Safety and Immunogenicity of an HIV Vaccine in Normal Adult Volunteers

Summary

This study will test the safety of an experimental vaccine against HIV infection and see if it causes an immune response to HIV. The vaccine is given by injection (shot) in the upper arm. It is made from DNA that codes for three HIV proteins. The DNA is inserted into an adenovirus that carries it into the muscle cells. The adenovirus normally can cause eye or upper respiratory infections, such as a cold; however, for the vaccine, it has been modified so that it cannot cause illness. Nor can the vaccine cause HIV infection, because it codes for only three of the nine HIV proteins. Healthy, normal volunteers between 18 and 44 years of age who are not HIV-infected may be eligible for this study. Candidates are screened with a medical history and physical examination and blood and urine tests. Participants are randomly assigned to receive either the experimental vaccine or a placebo (an inactive substance that looks like the vaccine). The vaccine or placebo is administered to participants in groups, according to their entry into the study. The first group receives the lowest study dose of vaccine. If this dose is safe, then the second group receives a higher dose. If this dose is also safe, then the third and final group receives the highest study dose. Clinic staff observe the subjects for side effects for 30 minutes after the injection, and subjects keep a diary card for the next 5 days, recording their temperature and any symptoms that may appear. Subjects are contacted by a nurse 2 days after the injection for follow-up. Participants are seen at the clinic for follow-up visits 1, 2, 4, 12, and 24 weeks after the injection, and then are contacted by telephone for follow-up once a year until 5 years after the injection. The clinic visits include a physical examination, medical history, blood and urine tests, and HIV counseling, as needed. Women have pregnancy tests at the screening evaluation and again at study week 24. All subjects are tested for HIV at screening and at study weeks 12 and 24, and all subjects complete a "social impact questionnaire" at week 24. All subjects are asked questions about their sexual behavior and drug use. ...

Timeline

Start

2004-05-18

Primary completion

2009-10-01

Completion

2009-10-01

Publications

• Background Borrow P, Lewicki H, Hahn BH, Shaw GM, Oldstone MB. Virus-specific CD8+ cytotoxic T-lymphocyte activity associated with control of viremia in primary human immunodeficiency virus type 1 infection. J Virol. 1994 Sep;68(9):6103-10. doi: 10.1128/JVI.68.9.6103-6110.1994.
• Background Koup RA, Safrit JT, Cao Y, Andrews CA, McLeod G, Borkowsky W, Farthing C, Ho DD. Temporal association of cellular immune responses with the initial control of viremia in primary human immunodeficiency virus type 1 syndrome. J Virol. 1994 Jul;68(7):4650-5. doi: 10.1128/JVI.68.7.4650-4655.1994.
• Background Pantaleo G, Demarest JF, Soudeyns H, Graziosi C, Denis F, Adelsberger JW, Borrow P, Saag MS, Shaw GM, Sekaly RP, et al. Major expansion of CD8+ T cells with a predominant V beta usage during the primary immune response to HIV. Nature. 1994 Aug 11;370(6489):463-7. doi: 10.1038/370463a0.
• Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Gu L, Martin JE, Novik L, Chakrabarti BK, Butman BT, Gall JG, King CR, Andrews CA, Sheets R, Gomez PL, Mascola JR, Nabel GJ, Graham BS; Vaccine Research Center 006 Study Team. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector. J Infect Dis. 2006 Dec 15;194(12):1638-49. doi: 10.1086/509258. Epub 2006 Nov 8.

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