一种B型和E型HIV初免-加强疫苗组合在泰国HIV阴性成年人中的安全性和免疫原性。

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

作者信息

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, Brown Arthur E

机构信息

Royal Thai Component, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.

出版信息

J Infect Dis. 2004 Aug 15;190(4):702-6. doi: 10.1086/422258. Epub 2004 Jul 20.

DOI:10.1086/422258

PMID:15272397

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.

摘要

在一项针对人类免疫缺陷病毒（HIV）阴性泰国成年人的1/2期试验中，对ALVAC-HIV（vCP1521）和AIDSVAX B/E进行了评估。在133名登记的志愿者中，122名完成了试验。没有与疫苗相关的严重不良事件，也没有并发HIV感染。63%的志愿者诱导出对糖蛋白120 E的淋巴细胞增殖反应，24%的志愿者诱导出HIV特异性CD8细胞毒性T淋巴细胞反应。抗体反应的频率和强度随着AIDSVAX B/E剂量水平的增加而增加。接受600微克AIDSVAX B/E的志愿者中，分别有100%和98%诱导出针对MN株的结合抗体和中和抗体，这些志愿者中分别有96%和71%诱导出针对E株的此类抗体。这种疫苗组合耐受性良好且具有免疫原性，达到了推进到3期评估的里程碑。