Evidence map›Paper›PMID 42469934›Full record

ArticleSystematic reviews2026

Safety, immunogenicity, efficacy, and effectiveness of mpox vaccines in pregnant persons, children, and adolescents: a protocol for a living systematic review and meta-analysis.

Jamile Ballivian, Agustín Ciapponi, Mabel Berrueta, Juan Manuel Sambade, Ariel Bardach, Martin Brizuela, Julieta Caravario, Noelia Castellana, Esteban Couto, Daniel Comandé and 10 more

Abstract read
In one paragraph

Article in Systematic reviews, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

20 authors.

Jamile Ballivian *Instituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina. jballivian@iecs.org.ar.ORCID http://orcid.org/0000-0002-2495-8040
Agustín Ciapponi *Instituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina.
Mabel BerruetaInstituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina.
Juan Manuel SambadeInstituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina.
Ariel BardachInstituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina.
Martin BrizuelaInstituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina.
Julieta CaravarioInstituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina.
Noelia CastellanaInstituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina.
Esteban CoutoInstituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina.
Daniel ComandéInstituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina.
Agustina MazzoniInstituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina.
Vanesa OrtegaInstituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina.
Florencia SalvaInstituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina.
Katharina StegelmannInstituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina.
Juan Pablo SmutnyInstituto de Efectividad Clínica y Sanitaria (IECS), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina.
Edward P K ParkerThe Vaccine Centre, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.
Andy StergachisSchool of Pharmacy and School of Public Health, University of Washington, Seattle, WA, USA.
Xu XiongCelia Scott Weatherhead School of Public Health and Tropical Medicine, Tulane University, New Orleans, USA.
Flor M MunozBaylor College of Medicine, Texas Children's Hospital, 1102 Bates Ave, Houston, TX, 77030, USA.
Pierre M BuekensCelia Scott Weatherhead School of Public Health and Tropical Medicine, Tulane University, New Orleans, USA.

Funding

Coalition for Epidemic Preparedness Innovations not available
6 · The paper itself

Abstract

backgroundMpox is a zoonotic disease caused by the monkeypox virus (MPXV) that became a global health concern following the 2022 outbreak. It poses a significant threat to immunocompromised individuals, children, and pregnant persons. Disease spread in the Democratic Republic of the Congo (DRC) and propagation to other countries has led to recent declarations of public health emergencies. Smallpox vaccination cessation has further heightened population vulnerability to MPXV. In response, MVA-BN and LC16m8, vaccinia-based vaccines originally developed for smallpox, have been repurposed for mpox, demonstrating promising safety and immunogenicity profiles. Despite these advancements, challenges remain in vaccine distribution and in understanding vaccine efficacy across populations, particularly in key at-risk groups. Available evidence remains fragmented and largely derived from adult populations, with limited data in pregnant persons, children, and adolescents. This living systematic review (LSR) aims to evaluate the safety, efficacy, effectiveness, and immunogenicity of mpox vaccines across populations, with particular focus on pregnant persons, children, and adolescents.

methodsWe aim to conduct a LSR and meta-analysis based on biweekly searches of medical databases and clinical trial registries from inception to the current date to systematically identify relevant studies of mpox vaccines across populations. Pairs of reviewers will independently select eligible studies, extract data, and assess the risk of bias. We will include randomized clinical trials, quasi-experimental studies, cohort studies, case-control studies, cross-sectional studies, and case reports. Primary outcomes will include safety, efficacy/effectiveness, and immunogenicity of mpox vaccines across populations, including outcomes in pregnant persons (with neonatal outcomes), children, and adolescents. Meta-analyses will be conducted, including prespecified subgroup and sensitivity analyses. We will use the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to assess the certainty of evidence. DISCUSSION: This LSR will synthesize evidence on mpox vaccines across populations, with particular focus on pregnant persons, children, and adolescents. As mpox continues to pose a global threat, particularly in endemic and low-resource settings, timely and rigorous assessment of vaccine performance is essential to guide equitable immunization policies and maternal-child health strategies. SYSTEMATIC REVIEW REGISTRATION: International Prospective Register of Systematic Reviews (PROSPERO): CRD42024554330 (pregnant persons) and CRD42024556977 (children and adolescents).

Indexed as

Immunogenicity, VaccineMpox, MonkeypoxSmallpox VaccineVaccine EfficacyAdolescentChildFemaleHumansMeta-Analysis as TopicPregnancyResearch DesignSystematic Reviews as TopicSmallpox VaccineAdolescentsChildrenLiving systematic reviewMeta-analysesMpoxPregnancyProtocolVaccine

Identifiers

PMID42469934
PMCPMC13660160

What OpenQuestion holds

Textmetadata
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Registered trials

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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.