ArticleTrials2022
Safety, reactogenicity, and immunogenicity of a 2-dose Ebola vaccine regimen of Ad26.ZEBOV followed by MVA-BN-Filo in healthy adult pregnant women: study protocol for a phase 3 open-label randomized controlled trial.
Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04556526 (A Phase 3 Open-label Randomized Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of a 2-dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in Healthy Pregnant Women), which is not on this map. Cited by 11 papers.
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A Phase 3 Open-label Randomized Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of a 2-dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in Healthy Pregnant Women
Who cites it
11 citing papers in PubMed, 15 citations in OpenAlex.
- Heterologous two-dose Ebola vaccine regimen in pregnant women in Rwanda: a randomized controlled phase 3 trial.Nature medicine · 2025Trial
- Article
- Nucleoprotein and glycoprotein based serological assays for detection of Marburg virus infections.EBioMedicine · 2026Article
- Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025Review
- Single-dose replicon RNA Sudan virus vaccine uniformly protects female guinea pigs from disease.Nature communications · 2025Article
- Community members' knowledge, attitude, and practices towards Ebola virus prevention in the Western Province of Rwanda.Journal of health, population, and nutrition · 2025Article
- Contraception use and pregnancy in women receiving a 2-dose Ebola vaccine in Rwanda: A retrospective analysis of UMURINZI vaccination campaign data.PLoS medicine · 2025Article
- Implementing postpartum family planning services in rural Rwanda: A mixed-methods study.PloS one · 2025Article
- Article
- Best practices and lessons learned from implementing a massive Ebola vaccination program: Summarizing UMURINZI team experience.Health science reports · 2023Article
- Monitoring of Adverse Events in Recipients of the 2-Dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in the UMURINZI Ebola Vaccination Campaign.The Journal of infectious diseases · 2023Article
Corrections and comments
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Authors and funding
18 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRisks to mother and fetus following Ebola virus infection are very high. Evaluation of safety and immunogenicity of non-replicating Ebola vaccine candidates is a priority for use in pregnant women. This is the protocol for a randomized, open-label, single-center phase 3 clinical trial of the safety, reactogenicity, and immunogenicity of the 2-dose Ebola vaccine regimen in healthy adult pregnant women. This 2-dose regimen has been shown to be safe, judged effective, and approved in non-pregnant populations.
methodsA total of 2000 adult (≥ 18 years of age) pregnant women will be enrolled from antenatal care facilities in Western Rwanda and randomized (1:1) to receive the 2-dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo (group A)) or control (unvaccinated pregnant women (group B)). The primary objectives are to (1) assess adverse maternal/fetal outcomes in randomized pregnant women up to 1.5 months after delivery and (2) assess adverse neonatal/infant outcomes in neonates/infants born to randomized women up to 3.5 months after birth. The frequency and relatedness of all serious adverse events in women and newborns from randomization or birth, respectively, until study end will be reported. The reactogenicity and unsolicited adverse events of the 2-dose Ebola vaccine regimen in all vaccinated pregnant women (group A) will be reported. We will also assess the immunogenicity of the 2-dose Ebola vaccine regimen in 150 pregnant women who are anticipated to receive both vaccine doses within the course of their pregnancy (a subset of the 1000 pregnant vaccinated women from group A) compared to 150 non-pregnant women vaccinated after delivery (a subset of group B). The persistence of maternal antibodies in 75 infants born to women from the group A subset will be assessed. Exploratory analyses include assessment of acceptability of the 2-dose Ebola vaccine regimen among group A and assessment of maternal antibodies in breast milk in 50 women from group A and 10 controls (women from group B prior to vaccination). DISCUSSION: This study is intended to support a label variation to relax restrictions on use in pregnant women, a vulnerable population with high medical need.
trial registrationClinicaltrials.gov NCT04556526 . September 21, 2020.
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