Evidence map›Paper›PMID 38523332›Full record

Trial reportHuman vaccines & immunotherapeutics2024

Lot-to-lot consistency, immunogenicity, and safety of the Ad26.ZEBOV, MVA-BN-Filo Ebola virus vaccine regimen: A phase 3, randomized, double-blind, placebo-controlled trial.

Neil Goldstein, Chelsea McLean, Auguste Gaddah, Joachim Doua, Babajide Keshinro, Linda Bus-Jacobs, Jenny Hendriks, Kerstin Luhn, Cynthia Robinson, Macaya Douoguih

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04228783 (A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, Reactogenicity, and Consistency of a Heterologous 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN®-Filo in Adult Participants), which is 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
2.7field-weighted citation impact, top 10% 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.

NCT04228783 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, Reactogenicity, and Consistency of a Heterologous 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN®-Filo in Adult Participants

TypeinterventionalSponsorJanssen Vaccines & Prevention B.V.Ran2020 to 2022Enrolled974ConditionsEbolaArmsAd26.ZEBOV, MVA-BN-Filo, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

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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

10 authors at 3 institutions in 3 countries.

Neil GoldsteinJanssen Vaccines & Prevention B.V, Leiden, The Netherlands.
Chelsea McLeanJanssen Vaccines & Prevention B.V, Leiden, The Netherlands.
Auguste GaddahJanssen Research & Development, Beerse, Belgium.
Joachim DouaJanssen Research & Development, Beerse, Belgium.
Babajide KeshinroJanssen Vaccines & Prevention B.V, Leiden, The Netherlands.
Linda Bus-JacobsJanssen Vaccines & Prevention B.V, Leiden, The Netherlands.
Jenny HendriksJanssen Vaccines & Prevention B.V, Leiden, The Netherlands.
Kerstin LuhnJanssen Vaccines & Prevention B.V, Leiden, The Netherlands.
Cynthia RobinsonJanssen Vaccines & Prevention B.V, Leiden, The Netherlands.
Macaya DouoguihJanssen Vaccines & Prevention B.V, Leiden, The Netherlands.
Human Vaccines Project Europe · NLJanssen (Netherlands) · NLJanssen (Belgium) · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase-3, double-blind, placebo-controlled study (NCT04228783) evaluated lot-to-lot consistency of the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen. Participants were randomized (6:6:6:1) to receive the two-dose regimen from three consecutively manufactured lots of Ad26.ZEBOV on Day 1 paired with three consecutively manufactured lots of MVA-BN-Filo on Day 57 (Groups 1-3) or two doses of placebo (Group 4). An additional cohort also received an Ad26.ZEBOV booster or placebo 4 months post-dose 2. Equivalence of the immunogenicity at 21 days post-dose 2 between any two groups was demonstrated if the 95% confidence interval (CI) of the Ebola virus glycoprotein (EBOV GP)-binding antibody geometric mean concentration (GMC) ratio was entirely within the prespecified margin of 0.5-2.0. Lot-to-lot consistency (i.e., consecutive lots can be consistently manufactured) was accomplished if equivalence was shown for all three pairwise comparisons. Results showed that the primary objective in the per-protocol immunogenicity subset (

Indexed as

Ebola VaccinesEbolavirusHemorrhagic Fever, EbolaSmallpox VaccineAntibodies, ViralDouble-Blind MethodHumansImmunogenicity, VaccineVaccinationVaccines, AttenuatedAntibodies, ViralEbola Vaccinessmallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordicSmallpox VaccineVaccines, AttenuatedAd26.ZEBOVclinical trialEbolaimmunogenicityMVA-BN-Filovaccine

Identifiers

PMID38523332
PMCPMC10965106
OpenAlexW4393157059

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.