A randomized lot-to-lot immunogenicity consistency study of the candidate zoster vaccine HZ/su.

Autor: Strezova A; GSK, Wavre, Belgium. Electronic address: ana.x.strezova@gsk.com., Godeaux O; Janssen Vaccines & Prevention B.V., Leiden, Netherlands. Electronic address: ogodeaux@its.jnj.com., Aggarwal N; Aggarwal and Associates Limited, Brampton, Ontario, Canada. Electronic address: naresh.aggarwal@aaaresearch.ca., Leroux-Roels G; Ghent University and University Hospital, Ghent, Belgium. Electronic address: geert.lerouxroels@ugent.be., Lopez-Fauqued M; GSK, Wavre, Belgium. Electronic address: marta.x.lopez-fauqued@gsk.com., Van Damme P; Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium. Electronic address: pierre.vandamme@uantwerpen.be., Vanden Abeele C; GSK, Wavre, Belgium. Electronic address: carline.c.vanden-abeele@gsk.com., Vastiau I; GSK, Wavre, Belgium. Electronic address: ilse.x.vastiau@gsk.com., Heineman TC; Genocea Biosciences, Cambridge, MA, USA. Electronic address: thomas.heineman@genocea.com., Lal H; Pfizer Inc., 500 Arcola Road, Collegeville, PA, USA. Electronic address: himal.lal@pfizer.com.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2017 Dec 04; Vol. 35 (48 Pt B), pp. 6700-6706. Date of Electronic Publication: 2017 Oct 24.
DOI: 10.1016/j.vaccine.2017.10.017
Abstrakt: Background: The risk of developing herpes zoster (HZ) increases with age and is thought to be associated with a decrease in cell-mediated immunity in older adults. The adjuvanted varicella-zoster virus (VZV) glycoprotein E (gE) recombinant subunit vaccine (HZ/su) showed >90% efficacy in the prevention of HZ when administered in adults ≥50 years of age. Here we aim to evaluate immunogenicity consistency of 3 different HZ/su vaccine lots and to assess safety of these lots.
Methods: This multicenter, phase III, double-blind, randomized study (NCT02075515), assessed lot-to-lot consistency in terms of immunogenicity of HZ/su and also assessed safety of these lots. Participants aged 50 years or older were randomized (1:1:1) to receive 2 doses of HZ/su, 2 months apart, from 1 out of 3 randomized HZ/su lots (Lots A, B and C). Humoral immunogenicity was assessed pre-vaccination and 1 month post-second vaccination by anti-gE antibody enzyme-linked immunosorbent assay. Lot-to-lot consistency was demonstrated if the 2-sided 95% confidence intervals of the anti-gE geometric mean concentration ratio between all lot pairs were within 0.67 and 1.5. Solicited symptoms were recorded within 7 days and unsolicited adverse events (AEs) within 30 days after each vaccination. Serious AEs (SAEs) and potential immune-mediated diseases (pIMDs) were reported until study end (12 months post-second vaccination).
Results: Of 651 participants enrolled in the study, 638 received both doses of the HZ/su vaccine and 634 completed the study. Humoral immune responses were robust and consistency between 3 manufacturing lots was demonstrated. The incidence of solicited symptoms, unsolicited AEs and SAEs was comparable between all lots. Three fatal SAEs, 1 in each lot, were reported, none of which were considered vaccine-related by investigator assessment. Two out of the 8 reported pIMDs were considered vaccine-related by the investigator.
Conclusion: The three HZ/su manufacturing lots demonstrated consistent immunogenicity. No safety concerns were identified. Clinical trial registry number: NCT02075515 (ClinicalTrials.gov).
(Copyright © 2017 GlaxoSmithKline SA. Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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