Evidence map›Paper›PMID 23803900›Full record

Trial reportClinical and vaccine immunology : CVI2013

An inactivated, adjuvanted whole virion clade 2.2 H5N1 (A/Chicken/Astana/6/05) influenza vaccine is safe and immunogenic in a single dose in humans.

Abylay R Sansyzbay, Marianna K Erofeeva, Berik M Khairullin, Nurlan T Sandybayev, Zhailaubay K Kydyrbayev, Seidigapbar M Mamadaliyev, Markhabat M Kassenov, Maria V Sergeeva, Julia R Romanova, Vera Z Krivitskaya and 2 more

Open access · diamondAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical and vaccine immunology : CVI, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.6field-weighted citation impact, top 17% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 17 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

12 authors at 1 institution in 1 country.

Abylay R SansyzbayResearch Institute for Biological Safety Problems, Gvardeiskiy, Kazakhstan.
Marianna K Erofeeva
Berik M Khairullin
Nurlan T Sandybayev
Zhailaubay K Kydyrbayev
Seidigapbar M Mamadaliyev
Markhabat M Kassenov
Maria V Sergeeva
Julia R Romanova
Vera Z Krivitskaya
Oleg I Kiselev
Marina A Stukova
Research Institute of Influenza · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this study, we assessed in humans the immunogenicity and safety of one dose (7.5 or 15 μg of hemagglutinin [HA]) of a whole-virion inactivated prepandemic influenza vaccine adjuvanted with aluminum hydroxide. The vaccine strain was made by reverse genetics from the highly pathogenic avian A/Chicken/Astana/6/05 (H5N1) clade 2.2 strain isolated from a dead bird in Kazakhstan. The humoral immune response was evaluated after a single vaccination by hemagglutination inhibition (HI) and microneutralization (MN) assays. The vaccine was safe and immunogenic, inducing seroconversion in 55% of the evaluated patients, with a geometric mean titer (GMT) of 17.1 and a geometric mean increase (GMI) of 3.42 after a dose of 7.5 μg in the HI test against the vaccine strain. The rate of seroconversion increased up to 70% when the dose of 15 μg was used. The percentages of individuals achieving anti-HA titers of ≥1:40 were 52.5% and 57.5% for the 7.5- and 15-μg dose groups, respectively. Similar results were obtained when antibodies were analyzed in an MN test. Substantial cross-neutralization titers (seroconversion in 35% and 52.5% of subjects in the two dose groups, respectively) were detected against heterologous clade 1 strain NIBRG14 (H5N1). Thus, one dose of this whole-virion prepandemic vaccine adjuvanted with aluminum has the potential to be effective against H5N1 viruses of different clades.

Indexed as

Adjuvants, ImmunologicAdultAluminum HydroxideAnimalsAntibodies, ViralCross ReactionsHemagglutination Inhibition TestsHumansInfluenza A Virus, H5N1 SubtypeInfluenza, HumanInfluenza VaccinesKazakhstanMaleMiddle AgedNeutralization TestsReverse GeneticsAdjuvants, ImmunologicAluminum HydroxideAntibodies, ViralInfluenza VaccinesVaccines, Inactivated

Identifiers

PMID23803900
PMCPMC3754517
OpenAlexW2011227029

What OpenQuestion holds

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Registered trials

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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.