Evidence map›Paper›PMID 36450746›Full record

ArticleNPJ vaccines2022

Non-human primate to human immunobridging demonstrates a protective effect of Ad26.ZEBOV, MVA-BN-Filo vaccine against Ebola.

Viki Bockstal, Maarten Leyssen, Dirk Heerwegh, Bart Spiessens, Cynthia Robinson, Jeroen N Stoop, Ramon Roozendaal, Thierry Van Effelterre, Auguste Gaddah, Griet A Van Roey and 8 more

5 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in NPJ vaccines, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.9field-weighted citation impact, top 12% 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.

NCT02416453 phase2completednot on this map

A Randomized, Observer-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Prime-Boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults in Europe

TypeinterventionalSponsorJanssen Vaccines & Prevention B.V.Ran2015 to 2018Enrolled423ConditionsEbola Viral DiseaseArmsMVA-BN-Filo, Ad26.ZEBOV, Placebo
NCT02509494 phase3completednot on this map

A Staged Phase 3 Study, Including a Double-Blinded Controlled Stage to Evaluate the Safety and Immunogenicity of Ad26.ZEBOV and MVA-BN-Filo as Candidate Prophylactic Vaccines for Ebola

TypeinterventionalSponsorJanssen Vaccines & Prevention B.V.Ran2015 to 2019Enrolled1,023ConditionsEbola Virus DiseaseArmsAd26.ZEBOV, MVA-BN-Filo, MenACWY, Placebo
NCT02543268 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of a Heterologous Prime-Boost Regimen Using Three Different Batches of Ad26.ZEBOV and a Single Batch of MVA-BN®-Filo in Healthy Adult Subjects

TypeinterventionalSponsorCrucell Holland BVRan2015 to 2016Enrolled329ConditionsHealthyArmsAd26.ZEBOV-Batch #1, Ad26.ZEBOV-Batch #2, Ad26.ZEBOV-Batch #3, MVA-BN-Filo, Placebo
NCT02543567 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate A Range of Dose Levels of a Heterologous Prime-Boost Regimen of Ad26.ZEBOV and MVA-BN®-Filo in Healthy Adult Subjects

TypeinterventionalSponsorJanssen Vaccines & Prevention B.V.Ran2015 to 2016Enrolled525ConditionsHealthyArmsAd26.ZEBOV 5*10^10 viral particles (vp), Ad26.ZEBOV 2*10^10 (vp), Ad26.ZEBOV 0.8*10^10 (vp), MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.], MVA-BN-Filo 5*10^7 Inf. U.
NCT02564523 phase2completednot on this map

A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults, Including Elderly Subjects, HIV-infected Subjects, and Healthy Children in Two Age Strata in Africa

TypeinterventionalSponsorJanssen Vaccines & Prevention B.V.Ran2015 to 2019Enrolled1,075ConditionsHemorrhagic Fever, EbolaArmsAd26.ZEBOV, MVA-BN-Filo, Placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 20 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

18 authors at 2 institutions in 2 countries.

Viki Bockstal *Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Maarten Leyssen *Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Dirk HeerweghJanssen Research and Development, Beerse, Belgium.
Bart SpiessensJanssen Research and Development, Beerse, Belgium.
Cynthia RobinsonJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Jeroen N StoopJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Ramon RoozendaalJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.ORCID http://orcid.org/0000-0002-4084-4801
Thierry Van EffelterreJanssen Research and Development, Beerse, Belgium.
Auguste GaddahJanssen Research and Development, Beerse, Belgium.
Griet A Van RoeyJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Laura SolforosiJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Roland ZahnJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.ORCID http://orcid.org/0000-0003-2822-6231
Benoit CallendretJanssen 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. kluhn@its.jnj.com.ORCID http://orcid.org/0000-0001-8451-1294
Macaya DouoguihJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.ORCID http://orcid.org/0000-0002-2707-5729
Hanneke SchuitemakerJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.ORCID http://orcid.org/0000-0001-8563-2266
Johan Van HoofJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Janssen (Netherlands) · NLJanssen (Belgium) · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Without clinical efficacy data, vaccine protective effect may be extrapolated from animals to humans using an immunologic marker that correlates with protection in animals. This immunobridging approach was used for the two-dose Ebola vaccine regimen Ad26.ZEBOV, MVA-BN-Filo. Ebola virus (EBOV) glycoprotein binding antibody data obtained from 764 vaccinated healthy adults in five clinical studies (NCT02416453, NCT02564523, NCT02509494, NCT02543567, NCT02543268) were used to calculate mean predicted survival probability (with preplanned 95% confidence interval [CI]). We used a logistic regression model based on EBOV glycoprotein binding antibody responses in vaccinated non-human primates (NHPs) and NHP survival after EBOV challenge. While the protective effect of the vaccine regimen in humans can be inferred in this fashion, the extrapolated survival probability cannot be directly translated into vaccine efficacy. The primary immunobridging analysis evaluated the lower limit of the CI against predefined success criterion of 20% and passed with mean predicted survival probability of 53.4% (95% CI: 36.7-67.4).

Identifiers

PMID36450746
PMCPMC9712521
OpenAlexW4310642152

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.