Evidence map›Paper›PMID 30796816›Full record

Trial reportThe Journal of infectious diseases2019

Safety and Immunogenicity of a 2-Dose Heterologous Vaccine Regimen With Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: 12-Month Data From a Phase 1 Randomized Clinical Trial in Nairobi, Kenya.

Gaudensia Mutua, Omu Anzala, Kerstin Luhn, Cynthia Robinson, Viki Bockstal, Dickson Anumendem, Macaya Douoguih

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02376426 (A Phase 1 Study to Evaluate the Safety, Tolerability and Immunogenicity of Heterologous Prime-Boost Regimens Using MVA-BN®-Filo and Ad26.ZEBOV Administered in Different Sequences and Schedules in Healthy Adults), which is not on this map. Cited by 57 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 1 pooled it
9.4field-weighted citation impact, top 1% of its field
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.

NCT02376426 phase1completednot on this map

A Phase 1 Study to Evaluate the Safety, Tolerability and Immunogenicity of Heterologous Prime-Boost Regimens Using MVA-BN®-Filo and Ad26.ZEBOV Administered in Different Sequences and Schedules in Healthy Adults

TypeinterventionalSponsorCrucell Holland BVRan2015 to 2016Enrolled72ConditionsHealthyArmsMVA-BN-Filo, Ad26.ZEBOV, Placebo
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 1 synthesis or guideline pooled it, 95 citations in OpenAlex.

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  15. Orf virus-based vectors induce potent germinal center B cell, Tfh cell, and CD8Molecular therapy : the journal of the American Society of Gene Therapy · 2025
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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

7 authors at 3 institutions in 2 countries.

Gaudensia MutuaKenya AIDS Vaccine Initiative Institute of Clinical Research, College of Health Sciences, University of Nairobi, Kenya.
Omu AnzalaKenya AIDS Vaccine Initiative Institute of Clinical Research, College of Health Sciences, University of Nairobi, Kenya.
Kerstin LuhnJanssen Vaccines and Prevention, Leiden, the Netherlands.
Cynthia RobinsonJanssen Vaccines and Prevention, Leiden, the Netherlands.
Viki BockstalJanssen Vaccines and Prevention, Leiden, the Netherlands.
Dickson AnumendemJanssen Vaccines and Prevention, Leiden, the Netherlands.
Macaya DouoguihJanssen Vaccines and Prevention, Leiden, the Netherlands.
Janssen (Netherlands) · NLKenya AIDS Vaccine Initiative · KEUniversity of Nairobi · KE

Funding

NIAID NIH HHS HHSN272200800056C
6 · The paper itself

Abstract

backgroundDuring the 2014 West African Ebola outbreak, Ebola vaccine development was accelerated. The phase 1 VAC52150EBL1003 study was performed to investigate 2-dose heterologous vaccination with Ad26.ZEBOV and MVA-BN-Filo in an African population located in a high-altitude setting in Nairobi, Kenya.

methodsHealthy adult volunteers were randomized to receive one of four 2-dose vaccination schedules. The first vaccination was administered at baseline (Ad26.ZEBOV or MVA-BN-Filo), followed by the second vaccination with the alternate vaccine after either 28 or 56 days. Each schedule had a placebo comparator group. The primary objective was to assess the safety and tolerability of these regimens.

resultsSeventy-two volunteers were randomized into 4 groups of 18 (15 received vaccine, and 3 received placebo). The most frequent solicited systemic adverse event was headache (frequency, 50%, 61%, and 42% per dose for MVA-BN-Filo, Ad26.ZEBOV, and placebo, respectively). The most frequent solicited local AE was injection site pain (frequency, 78%, 63%, and 33% per dose for MVA-BN-Filo, Ad26.ZEBOV, and placebo, respectively). No differences in adverse events were observed among the different vaccine regimens. High levels of binding and neutralizing anti-Ebola virus glycoprotein antibodies were induced by all regimens and sustained to day 360 after the first dose.

conclusionsTwo-dose heterologous vaccination with Ad26.ZEBOV and MVA-BN-Filo was well tolerated and highly immunogenic against Ebola virus glycoprotein. CLINICAL TRIALS REGISTRATION: NCT02376426.

Indexed as

AdolescentAdultAntibodies, ViralDisease OutbreaksEbola VaccinesEbolavirusFemaleHealthy VolunteersHemorrhagic Fever, EbolaHumansKenyaMaleMiddle AgedVaccinationVaccines, DNAViral VaccinesAntibodies, ViralEbola VaccinesMVA vaccineVaccines, DNAViral VaccinesAd26.ZEBOVEbola vaccineheterologous 2-doseMVA-BN-Filosafety and immunogenicity

Identifiers

PMID30796816
PMCPMC6548899
OpenAlexW2930141921

What OpenQuestion holds

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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.