Evidence map›Paper›PMID 33176806›Full record

Trial reportPediatric rheumatology online journal2020

Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in patients with juvenile dermatomyositis: a real-world multicentre study.

Ingrid Herta Rotstein Grein, Natalia Balera Ferreira Pinto, Noortje Groot, Camila Bertini Martins, Aline Lobo, Nadia Emi Aikawa, Cassia Barbosa, Maria Teresa Terreri, Aline Coelho Moreira da Fraga, Sheila Knupp Feitosa de Oliveira and 14 more

Open access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Pediatric rheumatology online journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 43% 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

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Vaccination Update and Specific Concerns for RA.Current rheumatology reports · 2025
    Review
  3. Review
  4. Review
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

24 authors at 14 institutions in 3 countries.

Ingrid Herta Rotstein GreinDepartment of Paediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht, The Netherlands. pedro.grein@gmail.com.ORCID http://orcid.org/0000-0002-2290-5906
Natalia Balera Ferreira PintoDepartment of Paediatrics, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, São Paulo, Brazil.
Noortje GrootDepartment of Paediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht, The Netherlands.
Camila Bertini MartinsDepartment of Preventive Medicine, Universidade Federal de São Paulo, São Paulo, Brazil.
Aline LoboDepartment of Paediatrics, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, São Paulo, Brazil.
Nadia Emi AikawaDepartment of Paediatric Rheumatology, Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
Cassia BarbosaDepartment of Paediatric Rheumatology, Universidade Federal de São Paulo, São Paulo, Brazil.
Maria Teresa TerreriDepartment of Paediatric Rheumatology, Universidade Federal de São Paulo, São Paulo, Brazil.
Aline Coelho Moreira da FragaDepartment of Paediatric Rheumatology, Hospital Estadual Infantil Nossa Senhora da Glória, Vitória, Brazil.
Sheila Knupp Feitosa de OliveiraDepartment of Paediatric Rheumatology, Instituto de Puericultura e Pediatria Martagão Gesteira (IPPMG), Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.
Flavio SztajnbokDepartment of Paediatric Rheumatology, Universidade Estadual do Rio de Janeiro, Rio de Janeiro, Brazil.
Luciana B Paim MarquesDepartment of Paediatric Rheumatology, Hospital Infantil Albert Sabin, Fortaleza, Brazil.
Aline Garcia IslabãoDepartment of Paediatric Rheumatology, Hospital da Criança de Brasília José Alencar, Brasília, Brazil.
Simone AppenzellerDepartment of Paediatric Rheumatology, Universidade Estadual de Campinas, São Paulo, Brazil.
Blanca BicaDepartment of Paediatric Rheumatology, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.
Juliana de Oliveira SatoDepartment of Paediatric Rheumatology, Universidade Estadual Paulista, Botucatu, São Paulo, Brazil.
Claudia Saad MagalhãesDepartment of Paediatric Rheumatology, Universidade Estadual Paulista, Botucatu, São Paulo, Brazil.
Virgínia FerrianiDepartment of Paediatric Rheumatology, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, São Paulo, Brazil.
Hella PasmansCentre for Infectious Disease Control, National Institute of Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
Rutger ScheppCentre for Infectious Disease Control, National Institute of Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
Fiona van der KlisCentre for Infectious Disease Control, National Institute of Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
Sytze de RoockDepartment of Paediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht, The Netherlands.
Nico WulffraatDepartment of Paediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht, The Netherlands.
Gecilmara Salviato PileggiFaculdade de Ciências da Saude Dr Paulo Prata (FACISB) e Instituto de Ensino e Pesquisa (IEP), Hospital de Câncer de Barretos, São Paulo, Brazil.
National Institute for Public Health and the Environment · NLUniversidade de São Paulo · BRUniversidade Federal de São Paulo · BRWilhelmina Children's Hospital · NLUniversidade Estadual Paulista (Unesp) · BRUniversidade Federal do Rio de Janeiro · BRHospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRHospital de Câncer de Barretos · BRHospital de Clínicas Universidade Federal do Paraná · BRHospital Infantil Albert Sabin · BRHospital Nossa Senhora da Conceição · BRHospital Universitário de Brasília · BRUniversidade do Estado do Rio de Janeiro · BRUniversidade Estadual de Campinas (UNICAMP) · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundConcerns about the safety and efficacy of vaccines in patients with autoimmune diseases (AID) have led to contradictions and low vaccination coverage in this population, who are at a higher risk of infections, including by human papillomavirus (HPV). Although HPV vaccines have been recommended for immunocompromised patients, there is still a lack of data to support its use for AID patients, such as juvenile dermatomyositis (JDM) patients. The aim of this study was to assess the safety and immunogenicity of the quadrivalent HPV (qHPV) vaccine in a cohort of JDM patients.

methodsJDM patients aged from 9 to 20 years and healthy controls (HC) were enrolled to receive a 3-dose schedule of qHPV vaccine from March/2014 to March/2016. Study visits were performed before the first dose, 1 month after the second and third doses, and 6 months after the third dose. Participants completed a diary of possible adverse events for 14 days following each dose of vaccination (AEFV). Disease activity and current therapy were analyzed at each visit for JDM patients. In addition, serum samples from all participants were collected to test antibody concentrations against HPV16 and 18 at each visit. Participant recruitment was conducted in ten Brazilian centres. From 47 eligible JDM patients and 41 HC, 42 and 35, respectively, completed the 3-dose schedule of the vaccine, given that five JDM patients and two HC had received doses prior to their inclusion in the study.

resultsThe AEFVs presented by the participants were mild and in general did not differ between JDM and HC groups. No severe AEFVs were related to the vaccination. Disease activity was stable, or even improved during the follow-up. One month after the third dose of the vaccine the JDM group presented seropositivity of 100% for HPV16 and 97% for HPV18, similarly to the HC group, who presented 100% for both serotypes (p = 1.000). Six months after the third dose the seropositivity for the patient group was 94% for both HPV types.

conclusionsThe HPV vaccination in this cohort of JDM patients was safe and immunogenic. Since the seropositivity against HPV16 and 18 was very high after the 3-dose schedule, this regimen should be recommended for JDM patients.

trial registrationBrazilian Clinical Trials Registry, number: RBR-9ypbtf . Registered 20 March 2018 - Retrospectively registered.

Indexed as

DermatomyositisPapillomavirus InfectionsPapillomavirus VaccinesAdrenal Cortex HormonesAlphapapillomavirusBrazilChildFemaleHumansImmunocompromised HostImmunogenicity, VaccineOutcome and Process Assessment, Health CareYoung AdultAdrenal Cortex HormonesPapillomavirus VaccinesImmunogenicityJuvenile dermatomyositisQuadrivalent HPV vaccineSafety

Identifiers

PMID33176806
PMCPMC7659057
OpenAlexW3099477153

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.