HIV Infections Clinical Trial
Official title:
A Phase I, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by Recombinant, Multiclade HIV-1 Adenoviral Vector Vaccine or the Multiclade HIV-1 Adenoviral Vector Vaccine Alone in Healthy Adult Volunteers Not Infected With HIV
Verified date | October 2021 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVADV014-00-VP, with or without a second investigational HIV vaccine, VRC-HIVDNA016-00-VP, in HIV uninfected adults.
Status | Completed |
Enrollment | 114 |
Est. completion date | April 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Willing to follow all the requirements of the study and available for follow-up for the duration of the study - 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: - HIV infected - 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 |
Country | Name | City | State |
---|---|---|---|
Kenya | KEMRI, Ctr. for Geographic Medicine Research Coast at Kilifi | Kilifi | |
Kenya | KAVI, KNH at Kangemi | Nairobi | |
Rwanda | Projet San Francisco | Kigali |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
Kenya, Rwanda,
Esparza J, Osmanov S. HIV vaccines: a global perspective. Curr Mol Med. 2003 May;3(3):183-93. Review. — View Citation
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. Review. — View Citation
Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Local reactogenicity signs and symptoms | |||
Primary | systemic reactogenicity signs and symptoms | |||
Primary | laboratory measures of safety | |||
Primary | adverse and serious adverse experiences | |||
Secondary | Proportion of volunteers who have HIV-1 specific T-cell responses quantified by intracellular cytokine staining (ICS; both CD4+ and CD8+) and ELISPOT and magnitude of the responses | |||
Secondary | proportion of volunteers with HIV-1 specific antibodies and magnitude of the response | |||
Secondary | proportion of volunteers with increase in antibodies to rAd5 | |||
Secondary | impact of pre-existing immunity to rAd5 on immunogenicity | |||
Secondary | proportion of volunteers who test "false positive" on standard HIV testing algorithm. |
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