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.
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;
+19 more...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;
Tujiokowe Study Consortium;
(2024)
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.
Vaccines, 12 (8).
p. 828.
ISSN 2076-393X
DOI: https://doi.org/10.3390/vaccines12080828
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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.
