Evidence map›Paper›PMID 33146720›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021

Induction of Cross-Reactive Hemagglutination Inhibiting Antibody and Polyfunctional CD4+ T-Cell Responses by a Recombinant Matrix-M-Adjuvanted Hemagglutinin Nanoparticle Influenza Vaccine.

Vivek Shinde, Rongman Cai, Joyce Plested, Iksung Cho, Jamie Fiske, Xuan Pham, Mingzhu Zhu, Shane Cloney-Clark, Nan Wang, Haixia Zhou and 9 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03658629 (Phase 2 Clinical Trial to Confirm the Dose and Formulation of a Recombinant Quadrivalent Nanoparticle Influenza Vaccine), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
4.2field-weighted citation impact, top 5% 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.

NCT03658629 phase2terminatednot on this map

Phase 2 Clinical Trial to Confirm the Dose and Formulation of a Recombinant Quadrivalent Nanoparticle Influenza Vaccine (Quad-NIV) With or Without Matrix-M1™ Adjuvant in Healthy Adults ≥ 65 Years of Age

TypeinterventionalSponsorNovavaxRan2018 to 2019Enrolled1,375ConditionsInfluenza, HumanArmsNanoFlu (Quad-NIV), Matrix-M Adjuvant, Placebo, Fluzone HD, Flublok Quadrivalent
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 41 citations in OpenAlex.

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  14. Review
  15. Summary of the National Advisory Committee on Immunization (NACI) Supplemental Statement on Recombinant Influenza Vaccines.Canada communicable disease report = Releve des maladies transmissibles au Canada · 2022
    Article
  16. Summary of the National Advisory Committee on Immunization (NACI) Seasonal Influenza Vaccine Statement for 2022-2023.Canada communicable disease report = Releve des maladies transmissibles au Canada · 2022
    Article
  17. Review
  18. Review
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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

19 authors at 1 institution in 1 country.

Vivek ShindeNovavax, Inc., Gaithersburg, Maryland, USA.
Rongman CaiPreviously with Novavax, Inc., Gaithersburg, Maryland, USA.
Joyce PlestedNovavax, Inc., Gaithersburg, Maryland, USA.
Iksung ChoNovavax, Inc., Gaithersburg, Maryland, USA.
Jamie FiskeNovavax, Inc., Gaithersburg, Maryland, USA.
Xuan PhamPreviously with Novavax, Inc., Gaithersburg, Maryland, USA.
Mingzhu ZhuNovavax, Inc., Gaithersburg, Maryland, USA.
Shane Cloney-ClarkNovavax, Inc., Gaithersburg, Maryland, USA.
Nan WangPreviously with Novavax, Inc., Gaithersburg, Maryland, USA.
Haixia ZhouNovavax, Inc., Gaithersburg, Maryland, USA.
Bin ZhouNovavax, Inc., Gaithersburg, Maryland, USA.
Nita PatelNovavax, Inc., Gaithersburg, Maryland, USA.
Michael J MassareNovavax, Inc., Gaithersburg, Maryland, USA.
Amy FixPreviously with Novavax, Inc., Gaithersburg, Maryland, USA.
Michelle SpindlerPreviously with Novavax, Inc., Gaithersburg, Maryland, USA.
David Nigel ThomasPreviously with Novavax, Inc., Gaithersburg, Maryland, USA.
Gale SmithNovavax, Inc., Gaithersburg, Maryland, USA.
Louis FriesNovavax, Inc., Gaithersburg, Maryland, USA.
Gregory M GlennNovavax, Inc., Gaithersburg, Maryland, USA.
Novavax (United States) · US

Funding

Novavax Inc
6 · The paper itself

Abstract

backgroundRecurrent reports of suboptimal influenza vaccine effectiveness have renewed calls to develop improved, broadly cross-protective influenza vaccines. Here, we evaluated the safety and immunogenicity of a novel, saponin (Matrix-M)-adjuvanted, recombinant hemagglutinin (HA) quadrivalent nanoparticle influenza vaccine (qNIV).

methodsWe conducted a randomized, observer-blind, comparator-controlled (trivalent high-dose inactivated influenza vaccine [IIV3-HD] or quadrivalent recombinant influenza vaccine [RIV4]), safety and immunogenicity trial of qNIV (5 doses/formulations) in healthy adults ≥65 years. Vaccine immunogenicity was measured by hemagglutination-inhibition assays using reagents that express wild-type hemagglutination inhibition (wt-HAI) sequences and cell-mediated immune responses.

resultsA total of 1375 participants were randomized, immunized, and followed for safety and immunogenicity. Matrix-M-adjuvanted qNIV induced superior wt-HAI antibody responses against 5 of 6 homologous or drifted strains compared with unadjuvanted qNIV. Adjuvanted qNIV induced post-vaccination wt-HAI antibody responses at day 28 that were statistically higher than IIV3-HD against a panel of homologous or drifted A/H3N2 strains, similar to IIV3-HD against homologous A/H1N1 and B (Victoria) strains and similar to RIV4 against all homologous and drifted strains evaluated. The qNIV formulation with 75 µg Matrix-M adjuvant induced substantially higher post-vaccination geometric mean fold increases of influenza HA-specific polyfunctional CD4+ T cells compared with IIV3-HD or RIV4. Overall, similar frequencies of solicited and unsolicited adverse events were reported in all treatment groups.

conclusionsqNIV with 75 µg Matrix-M adjuvant was well tolerated and induced robust antibody and cellular responses, notably against both homologous and drifted A/H3N2 viruses. Further investigation in a pivotal phase 3 trial is underway. CLINICAL TRIALS REGISTRATION: NCT03658629.

Indexed as

Influenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesNanoparticlesSaponinsAdultAntibodies, ViralCD4-Positive T-LymphocytesHemagglutinationHemagglutination Inhibition TestsHemagglutininsHumansImmunogenicity, VaccineInfluenza A Virus, H3N2 SubtypeVaccines, InactivatedAntibodies, ViralHemagglutininsInfluenza VaccinesMatrix-MSaponinsVaccines, Inactivatedcell-mediated immunityhemagglutination inhibitioninfluenzavaccination

Identifiers

PMID33146720
PMCPMC8664440
OpenAlexW3096456697

What OpenQuestion holds

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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.