Evidence map›Paper›PMID 41117170›Full record

Trial reportJournal of medical virology2025

Detection of Anti-SARS-CoV-2 Mucosal Immunoglobulin A in Clinical Saliva Samples After a Dose of Novavax COVID-19 Vaccine.

Mingzhu Zhu, Edmond Massuda, Urvashi Patel, Gordon Chau, Raj Kalkeri, Shane Cloney-Clark, Katherine Smith, Susan Neal, Joyce S Plested, Raburn M Mallory and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of medical virology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05973006 (A Phase 3, Randomized, Double-Blinded Study to Evaluate the Safety and Immunogenicity of Omicron Subvariant and Bivalent SARS-CoV-2 rS Vaccines in Adolescents Previously Vaccinated With mRNA 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.

NCT05973006 phase3completednot on this map

A Phase 3, Randomized, Double-Blinded Study to Evaluate the Safety and Immunogenicity of Omicron Subvariant and Bivalent SARS-CoV-2 rS Vaccines in Adolescents Previously Vaccinated With mRNA COVID-19 Vaccines

TypeinterventionalSponsorNovavaxRan2023 to 2024Enrolled400ConditionsCOVID-19ArmsNVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine, Prototype/XBB.1.5 Bivalent Vaccine (5 µg)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  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

11 authors.

Mingzhu ZhuNovavax Inc., Gaithersburg, Maryland, USA.
Edmond MassudaNovavax Inc., Gaithersburg, Maryland, USA.
Urvashi PatelNovavax Inc., Gaithersburg, Maryland, USA.
Gordon ChauNovavax Inc., Gaithersburg, Maryland, USA.
Raj KalkeriNovavax Inc., Gaithersburg, Maryland, USA.
Shane Cloney-ClarkNovavax Inc., Gaithersburg, Maryland, USA.
Katherine SmithNovavax Inc., Gaithersburg, Maryland, USA.
Susan NealNovavax Inc., Gaithersburg, Maryland, USA.
Joyce S PlestedNovavax Inc., Gaithersburg, Maryland, USA.
Raburn M MalloryNovavax Inc., Gaithersburg, Maryland, USA.
Chijioke BennettNovavax Inc., Gaithersburg, Maryland, USA.

Funding

This study was funded by Novavax Inc.
6 · The paper itself

Abstract

Immunoglobulin (Ig) A acts as a first line of defense against respiratory pathogens. Mucosal IgA in salivary and nasal passages has a rapid response to antigens and can play a protective role against reinfection. The mainstay for analyzing SARS-CoV-2 infection and vaccine efficacy has been assessment of serum IgG levels; however, validated assays for assessment of mucosal IgA in clinical samples are necessary as new and adapted measures are generated to combat immune-evasive viral variants. A mucosal IgA assay was developed and tested through assessment of IgA levels in salivary samples from participants of the 2019nCoV-314/NCT05973006 study. These participants had previously received ≥ 2 mRNA-based COVID-19 vaccinations prior to enrollment and received a single intramuscular study dose of NVX-CoV2601 (XBB.1.5) or bivalent vaccine (NVX-CoV2601 + NVX-CoV2373 [Wuhan]). Salivary samples were collected prior to vaccination on Day 0 and on Day 28 to assess response postvaccination. Both vaccine groups elicited a significant increase in anti-SARS-CoV-2 spike IgA against XBB.1.5. Furthermore, cross-reactivity by identification of anti-JN.1 and anti-Wuhan IgA was also observed. The detection of IgA in clinical mucosal samples using this assay will be a valuable tool in supporting vaccine development.

Indexed as

Antibodies, ViralCOVID-19COVID-19 VaccinesImmunoglobulin ASalivaSARS-CoV-2AdultFemaleHumansImmunity, MucosalMaleMiddle AgedVaccinationAntibodies, ViralCOVID-19 VaccinesImmunoglobulin AboosterCOVID‐19IgAIgGimmunogenicitymucosalrespiratoryvirus

Identifiers

PMID41117170
PMCPMC12538530

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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.