Safety and immunogenicity of an HIV subtype B and E prime-boost vaccine combination in HIV-negative Thai adults

• Main Authors: Nitayaphan S., Pitisuttithum P., Karnasuta C., Eamsila C., De Souza M., Morgan P., Polonis V., Benenson M., VanCott T., Ratto-Kim S., Kim J., Thapinta D., Garner R., Bussaratid V., Singharaj P., El Habib R., Gurunathan S., Heyward W., Birx D., McNeil J., Brown A.E.
• Format: Article
• Language: English
• Published: 2014
• Online Access: http://www.scopus.com/inward/record.url?eid=2-s2.0-20244383550&partnerID=40&md5=38ab371d67cdb685204f63a69ffcec10; http://cmuir.cmu.ac.th/handle/6653943832/4402
• Institution: Chiang Mai University

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 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.