This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The primary hypotheses is that the HIV-1 gag DNA vaccine will be generally safe and well tolerated. Specifically, no vaccine-related serious adverse event is expected during the planned follow-up period. The primary objective is to assess the general safety and tolerability of the HIV-1 gag DNA vaccine at two dosage levels (1mg and 5mg), in terms of vaccine-related serious adverse experiences, local and systemic reactions, temperatures, nad out of range laboratory values.Secondary objectives include:1.) To summarize the immunogenicity of the vaccine in all groups, as measured in bulk culture CTL and IFN-y ELIspot assays 4 weeks following the third dose of HIV-1 gag DNA vaccine.2.) To summarize the immunogenicity of the vaccine as measured by bulk culture CTL and IFN-y ELI spot at all other immunogenicity time points.3.) To summarize gag antibody responses in all vaccine groups at all immunogenicity time points.4.) To explore the MHC (HLA) Type 1 A2.1 Tetramer assay in subjects receiving HIV-1 gag DNA.5.) To summarize the Adeno5 neutralization titers (GMTs) in all vaccine groups.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000095-47
Application #
7605527
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-12-01
Project End
2007-09-16
Budget Start
2006-12-01
Budget End
2007-09-16
Support Year
47
Fiscal Year
2007
Total Cost
$1,970
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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