Evidence map›Paper›PMID 39052718›Full record

Trial reportThe Journal of infectious diseases2024

Immunogenicity and Safety of Heterologous Omicron BA.1 and Bivalent SARS-CoV-2 Recombinant Spike Protein Booster Vaccines: A Phase 3 Randomized Clinical Trial.

Chijioke Bennett, E Joy Rivers, Wayne Woo, Mark Bloch, King Cheung, Paul Griffin, Rahul Mohan, Sachin Deshmukh, Mark Arya, Oscar Cumming and 15 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
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. It is linked to trial NCT05372588 (A Multi-Part, Phase 3, Randomized, Observer Blinded Study to Evaluate the Safety and Immunogenicity of Omicron Subvariant and Bivalent SARS-CoV-2 rS Vaccines in Adults Previously Vaccinated With Other COVID-19 Vaccines), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT05372588 phase3completednot on this map

A Multi-Part, Phase 3, Randomized, Observer Blinded Study to Evaluate the Safety and Immunogenicity of Omicron Subvariant and Bivalent SARS-CoV-2 rS Vaccines in Adults Previously Vaccinated With Other COVID-19 Vaccines

TypeinterventionalSponsorNovavaxRan2022 to 2024Enrolled1,340ConditionsCOVID-19, SARS CoV 2 InfectionArmsNVX-CoV2515, NVX-Cov2373, NVX-CoV2373 + NVX-CoV2515, NVX-CoV2540, NVX-CoV2373 + NVX-CoV2540
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
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

25 authors.

Chijioke BennettNovavax, Inc., Gaithersburg, Maryland, USA.
E Joy RiversNovavax, Inc., Gaithersburg, Maryland, USA.
Wayne WooNovavax, Inc., Gaithersburg, Maryland, USA.
Mark BlochHoldsworth House Medical Practice and Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.
King CheungEmeritus Research, Camberwell, Victoria, Australia.
Paul GriffinMater Misericordiae Ltd and University of Queensland, South Brisbane, Queensland, Australia.
Rahul MohanParatus Clinical Research Western Sydney, Blacktown, New South Wales, Australia.
Sachin DeshmukhGriffith University, Southport, Queensland, Australia.
Mark AryaAustralian Clinical Research Network, Maroubra, New South Wales, Australia.
Oscar CummingNovatrials, Newcastle, New South Wales, Australia.
A Munro NevilleAusTrials, Brisbane, Queensland, Australia.
Toni McCallum PardeyNovatrials, Newcastle, New South Wales, Australia.
Joyce S PlestedNovavax, Inc., Gaithersburg, Maryland, USA.
Shane Cloney-ClarkNovavax, Inc., Gaithersburg, Maryland, USA.
Mingzhu ZhuNovavax, Inc., Gaithersburg, Maryland, USA.
Raj KalkeriNovavax, Inc., Gaithersburg, Maryland, USA.
Nita PatelNovavax, Inc., Gaithersburg, Maryland, USA.
Agi BuchananNovavax, Inc., Gaithersburg, Maryland, USA.
Alex MarcheschiNovavax, Inc., Gaithersburg, Maryland, USA.
Jennifer SwanNovavax, Inc., Gaithersburg, Maryland, USA.
Gale SmithNovavax, Inc., Gaithersburg, Maryland, USA.
Iksung ChoNovavax, Inc., Gaithersburg, Maryland, USA.
Gregory M GlennNovavax, Inc., Gaithersburg, Maryland, USA.
Robert WalkerNovavax, Inc., Gaithersburg, Maryland, USA.
Raburn M MalloryNovavax, Inc., Gaithersburg, Maryland, USA.

Funding

Novavax, Inc
6 · The paper itself

Abstract

backgroundMutations present in emerging SARS-CoV-2 variants permit evasion of neutralization with prototype vaccines. A novel Omicron BA.1 subvariant-specific vaccine (NVX-CoV2515) was tested alone or as a bivalent preparation with the prototype vaccine (NVX-CoV2373) to assess antibody responses to SARS-CoV-2.

methodsParticipants aged 18 to 64 years immunized with 3 doses of prototype mRNA vaccines were randomized 1:1:1 to receive a single dose of NVX-CoV2515, NVX-CoV2373, or the bivalent mixture in a phase 3 study investigating heterologous boosting with SARS-CoV-2 recombinant spike protein vaccines. Immunogenicity was measured 14 and 28 days after vaccination for the SARS-CoV-2 Omicron BA.1 sublineage and ancestral strain. Safety profiles of vaccines were assessed.

resultsOf participants who received trial vaccine (N = 829), those administered NVX-CoV2515 (n = 286) demonstrated a superior neutralizing antibody response to BA.1 vs NVX-CoV2373 (n = 274) at day 14 (geometric mean titer ratio, 1.6; 95% CI, 1.33-2.03). Seroresponse rates were 73.4% (91/124; 95% CI, 64.7-80.9) for NVX-CoV2515 vs 50.9% (59/116; 95% CI, 41.4-60.3) for NVX-CoV2373. All formulations were similarly well tolerated.

conclusionsNVX-CoV2515 elicited a superior neutralizing antibody response against the Omicron BA.1 subvariant as compared with NVX-CoV2373 when administered as a fourth dose. Safety data were consistent with the established safety profile of NVX-CoV2373. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov (NCT05372588).

Indexed as

Antibodies, NeutralizingAntibodies, ViralCOVID-19COVID-19 VaccinesImmunization, SecondaryImmunogenicity, VaccineSARS-CoV-2Spike Glycoprotein, CoronavirusAdolescentAdultFemaleHumansMaleMiddle AgedVaccines, SyntheticYoung AdultAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesNVX-CoV2373 adjuvated lipid nanoparticleSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2Vaccines, Syntheticneutralizing antibodyNVX-CoV2373omicron BA.1reactogenicitySARS-CoV-2

Identifiers

PMID39052718
PMCPMC11272042

What OpenQuestion holds

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LicenceCC BY
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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.