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Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials.
Oostvogels, Lidia; Heineman, Thomas C; Johnson, Robert W; Levin, Myron J; McElhaney, Janet E; Van den Steen, Peter; Zahaf, Toufik; Dagnew, Alemnew F; Chlibek, Roman; Diez-Domingo, Javier; Gorfinkel, Iris S; Hervé, Caroline; Hwang, Shinn-Jang; Ikematsu, Hideyuki; Kalema, George; Lal, Himal; McNeil, Shelly A; Mrkvan, Tomas; Pauksens, Karlis; Smetana, Jan; Watanabe, Daisuke; Weckx, Lily Yin; Cunningham, Anthony L.
Afiliación
  • Oostvogels L; GSK, Wavre, Belgium.
  • Heineman TC; GSK, King of Prussia, PA, USA.
  • Johnson RW; Faculty of Health Sciences, University of Bristol, Bristol, UK.
  • Levin MJ; Departments of Pediatrics and Medicine, University of Colorado, Anschutz Medical Campus, Aurora, CO, USA.
  • McElhaney JE; Health Sciences North Research Institute, Sudbury, Ontario, Canada.
  • Van den Steen P; GSK, Wavre, Belgium.
  • Zahaf T; GSK, Wavre, Belgium.
  • Dagnew AF; GSK, Rockville, MD, USA.
  • Chlibek R; Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic.
  • Diez-Domingo J; Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain.
  • Gorfinkel IS; PrimeHealth Clinical Research, Toronto, Ontario, Canada.
  • Hervé C; GSK, Wavre, Belgium.
  • Hwang SJ; Department of Family Medicine, Taipei Veterans General Hospital and National Yang Ming University School of Medicine, Taipei, Taiwan.
  • Ikematsu H; Japan Physicians Association, Tokyo, Japan.
  • Kalema G; Keyrus Biopharma, Waterloo, Belgium, on behalf of GSK.
  • Lal H; GSK, King of Prussia, PA, USA.
  • McNeil SA; Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie, University, Halifax, Canada.
  • Mrkvan T; GSK, Wavre, Belgium.
  • Pauksens K; Department of Infectious Diseases, Uppsala University Hospital, Uppsala, Sweden.
  • Smetana J; Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic.
  • Watanabe D; Department of Dermatology, Aichi Medical University, Nagakute, Japan.
  • Weckx LY; Department of Pediatrics, Federal University of Sao Paulo, Sao Paulo, Brazil.
  • Cunningham AL; The Westmead Institute for Medical Research, Westmead, University of Sydney, Sydney, NSW, Australia.
Hum Vaccin Immunother ; 15(12): 2865-2872, 2019.
Article en En | MEDLINE | ID: mdl-31216205
In two pivotal efficacy studies (ZOE-50; ZOE-70), the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster (HZ).Adults aged ≥50 or ≥70 years (ZOE-50 [NCT01165177]; ZOE-70 [NCT01165229]) were randomized to receive 2 doses of RZV or placebo 2 months apart. Vaccine efficacy and safety were evaluated post-hoc in the pooled (ZOE-50/70) population according to the number and type of selected medical conditions present at enrollment.At enrollment, 82.3% of RZV and 82.7% of placebo recipients reported ≥1 of the 15 selected medical conditions. Efficacy against HZ ranged from 84.5% (95% Confidence Interval [CI]: 46.4-97.1) in participants with respiratory disorders to 97.0% (95%CI: 82.3-99.9) in those with coronary heart disease. Moreover, efficacy remained >90% irrespective of the number of selected medical conditions reported by a participant.As indicated by the similarity of the point estimates, this post-hoc analysis suggests that RZV efficacy remains high in all selected medical conditions, as well as with increasing number of medical conditions. No safety concern was identified by the type or number of medical conditions present at enrollment.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Neuralgia Posherpética / Vacuna contra el Herpes Zóster / Potencia de la Vacuna / Herpes Zóster Tipo de estudio: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Hum Vaccin Immunother Año: 2019 Tipo del documento: Article País de afiliación: Bélgica

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Neuralgia Posherpética / Vacuna contra el Herpes Zóster / Potencia de la Vacuna / Herpes Zóster Tipo de estudio: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Hum Vaccin Immunother Año: 2019 Tipo del documento: Article País de afiliación: Bélgica