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
Edward Man-Lik Choi,
Kambale Kasonia,
Hugo Kavunga-Membo,
Daniel Mukadi-Bamuleka,
Aboubacar Soumah,
Zephyrin Mossoko,
Tansy Edwards,
Darius Tetsa-Tata,
Rockyath Makarimi,
Oumar Toure,
Grace Mambula,
Hannah Brindle,
Anton Camacho,
Nicholas E. Connor,
Pierre Mukadi,
Chelsea McLean,
Babajide Keshinro,
Auguste Gaddah,
Cynthia Robinson,
Kerstin Luhn,
Julie Foster,
Chrissy h. Roberts,
John Emery Johnson,
Nathalie Imbault,
Daniel G. Bausch,
Rebecca F. Grais,
Deborah Watson-Jones,
Jean Jacques Muyembe-Tamfum
Affiliations
Edward Man-Lik Choi
Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK
Kambale Kasonia
Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK
Hugo Kavunga-Membo
Institut National de Recherche Biomédicale, Kinshasa P.O. Box 1192, Democratic Republic of the Congo
Daniel Mukadi-Bamuleka
Institut National de Recherche Biomédicale, Kinshasa P.O. Box 1192, Democratic Republic of the Congo
Aboubacar Soumah
Epicentre, 75019 Paris, France
Zephyrin Mossoko
Institut National de Recherche Biomédicale, Kinshasa P.O. Box 1192, Democratic Republic of the Congo
Tansy Edwards
MRC International Statistics and Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK
Darius Tetsa-Tata
Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK
Rockyath Makarimi
Epicentre, 75019 Paris, France
Oumar Toure
Epicentre, 75019 Paris, France
Grace Mambula
Epicentre, 75019 Paris, France
Hannah Brindle
Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK
Anton Camacho
Epicentre, 75019 Paris, France
Nicholas E. Connor
Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK
Pierre Mukadi
Institut National de Recherche Biomédicale, Kinshasa P.O. Box 1192, Democratic Republic of the Congo
Chelsea McLean
Janssen Vaccines and Prevention B.V., 2333 CN Leiden, The Netherlands
Babajide Keshinro
Janssen Vaccines and Prevention B.V., 2333 CN Leiden, The Netherlands
Auguste Gaddah
Janssen Research & Development, 2340 Beerse, Belgium
Cynthia Robinson
Janssen Vaccines and Prevention B.V., 2333 CN Leiden, The Netherlands
Kerstin Luhn
Janssen Vaccines and Prevention B.V., 2333 CN Leiden, The Netherlands
Julie Foster
Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK
Chrissy h. Roberts
Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK
John Emery Johnson
Médecins Sans Frontières, 75019 Paris, France
Nathalie Imbault
Coalition for Epidemic Preparedness Innovations, 0191 Oslo, Norway
Daniel G. Bausch
Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK
Rebecca F. Grais
Epicentre, 75019 Paris, France
Deborah Watson-Jones
Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK
Jean Jacques Muyembe-Tamfum
Institut National de Recherche Biomédicale, Kinshasa P.O. Box 1192, 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 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.
