Background The unprecedented 2014 epidemic of @entity2598 ( @entity2598 ) has prompted an international response to accelerate the availability of a preventive vaccine. A replication-defective recombinant @entity831 adenovirus type 3-vectored ebolavirus vaccine (cAd3-EBO), encoding the glycoprotein from Zaire and Sudan species that offers protection in the nonhuman primate model, was rapidly advanced into phase 1 clinical evaluation. Methods We conducted a phase 1, dose-escalation, open-label trial of cAd3-EBO. Twenty healthy adults, in sequentially enrolled groups of 10 each, received vaccination intramuscularly in doses of 2*10(10) particle units or 2*10(11) particle units. Primary and secondary end points related to safety and immunogenicity were assessed throughout the first 4 weeks after vaccination. Results In this small study, no safety concerns were identified; however, transient fever developed within 1 day after vaccination in two @entity1 who had received the 2*10(11) particle-unit dose. Glycoprotein-specific antibodies were induced in all 20 @entity1 ; the titers were of greater magnitude in the group that received the 2*10(11) particle-unit dose than in the group that received the 2*10(10) particle-unit dose (geometric mean titer against the Zaire antigen, 2037 vs. 331; P=0.001). Glycoprotein-specific T-cell responses were more frequent among those who received the 2x10(11) particle-unit dose than among those who received the 2*10(10) particle-unit dose, with a @entity404 response in 10 of 10 @entity1 versus 3 of 10 @entity1 (P=0.004) and a @entity405 response in 7 of 10 @entity1 versus 2 of 10 @entity1 (P=0.07). Conclusions Reactogenicity and immune responses to cAd3-EBO vaccine were dose-dependent. At the 2*10(11) particle-unit dose, glycoprotein Zaire-specific antibody responses were in the range reported to be associated with vaccine-induced protective immunity in challenge studies involving nonhuman primates. Clinical trials assessing cAd3-EBO are ongoing. (Funded by the Intramural Research Program of the National Institutes of Health; VRC 207 ClinicalTrials.gov number, NCT02231866 .).

XXXX Adenovirus Vector Ebola Vaccine - Preliminary Report.

@entity1 :: ('9606', 'Species') :: ['participants'] @entity404 :: ('920', 'Gene') :: ['CD4'] @entity2598 :: ('MESH:D019142', 'Disease') :: ['Ebola virus disease', 'EVD'] @entity831 :: ('9598', 'Species') :: ['chimpanzee'] @entity405 :: ('925', 'Gene') :: ['CD8']
@entity831 :: (9598,Species) :: ['Chimpanzee']
