Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials
Por:
Lopez-Fauqued, M, Campora, L, Delannois, F, El Idrissi, M, Oostvogels, L, De Looze, FJ, Diez-Domingo, J, Heineman, TC, Lal, H, McElhaney, JE, McNeil, SA, Yeo, W, Tavares-Da-Silva, F, Ahonen, A, Avelino-Silva, TJ, Barba-Gomez, JF, Berglund, J, Cuixart, CB, Caso, C, Chlibek, R, Choi, WS, Cunningham, AL, Desole, MG, Eizenberg, P, Esen, M, Espie, E, Gervais, P, Ghesquiere, W, Godeaux, O, Gorfinkel, I, Hui, DSC, Hwang, SJ, Korhonen, T, Kovac, M, Ledent, E, Leung, E, Levin, MJ, Perez, SN, Neto, JL, Pauksens, K, Poder, A, de la Pinta, MLR, Rombo, L, Schwarz, TF, Smetana, J, Staniscia, T, Tinoco, JC, Toma, A, Vastiau, I, Vesikari, T, Volpi, A, Watanabe, D, Weckx, LY, Zahaf, T
Publicada:
24 abr 2019
Resumen:
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. Published by Elsevier Ltd.
Filiaciones:
Lopez-Fauqued, M:
GSK, Ave Fleming 20, B-1300 Wavre, Belgium
Campora, L:
GSK, Ave Fleming 20, B-1300 Wavre, Belgium
Delannois, F:
GSK, Ave Fleming 20, B-1300 Wavre, Belgium
El Idrissi, M:
GSK, Rixensart, Belgium
Oostvogels, L:
GSK, Ave Fleming 20, B-1300 Wavre, Belgium
CureVac AG, Tubingen, Germany
De Looze, FJ:
Univ Queensland, Sch Med, Brisbane, Qld, Australia
AusTrials Pty Ltd, Sherwood, Qld, Australia
Diez-Domingo, J:
Fdn Fomento Invest Sanitaria & Biomed, Vaccine Res Unit, Valencia, Spain
Heineman, TC:
Halozyme Therapeut, San Diego, CA USA
GSK, King Of Prussia, PA USA
Lal, H:
GSK, King Of Prussia, PA USA
Pfizer Vaccine Inc, Collegeville, PA USA
McElhaney, JE:
Hlth Sci North Res Inst, Sudbury, ON, Canada
McNeil, SA:
Dalhousie Univ, IWK Hlth Ctr, Halifax, NS, Canada
Dalhousie Univ, Nova Scotia Hlth Author, Halifax, NS, Canada
Dalhousie Univ, Canadian Ctr Vaccinol, Halifax, NS, Canada
Yeo, W:
Univ Wollongong, Sch Med, Wollongong, NSW, Australia
Tavares-Da-Silva, F:
GSK, Ave Fleming 20, B-1300 Wavre, Belgium
Ahonen, A:
Univ Tampere, Jarvenpaa Vaccine Clin, Tampere, Finland
Avelino-Silva, TJ:
Univ Sao Paulo, Sch Med, Sao Paulo, Brazil
Barba-Gomez, JF:
Inst Dermatol Jalisco, Guadalajara, Jalisco, Mexico
Berglund, J:
Blekinge Inst Technol, Karlskrona, Sweden
Cuixart, CB:
EAP Sardenya, Barcelona, Spain
Caso, C:
Hosp Clin San Carlos, Madrid, Spain
Chlibek, R:
Univ Def, Fac Mil Hlth Sci, Brno, Czech Republic
Choi, WS:
Korea Univ, Coll Med, Seoul, South Korea
Cunningham, AL:
Univ Sydney, Westmead Inst Med Res, Sydney, NSW, Australia
Desole, MG:
Serv Igiene Pubbl, Sassari, Italy
Eizenberg, P:
Doctors Ivanhoe, Ivanhoe, Australia
Esen, M:
Univ Clin Tubingen, Inst Tropenmed, Tubingen, Germany
Espie, E:
GSK, Brussels, Belgium
Gervais, P:
Q&T Res Sherbrooke, Sherbrooke, PQ, Canada
Ghesquiere, W:
Univ British Columbia, Vancouver, BC, Canada
Godeaux, O:
GSK, Brussels, Belgium
Gorfinkel, I:
York Univ, N York, ON, Canada
Hui, DSC:
Prince Wales Hosp, Hong Kong, Peoples R China
Hwang, SJ:
Taipei Vet Gen Hosp, Taipei, Taiwan
Natl Yang Ming Univ, Sch Med, Taipei, Taiwan
Korhonen, T:
Univ Tampere, Sch Med, Vaccine Res Ctr, Tampere, Finland
Kovac, M:
GSK, New York, NY USA
Ledent, E:
GSK, Rixensart, Belgium
Leung, E:
Hong Kong Assoc Gerontol, Hong Kong, Peoples R China
Levin, MJ:
Univ Colorado, Anschutz Med Campus, Aurora, CO USA
Perez, SN:
CAP Centelles, Centelles, Spain
Neto, JL:
Inst AZ Pesquisa & Ensino, Curitiba, Parana, Brazil
Pauksens, K:
Uppsala Univ Hosp, Uppsala, Sweden
Poder, A:
Kliiniliste Uuringute Keskus, Tartu, Estonia
de la Pinta, MLR:
Hosp Puerta de Hierro, Madrid, Spain
Rombo, L:
Uppsala Univ, Uppsala, Sweden
Schwarz, TF:
Standort Juliusspital, Wurzburg, Germany
Smetana, J:
Univ Def, Fac Mil Hlth Sci, Brno, Czech Republic
Staniscia, T:
Univ G dAnnunzio, Chieti, Italy
Tinoco, JC:
Hosp Gen Durango, Durango, Mexico
Toma, A:
Manna Res, Toronto, ON, Canada
Vastiau, I:
GSK, Ave Fleming 20, B-1300 Wavre, Belgium
Vesikari, T:
Univ Tampere, Tampere, Finland
Volpi, A:
AO Univ Policlin Tor Vergata, Rome, Italy
Watanabe, D:
Kobe Univ, Grad Sch Med, Kobe, Hyogo, Japan
Weckx, LY:
Univ Fed Sao Paulo, Sao Paulo, Brazil
Zahaf, T:
GSK, Brussels, Belgium
Green Published, hybrid
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