Schwartz D H, Gorse G, Clements M L, Belshe R, Izu A, Duliege A M, Berman P, Twaddell T, Stablein D, Sposto R
Center for Immunization Research, Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland 21205-1901.
Lancet. 1993 Jul 10;342(8863):69-73. doi: 10.1016/0140-6736(93)91283-r.
A recombinant human immunodeficiency virus 1 IIIB (HIV-1IIIB) gp120 subunit vaccine (IIIB-rgp120/HIV-1, Genentech) was tested for safety and immunogenicity in a randomised, double-blind, placebo-controlled phase-I trial. HIV-1-seronegative adult volunteers received three 100 micrograms or 300 micrograms doses of IIIB-rgp120/HIV-1 in alum adjuvant (10 vaccinees in each group), or alum adjuvant alone (8 vaccinees), at 0, 4, and 32 weeks by intramuscular injection. The three injections were well tolerated in both vaccine groups. Antibodies that neutralised homologous HIV-1IIIB were induced in 9 of 10 recipients after three 300 micrograms doses, and 6 of these 9 sera also neutralised heterologous HIV-1SF2. A dose response was evident, since three 100 micrograms injections induced lower titres of HIV-1IIIB neutralising antibodies and in fewer recipients (5 of 9) than the higher dose, with no neutralisation of HIV-1SF2. Similarly, syncytia-inhibiting, CD4-rgp120-blocking, and HIV-1IIIB V3-binding antibodies were induced in a dose dependent manner. Response to the 300 micrograms per dose vaccination occurred in a larger proportion of volunteers and at higher mean titres than seen in previous human trials with other recombinant envelope subunit vaccines or live vaccinia-env priming followed by envelope subunit boosting.
一种重组人免疫缺陷病毒1型IIIB株（HIV-1IIIB）gp120亚单位疫苗（IIIB-rgp120/HIV-1，基因泰克公司）在一项随机、双盲、安慰剂对照的I期试验中进行了安全性和免疫原性测试。HIV-1血清学阴性的成年志愿者在第0、4和32周通过肌肉注射接受了三剂100微克或300微克的IIIB-rgp120/HIV-1（每组10名受试者），佐剂为明矾，或仅接受明矾佐剂（8名受试者）。两个疫苗组对这三次注射的耐受性均良好。在接受三剂300微克疫苗的10名受试者中，有9名诱导出了中和同源HIV-1IIIB的抗体，这9份血清中的6份还中和了异源HIV-1SF2。剂量反应明显，因为三剂100微克注射诱导出的HIV-1IIIB中和抗体滴度低于高剂量组，且诱导出中和抗体的受试者较少（9名中的5名），且未出现对HIV-1SF2的中和作用。同样，抑制合胞体形成、阻断CD4-rgp120以及结合HIV-1IIIB V3的抗体均呈剂量依赖性诱导产生。与之前使用其他重组包膜亚单位疫苗或痘苗病毒包膜初免后再用包膜亚单位加强免疫的人体试验相比，每剂300微克疫苗接种在更大比例的志愿者中产生了反应，且平均滴度更高。
