1,304
Views
2
CrossRef citations to date
0
Altmetric
Coronavirus – Research Paper

Safety and immunogenicity of inactivated COVID-19 vaccination in adult rheumatic patients in South China: a prospective study

, , , , , , , , , , & show all
Article: 2090176 | Received 17 Mar 2022, Accepted 13 Jun 2022, Published online: 25 Jul 2022

References

  • World Health Organization. WHO coronavirus disease (COVID-19) dashboard. [ accessed 2021 Oct 16]. https://covid19.who.int/?gclid=EAIaIQobChMI2_CM6eDZ6gIVghh9Ch3nDQm1EAAYASAAEgLqwPD_BwE.
  • Li L, Guo P, Zhang X, Yu Z, Zhang W, Sun H. SARS-CoV-2 vaccine candidates in rapid development. Hum Vaccin Immunother. 2021 Mar 4;17(3):1–8. doi:10.1080/21645515.2020.1804777.
  • Akiyama S, Hamdeh S, Micic D, et al. Prevalence and clinical outcomes of COVID-19 in patients with autoimmune diseases: a systematic review and meta-analysis. Ann Rheum Dis.2020 Oct 13;80:384–391. annrheumdis-2020-218946
  • Friedman MA, Winthrop KL. Vaccines and disease-modifying antirheumatic drugs: practical implications for the rheumatologist. Rheum Dis Clin North Am. 2017;43(1):1–13. doi:10.1016/j.rdc.2016.09.003.
  • Sanchez-Piedra C, Diaz-Torne C, Manero J, Pego-Reigosa JM, Rúa-Figueroa Í, Gonzalez-Gay MA, Gomez-Reino J, Alvaro-Gracia JM. Clinical features and outcomes of COVID-19 in patients with rheumatic diseases treated with biological and synthetic targeted therapies. Ann Rheum Dis. 2020;79(7):988–990. doi:10.1136/annrheumdis-2020-217948.
  • Holvast A, Huckriede A, Wilschut J, et al. Safety and efficacy of influenza vaccination in systemic lupus erythematosus patients with quiescent disease. Ann Rheum Dis. 2006;65(7):913–918. doi:10.1136/ard.2005.043943.
  • van Aalst M, Langedijk AC, Spijker R, et al. The effect of immunosuppressive agents on immunogenicity of pneumococcal vaccination: a systematic review and meta-analysis. Vaccine. 2018 Sep 18;36(39):5832–5845. doi:10.1016/j.vaccine.2018.07.039.
  • Park JK, Lee EB, Shin K, et al. Korean college of rheumatology task force for COVID-19 vaccine guidance for patients with autoimmune inflammatory rheumatic diseases. COVID-19 vaccination in patients with autoimmune inflammatory rheumatic diseases: clinical guidance of the Korean college of rheumatology. J Korean Med Sci. 2021 Mar 29;36(12):e95. doi:10.3346/jkms.2021.36.e95.
  • Schulze-Koops H, Krüger K, Hoyer BF, Leipe J, Iking-Konert C, Specker C. Commission for pharmacotherapy and the board of directors of the German society for rheumatology. Updated recommendations of the German society for rheumatology for the care of patients with inflammatory rheumatic diseases in times of SARS-CoV-2-methodology, key messages and justifying information. Rheumatology (Oxford). 2021 May 14;60(5):2128–2133. doi:10.1093/rheumatology/keab072.
  • Curtis JR, Johnson SR, Anthony DD, Arasaratnam RJ, Baden LR, Bass AR, Calabrese C, Gravallese EM, Harpaz R, Kroger A, et al. American college of rheumatology guidance for COVID-19 vaccination in patients with rheumatic and Musculoskeletal diseases: version 3. Arthritis Rheumatol. 2021;73(10):e60–e75. doi:10.1002/art.41928.
  • Medeiros-Ribeiro AC, Aikawa NE, Saad CGS, Yuki EFN, Pedrosa T, Fusco SRG, Rojo PT, Pereira RMR, Shinjo SK, Andrade DCO, et al. Immunogenicity and safety of the Corona Vac inactivated vaccine in patients with autoimmune rheumatic diseases: a phase 4 trial. Nat Med. 2021;27(10):1744–1751. doi:10.1038/s41591-021-01469-5.
  • Seyahi E, Bakhdiyarli G, Oztas M, Kuskucu MA, Tok Y, Sut N, Ozcifci G, Ozcaglayan A, Balkan II, Saltoglu N, et al. Antibody response to inactivated COVID-19 vaccine (CoronaVac) in immune-mediated diseases: a controlled study among hospital workers and elderly. Rheumatol Int. 2021;41(8):1429–1440. doi:10.1007/s00296-021-04910-7.
  • Stowe RP, Peek MK, Cutchin MP, Goodwin JS. Plasma cytokine levels in a population-based study: relation to age and ethnicity. J Gerontol a Biol Sci Med Sci. 2010;65(4):429–433. doi:10.1093/gerona/glp198.
  • Moyon Q, Sterlin D, Miyara M, Anna F, Mathian A, Lhote R, Ghillani-Dalbin P, Breillat P, Mudumba S, de Alba S, et al. Bnt162b2 vaccine-induced humoral and cellular responses against SARS-CoV-2 variants in systemic lupus erythematosus. Ann Rheum Dis. 2021 Oct 4;81(4):575–583: annrheumdis-2021-221097. doi:10.1136/annrheumdis-2021-221097.
  • Ruddy JA, Connolly CM, Boyarsky BJ, Werbel WA, Christopher-Stine L, Garonzik-Wang J, Segev DL, Paik JJ. High antibody response to two-dose SARS-CoV-2 messenger RNA vaccination in patients with rheumatic and musculoskeletal diseases. Ann Rheum Dis. 2021;80(10):1351–1352. doi:10.1136/annrheumdis-2021-220656.
  • Haberman RH, Herati R, Simon D, Samanovic M, Blank RB, Tuen M, Koralov SB, Atreya R, Tascilar K, Allen JR, et al. Methotrexate hampers immunogenicity to BNT162b2 mRNA COVID-19 vaccine in immune-mediated inflammatory disease. Ann Rheum Dis. 2021;80(10):1339–1344. doi:10.1136/annrheumdis-2021-220597. Epub 2021 May 25. PMID: 34035003; PMCID: PMC8219484
  • Hua C, Barnetche T, Combe B, Morel J. Effect of methotrexate, anti-tumor necrosis factor α, and rituximab on the immune response to influenza and pneumococcal vaccines in patients with rheumatoid arthritis: a systematic review and meta-analysis. Arthritis Care Res (Hoboken). 2014;66(7):1016–1026. doi:10.1002/acr.22246. PMID: 24339395.
  • Chan ES, Cronstein BN. Methotrexate—how does it really work? Nat Rev Rheumatol. 2010;6(3):175–178. doi:10.1038/nrrheum.2010.5. PMID: 20197777.
  • Burns CM. The history of cortisone discovery and development. Rheum Dis Clin North Am. 2016;42(1):1–14, vii. doi:10.1016/j.rdc.2015.08.001. PMID: 26611547.
  • Schrezenmeier E, Dörner T. Mechanisms of action of hydroxychloroquine and chloroquine: implications for rheumatology. Nat Rev Rheumatol. 2020;16(3):155–166. doi:10.1038/s41584-020-0372-x. Epub 2020 Feb 7. PMID: 32034323.
  • Mohammadi O, Ta K. Azathioprine. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing ; 2022. https://www.ncbi.nlm.nih.gov/books/NBK542190/. 2022 Jan. PMID: 31194347
  • Prakash A, Jarvis B. Leflunomide: a review of its use in active rheumatoid arthritis. Drugs. 1999;58(6):1137–1164. doi:10.2165/00003495-199958060-00010. PMID: 10651393.
  • Mucke HA. Iguratimod: a new disease-modifying antirheumatic drug. Drugs Today (Barc). 2012;48(9):577–586. doi:10.1358/dot.2012.48.9.1855758. PMID: 23032798.
  • Prasad N, Manjunath R, Rangaswamy D, Jaiswal A, Agarwal V, Bhadauria D, Kaul A, Sharma R, Gupta A. Efficacy and safety of cyclosporine versus tacrolimus in steroid and cyclophosphamide resistant nephrotic syndrome: a prospective study. Indian J Nephrol. 2018;28(1):46–52. doi:10.4103/ijn.IJN_240_16. PMID: 29515301; PMCID: PMC5830809.
  • Gadina M, Le MT, Schwartz DM, Silvennoinen O, Nakayamada S, Yamaoka K, O’-Shea JJ. Janus kinases to jakinibs: from basic insights to clinical practice. Rheumatology (Oxford). 2019 Feb 1;58(Suppl 1):i4–i16. doi:10.1093/rheumatology/key432; PMID: 30806710; PMCID: PMC6657570
  • Gerriets V, Goyal A, Khaddour K. Tumor necrosis factor inhibitors. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Apr 30. https://www.ncbi.nlm.nih.gov/books/NBK482425/. 2022 Jan. PMID: 29494032
  • Fobelo Lozano MJ, Serrano Giménez R, Castro Fernández M. Emergence of inflammatory bowel disease during treatment with secukinumab. J Crohns Colitis. 2018 Aug 29;12(9):1131–1133. doi:10.1093/ecco-jcc/jjy063; PMID: 29746636
  • Jordan N, D’-Cruz DP. Belimumab for the treatment of systemic lupus erythematosus. Expert Rev Clin Immunol. 2015;11(2):195–204. doi:10.1586/1744666X.2015.996550. Epub 2014 Dec 29. PMID: 25543845.
  • Furer V, Rondaan C, Heijstek MW, Agmon-Levin N, van Assen S, Bijl M, Breedveld FC, D’Amelio R, Dougados M, Kapetanovic MC, et al. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2020;79(1):39–52. doi:10.1136/annrheumdis-2019-215882.
  • Ramasamy MN, Jessop LJ. CoronaVac: more data for regulators and policy makers. Lancet. 2021 Jul 17;398(10296):186–188. doi:10.1016/S0140-6736(21)01543-9.
  • Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, Han W, Chen Z, Tang R, Yin W, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021;21(2):181–192. doi:10.1016/S1473-3099(20)30843-4.
  • R A, Wang H, Wang W, Tan W. Summary of the detection kits for SARS-CoV-2 approved by the national medical products administration of China and their application for diagnosis of COVID-19. Virol Sin. 2020;35(6):699–712. doi:10.1007/s12250-020-00331-1. Epub 2020 Dec 22. PMID: 33351166; PMCID: PMC7754703.
  • Nand IS, Fisher LD, Chiang Y-T, Latini R, Masson S, Maggioni AP, Glazer RD, Tognoni G, Cohn JN. Changes in brain natriuretic peptide and norepinephrine over time and mortality and morbidity in the Valsartan Heart Failure Trial (Val-HeFT). Circulation. 2003;107(9):1278–1283. doi:10.1161/01.CIR.0000054164.99881.00.
  • Von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology(STROBE) statement: guidelines for reporting observational studies. The The Lancet. 2007;370(9596):1453–1457. doi:10.1016/S0140-6736(07)61602-X.
  • WHO Coronavirus (COVID-19) Dashboard with vaccination data. WHO; 2021. https://covid19.who.int.
  • Kumar S, Çalışkan DM, Janowski J, Faist A, Conrad BCG, Lange J, Ludwig S, Brunotte L. Beyond vaccines: clinical status of prospective COVID-19 therapeutics. Front Immunol. 2021 Oct 1;12:752227. doi:10.3389/fimmu.2021.752227.
  • Bueno SM, Abarca K, González PA, Gálvez NMS, Soto JA, Duarte LF, Schultz BM, Pacheco GA, González LA, Vázquez Y, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in a subgroup of healthy adults in Chile. Clin Infect Dis. 2021 Sep 19: ciab823. doi:10.1093/cid/ciab823.
  • Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF, Tan W, Wu G, Xu M, Lou Z, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infect Dis. 2021;21(1):39–51. doi:10.1016/S1473-3099(20)30831-8.
  • Furer V, Eviatar T, Zisman D, Peleg H, Paran D, Levartovsky D, Zisapel M, Elalouf O, Kaufman I, Meidan R, et al. Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study. Ann Rheum Dis.2021;80(10):1330–1338. doi:10.1136/annrheumdis-2021-220647.
  • Boyarsky BJ, Ruddy JA, Connolly CM, Ou MT, Werbel WA, Garonzik-Wang JM, Segev DL, Paik JJ. Antibody response to a single dose of SARS-CoV-2 mRNA vaccine in patients with rheumatic and musculoskeletal diseases. Ann Rheum Dis. 2021 Mar 23;80(8):1098–1099: annrheumdis-2021-220289. doi:10.1136/annrheumdis-2021-220289.
  • Zhao T, Shen J, Zhu Y, Tian X, Wen G, Wei Y, Xu B, Fu C, Xie Z, Xi Y, et al. Immunogenicity of inactivated SARS-CoV-2 vaccines in patients with rheumatoid arthritis: a case series. Front Public Health. 2022 Apr 25;10:875558. doi:10.3389/fpubh.2022.875558. PMID: 35548080; PMCID: PMC9081335
  • Li X, Tong X, Yeung WWY, Kuan P, Yum SHH, Chui CSL, Lai FTT, Wan EYF, Wong CKH, Chan EWY, et al. Two-Dose COVID-19 vaccination and possible arthritis flare among patients with rheumatoid arthritis in Hong Kong. Ann Rheum Dis. 2022;81(4):564–568. doi:10.1136/annrheumdis-2021-221571. Epub 2021 Oct 22. PMID: 34686479; PMCID: PMC8550868
  • Boekel L, Steenhuis M, Hooijberg F, et al. Antibody development after COVID-19 vaccination in patients with autoimmune diseases in the Netherlands: a substudy of data from two prospective cohort studies. Lancet Rheumatol 2021 Aug 6; 3(11): 778–788. doi:10.1016/S2665-9913(21)00222-8.
  • Lee H, Kong SY, Sohn JY, et al. Elevated red blood cell distribution width as a simple prognostic factor in patients with symptomatic multiple myeloma. Biomed Res Int. 2014;2014:145619. doi:10.1155/2014/145619.
  • Wang H, Wang J, Huang R, Xia J, Zuo L, Yan X, Yang Y, Wu C. Red blood cell distribution width for predicting significant liver inflammation in patients with autoimmune hepatitis. Eur J Gastroenterol Hepatol. 2019;31(12):1527–1532. doi:10.1097/MEG.0000000000001447.
  • Balandya E, Reynolds T, Obaro S, Makani J. Alteration of lymphocyte phenotype and function in sickle cell anemia: implications for vaccine responses. Am J Hematol. 2016;91(9):938–946. doi:10.1002/ajh.24438.
  • Frasca D, Blomberg BB. Aging induces B cell defects and decreased antibody responses to influenza infection and vaccination. Immun Ageing. 2020 Nov 19;17(1):37. doi:10.1186/s12979-020-00210-z.
  • Deepak P, Kim W, Paley MA, et al. Effect of Immunosuppression on the immunogenicity of mRNA vaccines to SARS-CoV-2 : a prospective cohort study Ann Intern Med2021 Aug 31;174 (11):1572–1585. doi:10.7326/M21-1757.
  • Haberman RH, Herati RS, Simon D, et al. Methotrexate hampers immunogenicity to BNT162b2 mRNA COVID-19 vaccine in immune-mediated inflammatory disease. Ann Rheum Dis. 2021;80(10): 1339–1344. doi:10.1136/annrheumdis-2021-220597.
  • Aikawa NE, Campos LM, Silva CA, Carvalho JF, Saad CGS, Trudes G, Duarte A, Miraglia JL, Timenetsky MDCS, Viana VST, et al. Glucocorticoid: major factor for reduced immunogenicity of 2009 influenza a (H1N1) vaccine in patients with juvenile autoimmune rheumatic disease. J Rheumatol. 2012;39(1):167–173. doi:10.3899/jrheum.110721.
  • Bugatti S, De Stefano L, Balduzzi S, Greco MI, Luvaro T, Cassaniti I, Bogliolo L, Mazzucchelli I, D’-Onofrio B, di Lernia M, et al. Methotrexate and glucocorticoids, but not anticytokine therapy, impair the immunogenicity of a single dose of the BNT162b2 mRNA COVID-19 vaccine in patients with chronic inflammatory arthritis. Ann Rheum Dis. 2021;80(12):1635–1638. doi:10.1136/annrheumdis-2021-220862.
  • Sakuraba A, Luna A, Micic D. Serologic response to coronavirus disease 2019 (COVID-19) vaccination in patients with immune-mediated inflammatory diseases: a systematic review and meta-analysis. Gastroenterology. 2021 Sep 29;162(1): 88–108. doi:10.1053/j.gastro.2021.09.055.
  • Nozaki YI. Novel molecular insights and a new csDMARD for rheumatoid arthritis, from Japan to the world. Life (Basel). 2021 May 20;11(5):457.
  • Oliver SE, Gargano JW, Scobie H, Wallace M, Hadler SC, Leung J, Blain AE, McClung N, Campos-Outcalt D, Morgan RL, et al. The advisory committee on immunization practices’ interim recommendation for use of Janssen COVID-19 vaccine — United States, February 2021. MMWR Morb Mortal Wkly Rep. 2021 Mar 5;70(9):329–332. doi:10.15585/mmwr.mm7009e4.
  • Damasceno DHP, Amaral AA, Silva CA, Simões E, Silva AC. The impact of vaccination worldwide on SARS-CoV-2 infection: A review on vaccine mechanisms, results of clinical trials, vaccinal coverage and interactions with novel variants. Curr Med Chem. 2022 Sep 1; 29(15):2673–2690. doi:10.2174/0929867328666210902094254.
  • Shibata K, Tanaka H, Otani A, Kubo M, Hasegawa A, Amano I. Development of thrombocytopenic purpura following BNT162b2 mRNA COVID-19 vaccination. Rinsho Ketsueki. 2021;62(10):1519–1521. doi:10.11406/rinketsu.62.1519.
  • Bozkurt B, Kamat I, Hotez PJ. Myocarditis with COVID-19 mRNA vaccines. Circulation. 2021 Aug 10;144(6):471–484. doi:10.1161/CIRCULATIONAHA.121.056135.
  • Li X, Ostropolets A, Makadia R, et al. Characterizing the incidence of adverse events of special interest for COVID-19 vaccines across eight countries: a multinational network cohort study. medRxiv[Preprint]. 2021 Apr 17:03.25.21254315. doi:10.1101/2021.03.25.21254315.
  • Chiang TP, Connolly CM, Ruddy JA, Boyarsky BJ, Alejo JL, Werbel WA, Massie A, Christopher-Stine L, Garonzik-Wang J, Segev DL, et al. Antibody response to the Janssen/Johnson & Johnson SARS-CoV-2 vaccine in patients with rheumatic and musculoskeletal diseases. Ann Rheum Dis. 2021;80(10):1365–1366. doi:10.1136/annrheumdis-2021-221145.
  • Li D, Sempowski GD, Saunders KO, Acharya P, Haynes BF. SARS-CoV-2 neutralizing antibodies for COVID-19 prevention and treatment. Annu Rev Med. 2022 Jan 27;73(1):1–16. doi:10.1146/annurev-med-042420-113838. Epub 2021 Aug 24. PMID: 34428080