title: Safety and immunogenicity of combinations of recombinant subtype E and B human immunodeficiency virus type 1 envelope glycoprotein 120 vaccines in healthy Thai adults.
abstract: Safety and immunogenicity of 2 recombinant human immunodeficiency virus (HIV) type 1 envelope glycoprotein (gp) 120 vaccines derived from SF2 (subtype B) and CM235 (CRF01_AE, Thai E) were evaluated in 370 Thai adults at low risk of HIV infection. Various doses of CM235 (25, 50, or 100 microg) and SF2 (0, 25, or 50 microg) gp120 were used. Eighty volunteers received placebo. There were no serious adverse events related to vaccination. Binding antibody developed in all vaccine recipients. There was no dose response to CM235 gp120, but a dose response to gp120 SF2 was present. Neutralizing antibodies to subtype E HIV-1 NPO3 and subtype B HIV-1 SF2 developed in 84% and 82% of vaccine recipients, respectively. Lymphoproliferative responses were detected in >95% of vaccine recipients. There was no evidence of antigenic interference in HIV-specific humoral or cellular responses. The gp120 Thai E and SF2 vaccines were safe and immunogenic in combination and could be advanced into phase 3 testing.
authors.affiliation: Vaccine Trial Centre, Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Siriraj Hospital, Mahidol University, 420/6 Rajvithi Road, Bangkok 10400, Thailand. tmppt@mucc.mahidol.ac.th
authors.forename: Punnee
authors.initials: P
authors.lastname: Pitisuttithum
authors.forename: Sorachai
authors.initials: S
authors.lastname: Nitayaphan
authors.forename: Prasert
authors.initials: P
authors.lastname: Thongcharoen
authors.forename: Chirasak
authors.initials: C
authors.lastname: Khamboonruang
authors.forename: Jerome
authors.initials: J
authors.lastname: Kim
authors.forename: Mark
authors.initials: M
authors.lastname: de Souza
authors.forename: Thippawan
authors.initials: T
authors.lastname: Chuenchitra
authors.forename: Robin P
authors.initials: RP
authors.lastname: Garner
authors.forename: Darawan
authors.initials: D
authors.lastname: Thapinta
authors.forename: Victoria
authors.initials: V
authors.lastname: Polonis
authors.forename: Silvia
authors.initials: S
authors.lastname: Ratto-Kim
authors.forename: Penprapa
authors.initials: P
authors.lastname: Chanbancherd
authors.forename: Joseph
authors.initials: J
authors.lastname: Chiu
authors.forename: Deborah L
authors.initials: DL
authors.lastname: Birx
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Duliege
authors.forename: John G
authors.initials: JG
authors.lastname: McNeil
authors.forename: Arthur E
authors.initials: AE
authors.lastname: Brown
mesh_terms: D016915:AIDS Vaccines / Q000009:adverse effects* / Q000235:genetics / Q000276:immunology*; D000328:Adult; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D015483:HIV Antibodies / Q000097:blood / Q000276:immunology; D015699:HIV Envelope Protein gp120 / Q000235:genetics / Q000276:immunology*; D015658:HIV Infections / Q000276:immunology*; D015497:HIV-1 / Q000235:genetics / Q000276:immunology*; D006801:Humans; D008297:Male; D009500:Neutralization Tests; D013785:Thailand
chemical_list: D016915:AIDS Vaccines; D015483:HIV Antibodies; D015699:HIV Envelope Protein gp120