Evidence map›Paper›PMID 38400193›Full record

ArticleVaccines2024

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 and 9 more

3 registry-linked trialsAbstract read
In one paragraph

Article in Vaccines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02661464 phase3terminatednot on this map

A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo

TypeinterventionalSponsorJanssen Vaccines & Prevention B.V.Ran2016 to 2021Enrolled677ConditionsHemorrhagic Fever, EbolaArmsAd26.ZEBOV, MVA-BN-Filo
NCT06844487 phase3active not recruitingnot on this mapstarted 2025, after this paper: background citation

Phase 3, Randomised Maternal and Infant (From 4 to 24 Months of Age) Safety and Immunogenicity Trial of MVA-BN® Vaccine in the Democratic Republic of the Congo

TypeinterventionalSponsorJean-Pierre Van geertruydenRan2025 to 2027Enrolled344ConditionsMpox (Monkeypox), Vaccination, Immunogenicity, SafetyArmsMVA-BN standard regimen, MVA-BN half-dose regimen
NCT06844500 phase3active not recruitingnot on this mapstarted 2025, after this paper: background citation

Phase 3, Randomised Maternal and Infant (From 4 to 24 Months of Age) Safety and Immunogenicity Trial of MVA-BN® Vaccine in the Democratic Republic of the Congo

TypeinterventionalSponsorJean-Pierre Van geertruydenRan2025 to 2027Enrolled359ConditionsNeonate, Maternal Transmission, Mpox, VaccinationArmsMVA-BN standard regimen, MVA-BN standard regimen (Administered as PEP)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. The immunogenicity and safety of adenoviral-based vaccines.Current opinion in allergy and clinical immunology · 2026
    Review
  3. Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025
    Review
  4. Article
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Adeep PuriHammersmith Medicines Research Limited, Cumberland Avenue, London NW10 7EW, UK.
Andrew J PollardOxford 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.ORCID 0000-0001-7361-719X
Catherine Schmidt-MutterInserm CIC 1434, CHU Strasbourg, 1 Place de l'Hôpital, 67091 Strasbourg, France.ORCID 0000-0002-8154-117X
Fabrice LainéInserm CIC 1414, CHU Rennes, Rue Henri Le Guillou, 35033 Rennes, France.
George PrayGodMwanza Research Center, National Institute for Medical Research, Isamilo Road, Mwanza P.O. Box 1462, Tanzania.
Hannah KibuukaMakerere University Walter Reed Project, Plot 42 Nakasero Road, Kampala P.O. Box 16524, Uganda.
Houreratou BarryCentre MURAZ, 2054 Avenue Mamadou Konaté, Bobo Dioulasso 01 BP 390, Burkina Faso.ORCID 0000-0001-8114-1240
Jean-François NicolasCentre International de Recherche en Infectiologie (CIRI), INSERM U1111, Université Claude Bernard Lyon I, 69364 Lyon, France.ORCID 0000-0003-4204-803X
Jean-Daniel LelièvreINSERM U955, Vaccine Research Institute, CHU Henri Mondor 1 rue Gustave Eiffel, 94000 Créteil, France.ORCID 0000-0002-8182-3628
Sodiomon Bienvenu SirimaGroupe de Recherche Action en Santé (GRAS), Ouagadougou 06 BP 10248, Burkina Faso.ORCID 0000-0002-0972-4211
Beatrice KamalaMwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza P.O. Box 11936, Tanzania.
Daniela MannoDepartment of Clinical Research, London School of Hygiene and Tropical Medicine, Keppel St, London WC1E 7HT, UK.
Deborah Watson-JonesMwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza P.O. Box 11936, Tanzania.ORCID 0000-0001-6247-1746
Auguste GaddahJanssen Research & Development, Turnhoutseweg 30, B-2340 Beerse, Belgium.
Babajide KeshinroJanssen Vaccines & Prevention B.V., Archimedesweg 6, 2333 CN Leiden, The Netherlands.ORCID 0000-0003-4673-2955
Kerstin LuhnJanssen Vaccines & Prevention B.V., Archimedesweg 6, 2333 CN Leiden, The Netherlands.
Cynthia RobinsonJanssen Vaccines & Prevention B.V., Archimedesweg 6, 2333 CN Leiden, The Netherlands.
Macaya DouoguihJanssen Vaccines & Prevention B.V., Archimedesweg 6, 2333 CN Leiden, The Netherlands.
EBL4001 Study Group

Funding

NIAID NIH HHS HHSN272200800056C
6 · The paper itself

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.

Indexed as

Ad26.ZEBOVclinical trialsEbola virusMVA-BN-Filosafetyvaccines

Identifiers

PMID38400193
PMCPMC10892482

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.