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A Replication Defective Recombinant Ad5 Vaccine Expressing Ebola Virus GP is Safe and Immunogenic in Healthy Adults


Journal Article

Ledgerwood, J.E.; Costner, P.; Desai, N.; Holman, L.; Enama, M.E.; Yamshchikov, G.; Mulangu, S.; Hu, Z.; Andrews, C.A.; Sheets, R.A.; Koup, R.A.; Roederer, M.; Bailer, R.; , ; Pau, M.G.; Sullivan, N.J.; Goudsmit, J.; Nabel, G.J.; Graham, B.S.; Team, T.V.R.C. 205 St





Adenoviruses; Antibodies; Ebola Vaccines; Ebolavirus/genetics/immunology; Neutralizing/blood Antibodies; Viral/blood Cytokines/immunology

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 2x10(9) (n=12), or 2x10(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.

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