Safety of and Immune Response to an Adenoviral HIV Vaccine (VRC-HIVADV014-00-VP) With or Without a Plasmid HIV Vaccine (VRC-HIVDNA016-00-VP) in HIV Uninfected Adults
NCT ID: NCT00124007
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
114 participants
INTERVENTIONAL
2005-11-30
2007-04-30
Brief Summary
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Detailed Description
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Volunteers will participate in this study for 1 year. Participants will be randomly assigned to one of four groups:
* Group A participants will receive a low dose of the adenovirus-vectored vaccine or placebo at study entry.
* Group B participants will receive a higher dose of the adenovirus-vectored vaccine or placebo at study entry.
* Group C participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2. They will receive either a low dose of the adenovirus-vectored vaccine or placebo at Month 6.
* Group D participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2. They will receive either a higher dose of the adenovirus-vectored vaccine or placebo at Month 6.
All participants will undergo vital signs measurements before and after receiving each vaccination.
Participants in Groups A and B will have 9 study visits over 12 months. A physical exam, adverse events reporting, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits.
Participants in Groups C and D will have 17 study visits over 12 months. A physical exam, adverse events reporting, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Interventions
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VRC-HIVADV014-00-VP
VRC-HIVDNA016-00-VP
Eligibility Criteria
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Inclusion Criteria
* Have understanding of the study and provide written informed consent
* Willing to undergo HIV testing and counseling and willing to receive HIV test results
* Willing to use acceptable forms of contraception
Exclusion Criteria
* Hepatitis B virus infected
* Hepatitis C virus infected
* Active or untreated syphilis
* 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.
* Any clinically significant abnormality in history or upon examination (e.g., immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the investigator) within 6 months prior to study entry
* Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would make the volunteer unsuitable for the study
* Live attenuated vaccines within 30 days prior to study entry OR plan to receive a live attenuated vaccine within 60 days after vaccination in this study
* Subunit or killed vaccines within 14 days prior to study entry OR plan to receive a subunit or killed vaccine within 14 days after vaccination in this study
* Blood transfusion or blood products within 120 days prior to study entry
* Immunoglobulin within 60 days prior to study entry
* Participation in another investigational product clinical trial in the 3 months prior to study entry OR expected to participate in another investigational trial during this study
* Any other investigational HIV vaccine at any time
* History of severe local or systemic reactogenicity to vaccines or history of severe allergic reactions
* Major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicide attempt or suicidal thoughts within the 3 years prior to study entry
* Uncontrolled hypertension
* Pregnant, breastfeeding, or plan to become pregnant
18 Years
50 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Job Bwayo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kenya AIDS Vaccine Initiative, University of Nairobi
Etienne Karita, MD
Role: PRINCIPAL_INVESTIGATOR
Project San Francisco
Locations
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KEMRI, Ctr. for Geographic Medicine Research Coast at Kilifi
Kilifi, , Kenya
KAVI, KNH at Kangemi
Nairobi, , Kenya
Projet San Francisco
Kigali, , Rwanda
Countries
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References
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Esparza J, Osmanov S. HIV vaccines: a global perspective. Curr Mol Med. 2003 May;3(3):183-93. doi: 10.2174/1566524033479825.
Gaschen 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.
Stratov 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.
Omosa-Manyonyi GS, Jaoko W, Anzala O, Ogutu H, Wakasiaka S, Malogo R, Nyange J, Njuguna P, Ndinya-Achola J, Bhatt K, Farah B, Oyaro M, Schmidt C, Priddy F, Fast P. Reasons for ineligibility in phase 1 and 2A HIV vaccine clinical trials at Kenya AIDS vaccine initiative (KAVI), Kenya. PLoS One. 2011 Jan 21;6(1):e14580. doi: 10.1371/journal.pone.0014580.
Jaoko W, Karita E, Kayitenkore K, Omosa-Manyonyi G, Allen S, Than S, Adams EM, Graham BS, Koup RA, Bailer RT, Smith C, Dally L, Farah B, Anzala O, Muvunyi CM, Bizimana J, Tarragona-Fiol T, Bergin PJ, Hayes P, Ho M, Loughran K, Komaroff W, Stevens G, Thomson H, Boaz MJ, Cox JH, Schmidt C, Gilmour J, Nabel GJ, Fast P, Bwayo J. Safety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa. PLoS One. 2010 Sep 21;5(9):e12873. doi: 10.1371/journal.pone.0012873.
Other Identifiers
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10380
Identifier Type: REGISTRY
Identifier Source: secondary_id
IAVI V001
Identifier Type: -
Identifier Source: org_study_id