Evidence map›Paper›PMID 36404171›Full record

Trial reportVaccine2023

An evaluation of the safety and immunogenicity of MVC-COV1901: Results of an interim analysis of a phase III, parallel group, randomized, double-blind, active-controlled immunobridging study in Paraguay.

Julio Torales, Osmar Cuenca-Torres, Laurentino Barrios, Luis Armoa-Garcia, Gladys Estigarribia, Gabriela Sanabria, Meei-Yun Lin, Josue Antonio Estrada, Lila Estephan, Hao-Yuan Cheng and 3 more

Open access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Vaccine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 6% 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

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Molecular mechanisms of SARS-CoV-2 entry: implications for biomedical strategies.Microbiology and molecular biology reviews : MMBR · 2025
    Review
  5. Article
  6. Observational
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  12. 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
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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

13 authors at 3 institutions in 3 countries.

Julio ToralesSchool of Medical Sciences, National University of Asunción, San Lorenzo, Paraguay. Electronic address: juliotorales@gmail.com.
Osmar Cuenca-TorresSchool of Medical Sciences, National University of Asunción, San Lorenzo, Paraguay. Electronic address: cuencatorres@gmail.com.
Laurentino BarriosSchool of Medical Sciences, National University of Asunción, San Lorenzo, Paraguay. Electronic address: laurentinobarrios@gmail.com.
Luis Armoa-GarciaSchool of Medical Sciences, National University of Asunción, San Lorenzo, Paraguay. Electronic address: luisarmoa@hotmail.com.
Gladys EstigarribiaSchool of Medical Sciences, National University of Asunción, San Lorenzo, Paraguay. Electronic address: lalyestigarr@hotmail.com.
Gabriela SanabriaSchool of Medical Sciences, National University of Asunción, San Lorenzo, Paraguay. Electronic address: gabysanabria@gmail.com.
Meei-Yun LinMedigen Vaccine Biologics Corporation, Taipei, Taiwan. Electronic address: meeiyun@medigenvac.com.
Josue Antonio EstradaMedigen Vaccine Biologics Corporation, Taipei, Taiwan. Electronic address: josueestrada@medigenvac.com.
Lila EstephanMedigen Vaccine Biologics Corporation, Taipei, Taiwan. Electronic address: lilaestephan@medigenvac.com.
Hao-Yuan ChengMedigen Vaccine Biologics Corporation, Taipei, Taiwan. Electronic address: howardcheng@medigenvac.com.
Charles ChenMedigen Vaccine Biologics Corporation, Taipei, Taiwan. Electronic address: charles@medigenvac.com.
Robert JanssenDynavax Technologies Corporation, Emeryville, CA, USA. Electronic address: rjanssen@dynavax.com.
Chia-En LienMedigen Vaccine Biologics Corporation, Taipei, Taiwan; Institute of Public Health, National Yang-Ming Chiao Tung University, Taipei, Taiwan. Electronic address: allenlien@medigenvac.com.
Universidad Nacional de Asunción · PYDynavax Technologies (United States) · USNational Yang Ming Chiao Tung University · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundData from previous studies of the MVC-COV1901 vaccine, a subunit vaccine against SARS-CoV-2 based on the stable prefusion spike protein (S-2P) adjuvanted with CpG 1018 adjuvant and aluminum hydroxide, suggest that the vaccine is generally safe and elicits a good immune response in healthy adults and adolescents. By comparing with AZD1222, this study adds to the findings from previous trials and further evaluates the breadth of protection offered by MVC-COV1901.

methodsIn this phase 3, parallel group, randomized, double-blind, active-controlled trial conducted in 2 sites in Paraguay, we assigned adults aged 18-91 years in a 1:1 ratio to receive intramuscular doses of MVC-COV1901 or AZD1222 administered as scheduled in the clinical trial. Serum samples were collected on the day of vaccination and 14 days after the second dose. Primary and secondary safety and immunogenicity endpoints were assessed. In addition, other outcomes investigated were cross-reactive immunity against the Omicron strain and the induction of IgG subclasses.

resultsA total of 1,030 participants underwent randomization. Safety data was derived from this set while primary immunogenicity data involved a per-protocol immunogenicity (PPI) subset including 225 participants. Among the participants, 58% are seropositive at baseline. When compared against AZD1222, MVC-COV1901 exhibited superiority in terms of neutralizing antibody titers and non-inferiority in terms of seroconversion rates. Reactogenicity was generally mild and no serious adverse event was attributable to MVC-COV1901. Both vaccines have a Th1-biased response predominated by the production of IgG1 and IgG3 subclasses. Omicron-neutralizing titers were 44.5 times lower compared to wildtype-neutralizing titers among seronegative individuals at baseline. This fold-reduction was 3.0 times among the seropositive.

conclusionSafety and immunogenicity data of MVC-COV1901 from the study in Paraguay confirm previous results. The previous infection coupled with vaccination of this vaccine may offer protection against the Omicron strain though its durability is still unknown.

Indexed as

COVID-19COVID-19 VaccinesAdjuvants, ImmunologicAdolescentAdultAntibodies, NeutralizingAntibodies, ViralChAdOx1 nCoV-19Double-Blind MethodHumansImmunogenicity, VaccineImmunoglobulin GParaguaySARS-CoV-2Vaccines, SubunitAdjuvants, ImmunologicAntibodies, NeutralizingAntibodies, ViralChAdOx1 nCoV-19COVID-19 VaccinesImmunoglobulin GMVC-COV1901 vaccineVaccines, SubunitCOVID-19MVC-COV1901Omicron strainPhase 3 trialSARS-CoV-2 vaccineSubunit vaccine

Identifiers

PMID36404171
PMCPMC9671637
OpenAlexW4309258176

What OpenQuestion holds

Textmetadata
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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.