Safety and Immunogenicity of an HIV Subtype B and E Prime-Boost Vaccine Combination in HIV-Negative Thai Adults.

Autor: Nitayaphan, Sorachai, Pitisuttithum, Punnee, Karnasuta, Chitraporn, Eamsila, Chirapa, De Souza, Mark, Morgan, Patricia, Polonis, Victoria, Benenson, Michael, Vancott, Tom, Ratto-Kim, Silvia, Kim, Jerome, Thapinta, Darawan, Garner, Robin, Bussaratid, Valai, Singharaj, Pricha, El Habib, Raphaelle, Gurunathan, Sanjay, Heyward, William, Birx, Deborah, Mcneil, John
Předmět:
Zdroj: Journal of Infectious Diseases; 8/15/2004, Vol. 190 Issue 4, p702-706, 5p
Abstrakt: ALVAC-HIV (vCP1521) and AIDSVAX B/E were evaluated in a phase ½ 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. Lympho- proliferative 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 μg 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. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index