Evidence map›Paper›PMID 24533064›Full record

Trial reportPloS one2014

Assessment of human immune responses to H7 avian influenza virus of pandemic potential: results from a placebo-controlled, randomized double-blind phase I study of live attenuated H7N3 influenza vaccine.

Larisa Rudenko, Irina Kiseleva, Anatoly N Naykhin, Marianna Erofeeva, Marina Stukova, Svetlana Donina, Galina Petukhova, Maria Pisareva, Vera Krivitskaya, Michael Grudinin and 12 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01511419 (Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/Mallard/Netherlands/00/95), which is not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
8.8field-weighted citation impact, top 2% 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.

NCT01511419 phase1completednot on this map

Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/Mallard/Netherlands/00/95 (H7N3) Influenza Vaccine

TypeinterventionalSponsorPATHRan2012 to 2012Enrolled40ConditionsInfluenza, Avian InfluenzaArmsLAIV H7N3, placebo
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.

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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

22 authors at 3 institutions in 2 countries.

Larisa RudenkoDepartment of Virology, Institute of Experimental Medicine, Saint Petersburg, Russia.
Irina KiselevaDepartment of Virology, Institute of Experimental Medicine, Saint Petersburg, Russia.
Anatoly N NaykhinDepartment of Virology, Institute of Experimental Medicine, Saint Petersburg, Russia.
Marianna ErofeevaDepartment of Epidemiology and Prophylaxis, Institute of Influenza, Saint Petersburg, Russia.
Marina StukovaDepartment of Molecular Virology, Institute of Influenza, Saint Petersburg, Russia.
Svetlana DoninaDepartment of Virology, Institute of Experimental Medicine, Saint Petersburg, Russia.
Galina PetukhovaDepartment of Virology, Institute of Experimental Medicine, Saint Petersburg, Russia.
Maria PisarevaDepartment of Molecular Virology, Institute of Influenza, Saint Petersburg, Russia.
Vera KrivitskayaDepartment of Biotechnology, Institute of Influenza, Saint Petersburg, Russia.
Michael GrudininDepartment of Molecular Virology, Institute of Influenza, Saint Petersburg, Russia.
Zhanna BuzitskayaDepartment of Molecular Virology, Institute of Influenza, Saint Petersburg, Russia.
Irina Isakova-SivakDepartment of Virology, Institute of Experimental Medicine, Saint Petersburg, Russia.
Svetlana KuznetsovaDepartment of Virology, Institute of Experimental Medicine, Saint Petersburg, Russia.
Natalie LarionovaDepartment of Virology, Institute of Experimental Medicine, Saint Petersburg, Russia.
Julia DeshevaDepartment of Virology, Institute of Experimental Medicine, Saint Petersburg, Russia.
Irina DubrovinaDepartment of Virology, Institute of Experimental Medicine, Saint Petersburg, Russia.
Alexandra NikiforovaDepartment of Preclinical Trials, Microgen, Moscow, Russia.
John C VictorProgram for Appropriate Technologies in Health, Seattle, Washington, United States of America.
Kathy NeuzilProgram for Appropriate Technologies in Health, Seattle, Washington, United States of America.
Jorge FloresProgram for Appropriate Technologies in Health, Seattle, Washington, United States of America.
Vadim TsvetnitskyProgram for Appropriate Technologies in Health, Seattle, Washington, United States of America.
Oleg KiselevDepartment of Molecular Virology, Institute of Influenza, Saint Petersburg, Russia.
Institute of Experimental Medicine · RUResearch Institute of Influenza · RUProgram for Appropriate Technology in Health · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLive attenuated influenza vaccines (LAIVs) are being developed to protect humans against future epidemics and pandemics. This study describes the results of a double-blinded randomized placebo-controlled phase I clinical trial of cold-adapted and temperature sensitive H7N3 live attenuated influenza vaccine candidate in healthy seronegative adults.

objectiveThe goal of the study was to evaluate the safety, tolerability, immunogenicity and potential shedding and transmission of H7N3 LAIV against H7 avian influenza virus of pandemic potential. METHODS AND

findingsTwo doses of H7N3 LAIV or placebo were administered to 40 randomly divided subjects (30 received vaccine and 10 placebo). The presence of influenza A virus RNA in nasal swabs was detected in 60.0% and 51.7% of subjects after the first and second vaccination, respectively. In addition, vaccine virus was not detected among placebo recipients demonstrating the absence of person-to-person transmission. The H7N3 live attenuated influenza vaccine demonstrated a good safety profile and was well tolerated. The two-dose immunization resulted in measurable serum and local antibody production and in generation of antigen-specific CD4⁺ and CD8⁺ memory T cells. Composite analysis of the immune response which included hemagglutinin inhibition assay, microneutralization tests, and measures of IgG and IgA and virus-specific T cells showed that the majority (86.2%) of vaccine recipients developed serum and/or local antibodies responses and generated CD4⁺ and CD8⁺ memory T cells.

conclusionsThe H7N3 LAIV was safe and well tolerated, immunogenic in healthy seronegative adults and elicited production of antibodies broadly reactive against the newly emerged H7N9 avian influenza virus.

trial registrationClinicalTrials.gov NCT01511419.

Indexed as

Influenza A Virus, H7N3 SubtypeAdolescentAdultAntibodies, ViralCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesCold TemperatureFemaleHumansImmunoglobulin AImmunoglobulin GInfluenza A Virus, H7N9 SubtypeInfluenza, HumanInfluenza VaccinesMaleMiddle AgedAntibodies, ViralImmunoglobulin AImmunoglobulin GInfluenza VaccinesVaccines, Attenuated

Identifiers

PMID24533064
PMCPMC3922724
OpenAlexW1992068628

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.