Safety of an HIV DNA Vaccine Given to HIV Uninfected Adults

Summary

The purpose of this study is to see if the experimental HIV vaccine pGA2/JS2 is safe and is well tolerated at two different doses. Another important purpose of this study is to observe how the immune system responds to the vaccine at different dose levels. Vaccines are given to people to help their bodies fight infection. The vaccine being tested in this study is a DNA vaccine. The pGA2/JS2 plasmid DNA vaccine instructs the body to make some HIV proteins. These HIV proteins may trigger an immune response. Because only a few of the many proteins HIV needs are made through DNA vaccination, there is no risk of getting HIV from the vaccination. This and other similar DNA vaccines have been tested for safety in mice, rabbits, and monkeys. The vaccine has been well tolerated at doses to be used in this study.

Timeline

Start

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Primary completion

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Completion

2003-04

Publications

• Background Robinson HL, Pertmer TM. DNA vaccines for viral infections: basic studies and applications. Adv Virus Res. 2000;55:1-74. doi: 10.1016/s0065-3527(00)55001-5. No abstract available.
• Background Gurunathan S, Klinman DM, Seder RA. DNA vaccines: immunology, application, and optimization*. Annu Rev Immunol. 2000;18:927-74. doi: 10.1146/annurev.immunol.18.1.927.
• Background Amara RR, Villinger F, Altman JD, Lydy SL, O'Neil SP, Staprans SI, Montefiori DC, Xu Y, Herndon JG, Wyatt LS, Candido MA, Kozyr NL, Earl PL, Smith JM, Ma HL, Grimm BD, Hulsey ML, Miller J, McClure HM, McNicholl JM, Moss B, Robinson HL. Control of a mucosal challenge and prevention of AIDS by a multiprotein DNA/MVA vaccine. Science. 2001 Apr 6;292(5514):69-74. doi: 10.1126/science.1058915.
• Background Ramshaw IA, Ramsay AJ. The prime-boost strategy: exciting prospects for improved vaccination. Immunol Today. 2000 Apr;21(4):163-5. doi: 10.1016/s0167-5699(00)01612-1. No abstract available.

Drugs

Indications