioinjector
Eligibility Criteria
You may qualify if:
- Good general health
- Willing to follow all the requirements of the study and available for follow-up for the duration of the study (14 to 16 months)
- Able and willing to provide informed consent
- Willing to undergo HIV testing and counseling and willing to receive HIV test results
- Willing to not engage in high-risk behavior for HIV infection during the study
- Willing to provide location and be visited at home
- Willing to be identified with picture identification for study purposes
- Willing to use acceptable forms of contraception
- Pregnant women and those with conditions which render phlebotomy volumes hazardous will be allowed to participate using a minimized phlebotomy schedule
You may not qualify if:
- HIV or HBV infection
- HIV vaccines in prior HIV vaccine trial
- Immunosuppressive or cytotoxic medications within the 6 months prior to study entry. Participants who have used corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for acute uncomplicated dermatitis are not excluded.
- Blood products within 120 days prior to study entry
- Immunoglobulin within 60 days prior to study entry
- Live attenuated vaccines within 30 days prior to first study vaccine administration
- Medically indicated subunit or killed vaccines or allergy treatment with antigen injections within 14 days prior to first study vaccine administration
- Investigational research agents within 30 days prior to first study vaccine administration
- Current tuberculosis prophylaxis or therapy
- Participated in high-risk behavior for HIV infection within 6 months prior to study entry. More information on this criterion can be found in the protocol.
- Serious adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Autoimmune disease or immunodeficiency
- Unstable asthma or asthma requiring emergent or urgent care, hospitalization, intubation, or oral or intravenous corticosteroids during the 2 years prior to study entry
- Diabetes mellitus type 1 or 2. Patients with gestational diabetes are not excluded.
- Thyroid disease, including removal of thyroid or disease requiring medication within 3 years prior to study entry
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Kenya Med. Research Inst./Walter Reed Project, Clinical Research Centre, Off Hospital Road. Kericho
Kericho, 20200, Kenya
National Institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC) CRS
Mbeya, 025, Tanzania
Makerere University Walter Reed Project (MUWRP)
Kampala, Uganda
Related Publications (5)
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: 12089434BACKGROUNDStratov 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: 14738219BACKGROUNDKibuuka H, Kimutai R, Maboko L, Sawe F, Schunk MS, Kroidl A, Shaffer D, Eller LA, Kibaya R, Eller MA, Schindler KB, Schuetz A, Millard M, Kroll J, Dally L, Hoelscher M, Bailer R, Cox JH, Marovich M, Birx DL, Graham BS, Michael NL, de Souza MS, Robb ML. A phase 1/2 study of a multiclade HIV-1 DNA plasmid prime and recombinant adenovirus serotype 5 boost vaccine in HIV-Uninfected East Africans (RV 172). J Infect Dis. 2010 Feb 15;201(4):600-7. doi: 10.1086/650299.
PMID: 20078213DERIVEDKibuuka H, Guwatudde D, Kimutai R, Maganga L, Maboko L, Watyema C, Sawe F, Shaffer D, Matsiko D, Millard M, Michael N, Wabwire-Mangen F, Robb M. Contraceptive use in women enrolled into preventive HIV vaccine trials: experience from a phase I/II trial in East Africa. PLoS One. 2009;4(4):e5164. doi: 10.1371/journal.pone.0005164. Epub 2009 Apr 10.
PMID: 19360102DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Merlin Robb, MD
US Military HIV Research Program
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2005
First Posted
July 26, 2005
Study Start
May 1, 2006
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
November 9, 2021
Record last verified: 2014-07