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Safety of and Immune Response to the Experimental Preventive HIV Vaccine, EP HIV-1090, in Healthy, HIV-1 Uninfected Adults

HIV Infections Clinical Trial

Official title:
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Protein Vaccine EP-1043 and the DNA Vaccine EP HIV-1090 Given Alone or in Combination in Healthy, HIV-1-Uninfected Adult Participants

Clinical Trial Summary

The purpose of the study is to determine the safety of and immune response to the investigational HIV vaccine, EP HIV-1090, in HIV uninfected adults.

Clinical Trial Description

The worldwide HIV/AIDS epidemic may only be controlled through the development of a safe and effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct, readily produced in large quantities, and stable for long periods of time. EP HIV-1090 is a DNA HIV CTL vaccine; the proteins for which its genes code are designed to interact with CD8 cells (CTL) and cause CD8 cell proliferation. The DNA plasmids in EP HIV-1090 code for proteins conserved among HIV subtypes A, B, C, D, F, and G, which encompass the HLA subtypes of 85% of the worldwide general population. Participants will be enrolled in this study for 1 year. Group 4 participants will receive EP HIV-1090 or placebo at study entry and Months 1, 3, and 6. There will be 11 study visits that will occur at screening; study entry; and Months 0.5, 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12. A physical exam and risk reduction/pregnancy prevention counseling will occur at each visit. Participants will be asked about their adverse experiences from vaccination at each visit. Blood and urine collection will occur at selected visits. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00141024
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Start date January 2006
Completion date December 2007
View Details
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