Safety and immunogenicity of recombinant low-dosage HIV-1 a vaccine candidates vectored by plasmid pTHr DNA or modified vaccinia virus Ankara (MVA) in humans in East Africa

被引：75

作者：

Jaoko, Walter ^{[1
]}

Nakwagala, Frederick N. ^{[2
]}

Anzala, Omu ^{[1
]}

Manyonyi, Gloria Omosa ^{[1
]}

Birungi, Josephine ^{[2
]}

Nanvubya, Annet ^{[2
]}

Bashir, Farah ^{[1
]}

Bhatt, Kirana ^{[1
]}

Ogutu, Hilda ^{[1
]}

Wakasiaka, Sabina ^{[1
]}

Matu, Lucy ^{[1
]}

Waruingi, Wambui ^{[1
]}

Odada, Jane ^{[1
]}

Oyaro, Micah ^{[1
]}

Indangasi, Jackton ^{[1
]}

Ndinya-Achola, Jeckonia ^{[1
]}

Konde, Carol ^{[2
]}

Mugisha, Emmanuel ^{[2
]}

Fast, Patricia ^{[3
]}

Schmidt, Claudia ^{[3
]}

Gilmour, Jill ^{[4
]}

Tarragona, Tony ^{[4
]}

Smith, Carol ^{[5
]}

Barin, Burc ^{[5
]}

Dally, Len ^{[5
]}

Johnson, Bruce ^{[3
]}

Muluubya, Andrew ^{[2
]}

Nielsen, Leslie ^{[3
]}

Hayes, Peter ^{[4
]}

Boaz, Mark ^{[4
]}

Hughes, Peter ^{[6
]}

Hanke, Tomas ^{[7
]}

McMichael, Andrew ^{[7
]}

Bwayo, Job ^{[1
]}

Kaleebu, Pontiano ^{[2
,6
]}

机构：

[1] Univ Nairobi, Dept Med Microbiol, KAVI, Nairobi 00202, Kenya

[2] Uganda Virus Res Inst, IAVI HIV Vaccine Program, Entebbe, Uganda

[3] Int AIDS Vaccine Initiat, New York, NY 10038 USA

[4] Univ London Imperial Coll Sci Technol & Med, Chelsea & Westminster Hosp, IAVI CORE Immunol Lab, Dept Immunol, London SW10 9NH, England

[5] EMMES Corp, Rockville, MD 20850 USA

[6] Uganda Virus Res Inst, MRC, AIDS Res Unit, Entebbe, Uganda

[7] Univ Oxford, Weatherall Inst Mol Med, Oxford, England

来源：

VACCINE | 2008年 / 26卷 / 22期

基金：

英国医学研究理事会;

关键词：

HIV-AIDS vaccine; phase 1 clinical trials; East Africa; DNA vaccine; recombinant MVA vaccine;

D O I：

10.1016/j.vaccine.2008.02.071

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

The safety and immunogenicity of plasmid pTHr DNA, modified vaccinia virus Ankara (MVA) human immunodeficiency virus type 1 (HIV-1) vaccine candidates were evaluated in four Phase I clinical trials in Kenya and Uganda. Both vaccines, expressing HIV-1 subtype A gag p24/p17 and a string of CD8 T-cell epitopes (HIVA), were generally safe and well-tolerated. At the dosage levels and intervals tested, the percentage of vaccine recipients with HIV-1-specific cell-mediated immune responses, assessed by a validated ex vivo interferon gamma (IFN-gamma) ELISPOT assay and Cytokine Flow Cytometry (CFC), did not significantly differ from placebo recipients. These trials demonstrated the feasibility of conducting high-quality Phase 1 trials in Africa. (C) 2008 Elsevier Ltd. All rights reserved.

引用

页码：2788 / 2795

页数：8

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