Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

Imagem de Miniatura
Arquivos
art_LOPEZ-FAUQUED_Safety_profile_of_the_adjuvanted_recombinant_zoster_vaccine_2019.PDF (484.57 KB)
Citações na Scopus
33
Tipo de produção
article
Data de publicação
2019
DOI
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
ELSEVIER SCI LTD
Autores
LOPEZ-FAUQUED, Marta
CAMPORA, Laura
DELANNOIS, Frederique
IDRISSI, Mohamed El
OOSTVOGELS, Lidia
LOOZE, Ferdinandus J. De
DIEZ-DOMINGO, Javier
HEINEMAN, Thomas C.
LAL, Himal
MCELHANEY, Janet E.
Citação
VACCINE, v.37, n.18, p.2482-2493, 2019
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was >= 90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Methods: Adults aged >= 50 (ZOE-50) and >= 70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Results: Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. Conclusions: No safety concerns arose, supporting the favorable benefit-risk profile of RZV. (C) 2019 GlaxoSmithKline Biologicals SA.
Palavras-chave
Varicella-zoster virus, Vaccine, Safety, Reactogenicity
URI
https://observatorio.fm.usp.br/handle/OPI/32563
Referências
  1. Agmon-Levin N, 2009, ISR MED ASSOC J, V11, P183
  2. Angelo MG, 2014, PHARMACOEPIDEM DR S, V23, P466, DOI 10.1002/pds.3554
  3. Biswal S, 2013, ECANCERMEDICALSCIENC, V7, DOI 10.3332/ecancer.2013.310
  4. CDC, LEAD CAUS DEATH MAL
  5. Chlibek R, 2014, VACCINE, V32, P1745, DOI 10.1016/j.vaccine.2014.01.019
  6. Chlibek R, 2013, J INFECT DIS, V208, P1953, DOI 10.1093/infdis/jit365
  7. Cohen JI, 2013, NEW ENGL J MED, V369, P255, DOI 10.1056/NEJMcp1302674
  8. Crowson CS, 2011, ARTHRITIS RHEUM-US, V63, P633, DOI 10.1002/art.30155
  9. Cunningham AL, 2016, NEW ENGL J MED, V375, P1019, DOI 10.1056/NEJMoa1603800
  10. Da Silva FT, 2013, VACCINE, V31, P1870, DOI 10.1016/j.vaccine.2013.01.042
  11. Diamantopoulos AP, 2014, RHEUMATOLOGY, V53, P15
  12. Didierlaurent AM, 2014, J IMMUNOL, V193, P1920, DOI 10.4049/jimmunol.1400948
  13. Gencer S, 2003, J INFECTION, V47, P65, DOI 10.1016/S0163-4453(03)00044-6
  14. ICH, CLIN SAF DAT MAN DEF
  15. Israeli E, 2009, LUPUS, V18, P1217, DOI 10.1177/0961203309345724
  16. Johnson BH, 2015, BMC INFECT DIS, V15, DOI 10.1186/s12879-015-1262-8
  17. Kawai K, 2014, BMJ OPEN, V4, DOI 10.1136/bmjopen-2014-004833
  18. Lal H, 2015, NEW ENGL J MED, V372, P2087, DOI 10.1056/NEJMoa1501184
  19. Leroux-Roels I, 2012, J INFECT DIS, V206, P1280, DOI 10.1093/infdis/jis497
  20. Perola O, 2005, EUR J CLIN MICROBIOL, V24, P766, DOI 10.1007/s10096-005-0045-3
  21. Prince MJ, 2015, LANCET, V385, P549, DOI 10.1016/S0140-6736(14)61347-7
  22. Rasch EK, 2003, ARTHRITIS RHEUM, V48, P917, DOI 10.1002/art.10897
  23. Salemi S, 2010, INT REV IMMUNOL, V29, P247, DOI 10.3109/08830181003746304
  24. Shoenfeld Y, 2011, J AUTOIMMUN, V36, P4, DOI 10.1016/j.jaut.2010.07.003
  25. Stadtmauer EA, 2014, BLOOD, V124, P2921, DOI 10.1182/blood-2014-04-573048
  26. Vanderpump MPJ, 2011, BRIT MED BULL, V99, P39, DOI 10.1093/bmb/ldr030
  27. Wraith DC, 2003, LANCET, V362, P1659, DOI 10.1016/S0140-6736(03)14802-7
  28. 2015, DEMOGRAPHY, V52, P593, DOI 10.1007/S13524-015-0372-7

Coleções
Artigos e Materiais de Revistas Científicas - HC/ICHC
Artigos e Materiais de Revistas Científicas - LIM/66
Artigos e Materiais de Revistas Científicas - ODS/03