Schwander S, Opravil M, Lüthy R, Hanson D G, Schindler J, Dawson A, Letwin B, Dietrich M
Case Western Reserve University, School of Medicine, Cleveland, Ohio 44106.
Infection. 1994 Mar-Apr;22(2):86-91. doi: 10.1007/BF01739010.
In order to evaluate tolerance, toxicity, and in vivo antigenicity, 29 HIV-1-infected patients (eight with ARC and 21 with AIDS) were vaccinated with a synthetic peptide derived from the gp41 transmembrane protein of the HIV-1. This peptide had been coupled with 2.4 dinitrophenyl-Ficoll (F46), a T-cell independent adjuvant. The patients received a single intradeltoid injection of either 0.1 or 0.3 mg of F46. Five of the individuals with AIDS were boostered, four of them twice. Anti-F46 antibody titers were measured before vaccination, and on days 7, 14, 21, 28, 90, 180 and 270 after vaccination. Anti-F46 titers rose at least twofold over prestudy values in 10/21 individuals with AIDS and in 1/8 individuals with ARC at least once during the observation period. The overall response, however, consisted of only weak antibody production that was independent of the dose or patient characteristics. No signs of toxicity or of clinical progression related to the vaccination were observed in this phase I/II trial of a T-cell independent therapeutic vaccine.
为了评估耐受性、毒性和体内抗原性，对29名HIV-1感染患者（8名患艾滋病相关综合征，21名患艾滋病）接种了一种源自HIV-1 gp41跨膜蛋白的合成肽。该肽已与2,4-二硝基苯基-聚蔗糖（F46）偶联，F46是一种非T细胞依赖性佐剂。患者接受了0.1毫克或0.3毫克F46的单次三角肌内注射。5名艾滋病患者接受了加强注射，其中4人接受了两次加强注射。在接种疫苗前以及接种后第7、14、21、28、90、180和270天测量抗F46抗体滴度。在观察期内，21名艾滋病患者中的10名以及8名艾滋病相关综合征患者中的1名，其抗F46滴度至少有一次比研究前值升高了两倍。然而，总体反应仅包括微弱的抗体产生，且与剂量或患者特征无关。在这项非T细胞依赖性治疗性疫苗的I/II期试验中，未观察到与接种疫苗相关的毒性或临床进展迹象。
