Determining an Effective Site (Groin Versus Arm) for Giving HIV Vaccines
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||The Role of Immunization Site in Eliciting Mucosal Immunity|
- Safety of administering TBC-3B vaccinations to vaccinia naive individuals
- Immunogenicity of subcutaneous vaccination with 3 doses of TBC-3B administered in the groin area, as measured by increased levels of CTL activity directed to vaccinia and HIV-1 env, gag and pol gene products
- immunogenicity of subcutaneous vaccination with 3 doses of TBC-3B administered in the groin area, as measured by anti-HIV-1 directed CD4+ T cell proliferative response to soluble p24 antigen
- immunogenicity of subcutaneous vaccination with 3 doses of TBC-3B administered in the groin area, as measured by CD8+ T cell specificity for HIV-1 epitopes
- immunogenicity of subcutaneous vaccination with 3 doses of TBC-3B administered in the groin area, as measured by serum and mucosal immunoglobulins against HIV-1 epitopes
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056745
|United States, California|
|University of California at Los Angelos Center for HIV and Digestive Diseases|
|Los Angeles, California, United States, 90095-7019|
|Principal Investigator:||Peter Anton, MD||University of California at Los Angeles|