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Tracking Information | |||||||||
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First Received Date † | September 8, 2004 | ||||||||
Last Updated Date | August 6, 2008 | ||||||||
Start Date † | |||||||||
Current Primary Outcome Measures † | |||||||||
Original Primary Outcome Measures † | |||||||||
Change History | Complete list of historical versions of study NCT00091416 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † | |||||||||
Original Secondary Outcome Measures † | |||||||||
Descriptive Information | |||||||||
Brief Title † | Safety of and Immune Response to an HIV-1 Vaccine Boost (VRC-HIVADV014-00-VP) in HIV Uninfected Adults Who Participated in HVTN 052 | ||||||||
Official Title † | A Phase I Clinical Trial to Evaluate the Safety of a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Administered to Healthy, HIV-1 Uninfected, Adult Participants Who Received DNA Plasmid Vaccine or Placebo in the HVTN 052 Clinical Trial | ||||||||
Brief Summary | The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, VRC-HIVADV014-00-VP, when given as a vaccine booster to HIV uninfected adults who participated in HVTN 052. |
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Detailed Description | The worldwide HIV epidemic highlights the importance of developing an affordable, globally successful vaccine for HIV prevention. The VRC-HIVADV014-00-VP adenoviral vector vaccine used in this study was developed to stimulate strong virus-specific CD8 cytotoxic T-lymphocyte (CTL) responses thought to be crucial in an effective preventive HIV vaccine. The purpose of this study is to determine the safety and immunogenicity of a VRC-HIVADV014-00-VP vaccine boost given to healthy, HIV uninfected individuals who participated in HVTN 052, which evaluated the VRC-HIVDNA009-00-VP DNA plasmid vaccine. In that study, participants received either 3 injections of vaccine, 2 injections of vaccine and 1 injection of placebo, or 3 injections of placebo over a 2-month period. This study will last one year. Participants will be randomly assigned to receive vaccine boost or placebo by intramuscular injection. The injections will be given 6 to 9 months after each participant's first HVTN 052 study injection, preferably as close to 6 months after the first HVTN 052 injection as possible. After a screening visit, study visits will occur at enrollment (when the injection will be given), at Week 2, and at Months 1, 3, 6, and 12. Blood collection, physical exam, and medication assessment will occur at every study visit; urine collection will occur at selected visits. |
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Study Phase | Phase I | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study | ||||||||
Condition † | HIV Infections | ||||||||
Intervention † | Biological: VRC-HIVADV014-00-VP | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Active, not recruiting | ||||||||
Enrollment † | 70 | ||||||||
Completion Date | |||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years to 50 Years | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts †† | |||||||||
Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00091416 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
Verification Date | June 2006 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |