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


Por: Oostvogels, L, Heineman, T, Johnson, R, Levin, M, McElhaney, J, Van den Steen, P, Zahaf, T, Dagnew, A, Chlibek, R, Diez-Domingo, J, Gorfinkel, I, Herve, C, Hwang, S, Ikematsu, H, Kalema, G, Lal, H, McNeil, S, Mrkvan, T, Pauksens, K, Smetana, J, Watanabe, D, Weckx, L, Cunningham, A, Ahonen, A, Athan, E, Berglund, J, Choi, W, de Looze, F, Desole, M, Esen, M, Geeraerts, B, Ghesquiere, W, Rombo, L, Volpi, A and ZOE-50 70 Study Grp

Fecha de Publicación: 02/12/2019
Resumen:
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.

Direcciones
Oostvogels, L: GSK, Ave Fleming 20, B-1300 Wavre, Belgium; CureVac AG, Tubingen, Germany
Heineman, TC: GSK, King Of Prussia, PA USA; Halozyme Therapeut, San Diego, CA USA
Johnson, RW: Univ Bristol, Fac Hlth Sci, Bristol, Avon, England
Levin, MJ: Univ Colorado, Dept Pediat, Anschutz Med Campus, Aurora, CO USA; Univ Colorado, Dept Med, Anschutz Med Campus, Aurora, CO USA
McElhaney, JE: Hlth Sci North Res Inst, Sudbury, ON, Canada
Van den Steen, P: GSK, Ave Fleming 20, B-1300 Wavre, Belgium
Zahaf, T: GSK, Ave Fleming 20, B-1300 Wavre, Belgium
Dagnew, AF: GSK, Rockville, MD USA
Chlibek, R: Univ Def, Fac Mil Hlth Sci, Hradec Kralove, Czech Republic
Diez-Domingo, J: Fdn El Fomento Invest Sanitaria & Biomed, Valencia, Spain
Gorfinkel, IS: PrimeHlth Clin Res, Toronto, ON, Canada
Herve, C: GSK, Ave Fleming 20, B-1300 Wavre, Belgium
Hwang, SJ: Taipei Vet Gen Hosp, Dept Family Med, Taipei, Taiwan; Natl Yang Ming Univ, Sch Med, Taipei, Taiwan
Ikematsu, H: Japan Phys Assoc, Tokyo, Japan
Kalema, G: Keyrus Biopharma, Waterloo, ON, Belgium
Lal, H: GSK, King Of Prussia, PA USA; Pfizer Inc, Collegeville, PA USA
McNeil, SA: Dalhousie Univ, IWK Hlth Ctr, Canadian Ctr Vaccinol, Halifax, NS, Canada; Dalhousie Univ, Nova Scotia Hlth Author, Halifax, NS, Canada
Mrkvan, T: GSK, Ave Fleming 20, B-1300 Wavre, Belgium
Pauksens, K: Uppsala Univ Hosp, Dept Infect Dis, Uppsala, Sweden
Smetana, J: Univ Def, Fac Mil Hlth Sci, Hradec Kralove, Czech Republic
Watanabe, D: Aichi Med Univ, Dept Dermatol, Nagakute, Aichi, Japan
Weckx, LY: Univ Fed Sao Paulo, Dept Pediat, Sao Paulo, Brazil
Cunningham, AL: Univ Sydney, Westmead Inst Med Res, Sydney, NSW, Australia
ISSN: 21645515





HUMAN VACCINES & IMMUNOTHERAPEUTICS
Editorial
TAYLOR & FRANCIS INC, United States, Estados Unidos America
Tipo de documento: Article
Volumen: 15 Número: 12
Páginas: 2865-2872s
WOS: 000473959400001
ID de PubMed: 31216205

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