Evidence map›Paper›PMID 39289377›Full record

ArticleNPJ vaccines2024

Phase 1 dose-escalation trial evaluating a group 2 influenza hemagglutinin stabilized stem nanoparticle vaccine.

Joseph P Casazza, Amelia R Hofstetter, Pamela J M Costner, LaSonji A Holman, Cynthia S Hendel, Alicia T Widge, Richard L Wu, William R Whalen, Jennifer Cunningham, Anita Arthur and 40 more

Registry-linked trialAbstract read
In one paragraph

Article in NPJ vaccines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04579250 (VRC 323), which is not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing 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.

NCT04579250 phase1completednot on this map

VRC 323: A Phase I Open-Label Clinical Trial to Evaluate the Dose, Safety, Tolerability and Immunogenicity of an Influenza H10 Stabilized Stem Ferritin Vaccine, VRC-FLUNPF0103-00-VP, in Healthy Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2020 to 2022Enrolled25ConditionsInfluenzaArmsVRC-FLUNPF0103-00-VP (H10ssF-6473)
3 · Its place in the literature

Who cites it

20 citing papers in PubMed.

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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

50 authors.

Joseph P CasazzaVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.ORCID http://orcid.org/0000-0001-5648-4639
Amelia R HofstetterVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.ORCID http://orcid.org/0000-0003-4113-5473
Pamela J M CostnerVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
LaSonji A HolmanVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Cynthia S HendelVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Alicia T WidgeVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Richard L WuVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.ORCID http://orcid.org/0009-0003-8864-4256
William R WhalenVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Jennifer CunninghamVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Anita ArthurVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Xiaolin WangVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Abidemi OlaVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Jamie SaundersVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Floreliz MendozaVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Laura NovikVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Maria C Burgos FlorezVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Ana M Ortega-VillaBiostatistics Research Branch, Division of Clinical Research, National Institutes of Health, Bethesda, MD, 20892, USA.
Preeti J ApteVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Larisa StromVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Lu WangVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Marjaan ImamVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Manjula BasappaVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Mursal NaisanVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Mike CastroVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.ORCID http://orcid.org/0000-0002-8045-1754
Jessica F TrostVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.ORCID http://orcid.org/0000-0003-0743-1228
Sandeep R NarpalaVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Hillary A VandervenAustralian Institute of Tropical Health and Medicine, James Cook University, Douglas, QLD, 4811, Australia.
Galina V YamshchikovVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Nina M BerkowitzVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Ingelise J GordonVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Sarah H PlummerVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Diane L WycuffVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Sandra VazquezVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Rebecca A GillespieVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Adrian CreangaVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
William C AdamsVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Kevin CarltonVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Jason G GallVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.ORCID http://orcid.org/0000-0002-8411-1351
Adrian B McDermottVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.ORCID http://orcid.org/0000-0003-0616-9117
Leonid A SerebryannyyVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Katherine V HouserVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA. katherine.houser@nih.gov.ORCID http://orcid.org/0000-0002-2147-186X
Richard A KoupVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Barney S GrahamVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Julie E LedgerwoodVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
John R MascolaVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Theodore C PiersonVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.
Sarah F AndrewsVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.ORCID http://orcid.org/0000-0002-2583-1949
Masaru KanekiyoVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.ORCID http://orcid.org/0000-0001-5767-1532
Lesia K DropulicVaccine Research Center, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, 20892, USA.ORCID http://orcid.org/0000-0003-1125-5597
VRC 323 study team

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The relative conservation of the influenza hemagglutinin (HA) stem compared to that of the immunodominant HA head makes the HA stem an attractive target for broadly protective influenza vaccines. Here we report the first-in-human, dose-escalation, open-label trial (NCT04579250) evaluating an unadjuvanted group 2 stabilized stem ferritin nanoparticle vaccine based on the H10 A/Jiangxi-Donghu/346/2013 influenza HA, H10ssF, in healthy adults. Participants received a single 20 mcg dose (n = 3) or two 60 mcg doses 16 weeks apart (n = 22). Vaccination with H10ssF was safe and well tolerated with only mild systemic and local reactogenicity reported. No serious adverse events occurred. Vaccination significantly increased homologous H10 HA stem binding and neutralizing antibodies at 2 weeks after both first and second vaccinations, and these responses remained above baseline at 40 weeks. Heterologous H3 and H7 binding antibodies also significantly increased after each vaccination and remained elevated throughout the study. These data indicate that the group 2 HA stem nanoparticle vaccine is safe and induces stem-directed binding and neutralizing antibodies.

Identifiers

PMID39289377
PMCPMC11408684

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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.