Evaluation of Influenza A/H3N2 Vaccine in Patients With Rheumatologic Diseases

Summary

Studies in the literature have shown reduced effectiveness of influenza A (H3N2) virus vaccine (20-40%) when compared to A (H1N1) and influenza B. This reduction in efficacy may partly result of the need to propagate A (H3N2) virus into egg components for the preparation of the vaccine. Other factors that may also contribute to the reduction of efficacy against A (H3N2) viruses include the high level of genetic diversity and the rate of rapid evolution of this particular virus subtype and the modification of the immune response to the vaccine secondary of prior infection or vaccination. Vaccine efficacy studies are required to verify the immunogenicity of the H3N2 influenza vaccine in immunosuppressed patients with rheumatologic disease. In addition, it is relevant to evaluate the safety of the vaccine in this population as well as the possibility of reactivation of the rheumatologic disease itself. The objectives of this study are to evaluate the immunogenicity of the H3N2 component of the inactivated and fragmented influenza vaccine in patients with two systemic autoimmune rheumatic diseases (Systemic Lupus Erythematosus - Adult and Juvenile, Primary Sjögren's Syndrome).

Timeline

Start

2018-04-23

Primary completion

2018-06-23

Completion

2018-08-23

Publications

• Background Silva CA, Aikawa NE, Bonfa E. Vaccinations in juvenile chronic inflammatory diseases: an update. Nat Rev Rheumatol. 2013 Sep;9(9):532-43. doi: 10.1038/nrrheum.2013.95. Epub 2013 Jul 2.
• Background Pasoto SG, Ribeiro AC, Bonfa E. Update on infections and vaccinations in systemic lupus erythematosus and Sjogren's syndrome. Curr Opin Rheumatol. 2014 Sep;26(5):528-37. doi: 10.1097/BOR.0000000000000084.
• Background Kuruma KA, Borba EF, Lopes MH, de Carvalho JF, Bonfa E. Safety and efficacy of hepatitis B vaccine in systemic lupus erythematosus. Lupus. 2007;16(5):350-4. doi: 10.1177/0961203307078225.
• Background Aikawa NE, Franca IL, Ribeiro AC, Sallum AM, Bonfa E, Silva CA. Short and long-term immunogenicity and safety following the 23-valent polysaccharide pneumococcal vaccine in juvenile idiopathic arthritis patients under conventional DMARDs with or without anti-TNF therapy. Vaccine. 2015 Jan 29;33(5):604-9. doi: 10.1016/j.vaccine.2014.12.030. Epub 2014 Dec 29.
• Background Saad CG, Borba EF, Aikawa NE, Silva CA, Pereira RM, Calich AL, Moraes JC, Ribeiro AC, Viana VS, Pasoto SG, Carvalho JF, Franca IL, Guedes LK, Shinjo SK, Sampaio-Barros PD, Caleiro MT, Goncalves CR, Fuller R, Levy-Neto M, Timenetsky Mdo C, Precioso AR, Bonfa E. Immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1 vaccine in a large cohort of autoimmune rheumatic diseases. Ann Rheum Dis. 2011 Jun;70(6):1068-73. doi: 10.1136/ard.2011.150250.
• Background Aikawa NE, Campos LM, Silva CA, Carvalho JF, Saad CG, Trudes G, Duarte A, Miraglia JL, Timenetsky Mdo C, Viana VS, Franca IL, Bonfa E, Pereira RM. Glucocorticoid: major factor for reduced immunogenicity of 2009 influenza A (H1N1) vaccine in patients with juvenile autoimmune rheumatic disease. J Rheumatol. 2012 Jan;39(1):167-73. doi: 10.3899/jrheum.110721. Epub 2011 Nov 15.
• Background Borba EF, Saad CG, Pasoto SG, Calich AL, Aikawa NE, Ribeiro AC, Moraes JC, Leon EP, Costa LP, Guedes LK, Silva CA, Goncalves CR, Fuller R, Oliveira SA, Ishida MA, Precioso AR, Bonfa E. Influenza A/H1N1 vaccination of patients with SLE: can antimalarial drugs restore diminished response under immunosuppressive therapy? Rheumatology (Oxford). 2012 Jun;51(6):1061-9. doi: 10.1093/rheumatology/ker427. Epub 2012 Jan 31.
• Results Korsun N, Angelova S, Trifonova I, Tzotcheva I, Mileva S, Voleva S, Georgieva I, Perenovska P. Predominance of influenza A(H3N2) viruses during the 2016/2017 season in Bulgaria. J Med Microbiol. 2018 Feb;67(2):228-239. doi: 10.1099/jmm.0.000668. Epub 2018 Jan 3.
• Results Chiu SS, Kwan MYW, Feng S, Wong JSC, Leung CW, Chan ELY, Chan KH, Ng TK, To WK, Cowling BJ, Peiris JSM. Influenza Vaccine Effectiveness Against Influenza A(H3N2) Hospitalizations in Children in Hong Kong in a Prolonged Season, 2016/2017. J Infect Dis. 2018 Apr 11;217(9):1365-1371. doi: 10.1093/infdis/jiy027.
• Results Skowronski DM, Chambers C, De Serres G, Dickinson JA, Winter AL, Hickman R, Chan T, Jassem AN, Drews SJ, Charest H, Gubbay JB, Bastien N, Li Y, Krajden M. Early season co-circulation of influenza A(H3N2) and B(Yamagata): interim estimates of 2017/18 vaccine effectiveness, Canada, January 2018. Euro Surveill. 2018 Feb;23(5):18-00035. doi: 10.2807/1560-7917.ES.2018.23.5.18-00035.
• Aikawa NE, Borba EF, Balbi VA, Sallum AME, Buscatti IM, Campos LMA, Kozu KT, Garcia CC, Capao ASV, de Proenca ACT, Leon EP, da Silva Duarte AJ, Lopes MH, Silva CA, Bonfa E. Safety and immunogenicity of influenza A(H3N2) component vaccine in juvenile systemic lupus erythematosus. Adv Rheumatol. 2023 Nov 28;63(1):55. doi: 10.1186/s42358-023-00339-7.
• Claudino Formiga FF, Silva CA, Pedrosa TDN, Aikawa NE, Pasoto SG, Garcia CC, Capao ASV, Martins VAO, Proenca ACT, Fuller R, Yuki EFN, Vendramini MBG, Rosario DCD, Brandao LMKR, Sartori AMC, Antonangelo L, Bonfa E, Borba EF. Influenza A/Singapore (H3N2) component vaccine in systemic lupus erythematosus: A distinct pattern of immunogenicity. Lupus. 2021 Oct;30(12):1915-1922. doi: 10.1177/09612033211040371. Epub 2021 Aug 28.

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