Phase I/II study of a candidate vaccine designed against the B and E subtypes of HIV-1
Phase I/II study of a candidate vaccine designed against the B and E subtypes of HIV-1
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DOI：
10.1097/01.qai.0000136091.72955.4b
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发表时间：
2004-09-01
影响因子：
3.6
通讯作者：
Francis, DP
中科院分区：
文献类型：
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作者：
Pitisuttithum, P;Berman, PW;Francis, DP
一种预防HIV感染的候选疫苗在泰国曼谷进行了I/II期试验，测试了AIDSVAX B/E (VaxGen, Inc., Brisbane， CA)，这是一种二价亚单位疫苗，由来自B亚型病毒（HIV-1(MN)）的重组gp120和来自E亚型病毒（HIV-1(A244)）的gp120在明质佐剂中组合而成。这些研究提供了不同剂量的非B亚型疫苗抗原组合的免疫原性的人体数据。结果表明，AIDSVAX B/E在人体内具有安全性和免疫原性。在发展中国家，人类的最佳剂量是每种抗原（B和E）各300杯。与单独免疫B相比，用gp120 B/E免疫可明显提高E级的应答。使用B/E组合不会干扰对任一分支的反应。AIDSVAX B/E抗体能够结合HIV-1原代分离株感染细胞表面的寡聚物gp120。
A phase I/II trial of a candidate vaccine to prevent HIV infection was carried out in Bangkok, Thailand, testing AIDSVAX B/E (VaxGen, Inc., Brisbane, CA), a bivalent subunit vaccine prepared by combining recombinant gp120 from a subtype B virus (HIV-1(MN)) with gp120 from a subtype E virus (HIV-1(A244)) in alum adjuvant. The studies provide human data on the immunogenicity of various dose combination of non-subtype B vaccine antigens. The results suggest that AIDSVAX B/E is safe and immunogenic in humans. The optimal dose for humans in developing countries was 300 mug of each antigen (B and E). Clade E responses were measurably increased by immunizing with gp120 B/E over B alone. Using the B/E combination did not interfere with the response to either clade. Antibodies to AIDSVAX B/E were able to bind to oligomeric gp120 on the surface of cells infected with primary isolates of HIV-1.