期刊
JOURNAL OF INFECTIOUS DISEASES
卷 216, 期 9, 页码 1080-1090出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/infdis/jix456
关键词
HIV vaccine; modified vaccinia Ankara; electroporation; needle-free injection
资金
- Department of Defense [W81XWH-07-2-0067, W81XWH-11-0174]
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- NIAID
- US Army Medical Research and Materiel Command [Y1-AI-2642-17]
- NIH/NIAID/Division of AIDS under an HIV Vaccine Design and Development Team [HHSN272200800063C]
Background. We report the first-in-human safety and immunogenicity evaluation of PENNVAX-G DNA/modified vaccinia Ankara-Chiang Mai double recombinant (MVA-CMDR) prime-boost human immuonodeficiency virus (HIV) vaccine, with intramuscular DNA delivery by either Biojector 2000 needle-free injection system (Biojector) or CELLECTRA electroporation device. Methods. Healthy, HIV-uninfected adults were randomized to receive 4 mg of PENNVAX-G DNA delivered intramuscularly by Biojector or electroporation at baseline and week 4 followed by intramuscular injection of 10(8) plaque forming units of MVA-CMDR at weeks 12 and 24. The open-label part A was conducted in the United States, followed by a double-blind, placebo-controlled part B in East Africa. Solicited and unsolicited adverse events were recorded, and immune responses were measured. Results. Eighty-eight of 100 enrolled participants completed all study injections, which were generally safe and well tolerated, with more immediate, but transient, pain in the electroporation group. Cellular responses were observed in 57% of vaccine recipients tested and were CD4 predominant. High rates of binding antibody responses to CRF01_AE antigens, including gp70 V1 V2 scaffold, were observed. Neutralizing antibodies were detected in a peripheral blood mononuclear cell assay, and moderate antibody-dependent, cell-mediated cytotoxicity activity was demonstrated. Discussion. The PVG/MVA-CMDR HIV-1 vaccine regimen is safe and immunogenic. Substantial differences in safety or immunogenicity between modes of DNA delivery were not observed.
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