Pharma Focus Asia

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, Adriana de Souza Azevedo, Waleska Dias Schwarcz, Ricardo Fuller, Eloisa Bonfá

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

Yellow fever(YF) is an infectious disease caused by a Flavivirus (Flaviviridae family) [1]. Severe cases may evolve to bleeding disorders and acute liver failure, and 47–80% of them die [2]. No antiviral is available, leaving immunization as the most effective approach to deal with this disease.
Brazil faced a YF outbreak from December 2016 to June 2017, with 777 confirmed cases and 261 deaths, followed by a second wave from July 2017 to June 2018 with 1,376 cases of YF and 483 deaths.

Materials and methods
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.

Study design
This was a prospective study conducted at a single tertiary referral site in Sao Paulo, Brazil, between January 2018 and April 2018. ARD patients who are regularly followed at the Rheumatology Division’s Outpatient Clinic (Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo) living in São Paulo city were invited to participate during the Public Health YFV campaign at the institution’s Immunization Center

This is the first prospective study designed to evaluate the immunogenicity of a fractional-dose 17DD-YFV in inactive ARD patients under low immunosuppression.

Acknowledgments: We are grateful to all study participants for their kind cooperation. We thank the Centro de Atenção ao Coloborador (CEAC) do HCFMUSP group for their support to perform this project and Dr. Hermes Ryoiti Higashino for clinical support.

Citation: Tonacio AC, do Nascimento Pedrosa T, Borba EF, Aikawa NE, Pasoto SG, Filho JCRF, et al. (2021) Immunogenicity and safety of primary fractional-dose yellow fever vaccine in autoimmune rheumatic diseases. PLoS Negl Trop Dis 15(11): e0010002.

Editor: Ran Wang, Beijing Children’s Hospital, Capital Medical University, CHINA.

Received: May 23, 2021; Accepted: November 16, 2021; Published: November 29, 2021.

Copyright: © 2021 Tonacio et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: All relevant data are within the manuscript and its Supporting Information files.

Funding: This study was supported by grants from Fundação de Amparo a Pesquisa do Estado de São Paulo - FAPESP, (FAPESP #2015/03756-4 to NEA, CAAS and to EFB, #2010/10749- 0 to EB, #2017/14352-7 to TNP, #2017/11516-9 to JCRFF and #2018/16162-3 to EFB) and National Council for Scientific and Technological Development - CNPq - http://www.cnpq. br - (CNPq #306879/2018-2 to EFB, #300248/2008-3 to CAAS, #300559/2009-7 to RMRP, #301411/2009-3 to EFB, #303422/2015-7 to CAAS and to EFB). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

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