Evidence map›Paper›PMID 36202997›Full record

Trial reportNature medicine2022

Safety, immunogenicity and antibody persistence of a bivalent Beta-containing booster vaccine against COVID-19: a phase 2/3 trial.

Spyros Chalkias, Frank Eder, Brandon Essink, Shishir Khetan, Biliana Nestorova, Jing Feng, Xing Chen, Ying Chang, Honghong Zhou, David Montefiori and 9 more

3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 94 papers.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed
14.5field-weighted citation impact, top 1% 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.

NCT04405076 phase2completednot on this map

A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older

TypeinterventionalSponsorModernaTX, Inc.Ran2020 to 2021Enrolled660ConditionsSARS-CoV-2ArmsBiological: mRNA-1273, Placebo, mRNA-1273.351
NCT04470427 phase3completednot on this map

A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older

TypeinterventionalSponsorModernaTX, Inc.Ran2020 to 2022Enrolled30,415ConditionsSARS-CoV-2ArmsmRNA-1273, Placebo
NCT04927065 phase2 / phase3completednot on this map

A Phase 2/3 Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 Variants

TypeinterventionalSponsorModernaTX, Inc.Ran2021 to 2023Enrolled5,161ConditionsSARS-CoV-2ArmsmRNA-1273.211, mRNA-1273, mRNA-1273.617.2, mRNA-1273.213, mRNA-1273.529
3 · Its place in the literature

Who cites it

94 citing papers in PubMed, 143 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. A Bivalent Omicron-Containing Booster Vaccine against Covid-19.The New England journal of medicine · 2022
    Trial
  7. Article
  8. Article
  9. Review
  10. Observational
  11. Article
  12. Article
  13. Review
  14. Broad neutralizing antibody response of a monomeric spike-based SARS-CoV-2 bivalent vaccine against diverse variants.Proceedings of the National Academy of Sciences of the United States of America · 2025
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review

34 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 3 institutions in 1 country.

Spyros ChalkiasModerna, Inc., Cambridge, MA, USA. spyros.chalkias@modernatx.com.
Frank EderMeridian Clinical Research, Binghamton, NY, USA.
Brandon EssinkMeridian Clinical Research, Omaha, NE, USA.
Shishir KhetanMeridian Clinical Research, Rockville, MD, USA.
Biliana NestorovaModerna, Inc., Cambridge, MA, USA.
Jing FengModerna, Inc., Cambridge, MA, USA.
Xing ChenModerna, Inc., Cambridge, MA, USA.ORCID http://orcid.org/0000-0002-6740-9535
Ying ChangModerna, Inc., Cambridge, MA, USA.
Honghong ZhouModerna, Inc., Cambridge, MA, USA.
David MontefioriDepartment of Surgery and Duke Human Vaccine Institute, Durham, NC, USA.
Darin K EdwardsModerna, Inc., Cambridge, MA, USA.ORCID http://orcid.org/0000-0002-2065-2941
Bethany GirardModerna, Inc., Cambridge, MA, USA.
Rolando PajonModerna, Inc., Cambridge, MA, USA.ORCID http://orcid.org/0000-0002-5155-5079
Frank J DutkoModerna, Inc., Cambridge, MA, USA.
Brett LeavModerna, Inc., Cambridge, MA, USA.
Stephen R WalshBrigham and Women's Hospital, Boston, MA, USA.ORCID http://orcid.org/0000-0002-0817-9370
Lindsey R BadenBrigham and Women's Hospital, Boston, MA, USA.
Jacqueline M MillerModerna, Inc., Cambridge, MA, USA.
Rituparna DasModerna, Inc., Cambridge, MA, USA.
Moderna Therapeutics (United States) · USMeridian Clinical Research · USBrigham and Women's Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Updated immunization strategies are needed to address multiple severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants. Here we report interim results from an ongoing, open-label phase 2/3 trial evaluating the safety and immunogenicity of the bivalent Coronavirus Disease 2019 (COVID-19) vaccine candidate mRNA-1273.211, which contains equal mRNA amounts encoding the ancestral SARS-CoV-2 and Beta variant spike proteins, as 50-µg (n = 300) and 100-µg (n = 595) first booster doses administered approximately 8.7-9.7 months after the mRNA-1273 primary vaccine series ( NCT04927065 ). The primary objectives were to evaluate the safety and reactogenicity of mRNA-1273.211 and to demonstrate non-inferior antibody responses compared to the mRNA-1273 100-µg primary series. Additionally, a pre-specified immunogenicity objective was to demonstrate superior antibody responses compared to the previously authorized mRNA-1273 50-µg booster. The mRNA-1273.211 booster doses (50-µg or 100-µg) 28 days after immunization elicited higher neutralizing antibody responses against the ancestral SARS-CoV-2 and Beta variant than those elicited 28 days after the second mRNA‑1273 dose of the primary series ( NCT04470427 ). Antibody responses 28 days and 180 days after the 50-µg mRNA-1273.211 booster dose were also higher than those after a 50-µg mRNA-1273 booster dose ( NCT04405076 ) against the ancestral SARS-CoV-2 and Beta, Omicron BA.1 and Delta variants, and all pre-specified immunogenicity objectives were met. The safety and reactogenicity profile of the bivalent mRNA-1273.211 booster (50-µg) was similar to the booster dose of mRNA-1273 (50-µg). Immunization with the primary series does not set a ceiling to the neutralizing antibody response, and a booster dose of the bivalent vaccine elicits a robust response with titers that are likely to be protective against COVID-19. These results indicate that bivalent booster vaccines can induce potent, durable and broad antibody responses against multiple variants, providing a new tool in response to emerging variants.

Indexed as

COVID-19Antibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesHumansImmunogenicity, VaccineSARS-CoV-2Vaccines, CombinedAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesVaccines, Combined

Identifiers

PMID36202997
PMCPMC9671805
OpenAlexW4302362524

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.