Study of an HIV Preventive Vaccine Given With or Without an Adjuvant in HIV Uninfected Adults

Summary

The purpose of this study is to evaluate the safety and tolerability of an experimental HIV vaccine. The vaccine will be given with or without IL-12 DNA adjuvant (at three escalating doses of 100, 500, and 1,500 mcg respectively), a substance that helps the body respond to a vaccine. This study will also determine the safety and tolerability of an experimental HIV vaccine boosted with two adjuvants.

Timeline

Start

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Primary completion

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Completion

2008-05

Publications

• Background Bolesta E, Gzyl J, Wierzbicki A, Kmieciak D, Kowalczyk A, Kaneko Y, Srinivasan A, Kozbor D. Clustered epitopes within the Gag-Pol fusion protein DNA vaccine enhance immune responses and protection against challenge with recombinant vaccinia viruses expressing HIV-1 Gag and Pol antigens. Virology. 2005 Feb 20;332(2):467-79. doi: 10.1016/j.virol.2004.09.043.
• Background Letvin NL. Progress toward an HIV vaccine. Annu Rev Med. 2005;56:213-23. doi: 10.1146/annurev.med.54.101601.152349.
• Background Sha BE, Onorato M, Bartlett JA, Bosch RJ, Aga E, Nokta M, Adams EM, Li XD, Eldridge J, Pollard RB. Safety and immunogenicity of a polyvalent peptide C4-V3 HIV vaccine in conjunction with IL-12. AIDS. 2004 May 21;18(8):1203-6. doi: 10.1097/00002030-200405210-00015.
• Jin X, Morgan C, Yu X, DeRosa S, Tomaras GD, Montefiori DC, Kublin J, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. Vaccine. 2015 May 11;33(20):2347-53. doi: 10.1016/j.vaccine.2015.03.036. Epub 2015 Mar 25.
• Kalams SA, Parker S, Jin X, Elizaga M, Metch B, Wang M, Hural J, Lubeck M, Eldridge J, Cardinali M, Blattner WA, Sobieszczyk M, Suriyanon V, Kalichman A, Weiner DB, Baden LR; NIAID HIV Vaccine Trials Network. Safety and immunogenicity of an HIV-1 gag DNA vaccine with or without IL-12 and/or IL-15 plasmid cytokine adjuvant in healthy, HIV-1 uninfected adults. PLoS One. 2012;7(1):e29231. doi: 10.1371/journal.pone.0029231. Epub 2012 Jan 5.

Drugs

Indications