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Tracking Information | |||||
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First Received Date † | March 21, 2003 | ||||
Last Updated Date | September 17, 2007 | ||||
Start Date † | |||||
Current Primary Outcome Measures † |
Safety of administering TBC-3B vaccinations to vaccinia naive individuals | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00056745 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Determining an Effective Site (Groin Versus Arm) for Giving HIV Vaccines | ||||
Official Title † | The Role of Immunization Site in Eliciting Mucosal Immunity | ||||
Brief Summary | The purpose of this study is to determine the safety and immune system response to the TBC-3B HIV vaccine when it is injected either into the groin area or into the arm. The goal is to determine which injection site is better at producing a particular type of immune response. This study is not evaluating the effectiveness of the vaccine, so volunteers must maintain low risk behavior for HIV transmission throughout the study. |
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Detailed Description | The goal of this vaccination study is to evaluate the safety and immunogenicity of the Therion Biologic Corporation (Cambridge, MA) TBC-3B vaccine. TBC-3B consists of live, recombinant vaccinia virus expressing the env and gag/pol genes of HIV-1 strain IIIB. TBC-3B will be administered by subcutaneous injection in the groin and in the deltoid region, with the aim of determining which site is better at inducing mucosal immune responses. Because the groin area drains to the inguinal lymph nodes, vaccines given there may stimulate local immunologic activity in the draining rectal mucosa as well as systemic immunologic activity in the blood. Volunteers will be followed for 20 months. The first 2 months of the study will be an evaluation of volunteers' normal immune function. Volunteers will then be randomly selected to receive the TBC-3B experimental HIV vaccine in either the groin area or in the deltoid region. Neither volunteers nor study personnel will know which group the volunteer will be in until the day of the first immunization. All volunteers will receive TBC-3B. During the 20 months of the study, volunteers will be asked to donate blood up to 14 times, undergo seven flexible sigmoidoscopies with biopsies, and receive three pairs of vaccine injections. For up to 36 days after each experimental vaccination, volunteers will be asked to abstain from activity that might spread the virus in the vaccine and put others at risk. Volunteers will receive specific instructions on how to avoid these risks. Volunteers will also be asked not to engage in receptive anal intercourse during the study. |
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Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | HIV Infections | ||||
Intervention † | Biological: TBC-3B | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* 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 † | Completed | ||||
Enrollment † | 12 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria
Exclusion Criteria
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Gender | Both | ||||
Ages | 18 Years to 33 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00056745 | ||||
Responsible Party | |||||
Secondary IDs †† | UCLA MIG-001, R01 AI 50467 | ||||
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 | July 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |