Evidence map›Paper›PMID 32532097›Full record

ArticleVaccines2020

A Phase 1 Randomized Placebo-Controlled Study to Assess the Safety, Immunogenicity and Genetic Stability of a New Potential Pandemic H7N9 Live Attenuated Influenza Vaccine in Healthy Adults.

Irina Kiseleva, Irina Isakova-Sivak, Marina Stukova, Marianna Erofeeva, Svetlana Donina, Natalie Larionova, Elena Krutikova, Ekaterina Bazhenova, Ekaterina Stepanova, Kirill Vasilyev and 8 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Vaccines, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03739229 (Reactogenicity, Safety and Immunogenicity of a Live Monovalent А/17/Hong Kong/2017/75108), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.6field-weighted citation impact, top 31% 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.

NCT03739229 phase1unknown statusnot on this map

Reactogenicity, Safety and Immunogenicity of a Live Monovalent А/17/Hong Kong/2017/75108 (H7N9) Influenza Vaccine

TypeinterventionalSponsorResearch Institute of Influenza, RussiaRan2018 to 2019Enrolled40ConditionsVaccine Adverse ReactionArmsPlacebo, H7N9 LAIV
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 7 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

18 authors at 3 institutions in 2 countries.

Irina KiselevaFederal State Budgetary Scientific Institution "Institute of Experimental Medicine", 197376 St Petersburg, Russia.ORCID 0000-0002-3892-9873
Irina Isakova-SivakFederal State Budgetary Scientific Institution "Institute of Experimental Medicine", 197376 St Petersburg, Russia.ORCID 0000-0002-2801-1508
Marina StukovaSmorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 St Petersburg, Russia.
Marianna ErofeevaSmorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 St Petersburg, Russia.
Svetlana DoninaFederal State Budgetary Scientific Institution "Institute of Experimental Medicine", 197376 St Petersburg, Russia.
Natalie LarionovaFederal State Budgetary Scientific Institution "Institute of Experimental Medicine", 197376 St Petersburg, Russia.
Elena KrutikovaFederal State Budgetary Scientific Institution "Institute of Experimental Medicine", 197376 St Petersburg, Russia.
Ekaterina BazhenovaFederal State Budgetary Scientific Institution "Institute of Experimental Medicine", 197376 St Petersburg, Russia.ORCID 0000-0003-3280-556X
Ekaterina StepanovaFederal State Budgetary Scientific Institution "Institute of Experimental Medicine", 197376 St Petersburg, Russia.ORCID 0000-0002-8670-8645
Kirill VasilyevSmorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 St Petersburg, Russia.ORCID 0000-0002-7750-9652
Victoria MatyushenkoFederal State Budgetary Scientific Institution "Institute of Experimental Medicine", 197376 St Petersburg, Russia.
Marina KrylovaThe Federal State Unitary Enterprise "Scientific and Production Association for Immunological Preparations "Microgen", Ministry of Health of Russian Federation, 127473 Moscow, Russia.
Julia GalatonovaThe Federal State Unitary Enterprise "Scientific and Production Association for Immunological Preparations "Microgen", Ministry of Health of Russian Federation, 127473 Moscow, Russia.
Aleksey ErshovThe Federal State Unitary Enterprise "Scientific and Production Association for Immunological Preparations "Microgen", Ministry of Health of Russian Federation, 127473 Moscow, Russia.
Dmitry LioznovSmorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 St Petersburg, Russia.
Erin Grace SparrowWorld Health Organization, 1211 Geneva, Switzerland.ORCID 0000-0003-3912-2550
Guido TorelliWorld Health Organization, 1211 Geneva, Switzerland.
Larisa RudenkoFederal State Budgetary Scientific Institution "Institute of Experimental Medicine", 197376 St Petersburg, Russia.
Institute of Experimental Medicine · RUMinistry of Health of the Russian Federation · RUWorld Health Organization · CH

Funding

Biomedical Advanced Research and Development Authority IDSEP130015-01Russian Ministry of Science and Education Program ID 0557-2019-0003
6 · The paper itself

Abstract

This study describes a double-blind randomized placebo-controlled phase I clinical trial in healthy adults of a new potential pandemic H7N9 live attenuated influenza vaccine (LAIV) based on the human influenza virus of Yangtze River Delta hemagglutinin lineage (ClinicalTrials.gov Identifier: NCT03739229). Two doses of H7N9 LAIV or placebo were administered intranasally to 30 and 10 subjects, respectively. The vaccine was well-tolerated and not associated with increased rates of adverse events or with any serious adverse events. Vaccine virus was detected in nasal swabs during the 6 days after vaccination or revaccination. A lower frequency of shedding was observed after the second vaccination. Twenty-five clinical viral isolates obtained after the first and second doses of vaccine retained the temperature-sensitive and cold-adapted phenotypic characteristics of LAIV. There was no confirmed transmission of the vaccine strain from vaccinees to placebo recipients. After the two H7N9 LAIV doses, an immune response was observed in 96.6% of subjects in at least one of the assays conducted.

Indexed as

cellular immunityclinical trialH7N9 influenzahumoral immunityimmune responseLAIVpotential pandemic vaccinesafetystability

Identifiers

PMID32532097
PMCPMC7350028
OpenAlexW3034837175

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.