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. 2024 Jul 23;12(8):828.
doi: 10.3390/vaccines12080828.

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  1 , Kambale Kasonia  1 , Hugo Kavunga-Membo  2 , Daniel Mukadi-Bamuleka  2 , Aboubacar Soumah  3 , Zephyrin Mossoko  2 , Tansy Edwards  4   5 , Darius Tetsa-Tata  1 , Rockyath Makarimi  3 , Oumar Toure  3 , Grace Mambula  3 , Hannah Brindle  1 , Anton Camacho  3 , Nicholas E Connor  1 , Pierre Mukadi  2 , Chelsea McLean  6 , Babajide Keshinro  6 , Auguste Gaddah  7 , Cynthia Robinson  6 , Kerstin Luhn  6 , Julie Foster  1 , Chrissy H Roberts  1 , John Emery Johnson  8 , Nathalie Imbault  9 , Daniel G Bausch  1   10 , Rebecca F Grais  3 , Deborah Watson-Jones  1   11 , Jean Jacques Muyembe-Tamfum  2 ; Tujiokowe Study Consortium
Affiliations

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 et al. Vaccines (Basel). .

Abstract

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.

Keywords: Ad26.ZEBOV; DRC; Democratic Republic of the Congo; Ebola; MVA-BN-Filo; Mvabea; Zabdeno; immunogenicity; interval; outbreak; vaccine.

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Conflict of interest statement

The funders advised on the study design and protocol, but had no role in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. Janssen Vaccines & Prevention B.V. was the vaccine manufacturer and donated the vaccine for this study. B.K., A.G., C.M., K.L., and C.R. were full-time employees of Janssen, Pharmaceutical Companies of Johnson & Johnson at the time of the study. A.G., C.M., K.L., and C.R. declared ownership of shares in Janssen, Pharmaceutical Companies of Johnson & Johnson. D.W.-J. and Janssen Vaccines & Prevention B.V. are consortium members for the EBOVAC1 and EBOVAC3 projects. All other authors declare no conflicts of interests.

Figures

Figure 1
Figure 1
Study timeline.
Figure 2
Figure 2
Disposition of delayed second dose immunogenicity subset participants.
Figure 3
Figure 3
Ebola virus glycoprotein-specific binding antibody responses at pre-dose 2 and 21 days post-dose 2 in participants receiving a delayed dose 2 vaccine—distribution by age group. Antibody geometric mean concentration (GMC, ELISA Unit (EU)/mL) in adults (18 years or above), adolescents (12–17 years), and children (4–11 years). Boxes indicate median and interquartile range; EBOV (Ebola virus); LLOQ (Lower limit of quantification); ULOQ (Upper limit of quantification).
Figure 4
Figure 4
Immunogenicity of extended dose intervals for the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen in this study and the EBL2002 trial. Closed circles depict immunogenicity results of healthy adult participants in the EBL2002 trial conducted in Burkina Faso, Côte D’Ivoire, Kenya, and Uganda who received dose 2 between 28 days to ≥280 days after dose 1. Open circles depict immunogenicity data collected in this DRC-EB-001 trial from immunogenicity subset adult participants in the DRC who received their dose 2 approximately 9.3 months after dose 1. A trendline (dashed line) is fitted by ordinary least square linear regression of EBL2002 data from healthy adults using STATA/SE 18.0.
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