RESUMEN
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.
Asunto(s)
Vacunas contra el SIDA/administración & dosificación , Vacunas contra el SIDA/inmunología , Infecciones por VIH/inmunología , Infecciones por VIH/prevención & control , Seronegatividad para VIH/inmunología , Vacunación , Vacunas contra el SIDA/efectos adversos , Adulto , Linfocitos T CD8-positivos/inmunología , Citotoxicidad Inmunológica , Femenino , Anticuerpos Anti-VIH/biosíntesis , Anticuerpos Anti-VIH/sangre , Proteína gp120 de Envoltorio del VIH/inmunología , Proteína gp120 de Envoltorio del VIH/farmacología , Infecciones por VIH/sangre , Humanos , Esquemas de Inmunización , Inmunización Secundaria , Leucocitos Mononucleares/inmunología , Activación de Linfocitos , Masculino , Persona de Mediana Edad , Pruebas de Neutralización , Tailandia , Factores de TiempoRESUMEN
In 1992 the Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand, collaborated with the Phramongkutklao Army Medical Center to set up the Joint Clinical Research Center (JCRC). The purpose of the Center is to conduct clinical research in support of HIV vaccine development and testing. To date, eight HIV vaccine-related research protocols have been conducted at the JCRC, involving 1,668 volunteers. The JCRC has been, and continues to be, a key site for the transfer of clinical trial expertise to new sites at universities, government clinics and hospitals in Thailand and other countries. Overall rates of follow-up have been excellent, while protocol violations and data clarification errors have been minimal.
