Evidence map›Paper›PMID 38349280›Full record

Trial reportThe Journal of infectious diseases2024

Interim Report of the Reactogenicity and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 XBB-Containing Vaccines.

Spyros Chalkias, Nichole McGhee, Jordan L Whatley, Brandon Essink, Adam Brosz, Joanne E Tomassini, Bethany Girard, Darin K Edwards, Kai Wu, Arshan Nasir and 8 more

Erratum issuedOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in The Journal of infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 38 papers.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed
23.7field-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.

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

38 citing papers in PubMed, 61 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 4 institutions in 1 country.

Spyros ChalkiasInfectious Disease, Research and Development, Moderna, Cambridge, Massachusetts, USA.ORCID 0000-0002-6254-1158
Nichole McGheeInfectious Disease, Research and Development, Moderna, Cambridge, Massachusetts, USA.
Jordan L WhatleyMeridian Clinical Research, Baton Rouge, Louisiana, USA.
Brandon EssinkMeridian Clinical Research, Omaha, Nebraska, USA.
Adam BroszMeridian Clinical Research, Grand Island, Nebraska, USA.
Joanne E TomassiniInfectious Disease, Research and Development, Moderna, Cambridge, Massachusetts, USA.ORCID 0000-0002-9399-2867
Bethany GirardInfectious Disease, Research and Development, Moderna, Cambridge, Massachusetts, USA.
Darin K EdwardsInfectious Disease, Research and Development, Moderna, Cambridge, Massachusetts, USA.
Kai WuInfectious Disease, Research and Development, Moderna, Cambridge, Massachusetts, USA.
Arshan NasirInfectious Disease, Research and Development, Moderna, Cambridge, Massachusetts, USA.
Diana LeeInfectious Disease, Research and Development, Moderna, Cambridge, Massachusetts, USA.
Laura E AvenaInfectious Disease, Research and Development, Moderna, Cambridge, Massachusetts, USA.
Jing FengInfectious Disease, Research and Development, Moderna, Cambridge, Massachusetts, USA.
Weiping DengInfectious Disease, Research and Development, Moderna, Cambridge, Massachusetts, USA.
David C MontefioriDepartment of Surgery, Duke University Medical Center, Durham, North Carolina, USA.
Lindsey R BadenDivision of Infectious Diseases, Brigham & Women's Hospital, Boston, Massachusetts, USA.
Jacqueline M MillerInfectious Disease, Research and Development, Moderna, Cambridge, Massachusetts, USA.
Rituparna DasInfectious Disease, Research and Development, Moderna, Cambridge, Massachusetts, USA.
Moderna Therapeutics (United States) · USMeridian Clinical Research · USBrigham and Women's Hospital · USDuke Medical Center · US

Funding

Moderna
6 · The paper itself

Abstract

backgroundMonovalent Omicron XBB.1.5-containing vaccines were approved for coronavirus disease 2019 (COVID-19) 2023-2024 immunizations.

methodsThis ongoing, open-label, phase 2/3 study evaluated messenger RNA (mRNA)-1273.815 monovalent (50-µg Omicron XBB.1.5 spike mRNA) and mRNA-1273.231 bivalent (25-µg each Omicron XBB.1.5 and BA.4/BA.5 spike mRNAs) vaccines, administered as fifth doses to adults who previously received primary series, third doses of an original mRNA COVID-19 vaccine, and fourth doses of an Omicron BA.4/BA.5 bivalent vaccine. Interim safety and immunogenicity 29 days after vaccination are reported.

resultsParticipants (randomized 1:1) received 50-µg of mRNA-1273.815 (n = 50) or mRNA-1273.231 (n = 51); median intervals (interquartile range) from prior BA.4/BA.5 bivalent doses were 8.2 (8.1-8.3) and 8.3 (8.1-8.4) months, respectively. Fold increases in neutralizing antibody (nAb) against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants from prebooster nAb levels were numerically higher against XBB.1.5, XBB.1.16, EG.5.1, BA.2.86, and JN.1 than BA.4/BA.5, BQ.1.1, or D614G on day 29. Monovalent vaccine also cross-neutralized FL.1.5.1, EG.5.1, BA.2.86, HK.3.1, HV.1, and JN.1 variants in a participant subset (n = 20) 15 days after vaccination. Reactogenicity was similar to that of mRNA-1273 vaccines.

conclusionsXBB.1.5-containing mRNA-1273 vaccines elicit robust, diverse nAb responses against more recent SARS-CoV-2 variants, including JN.1, supporting the XBB.1.5-spike update for COVID-19 vaccines.

Indexed as

2019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingAntibodies, ViralCOVID-19COVID-19 VaccinesImmunogenicity, VaccineSARS-CoV-2AdultAgedFemaleHumansMaleMiddle AgedSpike Glycoprotein, CoronavirusVaccinationYoung Adult2019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesSpike Glycoprotein, CoronavirusCOVID-19JN.1mRNA vaccineOmicron XBB.1.5SARS-CoV-2 variants

Identifiers

PMID38349280
PMCPMC11326827
OpenAlexW4391776402

What OpenQuestion holds

Textmetadata
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.