Phase I Study of APL 400-003, a Candidate HIV Vaccine, in HIV-Negative Volunteers

Summary

This is a randomized, double blind study of the safety and immunogenicity of APL 400-003, a plasmid DNA vaccine encoding the env and rev genes of HIV-1, in HIV-negative volunteers. Three doses of vaccine are being tested: 100, 300, and 1000 micro g. 8 volunteers per dose will be randomized: 6 to plasmid vaccine, and 2 to a vehicle control. Immunizations will be administered at day 0 and weeks 4 and 8, with a booster immunization administered at week 24. An additional 5 volunteers may be included in an open manner at the dose likely to be used in subsequent studies. The primary aims of the study are to determine: 1. the safety of APL 400-003, as evaluated by clinical and laboratory safety parameters and 2. the immunogenicity of APL 400-003, as determined by a broad range of laboratory assays. Up to 33 patients (allowing for drop-outs) will be enrolled in the study, and volunteers will be followed for one year after immunization.

Timeline

Start

1996-03

Primary completion

—

Completion

2001-04

Publications

• Background Kovacs JA, Vasudevachari MB, Easter M, Davey RT, Falloon J, Polis MA, Metcalf JA, Salzman N, Baseler M, Smith GE, et al. Induction of humoral and cell-mediated anti-human immunodeficiency virus (HIV) responses in HIV sero-negative volunteers by immunization with recombinant gp160. J Clin Invest. 1993 Aug;92(2):919-28. doi: 10.1172/JCI116667.
• Background Wang B, Boyer J, Srikantan V, Ugen K, Gilbert L, Phan C, Dang K, Merva M, Agadjanyan MG, Newman M, et al. Induction of humoral and cellular immune responses to the human immunodeficiency type 1 virus in nonhuman primates by in vivo DNA inoculation. Virology. 1995 Aug 1;211(1):102-12. doi: 10.1006/viro.1995.1383.
• Background Abrignani S, Montagna D, Jeannet M, Wintsch J, Haigwood NL, Shuster JR, Steimer KS, Cruchaud A, Staehelin T. Priming of CD4+ T cells specific for conserved regions of human immunodeficiency virus glycoprotein gp120 in humans immunized with a recombinant envelope protein. Proc Natl Acad Sci U S A. 1990 Aug;87(16):6136-40. doi: 10.1073/pnas.87.16.6136.

Drugs

Indications