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

Brazil 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. This study aimed to evaluate, prospectively for the first time, the short-term immunogenicity of the fractional YF...

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Published in:PLoS neglected tropical diseases Vol. 15; no. 11; p. e0010002
Main Authors: Tonacio, Adriana Coracini, do Nascimento Pedrosa, Tatiana, Borba, Eduardo Ferreira, Aikawa, Nadia Emi, Pasoto, Sandra Gofinet, Filho, Júlio Cesar Rente Ferreira, Sampaio Barros, Marília Mantovani, Leon, Elaine Pires, Lombardi, Suzete Cleusa Ferreira Spina, Junior, Alfredo Mendrone, Azevedo, Adriana de Souza, Schwarcz, Waleska Dias, Fuller, Ricardo, Yuki, Emily Figueiredo Neves, Ugolini Lopes, Michelle Remião, Rodrigues Pereira, Rosa Maria, Sampaio Barros, Percival Degrava, de Andrade, Danieli Castro Oliveira, de Medeiros-Ribeiro, Ana Cristina, de Moraes, Julio Cesar Bertacini, Shinjo, Samuel Katsuyuki, Miossi, Renata, da Silva Duarte, Alberto José, Lopes, Marta Heloisa, Kallás, Esper Georges, Almeida da Silva, Clovis Artur, Bonfá, Eloisa
Format: Journal Article
Language:English
Published: United States Public Library of Science 01-11-2021
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Summary:Brazil 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. This 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. A 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). Fractional-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. This clinical trial was registered with Clinicaltrials.gov (#NCT03430388).
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The authors have declared that no competing interests exist.
ISSN:1935-2735
1935-2727
1935-2735
DOI:10.1371/journal.pntd.0010002