title: Safety and immunogenicity of a canarypox-vectored human immunodeficiency virus Type 1 vaccine with or without gp120: a phase 2 study in higher- and lower-risk volunteers.
abstract: Live attenuated viral vectors that express human immunodeficiency virus (HIV) antigens are being developed as potential vaccines to prevent HIV infection. The first phase 2 trial with a canarypox vector (vCP205, which expresses gp120, p55, and protease) was conducted in 435 volunteers with and without gp120 boosting, to expand the safety database and to compare the immunogenicity of the vector in volunteers who were at higher risk with that in volunteers at lower risk for HIV infection. Neutralizing antibodies to the MN strain were stimulated in 94% of volunteers given vCP205 plus gp120 and in 56% of volunteers given vCP205 alone. CD8(+) cytotoxic T lymphocyte cells developed at some time point in 33% of volunteers given vCP205, with or without gp120. Phase 3 field trials with these or similar vaccines are needed, to determine whether efficacy in preventing HIV infection or in slowing disease progression among vaccinees who become infected is associated with the level and types of immune responses that were induced by the vaccines in this study.
authors: Department of Internal Medicine, Saint Louis University School of Medicine and St. Louis Veterans Affairs Medical Center, 3635 Vista Ave. (FDT-8N) St. Louis, MO 63110, USA. Belsherb@slu.edu
authors: R B
authors: RB
authors: Belshe
authors: C
authors: C
authors: Stevens
authors: G J
authors: GJ
authors: Gorse
authors: S
authors: S
authors: Buchbinder
authors: K
authors: K
authors: Weinhold
authors: H
authors: H
authors: Sheppard
authors: D
authors: D
authors: Stablein
authors: S
authors: S
authors: Self
authors: J
authors: J
authors: McNamara
authors: S
authors: S
authors: Frey
authors: J
authors: J
authors: Flores
authors: J L
authors: JL
authors: Excler
authors: M
authors: M
authors: Klein
authors: R E
authors: RE
authors: Habib
authors: A M
authors: AM
authors: Duliege
authors: C
authors: C
authors: Harro
authors: L
authors: L
authors: Corey
authors: M
authors: M
authors: Keefer
authors: M
authors: M
authors: Mulligan
authors: P
authors: P
authors: Wright
authors: C
authors: C
authors: Celum
authors: F
authors: F
authors: Judson
authors: K
authors: K
authors: Mayer
authors: D
authors: D
authors: McKirnan
authors: M
authors: M
authors: Marmor
authors: G
authors: G
authors: Woody
mesh_terms: D016915:AIDS Vaccines / Q000235:genetics / Q000276:immunology*; D000293:Adolescent; D000328:Adult; D018150:Avipoxvirus / Q000276:immunology*; D018414:CD8-Positive T-Lymphocytes / Q000276:immunology; D004311:Double-Blind Method; D005260:Female; D005822:Genetic Vectors; D015699:HIV Envelope Protein gp120 / Q000235:genetics / Q000276:immunology*; D015658:HIV Infections / Q000517:prevention & control; D016333:HIV Protease / Q000235:genetics / Q000276:immunology; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D012449:Safety; D013602:T-Lymphocytes, Cytotoxic / Q000276:immunology*; D014613:Vaccines, Attenuated; D014614:Vaccines, Synthetic
chemical_list: D016915:AIDS Vaccines; D015699:HIV Envelope Protein gp120; D014613:Vaccines, Attenuated; D014614:Vaccines, Synthetic; D016333:HIV Protease