Evidence map›Paper›PMID 36526640›Full record

ArticleNPJ vaccines2022

Safety and immunogenicity of SARS-CoV-2 vaccine MVC-COV1901 in Taiwanese adolescents: a randomized phase 2 trial.

Luke Tzu-Chi Liu, Cheng-Hsun Chiu, Nan-Chang Chiu, Boon-Fatt Tan, Chien-Yu Lin, Hao-Yuan Cheng, Meei-Yun Lin, Chia-En Lien, Charles Chen, Li-Min Huang

Registry-linked trialOpen 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 trial NCT04951388 (A Phase II, Prospective, Double-blinded, Multi-Center Study to Evaluate the Safety, Tolerability, and Immunogenicity of the SARS CoV 2 Vaccine Candidate MVC COV1901 in Adolescents), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.4field-weighted citation impact, top 17% 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.

NCT04951388 phase2completednot on this map

A Phase II, Prospective, Double-blinded, Multi-Center Study to Evaluate the Safety, Tolerability, and Immunogenicity of the SARS CoV 2 Vaccine Candidate MVC COV1901 in Adolescents

TypeinterventionalSponsorMedigen Vaccine Biologics Corp.Ran2021 to 2022Enrolled399ConditionsCovid19 VaccineArmsMVC-COV1901(S protein with adjuvant), MVC-COV1901(Saline)
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. How Taiwan has responded to COVID-19 and how COVID-19 has affected Taiwan, 2020-2022.Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi · 2023
    Review
  7. Review
  8. Article
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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 5 institutions in 2 countries.

Luke Tzu-Chi LiuMedigen Vaccine Biologics Corporation, Taipei, Taiwan.
Cheng-Hsun ChiuDepartment of Pediatrics, Chang Gung Children's Hospital, Chang Gung University College of Medicine, Taoyuan City, Taiwan.
Nan-Chang ChiuDepartment of Pediatrics, MacKay Children's Hospital, Taipei City, Taiwan.
Boon-Fatt TanDepartment of Pediatrics, National Taiwan University Hospital Hsinchu Branch, Hsinchu County, Taiwan.ORCID http://orcid.org/0000-0002-8547-9860
Chien-Yu LinDepartment of Pediatrics, Hsinchu MacKay Memorial Hospital, Hsinchu City, Taiwan.
Hao-Yuan ChengMedigen Vaccine Biologics Corporation, Taipei, Taiwan.
Meei-Yun LinMedigen Vaccine Biologics Corporation, Taipei, Taiwan.
Chia-En LienMedigen Vaccine Biologics Corporation, Taipei, Taiwan.
Charles ChenMedigen Vaccine Biologics Corporation, Taipei, Taiwan. charles@medigenvac.com.ORCID http://orcid.org/0000-0001-6888-009X
Li-Min HuangDepartment of Pediatrics, National Taiwan University Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan. lmhuang@ntu.edu.tw.ORCID http://orcid.org/0000-0002-9291-260X
Mackay Memorial Hospital · TWNational Taiwan University Hospital · TWChang Gung University · TWMediGEN · CZNational Yang Ming Chiao Tung University · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Adolescents and children play an important role in SARS-CoV-2 transmission and epidemiology. MVC-COV1901 is a subunit SARS-CoV-2 vaccine based on stabilized spike protein adjuvanted with CpG 1018 and aluminum hydroxide that has received emergency use approval (EUA) for adults in Taiwan. In this study, we have investigated the safety and immunogenicity of two doses of MVC-COV1901 in adolescents. Healthy adolescents from the age of 12-17 years were randomly assigned to receive two intramuscular doses of either MVC-COV1901 or placebo at 28 days apart. Adverse events were mostly mild and were similar in MVC-COV1901 and placebo groups, with the most commonly reported adverse events being pain/tenderness and malaise/fatigue. All immunogenicity endpoints in the adolescent group were non-inferior to the endpoints seen in the young adult and placebo groups. The results here advocate the use of MVC-COV1901 in adolescents in the ongoing efforts to control the pandemic.ClinicalTrials.gov registration: NCT04951388.

Identifiers

PMID36526640
PMCPMC9755761
OpenAlexW4312066663

What OpenQuestion holds

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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.