Article ; Online: Safety, tolerability, and immunogenicity of the Ebola Sudan chimpanzee adenovirus vector vaccine (cAd3-EBO S) in healthy Ugandan adults: a phase 1, open-label, dose-escalation clinical trial.
The Lancet. Infectious diseases
2023 Volume 23, Issue 12, Page(s) 1408–1417
Abstract: Background: Sudan Ebola virus can cause severe viral disease, with an average case fatality rate of 54%. A recent outbreak of Sudan Ebola virus in Uganda caused 55 deaths among 164 confirmed cases in the second half of 2022. Although vaccines and ... ...
| Abstract | Background: Sudan Ebola virus can cause severe viral disease, with an average case fatality rate of 54%. A recent outbreak of Sudan Ebola virus in Uganda caused 55 deaths among 164 confirmed cases in the second half of 2022. Although vaccines and therapeutics specific for Zaire Ebola virus have been approved for use during outbreak situations, Sudan Ebola virus is an antigenically distinct virus with no approved vaccines available. Methods: In this phase 1, open-label, dose-escalation trial we evaluated the safety, tolerability, and immunogenicity of a monovalent chimpanzee adenovirus 3 vaccine against Sudan Ebola virus (cAd3-EBO S) at Makerere University Walter Reed Project in Kampala, Uganda. Study participants were recruited from the Kampala metropolitan area using International Review Board-approved written and electronic media explaining the trial intervention. Healthy adults without previous receipt of Ebola, Marburg, or cAd3 vectored-vaccines were enrolled to receive cAd3-EBO S at either 1 × 10 Findings: 40 healthy adults were enrolled between July 22 and Oct 1, 2019, with 20 receiving 1 × 10 Interpretation: The cAd3-EBO S vaccine was safe at both doses, rapidly inducing immune responses in most participants after a single injection. The rapid onset and durability of the vaccine-induced antibodies make this vaccine a strong candidate for emergency deployment in Sudan Ebola virus outbreaks. Funding: National Institutes of Health via interagency agreement with Walter Reed Army Institute of Research. |
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| MeSH term(s) | Animals ; Humans ; Adult ; Hemorrhagic Fever, Ebola/prevention & control ; Ebola Vaccines ; Pan troglodytes ; Uganda ; Sudan ; Ebolavirus/genetics ; Antibodies, Viral ; Adenoviruses, Simian/genetics ; Adenoviridae/genetics ; Glycoproteins ; Immunogenicity, Vaccine ; Double-Blind Method |
| Chemical Substances | Ebola Vaccines ; Antibodies, Viral ; Glycoproteins |
| Language | English |
| Publishing date | 2023-08-03 |
| Publishing country | United States |
| Document type | Clinical Trial, Phase I ; Journal Article |
| ZDB-ID | 2061641-7 |
| ISSN | 1474-4457 ; 1473-3099 |
| ISSN (online) | 1474-4457 |
| ISSN | 1473-3099 |
| DOI | 10.1016/S1473-3099(23)00344-4 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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