Long-Term Clinical Safety of the Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: A Prospective, Multi-Country, Observational Study
Adeep Puri,
Andrew J. Pollard,
Catherine Schmidt-Mutter,
Fabrice Lainé,
George PrayGod,
Hannah Kibuuka,
Houreratou Barry,
Jean-François Nicolas,
Jean-Daniel Lelièvre,
Sodiomon Bienvenu Sirima,
Beatrice Kamala,
Daniela Manno,
Deborah Watson-Jones,
Auguste Gaddah,
Babajide Keshinro,
Kerstin Luhn,
Cynthia Robinson,
Macaya Douoguih
Affiliations
Adeep Puri
Hammersmith Medicines Research Limited, Cumberland Avenue, London NW10 7EW, UK
Andrew J. Pollard
Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), and NIHR Oxford Biomedical Research Centre, Churchill Hospital, Old Road, Headington, Oxford OX3 7LE, UK
Catherine Schmidt-Mutter
Inserm CIC 1434, CHU Strasbourg, 1 Place de l’Hôpital, 67091 Strasbourg, France
Fabrice Lainé
Inserm CIC 1414, CHU Rennes, Rue Henri Le Guillou, 35033 Rennes, France
George PrayGod
Mwanza Research Center, National Institute for Medical Research, Isamilo Road, Mwanza P.O. Box 1462, Tanzania
Hannah Kibuuka
Makerere University Walter Reed Project, Plot 42 Nakasero Road, Kampala P.O. Box 16524, Uganda
Houreratou Barry
Centre MURAZ, 2054 Avenue Mamadou Konaté, Bobo Dioulasso 01 BP 390, Burkina Faso
Jean-François Nicolas
Centre International de Recherche en Infectiologie (CIRI), INSERM U1111, Université Claude Bernard Lyon I, 69364 Lyon, France
Jean-Daniel Lelièvre
INSERM U955, Vaccine Research Institute, CHU Henri Mondor 1 rue Gustave Eiffel, 94000 Créteil, France
Sodiomon Bienvenu Sirima
Groupe de Recherche Action en Santé (GRAS), Ouagadougou 06 BP 10248, Burkina Faso
Beatrice Kamala
Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza P.O. Box 11936, Tanzania
Daniela Manno
Department of Clinical Research, London School of Hygiene and Tropical Medicine, Keppel St, London WC1E 7HT, UK
Deborah Watson-Jones
Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza P.O. Box 11936, Tanzania
Auguste Gaddah
Janssen Research & Development, Turnhoutseweg 30, B-2340 Beerse, Belgium
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.
