Evidence map›Paper›PMID 41974675›Full record

Trial reportNature communications2026

A group 1 hemagglutinin stem vaccine elicits broad humoral responses against influenza in phase 1/2a study.

Nina Hertoghs, Chan Tang, Vitalija van Paassen, Mandy Jongeneelen, Jeroen Tolboom, Lynn Yieh, Miao Wang, Krisztian Kaszas, Chelsea McLean, Sara van den Berg and 9 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Nature communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05901636 (A Randomized, Double-blind, Placebo-controlled, First-in-human Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of a Universal Influenza), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT05901636 phase1 / phase2completednot on this map

A Randomized, Double-blind, Placebo-controlled, First-in-human Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of a Universal Influenza (Uniflu) Vaccine With INFLUENZA G1 mHA in Healthy Adults

TypeinterventionalSponsorJanssen Vaccines & Prevention B.V.Ran2023 to 2024Enrolled170ConditionsInfluenza PreventionArmsINFLUENZA G1 mHA, Placebo, Al(OH)3
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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.

Nina Hertoghs *Johnson & Johnson, Leiden, the Netherlands.
Chan Tang *Johnson & Johnson, Leiden, the Netherlands.
Vitalija van PaassenJohnson & Johnson, Leiden, the Netherlands.
Mandy JongeneelenJohnson & Johnson, Leiden, the Netherlands.
Jeroen TolboomJohnson & Johnson, Leiden, the Netherlands.
Lynn YiehJohnson & Johnson, Leiden, the Netherlands.ORCID 0009-0003-6044-6696
Miao WangJohnson & Johnson, Leiden, the Netherlands.
Krisztian KaszasJohnson & Johnson, Leiden, the Netherlands.ORCID 0000-0002-8643-9262
Chelsea McLeanJohnson & Johnson, Leiden, the Netherlands.ORCID 0000-0002-3548-3482
Sara van den BergJohnson & Johnson, Leiden, the Netherlands.
David LowsonJohnson & Johnson, Leiden, the Netherlands.
Weihong HuJohnson & Johnson, Leiden, the Netherlands.
Zuleima AguilarJohnson & Johnson, Leiden, the Netherlands.ORCID 0009-0001-2927-0130
Jenny HendriksJohnson & Johnson, Leiden, the Netherlands.
Harmjan KuipersJohnson & Johnson, Leiden, the Netherlands.ORCID 0000-0003-1317-394X
Sarah KulkeJohnson & Johnson, Leiden, the Netherlands.
Jerald SadoffJohnson & Johnson, Leiden, the Netherlands.
Boerries BrandenburgJohnson & Johnson, Leiden, the Netherlands.
Roland ZahnJohnson & Johnson, Leiden, the Netherlands. RZahn@its.jnj.com.ORCID 0000-0003-2822-6231

Funding

Johnson and Johnson (Johnson & Johnson) N/AU.S. Department of Health & Human Services | Biomedical Advanced Research and Development Authority (BARDA) HSO100201700018C
6 · The paper itself

Abstract

Vaccines targeting the conserved stem region of influenza hemagglutinin (HA) may induce broad immunity and reduce reliance on strain-matched seasonal formulations. This Phase 1/2a study evaluates safety and immunogenicity of a universal influenza vaccine component comprising a soluble trimeric stabilized group 1 HA-stem protein (INFLUENZA G1 mHA). Healthy adults aged 18-to-45 received one or two doses at 45 µg or 135 µg, with or without Al(OH)₃. Primary endpoints were safety and reactogenicity. All regimens were well-tolerated with no vaccine-related serious adverse events. Secondary and exploratory endpoints included binding, neutralizing, and ADCC responses compared to a matched quadrivalent seasonal influenza vaccine cohort. A single dose induced robust binding antibody responses to H5 HA and homologous stem HA, with 6.5-16.4-fold increases at Day 29 versus baseline, exceeding responses elicited by the seasonal influenza vaccine. Additionally, we demonstrate broader binding to a panel of group 1 HAs, with responses maintained for at least one year. Neutralizing antibody and ADCC responses at Day 29 showed 7.9-15-fold and 4.9-8.6-fold increases, respectively. Importantly, serum from vaccinated participants protect mice against lethal heterologous H5N1 challenge. This study provides proof of concept that the HA stem vaccine elicits broad and durable influenza A group 1-directed immunity. This trial is registered with ClinicalTrials.gov (NCT05901636).

Indexed as

Hemagglutinin Glycoproteins, Influenza VirusImmunity, HumoralInfluenza, HumanInfluenza VaccinesAdolescentAdultAnimalsAntibodies, NeutralizingAntibodies, ViralAntibody-Dependent Cell CytotoxicityFemaleHumansInfluenza A Virus, H5N1 SubtypeMaleMiddle AgedYoung AdultAntibodies, NeutralizingAntibodies, ViralHemagglutinin Glycoproteins, Influenza VirusInfluenza Vaccines

Identifiers

PMID41974675
PMCPMC13076615

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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.