Evidence map›Paper›PMID 38017564›Full record

Trial reportAdvances in rheumatology (London, England)2023

Safety and immunogenicity of influenza A(H3N2) component vaccine in juvenile systemic lupus erythematosus.

Nadia Emi Aikawa, Eduardo Ferreira Borba, Verena Andrade Balbi, Adriana Maluf Elias Sallum, Izabel Mantovani Buscatti, Lucia Maria Arruda Campos, Kátia Tomie Kozu, Cristiana Couto Garcia, Artur Silva Vidal Capão, Adriana Coracini Tonacio de Proença and 5 more

Registry-linked trialOpen access · diamondAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Advances in rheumatology (London, England), 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
0.5field-weighted citation impact, top 30% 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, 2 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

15 authors at 2 institutions in 1 country.

Nadia Emi AikawaPediatric Rheumatology Unit, Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, 3Rd Floor, room 3190 - Cerqueira Cesar, São Paulo, SP, CEP 05403-010, Brazil. nadia.aikawa@gmail.com.ORCID 0000-0002-7585-4348
Eduardo Ferreira BorbaRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Verena Andrade BalbiPediatric Rheumatology Unit, Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, 3Rd Floor, room 3190 - Cerqueira Cesar, São Paulo, SP, CEP 05403-010, Brazil.
Adriana Maluf Elias SallumPediatric Rheumatology Unit, Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, 3Rd Floor, room 3190 - Cerqueira Cesar, São Paulo, SP, CEP 05403-010, Brazil.
Izabel Mantovani BuscattiPediatric Rheumatology Unit, Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, 3Rd Floor, room 3190 - Cerqueira Cesar, São Paulo, SP, CEP 05403-010, Brazil.
Lucia Maria Arruda CamposPediatric Rheumatology Unit, Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, 3Rd Floor, room 3190 - Cerqueira Cesar, São Paulo, SP, CEP 05403-010, Brazil.
Kátia Tomie KozuPediatric Rheumatology Unit, Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, 3Rd Floor, room 3190 - Cerqueira Cesar, São Paulo, SP, CEP 05403-010, Brazil.
Cristiana Couto GarciaLaboratory of Respiratory, Exanthematic Viruses, Enterovirus and Viral Emergencies, Instituto Oswaldo Cruz, FIOCRUZ, Rio de Janeiro, RJ, Brazil.
Artur Silva Vidal CapãoLaboratory of Respiratory, Exanthematic Viruses, Enterovirus and Viral Emergencies, Instituto Oswaldo Cruz, FIOCRUZ, Rio de Janeiro, RJ, Brazil.
Adriana Coracini Tonacio de ProençaDepartment of Infectious and Parasitic Diseases, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Elaine Pires LeonRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Alberto José da Silva DuarteClinical Laboratory Division - Department of Pathology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Marta Heloisa LopesDepartment of Infectious and Parasitic Diseases, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Clovis Artur SilvaPediatric Rheumatology Unit, Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, 3Rd Floor, room 3190 - Cerqueira Cesar, São Paulo, SP, CEP 05403-010, Brazil.
Eloisa BonfáRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, 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 303378/2022-0Conselho Nacional de Desenvolvimento Científico e Tecnológico 304984/2020-5Conselho Nacional de Desenvolvimento Científico e Tecnológico 305242/2019-9Fundação de Amparo à Pesquisa do Estado de São Paulo 2010/10749-0Fundação de Amparo à Pesquisa do Estado de São Paulo 2015/03756-4Fundação de Amparo à Pesquisa do Estado de São Paulo 2018/16162-3
6 · The paper itself

Abstract

introductionSeasonal influenza A (H3N2) virus is an important cause of morbidity and mortality in the last 50 years in population that is greater than the impact of H1N1. Data assessing immunogenicity and safety of this virus component in juvenile systemic lupus erythematosus (JSLE) is lacking in the literature.

objectiveTo evaluate short-term immunogenicity and safety of influenza A/Singapore (H3N2) vaccine in JSLE.

methods24 consecutive JSLE patients and 29 healthy controls (HC) were vaccinated with influenza A/Singapore/INFIMH-16-0019/2016(H3N2)-like virus. Influenza A (H3N2) seroprotection (SP), seroconversion (SC), geometric mean titers (GMT), factor increase in GMT (FI-GMT) titers were assessed before and 4 weeks post-vaccination. Disease activity, therapies and adverse events (AE) were also evaluated.

resultsJSLE patients and controls were comparable in current age [14.5 (10.1-18.3) vs. 14 (9-18.4) years, p = 0.448] and female sex [21 (87.5%) vs. 19 (65.5%), p = 0.108]. Before vaccination, JSLE and HC had comparable SP rates [22 (91.7%) vs. 25 (86.2%), p = 0.678] and GMT titers [102.3 (95% CI 75.0-139.4) vs. 109.6 (95% CI 68.2-176.2), p = 0.231]. At D30, JSLE and HC had similar immune response, since no differences were observed in SP [24 (100%) vs. 28 (96.6%), p = 1.000)], SC [4 (16.7%) vs. 9 (31.0%), p = 0.338), GMT [162.3 (132.9-198.3) vs. 208.1 (150.5-287.8), p = 0.143] and factor increase in GMT [1.6 (1.2-2.1) vs. 1.9 (1.4-2.5), p = 0.574]. SLEDAI-2K scores [2 (0-17) vs. 2 (0-17), p = 0.765] and therapies remained stable throughout the study. Further analysis of possible factors influencing vaccine immune response among JSLE patients demonstrated similar GMT between patients with SLEDAI < 4 compared to SLEDAI ≥ 4 (p = 0.713), as well as between patients with and without current use of prednisone (p = 0.420), azathioprine (p = 1.0), mycophenolate mofetil (p = 0.185), and methotrexate (p = 0.095). No serious AE were reported in both groups and most of them were asymptomatic (58.3% vs. 44.8%, p = 0.958). Local and systemic AE were alike in both groups (p > 0.05).

conclusionThis is the first study that identified adequate immune protection against H3N2-influenza strain with additional vaccine-induced increment of immune response and an adequate safety profile in JSLE. ( www. CLINICALTRIALS: gov , NCT03540823).

Indexed as

Influenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesLupus Erythematosus, SystemicAdolescentAntibodies, ViralChildFemaleHumansInfluenza A Virus, H3N2 SubtypeMaleAntibodies, ViralInfluenza VaccinesH3N2ImmunogenicityInfluenzaSafetySystemic lupus erythematosusVaccine

Identifiers

PMID38017564
OpenAlexW4389098293

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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.