Immunogenicity of an Extended Dose Interval for the Ad26.ZEBOV, MVA-BN-Filo Ebola Vaccine Regimen in Adults and Children in the Democratic Republic of the Congo

During the 2018–2020 Ebola virus disease outbreak in Democratic Republic of the Congo, a phase 3 trial of the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine (DRC-EB-001) commenced in Goma, with participants being offered the two-dose regimen given 56 days apart. Suspension of trial activities in 2020 due to...

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Vydané v:Vaccines Ročník 12; číslo 8; s. 828
Hlavní autori: Choi, Edward Man-Lik, Kasonia, Kambale, Kavunga-Membo, Hugo, Mukadi-Bamuleka, Daniel, Soumah, Aboubacar, Mossoko, Zephyrin, Edwards, Tansy, Tetsa-Tata, Darius, Makarimi, Rockyath, Toure, Oumar, Mambula, Grace, Brindle, Hannah, Camacho, Anton, Connor, Nicholas E., Mukadi, Pierre, McLean, Chelsea, Keshinro, Babajide, Gaddah, Auguste, Robinson, Cynthia, Luhn, Kerstin, Foster, Julie, Roberts, Chrissy h., Johnson, John Emery, Imbault, Nathalie, Bausch, Daniel G., Grais, Rebecca F., Watson-Jones, Deborah, Muyembe-Tamfum, Jean Jacques
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: Switzerland MDPI AG 23.07.2024
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ISSN:2076-393X, 2076-393X
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Shrnutí:During the 2018–2020 Ebola virus disease outbreak in Democratic Republic of the Congo, a phase 3 trial of the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine (DRC-EB-001) commenced in Goma, with participants being offered the two-dose regimen given 56 days apart. Suspension of trial activities in 2020 due to the COVID-19 pandemic led to some participants receiving a late dose 2 outside the planned interval. Blood samples were collected from adults, adolescents, and children prior to their delayed dose 2 vaccination and 21 days after, and tested for IgG binding antibodies against Ebola virus glycoprotein using the Filovirus Animal Nonclinical Group (FANG) ELISA. Results from 133 participants showed a median two-dose interval of 9.3 months. The pre-dose 2 antibody geometric mean concentration (GMC) was 217 ELISA Units (EU)/mL (95% CI 157; 301) in adults, 378 EU/mL (281; 510) in adolescents, and 558 EU/mL (471; 661) in children. At 21 days post-dose 2, the GMC increased to 22,194 EU/mL (16,726; 29,449) in adults, 37,896 EU/mL (29,985; 47,893) in adolescents, and 34,652 EU/mL (27,906; 43,028) in children. Participants receiving a delayed dose 2 had a higher GMC at 21 days post-dose 2 than those who received a standard 56-day regimen in other African trials, but similar to those who received the regimen with an extended interval.
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These authors contributed equally to this work.
ISSN:2076-393X
2076-393X
DOI:10.3390/vaccines12080828