Evidence map›Paper›PMID 35632411›Full record

ArticleVaccines2022

An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901.

Josue Antonio Estrada, Chien-Yu Cheng, Shin-Yen Ku, Hui-Chun Hu, Hsiu-Wen Yeh, Yi-Chun Lin, Cheng-Pin Chen, Shu-Hsing Cheng, Robert Janssen, I-Feng Lin

Abstract read
In one paragraph

Article in Vaccines, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–field-weighted citation impact
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

14 citing papers in PubMed.

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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.

Josue Antonio EstradaInternational and Governmental Affairs, Medigen Vaccine Biologics Corporation, Taipei 114, Taiwan.
Chien-Yu ChengDepartment of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan 330, Taiwan.ORCID 0000-0002-1886-0370
Shin-Yen KuDepartment of Nursing, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan 330, Taiwan.
Hui-Chun HuDepartment of Nursing, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan 330, Taiwan.
Hsiu-Wen YehDepartment of Nursing, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan 330, Taiwan.
Yi-Chun LinDepartment of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan 330, Taiwan.
Cheng-Pin ChenDepartment of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan 330, Taiwan.
Shu-Hsing ChengDepartment of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan 330, Taiwan.
Robert JanssenRegulatory and Medical Affairs, Dynavax Technologies Corporation, Emeryville, CA 94608, USA.ORCID 0000-0002-4904-6013
I-Feng LinInstitute of Public Health, School of Medicine, National Yang-Ming Chiao Tung University, Taipei 112, Taiwan.

Funding

Medigen Vaccine Biologics and the Taiwan Centres for Disease Control, Ministry of Health and Welfare No grant number
6 · The paper itself

Abstract

Rapid development and deployment of vaccines is crucial to control the continuously evolving COVID-19 pandemic. The placebo-controlled phase 3 efficacy trial is still the standard for authorizing vaccines in the majority of the world. However, due to a lack of eligible participants in parts of the world, this has not always been feasible. Recently, the Taiwan Food and Drug Administration, following the consensus of the International Coalition of Medicines Regulatory Authorities (ICMRA), adopted the use of immunobridging studies as acceptable for authorizing COVID-19 vaccines in lieu of efficacy data. Here, we describe a study in which our candidate vaccine, MVC-COV1901, an adjuvanted protein subunit vaccine, has been granted emergency use authorization (EUA) in Taiwan based on a noninferiority immunobridging study. Immunogenicity results from the per protocol immunogenicity (PPI) subset (

Indexed as

ChAdOx nCOV-19immunobridgingMVC-COV1901neutralizing antibodies

Identifiers

PMID35632411
PMCPMC9146038

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.