Evidence map›Paper›PMID 33335092›Full record

ArticleNPJ vaccines2020

Nonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidate.

Ramon Roozendaal, Jenny Hendriks, Thierry van Effelterre, Bart Spiessens, Liesbeth Dekking, Laura Solforosi, Dominika Czapska-Casey, Viki Bockstal, Jeroen Stoop, Daniel Splinter and 19 more

Open access · goldAbstract read
In one paragraph

Article in NPJ vaccines, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed
1.2field-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.

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

51 citing papers in PubMed, 71 citations in OpenAlex.

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  11. CD4Nature immunology · 2026
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  12. Cross-reactive Bundibugyo antibody responses after licensed Ebola vaccines.medRxiv : the preprint server for health sciences · 2026
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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

29 authors at 4 institutions in 4 countries.

Ramon RoozendaalJanssen Vaccines & Prevention B.V., Leiden, The Netherlands. RRoozend@its.jnj.com.ORCID http://orcid.org/0000-0002-4084-4801
Jenny HendriksJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Thierry van EffelterreJanssen R&D, Beerse, Belgium.
Bart SpiessensJanssen R&D, Beerse, Belgium.
Liesbeth DekkingJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Laura SolforosiJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Dominika Czapska-CaseyJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Viki BockstalJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Jeroen StoopJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Daniel SplinterJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Sarah JanssenJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Ben van BaelenJanssen R&D, Beerse, Belgium.
Nadia VerbruggenJanssen R&D, Beerse, Belgium.
Jan SerroyenJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Eline DekeysterJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Ariane VolkmannBavarian Nordic, Munich, Germany.
Yvonne WollmannBavarian Nordic, Munich, Germany.
Ricardo CarrionTexas Biomedical Research Institute, San Antonio, TX, USA.
Luis D GiavedoniTexas Biomedical Research Institute, San Antonio, TX, USA.
Cynthia RobinsonJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Maarten LeyssenJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Macaya DouoguihJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Kerstin LuhnJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Maria Grazia PauJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
Jerry SadoffJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.
An VandeboschJanssen R&D, Beerse, Belgium.
Hanneke SchuitemakerJanssen Vaccines & Prevention B.V., Leiden, The Netherlands.ORCID http://orcid.org/0000-0001-8563-2266
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.
Janssen (Netherlands) · NLJanssen (Belgium) · BEBavarian Nordic (Germany) · DETexas Biomedical Research Institute · US

Funding

The Southwest National Primate Research Center Supplement- Infrastructure improvements of ABSL2 holding areasP51OD011133 · OD · TEXAS BIOMEDICAL RESEARCH INSTITUTE · PI Larry S. Schlesinger · 2012 to 2026
$129.7M
NIAID NIH HHS HHSN272200800056CNIAID NIH HHS HHSN272201200003INIH HHS P51 OD011133U.S. Department of Health & Human Services | NIH | National Institute of Allergy and Infectious Diseases (NIAID) HHSN272201000006I
6 · The paper itself

Abstract

It has been proven challenging to conduct traditional efficacy trials for Ebola virus (EBOV) vaccines. In the absence of efficacy data, immunobridging is an approach to infer the likelihood of a vaccine protective effect, by translating vaccine immunogenicity in humans to a protective effect, using the relationship between vaccine immunogenicity and the desired outcome in a suitable animal model. We here propose to infer the protective effect of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen with an 8-week interval in humans by immunobridging. Immunogenicity and protective efficacy data were obtained for Ad26.ZEBOV and MVA-BN-Filo vaccine regimens using a fully lethal EBOV Kikwit challenge model in cynomolgus monkeys (nonhuman primates [NHP]). The association between EBOV neutralizing antibodies, glycoprotein (GP)-binding antibodies, and GP-reactive T cells and survival in NHP was assessed by logistic regression analysis. Binding antibodies against the EBOV surface GP were identified as the immune parameter with the strongest correlation to survival post EBOV challenge, and used to infer the predicted protective effect of the vaccine in humans using published data from phase I studies. The human vaccine-elicited EBOV GP-binding antibody levels are in a range associated with significant protection against mortality in NHP. Based on this immunobridging analysis, the EBOV GP-specific-binding antibody levels elicited by the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen in humans will likely provide protection against EBOV disease.

Identifiers

PMID33335092
PMCPMC7747701
OpenAlexW3112632192

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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.