Pitisuttithum Punnee, Nitayaphan Sorachai, Thongcharoen Prasert, Khamboonruang Chirasak, Kim Jerome, de Souza Mark, Chuenchitra Thippawan, Garner Robin P, Thapinta Darawan, Polonis Victoria, Ratto-Kim Silvia, Chanbancherd Penprapa, Chiu Joseph, Birx Deborah L, Duliege Anne-Marie, McNeil John G, Brown Arthur E
Vaccine Trial Centre, Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Siriraj Hospital, Mahidol University, 420/6 Rajvithi Road, Bangkok 10400, Thailand.
J Infect Dis. 2003 Jul 15;188(2):219-27. doi: 10.1086/376506. Epub 2003 Jul 3.
Safety and immunogenicity of 2 recombinant human immunodeficiency virus (HIV) type 1 envelope glycoprotein (gp) 120 vaccines derived from SF2 (subtype B) and CM235 (CRF01_AE, Thai E) were evaluated in 370 Thai adults at low risk of HIV infection. Various doses of CM235 (25, 50, or 100 microg) and SF2 (0, 25, or 50 microg) gp120 were used. Eighty volunteers received placebo. There were no serious adverse events related to vaccination. Binding antibody developed in all vaccine recipients. There was no dose response to CM235 gp120, but a dose response to gp120 SF2 was present. Neutralizing antibodies to subtype E HIV-1 NPO3 and subtype B HIV-1 SF2 developed in 84% and 82% of vaccine recipients, respectively. Lymphoproliferative responses were detected in >95% of vaccine recipients. There was no evidence of antigenic interference in HIV-specific humoral or cellular responses. The gp120 Thai E and SF2 vaccines were safe and immunogenic in combination and could be advanced into phase 3 testing.
在370名感染艾滋病毒风险较低的泰国成年人中，对两种分别源自SF2（B亚型）和CM235（CRF01_AE，泰国E株）的重组1型人类免疫缺陷病毒（HIV）包膜糖蛋白（gp）120疫苗的安全性和免疫原性进行了评估。使用了不同剂量的CM235（25、50或100微克）和SF2（0、25或50微克）gp120。80名志愿者接受了安慰剂。没有与疫苗接种相关的严重不良事件。所有疫苗接种者均产生了结合抗体。对CM235 gp120没有剂量反应，但对gp120 SF2存在剂量反应。分别有84%和82%的疫苗接种者产生了针对E亚型HIV-1 NPO3和B亚型HIV-1 SF2的中和抗体。在超过95%的疫苗接种者中检测到淋巴细胞增殖反应。在艾滋病毒特异性体液或细胞反应中没有抗原干扰的证据。泰国E株和SF2 gp120疫苗联合使用时安全且具有免疫原性，可推进到3期试验。
