| Literature DB >> 15272397 |
Sorachai Nitayaphan1, Punnee Pitisuttithum, Chitraporn Karnasuta, Chirapa Eamsila, Mark de Souza, Patricia Morgan, Victoria Polonis, Michael Benenson, Tom VanCott, Silvia Ratto-Kim, Jerome Kim, Darawan Thapinta, Robin Garner, Valai Bussaratid, Pricha Singharaj, Raphaelle el-Habib, Sanjay Gurunathan, William Heyward, Deborah Birx, John McNeil, Arthur E Brown.
Abstract
ALVAC-HIV (vCP1521) and AIDSVAX B/E were evaluated in a phase 1/2 trial of human immunodeficiency virus (HIV)-negative Thai adults. Of 133 volunteers enrolled, 122 completed the trial. There were no serious vaccine-related adverse events, nor were there intercurrent HIV infections. Lymphoproliferative responses to glycoprotein 120 E were induced in 63% of the volunteers, and HIV-specific CD8 cytotoxic T lymphocyte responses were induced in 24%. Antibody responses increased in frequency and magnitude in association with the dose level of AIDSVAX B/E. Binding and neutralizing antibodies to the MN strain were induced in 100% and 98%, respectively, of the volunteers receiving 600 microg of AIDSVAX B/E, and such antibodies to E strains were induced in 96% and 71%, respectively, of these volunteers. This vaccine combination was well tolerated and was immunogenic, meeting milestones for advancement to phase 3 evaluation.Entities:
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Year: 2004 PMID： 15272397 DOI： 10.1086/422258
Source DB: PubMed Journal: J Infect Dis ISSN： 0022-1899 Impact factor: 5.226