Evidence map›Paper›PMID 22087267›Full record

Trial reportPloS one2011

Immunogenicity and reactogenicity of 2009 influenza A (H1N1) inactivated monovalent non-adjuvanted vaccine in elderly and immunocompromised patients.

João L Miraglia, Edson Abdala, Paulo M Hoff, André M Luiz, Danise S Oliveira, Carla G S Saad, Ieda M M Laurindo, Ana T R Viso, Angela Tayra, Lígia C Pierrotti and 10 more

Registry-linked trialOpen access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01218685 (Evaluation Aof Safety and Immunogenicity of Non-adjuvanted Pandemic Influenza A), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
4.8field-weighted citation impact, top 5% 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.

NCT01218685 completednot on this map

Evaluation Aof Safety and Immunogenicity of Non-adjuvanted Pandemic Influenza A (H1N1) Vaccine in Chronic and or Immunocompromised Patients, Elderly and Pregnants, Produced by Butantan Institute

TypeobservationalSponsorButantan InstituteRan2010 to 2011Enrolled1,152ConditionsImmunocompromised Patients, Safety of Pandemic Influenza A (H1N1)Vaccine, Immunogenicity of Pandemic Influenza A (H1N1)VaccineArmsSplit inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

  1. Pooled it
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  6. Review
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  12. Targeting the skin for microneedle delivery of influenza vaccine.Advances in experimental medicine and biology · 2013
    Review
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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

20 authors at 5 institutions in 1 country.

João L MiragliaButantan Institute-Clinical Trials Division, São Paulo, Brazil. joaomiraglia@gmail.com
Edson Abdala
Paulo M Hoff
André M Luiz
Danise S Oliveira
Carla G S Saad
Ieda M M Laurindo
Ana T R Viso
Angela Tayra
Lígia C Pierrotti
Luiz S Azevedo
Lúcia Maria A Campos
Nádia E Aikawa
Maria do Carmo S T Timenetsky
Expedito Luna
Maria Regina A Cardoso
José da S Guedes
Isaias Raw
Jorge Kalil
Alexander R Precioso
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRInstituto Butantan · BRUniversidade de São Paulo · BRInstituto Adolfo Lutz · BRInstituto do Câncer do Estado de São Paulo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImmunosuppressed individuals present serious morbidity and mortality from influenza, therefore it is important to understand the safety and immunogenicity of influenza vaccination among them.

methodsThis multicenter cohort study evaluated the immunogenicity and reactogenicity of an inactivated, monovalent, non-adjuvanted pandemic (H1N1) 2009 vaccine among the elderly, HIV-infected, rheumatoid arthritis (RA), cancer, kidney transplant, and juvenile idiopathic arthritis (JIA) patients. Participants were included during routine clinical visits, and vaccinated according to conventional influenza vaccination schedules. Antibody response was measured by the hemagglutination-inhibition assay, before and 21 days after vaccination.

results319 patients with cancer, 260 with RA, 256 HIV-infected, 149 elderly individuals, 85 kidney transplant recipients, and 83 with JIA were included. The proportions of seroprotection, seroconversion, and the geometric mean titer ratios postvaccination were, respectively: 37.6%, 31.8%, and 3.2 among kidney transplant recipients, 61.5%, 53.1%, and 7.5 among RA patients, 63.1%, 55.7%, and 5.7 among the elderly, 59.0%, 54.7%, and 5.9 among HIV-infected patients, 52.4%, 49.2%, and 5.3 among cancer patients, 85.5%, 78.3%, and 16.5 among JIA patients. The vaccine was well tolerated, with no reported severe adverse events.

conclusionsThe vaccine was safe among all groups, with an acceptable immunogenicity among the elderly and JIA patients, however new vaccination strategies should be explored to improve the immune response of immunocompromised adult patients. (ClinicalTrials.gov, NCT01218685).

Indexed as

Influenza A Virus, H1N1 SubtypeAdolescentAdultAgedAged, 80 and overAge FactorsArthritis, JuvenileChildChild, PreschoolCohort StudiesComorbidityFemaleHIV InfectionsHumansImmunity, HumoralImmunocompromised HostInfluenza VaccinesVaccines, Inactivated

Identifiers

PMID22087267
PMCPMC3210772
OpenAlexW2079727844

What OpenQuestion holds

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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.