Reactogenicity and immune responses to cAd3-EBO vaccine were dose-dependent. Assessment of the durability of the antibody response showed that titers remained high at week 48, with the highest titers in those who received the 2×10 11 particle-unit dose. Glycoprotein-specific T-cell responses were more frequent among those who received the 2×10 11 particle-unit dose than among those who received the 2×10 10 particle-unit dose, with a CD4 response in 10 of 10 participants versus 3 of 10 participants (P=0.004) and a CD8 response in 7 of 10 participants versus 2 of 10 participants (P=0.07) at week 4. Glycoprotein-specific antibodies were induced in all 20 participants 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 at wvs. In this small study, no safety concerns were identified however, transient fever developed within 1 day after vaccination in two participants who had received the 2×10 11 particle-unit dose. Primary and secondary end points related to safety and immunogenicity were assessed throughout the first 8 weeks after vaccination in addition, longer-term vaccine durability was assessed at 48 weeks after vaccination. 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. We conducted a phase 1, dose-escalation, open-label trial of cAd3-EBO. A replication-defective recombinant chimpanzee 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. The unprecedented 2014 epidemic of Ebola virus disease (EVD) prompted an international response to accelerate the availability of a preventive vaccine.
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