Evidence map›Paper›PMID 34843469›Full record

Trial reportPLoS neglected tropical diseases2021

Immunogenicity and safety of primary fractional-dose yellow fever vaccine in autoimmune rheumatic diseases.

Adriana Coracini Tonacio, Tatiana do Nascimento Pedrosa, Eduardo Ferreira Borba, Nadia Emi Aikawa, Sandra Gofinet Pasoto, Júlio Cesar Rente Ferreira Filho, Marília Mantovani Sampaio Barros, Elaine Pires Leon, Suzete Cleusa Ferreira Spina Lombardi, Alfredo Mendrone Junior and 17 more

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in PLoS neglected tropical diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03430388 (Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% 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.

NCT03430388 nacompletednot on this map

Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2018 to 2019Enrolled600ConditionsSystemic Lupus, Rheumatoid Arthritis, Spondyloarthritis, Inflammatory MyopathyArmsYellow Fever vaccine (17D)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Guideline
  2. Review
  3. Article
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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

27 authors at 3 institutions in 1 country.

Adriana Coracini TonacioDepartment of Infectious and Parasitic Diseases, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0002-1038-8796
Tatiana do Nascimento PedrosaRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0003-0009-1013
Eduardo Ferreira BorbaRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0001-6194-5129
Nadia Emi AikawaRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0002-7585-4348
Sandra Gofinet PasotoRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0002-7343-6804
Júlio Cesar Rente Ferreira FilhoRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
Marília Mantovani Sampaio BarrosRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0002-4276-2121
Elaine Pires LeonRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
Suzete Cleusa Ferreira Spina LombardiLaboratório de Segurança Transfusional, Divisão de Pesquisa e Ensino, Fundação Pró-Sangue/Hemocentro de São Paulo, São Paulo, Brazil.
Alfredo Mendrone JuniorLaboratório de Segurança Transfusional, Divisão de Pesquisa e Ensino, Fundação Pró-Sangue/Hemocentro de São Paulo, São Paulo, Brazil.
Adriana de Souza AzevedoInstitute of Technology in Immunobiologicals, Bio-Manguinhos, Fundação Oswaldo Cruz Foundation, FIOCRUZ, Rio de Janeiro, Brazil.ORCID 0000-0001-7401-5107
Waleska Dias SchwarczInstitute of Technology in Immunobiologicals, Bio-Manguinhos, Fundação Oswaldo Cruz Foundation, FIOCRUZ, Rio de Janeiro, Brazil.ORCID 0000-0002-8095-8846
Ricardo FullerRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
Emily Figueiredo Neves YukiRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0001-8801-405X
Michelle Remião Ugolini LopesRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0002-3729-129X
Rosa Maria Rodrigues PereiraRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
Percival Degrava Sampaio BarrosRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
Danieli Castro Oliveira de AndradeRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
Ana Cristina de Medeiros-RibeiroRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0001-7168-5906
Julio Cesar Bertacini de MoraesRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
Samuel Katsuyuki ShinjoRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
Renata MiossiRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
Alberto José da Silva DuarteClinical Laboratory Division-Department of Pathology, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
Marta Heloisa LopesDepartment of Infectious and Parasitic Diseases, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0001-5236-6248
Esper Georges KallásDepartment of Infectious and Parasitic Diseases, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0003-2026-6925
Clovis Artur Almeida da SilvaRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
Eloisa BonfáRheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRFundação Oswaldo Cruz · BRFundação Pró-Sangue Hemocentro de São Paulo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBrazil faced a yellow fever(YF) outbreak in 2016-2018 and vaccination was considered for autoimmune rheumatic disease patients(ARD) with low immunosuppression due to YF high mortality.

objectiveThis study aimed to evaluate, prospectively for the first time, the short-term immunogenicity of the fractional YF vaccine(YFV) immunization in ARD patients with low immunossupression. METHODS AND

resultsA total of 318 participants(159 ARD and 159 age- and sex-matched healthy controls) were vaccinated with the fractional-dose(one fifth) of 17DD-YFV. All subjects were evaluated at entry(D0), D5, D10, and D30 post-vaccination for clinical/laboratory and disease activity parameters for ARD patients. Post-vaccination seroconversion rate(83.7%vs.96.6%, p = 0.0006) and geometric mean titers(GMT) of neutralizing antibodies[1143.7 (95%CI 1012.3-1292.2) vs.731 (95%CI 593.6-900.2), p<0.001] were significantly lower in ARD compared to controls. A lower positivity rate of viremia was also identified for ARD patients compared to controls at D5 (53%vs.70%, p = 0.005) and the levels persisted in D10 for patients and reduced for controls(51%vs.19%, p = 0.0001). The viremia was the only variable associated with seroconvertion. No serious adverse events were reported. ARD disease activity parameters remained stable at D30(p>0.05).

conclusionFractional-dose 17DD-YF vaccine in ARD patients resulted in a high rate of seroconversion rate(>80%) but lower than controls, with a longer but less intense viremia. This vaccine was immunogenic, safe and did not induce flares in ARD under low immunosuppression and may be indicated in YF outbreak situations and for patients who live or travel to endemic areas.

trial registrationThis clinical trial was registered with Clinicaltrials.gov (#NCT03430388).

Indexed as

AdultAntibodies, NeutralizingAntibodies, ViralBrazilFemaleHumansImmunosuppression TherapyMaleMiddle AgedProspective StudiesRheumatic DiseasesSeroconversionYellow FeverYellow Fever VaccineYoung AdultAntibodies, NeutralizingAntibodies, ViralYellow Fever Vaccine

Identifiers

PMID34843469
PMCPMC8659329
OpenAlexW3215272607

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.