Evidence map›Paper›PMID 24604819›Full record

Trial reportThe Journal of infectious diseases2014

A live attenuated influenza A(H5N1) vaccine induces long-term immunity in the absence of a primary antibody response.

Kawsar R Talaat, Catherine J Luke, Surender Khurana, Jody Manischewitz, Lisa R King, Bridget A McMahon, Ruth A Karron, Kristen D C Lewis, Jing Qin, Dean A Follmann and 3 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01109329 (Phase 1 Inpatient Study of rHMPV-SHs, a Human Metapneumovirus Challenge Strain, Administered to Healthy Adults in Isolation), which is not on this map. Cited by 62 papers.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed
10.9field-weighted citation impact, top 1% 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.

NCT01109329 phase1completednot on this map

Phase 1 Inpatient Study of rHMPV-SHs, a Human Metapneumovirus Challenge Strain, Administered to Healthy Adults in Isolation

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2010 to 2010Enrolled21ConditionsHuman MetapneumovirusArmsHMPV challenge virus
3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 99 citations in OpenAlex.

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  20. Live Attenuated Cold-Adapted Influenza Vaccines.Cold Spring Harbor perspectives in medicine · 2021
    Review

2 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 1 country.

Kawsar R TalaatCenter For Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore.
Catherine J LukeLaboratory of Infectious Diseases.
Surender KhuranaCenter for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland.
Jody ManischewitzCenter for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland.
Lisa R KingCenter for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland.
Bridget A McMahonCenter For Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore.
Ruth A KarronCenter For Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore.
Kristen D C LewisPATH, Seattle, Washington.
Jing QinBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health.
Dean A FollmannBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health.
Hana GoldingCenter for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland.
Kathleen M NeuzilPATH, Seattle, Washington.
Kanta SubbaraoLaboratory of Infectious Diseases.
Center for Biologics Evaluation and Research · USJohns Hopkins University · USNational Institute of Allergy and Infectious Diseases · USProgram for Appropriate Technology in Health · US

Funding

Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
Clinical Studies of Vaccines for Pandemic InfluenzaZIAAI000997 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI COHEN, JEFFREY · 2009 to 2021
$29.9M
Intramural NIH HHSNCATS NIH HHS UL1 TR001079
6 · The paper itself

Abstract

backgroundHighly pathogenic avian influenza A(H5N1) causes severe infections in humans. We generated 2 influenza A(H5N1) live attenuated influenza vaccines for pandemic use (pLAIVs), but they failed to elicit a primary immune response. Our objective was to determine whether the vaccines primed or established long-lasting immunity that could be detected by administration of inactivated subvirion influenza A(H5N1) vaccine (ISIV).

methodsThe following groups were invited to participate in the study: persons who previously received influenza A(H5N1) pLAIV; persons who previously received an irrelevant influenza A(H7N3) pLAIV; and community members who were naive to influenza A(H5N1) and LAIV. LAIV-experienced subjects received a single 45-μg dose of influenza A(H5N1) ISIV. Influenza A(H5N1)- and LAIV-naive subjects received either 1 or 2 doses of ISIV.

resultsIn subjects who had previously received antigenically matched influenza A(H5N1) pLAIV followed by 1 dose of ISIV compared with those who were naive to influenza A(H5N1) and LAIV and received 2 doses of ISIV, we observed an increased frequency of antibody response (82% vs 50%, by the hemagglutination inhibition assay) and a significantly higher antibody titer (112 vs 76; P = .04). The affinity of antibody and breadth of cross-clade neutralization was also enhanced in influenza A(H5N1) pLAIV-primed subjects.

conclusionsISIV administration unmasked long-lasting immunity in influenza A(H5N1) pLAIV recipients, with a rapid, high-titer, high-quality antibody response that was broadly cross-reactive across several influenza A(H5N1) clades. CLINICAL TRIALS REGISTRATION: NCT01109329.

Indexed as

AdultAntibodies, ViralAntibody AffinityAntibody FormationCross ReactionsFemaleHealthy VolunteersHemagglutination Inhibition TestsHumansInfluenza A Virus, H5N1 SubtypeInfluenza A Virus, H7N3 SubtypeInfluenza VaccinesMaleMiddle AgedVaccines, AttenuatedYoung AdultAntibodies, ViralInfluenza VaccinesVaccines, Attenuatedavian influenzaH5N1live attenuatedvaccine

Identifiers

PMID24604819
PMCPMC4047295
OpenAlexW2141710322

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.