Trial report in Clinical rheumatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04754698 (Immunogenicity and Safety of the CoronaVac Vacccine in Patients With Autoimmune Rheumatic Diseases and People Living With HIV/AIDS), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.
0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% 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.
Immunogenicity and Safety of the CoronaVac Vacccine in Patients With Autoimmune Rheumatic Diseases and People Living With HIV/AIDS
TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2021 to 2024Enrolled2,196ConditionsRheumatic Disease, HIV Infections, AIDS, Safety IssuesArmsCoronaVac
3 · Its place in the literature
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.
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
19 authors at 1 institution in 1 country.
Sandra Gofinet PasotoRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil. sandra.pasoto@hc.fm.usp.br.ORCID http://orcid.org/0000-0002-7343-6804
Ari Stiel Radu HalpernRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.ORCID http://orcid.org/0000-0003-3756-0928
Lissiane Karine Noronha GuedesRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.ORCID http://orcid.org/0000-0001-7440-6212
Ana Cristina Medeiros RibeiroRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.ORCID http://orcid.org/0000-0001-7168-5906
Emily Neves Figueiredo YukiRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.ORCID http://orcid.org/0000-0001-8801-405X
Carla Gonçalves Schahin SaadRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.ORCID http://orcid.org/0000-0001-9720-0719
Clovis Artur Almeida da SilvaRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.ORCID http://orcid.org/0000-0001-9250-6508
Léonard de Vinci Kanda KupaRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.ORCID http://orcid.org/0000-0002-8827-1360
Lorena Elizabeth Betancourt VillamarínRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.ORCID http://orcid.org/0000-0001-8382-1119
Victor Adriano de Oliveira MartinsRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.ORCID http://orcid.org/0000-0002-5926-3388
Carolina Campagnoli Machado Freire MartinsRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.ORCID http://orcid.org/0000-0002-6575-1628
Giordano Bruno Henriques DevezaRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.ORCID http://orcid.org/0000-0003-4277-3821
Elaine Pires LeonRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.ORCID http://orcid.org/0000-0001-9457-3317
Cleonice BuenoRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
Tatiana Nascimento PedrosaRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.ORCID http://orcid.org/0000-0003-0009-1013
Roseli Eliana Beseggio SantosCentral Laboratory Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Renata SoaresRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.ORCID http://orcid.org/0000-0003-0155-0162
Nádia Emi AikawaRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.ORCID http://orcid.org/0000-0002-7585-4348
Eloisa BonfaRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.ORCID http://orcid.org/0000-0002-0520-4681
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BR
Funding
Conselho 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 2015/03756-4Fundação de Amparo à Pesquisa do Estado de São Paulo 2017/14352-7Fundação de Amparo à Pesquisa do Estado de São Paulo 2018/09937-9Fundação de Amparo à Pesquisa do Estado de São Paulo 2019/17272-0Fundação de Amparo à Pesquisa do Estado de São Paulo 2020/09367-8Fundação de Amparo à Pesquisa do Estado de São Paulo 2020/11677-5Fundação de Amparo à Pesquisa do Estado de São Paulo 2021/08455-3
6 · The paper itself
Abstract
introductionThere is no study specifically focused on SARS-CoV-2 vaccine in primary Sjögren's syndrome (pSS).
objectivesTo assess the immunogenicity, safety, possible effects on disease activity, and autoantibody profile of the Sinovac-CoronaVac vaccine in pSS.
methodsFifty-one pSS patients and 102 sex- and age-balanced controls without autoimmune diseases were included in a prospective phase 4 trial of the Sinovac-CoronaVac vaccine (two doses 28 days apart, D0/D28). Participants were assessed in three face-to-face visits (D0/D28 and six weeks after the 2nd dose (D69)) regarding adverse effects; clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI); anti-SARS-CoV-2 S1/S2 IgG (seroconversion (SC) and geometric mean titers (GMT)); neutralizing antibodies (NAb); and pSS autoantibody profile.
resultsPatients and controls had comparable female sex frequency (98.0% vs. 98.0%, p = 1.000) and mean age (53.5 ± 11.7 vs. 53.4 ± 11.4 years, p = 0.924), respectively. On D69, pSS patients presented moderate SC (67.5% vs. 93.0%, p < 0.001) and GMT (22.5 (95% CI 14.6-34.5) vs. 59.6 (95% CI 51.1-69.4) AU/mL, p < 0.001) of anti-SARS-CoV-2 S1/S2 IgG but lower than controls, and also, moderate NAb frequency (52.5% vs. 73.3%, p = 0.021) but lower than controls. Median neutralizing activity on D69 was comparable in pSS (58.6% (IQR 43.7-63.6)) and controls (64% (IQR 46.4-81.1)) (p = 0.219). Adverse events were mild. clinESSDAI and anti-Ro(SS-A)/anti-La(SS-B) levels were stable throughout the study (p > 0.05).
conclusionSinovac-CoronaVac vaccine is safe in pSS, without a deleterious impact on disease activity, and has a moderate short-term humoral response, though lower than controls. Thus, a booster dose needs to be studied in these patients.
trial registrationClinicalTrials.gov Identifier: NCT04754698. Key Points • Sinovac-CoronaVac vaccine is safe in pSS, without a detrimental effect on systemic disease activity, and has a moderate short-term humoral response • A booster dose should be considered in these patients.
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.
Inactivated SARS-CoV-2 vaccine in primary Sjögren's syndrome: humoral response, safety, and effects on disease activity. · full record | OpenQuestion