Evidence map›Paper›PMID 37306813›Full record

ArticleClinical rheumatology2023

Robust immunogenicity to the H3N2 component of influenza A vaccine in primary Sjögren syndrome.

Sandra Gofinet Pasoto, Eduardo Ferreira Borba, Francisco Fellipe Claudino Formiga, Tatiana do Nascimento Pedrosa, Nadia Emi Aikawa, Marilda Agudo Mendonça Teixeira de Siqueira, Artur Silva Vidal Capão, Adriana Coracini Tonacio de Proença, Ricardo Fuller, Emily Figueiredo Neves Yuki and 6 more

Registry-linked trialAbstract read
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In one paragraph

Article in Clinical rheumatology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03540823 (Immunogenicity and Safety of Influenza A/H3N2 Vaccine in Patients With Rheumatologic Diseases), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.2field-weighted citation impact, top 49% 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.

NCT03540823 phase4completednot on this map

Immunogenicity and Safety of Influenza A/H3N2 Vaccine in Patients With Rheumatologic Diseases

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2018 to 2018Enrolled300ConditionsSystemic Lupus, Sjogren's SyndromeArmsInactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus, B / Phuket / 3073/2013-like virus)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

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

16 authors at 2 institutions in 1 country.

Sandra Gofinet PasotoRheumatology Division, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, SP, 01246-903, Brazil. sandra.pasoto@hc.fm.usp.br.ORCID http://orcid.org/0000-0002-7343-6804
Eduardo Ferreira BorbaRheumatology Division, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, SP, 01246-903, Brazil.
Francisco Fellipe Claudino FormigaRheumatology Division, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, SP, 01246-903, Brazil.
Tatiana do Nascimento PedrosaRheumatology Division, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, SP, 01246-903, Brazil.
Nadia Emi AikawaRheumatology Division, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, SP, 01246-903, Brazil.
Marilda Agudo Mendonça Teixeira de SiqueiraLaboratory of Respiratory Virus and Measles, Instituto Oswaldo Cruz, FIOCRUZ, Rio de Janeiro, RJ, Brazil.
Artur Silva Vidal CapãoLaboratory of Respiratory Virus and Measles, Instituto Oswaldo Cruz, FIOCRUZ, Rio de Janeiro, RJ, Brazil.
Adriana Coracini Tonacio de ProençaDepartment of Infectious and Parasitic Diseases, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, SP, 01246-903, Brazil.
Ricardo FullerRheumatology Division, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, SP, 01246-903, Brazil.
Emily Figueiredo Neves YukiRheumatology Division, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, SP, 01246-903, Brazil.
Elaine Pires LeonRheumatology Division, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, SP, 01246-903, Brazil.
Victor Adriano de Oliveira MartinsRheumatology Division, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, SP, 01246-903, Brazil.
Marta Heloisa LopesDepartment of Infectious and Parasitic Diseases, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, SP, 01246-903, Brazil.
Alberto José da Silva DuarteClinical Laboratory Division, Department of Pathology, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, SP, 01246-903, Brazil.
Clovis Artur Almeida da SilvaPediatric Rheumatology Unit, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, SP, 01246-903, Brazil.
Eloisa BonfaRheumatology Division, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, Sao Paulo, SP, 01246-903, Brazil.
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRFundação Oswaldo Cruz · BR

Funding

Conselho Nacional de Desenvolvimento Científico e Tecnológico 303116/2022-6Conselho Nacional de Desenvolvimento Científico e Tecnológico 304984/2020-5Conselho Nacional de Desenvolvimento Científico e Tecnológico 305242/2019-9Conselho Nacional de Desenvolvimento Científico e Tecnológico 306879/2018-2Fundação de Amparo à Pesquisa do Estado de São Paulo 2015/03756-4Fundação de Amparo à Pesquisa do Estado de São Paulo 2017/14352-7Fundação de Amparo à Pesquisa do Estado de São Paulo 305242/2019-9
6 · The paper itself

Abstract

introductionInfluenza A (H3N2) virus is the major cause of morbidity/mortality due to seasonal influenza over 50 years. Data about the safety/immunogenicity of influenza A/Singapore (H3N2) vaccine are scarce in primary Sjögren syndrome (pSS).

methodsTwenty-one consecutive pSS patients and 42 HC (healthy control individuals) were immunized with influenza A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus. Rates of SP (seroprotection) and SC (seroconversion), GMT (geometric mean titers), FI-GMT (factor increase in GMT), ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index), and adverse events were appraised before and 4 weeks post-vaccination.

resultspSS and HC had similar mean age (51.2 ± 14.2 vs. 50.6 ± 12.1 years, p = 0.886). Pre-vaccination SP rates were high in pSS and HC (90.5% vs. 71.4%, p = 0.114), and GMT were higher in pSS [80.0 (52.4-160.0) vs. 40.0 (20.0-80.0), p = 0.001]. The percentage of influenza vaccination in the preceding two years was elevated and similar in pSS and HC (94.1% vs. 94.6%, p = 1.000). GMT values augmented in both groups four weeks after vaccination and persisted higher in the first group [160.0 (80.0-320.0) vs. 80.0 (40.0-80.0), p < 0.001] with equivalent FI-GMT [1.4 (1.0-2.8) vs. 1.4 (1.0-2.0), p = 0.410]. Both groups had low and similar SC rates (19.0% vs. 9.5%, p = 0.423). ESSDAI values persisted steadily during the study (p = 0.313). No serious adverse events have occurred.

conclusionThe novel demonstration that the influenza A/Singapore (H3N2) vaccine induces a different pattern of immunogenicity from other influenza A constituents in pSS, featured by a desirable high pre- and post-vaccination immunogenicity, is in line with reported differences in immune responses between strains in trivalent vaccines and may be related to pre-existing immunity. CLINICALTRIALS: gov: #NCT03540823. Key Points • This prospective study demonstrated a robust pre- and post-vaccination immunogenicity to influenza A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus in primary Sjögren's syndrome (pSS). • This high immunogenicity pattern may be related to pre-existing immunization, or else it is related to immunogenicity differences of each strain. • This vaccine had an adequate safety profile in pSS, with no impact on disease activity.

Indexed as

Influenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesSjogren's SyndromeAntibodies, ViralHumansInfluenza A Virus, H3N2 SubtypeProspective StudiesAntibodies, ViralInfluenza VaccinesH3N2ImmunogenicityInfluenzaSafetySjogren syndromeVaccine

Identifiers

PMID37306813
OpenAlexW4380291336

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.