Evidence map›Paper›PMID 36112399›Full record

Trial reportThe New England journal of medicine2022

A Bivalent Omicron-Containing Booster Vaccine against Covid-19.

Spyros Chalkias, Charles Harper, Keith Vrbicky, Stephen R Walsh, Brandon Essink, Adam Brosz, Nichole McGhee, Joanne E Tomassini, Xing Chen, Ying Chang and 9 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04927065 (A Phase 2/3 Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 Variants), which is not on this map. Cited by 382 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
382citing papers in PubMed, 1 pooled it
63.9field-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.

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

382 citing papers in PubMed, 1 synthesis or guideline pooled it, 641 citations in OpenAlex.

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  8. Safety and Immunogenicity of an mRNA-1273 Booster in Children.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
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322 more citing papers are in PubMed but not listed here.

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

19 authors at 4 institutions in 1 country.

Spyros ChalkiasFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Charles HarperFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Keith VrbickyFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Stephen R WalshFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Brandon EssinkFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Adam BroszFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Nichole McGheeFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Joanne E TomassiniFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Xing ChenFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).ORCID 0000-0002-6740-9535
Ying ChangFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Andrea SutherlandFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
David C MontefioriFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Bethany GirardFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Darin K EdwardsFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Jing FengFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Honghong ZhouFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Lindsey R BadenFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Jacqueline M MillerFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Rituparna DasFrom Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical Research, Grand Island (A.B.) - all in Nebraska; and the Department of Surgery, Duke University Medical Center, Durham, NC (D.C.M.).
Moderna Therapeutics (United States) · USMeridian Clinical Research · USBrigham and Women's Hospital · USDuke Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe safety and immunogenicity of the bivalent omicron-containing mRNA-1273.214 booster vaccine are not known.

methodsIn this ongoing, phase 2-3 study, we compared the 50-μg bivalent vaccine mRNA-1273.214 (25 μg each of ancestral Wuhan-Hu-1 and omicron B.1.1.529 [BA.1] spike messenger RNAs) with the previously authorized 50-μg mRNA-1273 booster. We administered mRNA-1273.214 or mRNA-1273 as a second booster in adults who had previously received a two-dose (100-μg) primary series and first booster (50-μg) dose of mRNA-1273 (≥3 months earlier). The primary objectives were to assess the safety, reactogenicity, and immunogenicity of mRNA-1273.214 at 28 days after the booster dose.

resultsInterim results are presented. Sequential groups of participants received 50 μg of mRNA-1273.214 (437 participants) or mRNA-1273 (377 participants) as a second booster dose. The median time between the first and second boosters was similar for mRNA-1273.214 (136 days) and mRNA-1273 (134 days). In participants with no previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the geometric mean titers of neutralizing antibodies against the omicron BA.1 variant were 2372.4 (95% confidence interval [CI], 2070.6 to 2718.2) after receipt of the mRNA-1273.214 booster and 1473.5 (95% CI, 1270.8 to 1708.4) after receipt of the mRNA-1273 booster. In addition, 50-μg mRNA-1273.214 and 50-μg mRNA-1273 elicited geometric mean titers of 727.4 (95% CI, 632.8 to 836.1) and 492.1 (95% CI, 431.1 to 561.9), respectively, against omicron BA.4 and BA.5 (BA.4/5), and the mRNA-1273.214 booster also elicited higher binding antibody responses against multiple other variants (alpha, beta, gamma, and delta) than the mRNA-1273 booster. Safety and reactogenicity were similar with the two booster vaccines. Vaccine effectiveness was not assessed in this study; in an exploratory analysis, SARS-CoV-2 infection occurred in 11 participants after the mRNA-1273.214 booster and in 9 participants after the mRNA-1273 booster.

conclusionsThe bivalent omicron-containing vaccine mRNA-1273.214 elicited neutralizing antibody responses against omicron that were superior to those with mRNA-1273, without evident safety concerns. (Funded by Moderna; ClinicalTrials.gov number, NCT04927065.).

Indexed as

COVID-19COVID-19 VaccinesImmunization, SecondarymRNA VaccinesVaccines, Combined2019-nCoV Vaccine mRNA-1273AdultAntibodies, NeutralizingAntibodies, ViralHumansImmunogenicity, VaccineSARS-CoV-22019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesmRNA-1273.214 COVID-19 vaccinemRNA VaccinesVaccines, Combined

Identifiers

PMID36112399
PMCPMC9511634
OpenAlexW4296026861

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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.