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. 2024 Feb 17;12(2):210.
doi: 10.3390/vaccines12020210.

Long-Term Clinical Safety of the Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: A Prospective, Multi-Country, Observational Study

Adeep Puri  1 , Andrew J Pollard  2 , Catherine Schmidt-Mutter  3 , Fabrice Lainé  4 , George PrayGod  5 , Hannah Kibuuka  6 , Houreratou Barry  7 , Jean-François Nicolas  8 , Jean-Daniel Lelièvre  9 , Sodiomon Bienvenu Sirima  10 , Beatrice Kamala  11 , Daniela Manno  12 , Deborah Watson-Jones  11   12 , Auguste Gaddah  13 , Babajide Keshinro  14 , Kerstin Luhn  14 , Cynthia Robinson  14 , Macaya Douoguih  14 ; EBL4001 Study Group
Affiliations

Long-Term Clinical Safety of the Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: A Prospective, Multi-Country, Observational Study

Adeep Puri et al. Vaccines (Basel). .

Abstract

In this prospective, observational study (ClinicalTrials.gov Identifier: NCT02661464), long-term safety information was collected from participants previously exposed to the Ebola vaccines Ad26.ZEBOV and/or MVA-BN-Filo while enrolled in phase 1, 2, or 3 clinical studies. The study was conducted at 15 sites in seven countries (Burkina Faso, France, Kenya, Tanzania, Uganda, the United Kingdom, and the United States). Adult participants and offspring from vaccinated female participants who became pregnant (estimated conception ≤28 days after vaccination with MVA-BN-Filo or ≤3 months after vaccination with Ad26.ZEBOV) were enrolled. Adults were followed for 60 months after their first vaccination, and children born to female participants were followed for 60 months after birth. In the full analysis set (n = 614 adults; median age [range]: 32.0 [18-65] years), 49 (8.0%) had ≥1 serious adverse event (SAE); the incidence rate of any SAE was 27.4 per 1000 person-years (95% confidence interval: 21.0, 35.2). The unrelated SAEs of malaria were reported in the two infants in the full analysis set, aged 11 and 18 months; both episodes were resolved. No deaths or life-threatening SAEs occurred during the study. Overall, no major safety issues were identified; one related SAE was reported. These findings support the long-term clinical safety of the Ad26.ZEBOV and MVA-BN-Filo vaccines.

Keywords: Ad26.ZEBOV; Ebola virus; MVA-BN-Filo; clinical trials; safety; vaccines.

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Conflict of interest statement

A.P.’s institution was contracted by Janssen Pharmaceuticals to help conduct the study. A.J.P.’s institution received funding from the European Commission Innovative Medicines Initiative, he was a member of WHO’s SAGE until 2022, and he is chair of the UK Department of Health and Social Care’s Joint Committee on Vaccination and Immunisation. C.S.-M., F.L., J.-F.N., and S.B.S. declare no conflicts of interest. G.P.’s, B.K.’s (Beatrice Kamala’s), D.M.’s, and D.W.-J.’s institutions received funding from Janssen Vaccines & Prevention B.V. to conduct the EBL4001 study and from the Innovative Medicines Initiative to conduct the EBL3001, EBL3005, EBL2010, EBL2011, EBL2012, and EBL1004 studies. H.K.’s institution received funding from Janssen Vaccines & Prevention B.V. H.B.’s institution received funding from the Innovative Medicines Initiative to conduct the EBL2002 study. J.-D.L.’s institution received funding from the Innovative Medicines Initiative to conduct the EBL2002 study, he was a member of the WHO’s IVIR-AC until 2022, and he is currently a member of the French NITAG and chair of the SAG vaccine of EMA. A.G., B.K. (Babajide Keshinro), K.L., C.R., and M.D. were full-time employees of Janssen Pharmaceuticals at the time of the study and reported stock or stock options in Janssen Pharmaceuticals. Janssen Vaccines & Prevention B.V., the study sponsor, was involved in the design and conduct of the study, the collection and analysis of data, the writing of the manuscript, and the decision to publish the results.

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