A replication defective recombinant Ad5 vaccine expressing Ebola virus GP is safe and immunogenic in healthy adults

被引：166

作者：

Ledgerwood, J. E. ^{[1
]}

Costner, P. ^{[1
]}

Desai, N. ^{[1
]}

Holman, L. ^{[1
]}

Enama, M. E. ^{[1
]}

Yamshchikov, G. ^{[1
]}

Mulangu, S. ^{[1
]}

Hu, Z. ^{[1
]}

Andrews, C. A. ^{[1
]}

Sheets, R. A. ^{[1
]}

Koup, R. A. ^{[1
]}

Roederer, M. ^{[1
]}

Bailer, R. ^{[1
]}

Mascola, J. R. ^{[1
]}

Pau, M. G. ^{[2
]}

Sullivan, N. J. ^{[1
]}

Goudsmit, J. ^{[2
]}

Nabel, G. J. ^{[1
]}

Graham, B. S. ^{[1
]}

机构：

[1] NIAID, Vaccine Res Ctr, NIH, Bethesda, MD 20892 USA

[2] Crucell Holland BV, Leiden, Netherlands

来源：

VACCINE | 2010年 / 29卷 / 02期

关键词：

Adenovirus; Gene-based vaccines; Ebola; Filovirus vaccine; TYPE-1 GAG GENE; ADENOVIRUS VECTORS; NONHUMAN-PRIMATES; HIV-1; VACCINE; OF-CONCEPT; CANDIDATE VACCINE; HEMORRHAGIC-FEVER; INDUCED IMMUNITY; PHASE-1; SAFETY; RHESUS-MONKEYS;

D O I：

10.1016/j.vaccine.2010.10.037

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Ebola virus causes irregular outbreaks of severe hemorrhagic fever in equatorial Africa. Case mortality remains high; there is no effective treatment and outbreaks are sporadic and unpredictable. Studies of Ebola virus vaccine platforms in non-human primates have established that the induction of protective immunity is possible and safety and human immunogenicity has been demonstrated in a previous Phase I clinical trial of a 1st generation Ebola DNA vaccine. We now report the safety and immunogenicity of a recombinant adenovirus serotype 5 (rAd5) vaccine encoding the envelope glycoprotein (GP) from the Zaire and Sudan Ebola virus species, in a randomized, placebo-controlled, double-blinded, dose escalation, Phase I human study. Thirty-one healthy adults received vaccine at 2 x 10(9) (n = 12), or 2 x 10(10) (n = 11) viral particles or placebo (n = 8) as an intramuscular injection. Antibody responses were assessed by ELISA and neutralizing assays; and T cell responses were assessed by ELISpot and intracellular cytokine staining assays. This recombinant Ebola virus vaccine was safe and subjects developed antigen specific humoral and cellular immune responses. Published by Elsevier Ltd.

引用

页码：304 / 313

页数：10

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