Evidence map›Paper›PMID 36350017›Full record

Trial reportThe Journal of infectious diseases2022

Intranasal M2SR (M2-Deficient Single Replication) H3N2 Influenza Vaccine Provides Enhanced Mucosal and Serum Antibodies in Adults.

Joseph Eiden, Carlos Fierro, Howard Schwartz, Mark Adams, Kimberly J Ellis, Roger Aitchison, Renee Herber, Yasuko Hatta, David Marshall, Michael J Moser and 6 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03999554 (Phase 1b Clinical Study to Investigate the Safety and Immunogenicity of the Bris10), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–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.

NCT03999554 phase1completednot on this map

Phase 1b Clinical Study to Investigate the Safety and Immunogenicity of the Bris10 (A/Brisbane/10/2007) M2SR and Sing2016 (A/Singapore/INFIMH-16-0019/2016) M2SR H3N2 Monovalent Influenza Vaccines

TypeinterventionalSponsorFluGen IncRan2019 to 2020Enrolled206ConditionsInfluenza AArmsLD Sing2016 M2SR H3N2 influenza vaccine, MD Sing2016 M2SR H3N2 influenza vaccine, HD Sing2016 M2SR H3N2 influenza vaccine, LD Bris10 M2SR H3N2 influenza vaccine, Placebo
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Mucosal immune response in biology, disease prevention and treatment.Signal transduction and targeted therapy · 2025
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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

16 authors.

Joseph EidenFluGen, Inc, Madison, Wisconsin, USA.
Carlos FierroJohnson County Clin-Trials, Lenexa, Kansas, USA.
Howard SchwartzResearch Centers of America, Hollywood, Florida, USA.
Mark AdamsAlliance for Multispecialty Research, Lexington, Kentucky, USA.
Kimberly J EllisAlliance for Multispecialty Research, Norfolk, Virginia, USA.
Roger AitchisonNorth Rim Consulting, Longmont, Colorado, USA.
Renee HerberFluGen, Inc, Madison, Wisconsin, USA.
Yasuko HattaFluGen, Inc, Madison, Wisconsin, USA.
David MarshallFluGen, Inc, Madison, Wisconsin, USA.
Michael J MoserFluGen, Inc, Madison, Wisconsin, USA.
Robert BelsheSaint Louis University, St Louis, Missouri, USA.
Harry GreenbergStanford University, Stanford, California, USA.
Kathleen CoelinghSt Helena, California, USA.
Yoshihiro KawaokaInfluenza Research Institute, University of Wisconsin, Madison, Wisconsin, USA.
Gabriele NeumannInfluenza Research Institute, University of Wisconsin, Madison, Wisconsin, USA.
Pamuk BilselFluGen, Inc, Madison, Wisconsin, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe previously demonstrated that an intranasal dose of 108 50% tissue culture infectious dose (TCID50) M2-deficient single replication (M2SR) influenza vaccine protected against highly drifted H3N2 influenza challenge in a subset of subjects who demonstrated ≥2-fold increase in microneutralization (MN) antibodies to Belgium2015 (the challenge strain) after vaccination. Here, we describe a phase 1b, observer-blinded, dose-escalation study demonstrating an increased proportion of responders with this signal of immune protection.

methodsSerosusceptible subjects aged 18-49 years were randomized to receive 2 doses (108-109 TCID50) of M2SR or placebo administered 28 days apart. Clinical specimens were collected before and after each dose. The primary objective was to demonstrate safety of M2SR vaccines.

resultsThe vaccine was well tolerated at all dose levels. Against Belgium2015, ≥ 2-fold increases in MN antibodies were noted among 40% (95% confidence interval [CI], 24.9%-56.7%) of subjects following a single 108 TCID50 M2SR dose and among 80.6% (95% CI, 61.4%-92.3%) after 109 dose (P < .001). A single 109 TCID50 dose of M2SR generated ≥4-fold hemagglutination inhibition antibody seroconversion against the vaccine strain in 71% (95% CI, 52.0%-85.8%) of recipients. Mucosal and cellular immune responses were also induced.

conclusionsThese results indicate that M2SR may provide substantial protection against infection with highly drifted strains of H3N2 influenza. CLINICAL TRIALS REGISTRATION: NCT03999554.

Indexed as

Influenza, HumanInfluenza VaccinesAdultAntibodies, ViralHemagglutination Inhibition TestsHumansInfluenza A Virus, H3N2 SubtypeVaccinationAntibodies, ViralInfluenza VaccinesdriftH3N2influenzaintranasallivemucosalvaccine

Identifiers

PMID36350017
PMCPMC9796169

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.