This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Safety ' To characterize the safety and tolerability of a single dose of the adenoviral vector vaccine delivered at each of two escalating doses (1010 PU and 1011 PU IM) in participants with low (<1:12) titers of pre-existing Ad5 neutralizing antibodies. Secondary objectives Immunogenicity ' To evaluate the HIV-specific immunogenicity, as assessed by IFN-? ELISpot, ICS, ELISA for HIV-1-binding antibodies, and neutralizing antibody assays, of a single dose of the adenoviral vector vaccine delivered at each of two escalating doses (1010 PU and 1011 PU IM) in participants with low (<1:12) titers of pre-existing neutralizing antibodies to Ad5. ' Assess the magnitude of Ad5 neutralizing antibodies induced by the study vaccine. ' Assess the association between post-vaccine Ad5 neutralizing antibody titer and magnitude of HIV-1-specific immune reponses (IFN-? ELISpot, ICS, and HIV-1 neutralizing antibodies) induced by the study vaccine. Social impacts ' To evaluate the social impacts of trial participation.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000095-46
Application #
7375687
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
46
Fiscal Year
2006
Total Cost
$143,420
Indirect Cost
Name
Vanderbilt University Medical Center
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004413456
City
Nashville
State
TN
Country
United States
Zip Code
37212
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