Phase I safety and immunogenicity testing of clinical lots of the synthetic Plasmodium falciparum vaccine SPF66 produced under good manufacturing procedure conditions in the United States
Phase I safety and immunogenicity testing of clinical lots of the synthetic Plasmodium falciparum vaccine SPF66 produced under good manufacturing procedure conditions in the United States
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DOI：
10.4269/ajtmh.1996.55.63
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发表时间：
1996-07-01
影响因子：
3.3
通讯作者：
Ballou, WR
中科院分区：
文献类型：
--
作者：
Gordon, DM;Duffy, PE;Ballou, WR
美国生产的两批明矾吸附SPf66疫苗在单独的、开放标签的I期临床试验中进行了评估，涉及15名健康、未患疟疾、18-45岁的男性和女性。受试者在0个月、1个月和6个月时交替皮下注射2 mg剂量，通过监测局部和全身反应以及实验室参数来评估安全性。最常见的副作用是注射部位的红斑和局部压痛，随着随后的疫苗剂量增加，这些反应的频率会增加。这些局部反应被认为是轻微的，并在24-48小时内消失。14名志愿者中有11人接种了全部三剂疫苗，通过酶联免疫吸附试验进行了血清转换。高、中、低无应答者的分布与哥伦比亚生产的疫苗试验中看到的相似。一名高反应者通过免疫荧光和免疫印迹产生了与无性期寄生虫抗原反应的抗体。结果表明，在全成人剂量下，美国来源的SPf66具有温和的反应性，并诱导与哥伦比亚来源的SPf66相似的免疫反应。
Two clinical lots of alum-adsorbed SPf66 vaccine produced in the United States were evaluated in separate, open-label, Phase I clinical trials involving 15 healthy, malaria-naive, 18-45-year old men and women. Subjects received 2 mg doses subcutaneously in alternate arms at 0, one, and six months, Safety was assessed by monitoring local and systemic reactions and laboratory parameters. The most common side effects were erythema and local tenderness at the site of injection, which increased in frequency with subsequent doses of vaccine. These local reactions were considered mild and resolved within 24-48 hr. Eleven of 14 volunteers who received all three doses of vaccine seroconverted by enzyme-linked immunosorbent assay. The distribution of high, medium, and low nonresponders was comparable with that seen in trials of Colombian-produced vaccine. One high responder developed antibodies reactive with asexual stage parasite antigens by immunofluorescence and immunoblot. The results indicated that at full adult doses, SPf66 of U.S. origin is mildly reactogenic and induces immune responses similar to those reported for SPf66 of Colombian origin.