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Article Publish Status: FREE
Abstract Title:

The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged≥50 years: A randomized trial.

Abstract Source:

Vaccine. 2019 Sep 16 ;37(39):5877-5885. Epub 2019 Aug 20. PMID: 31443993

Abstract Author(s):

Ana Strezova, Himal Lal, Igwebuike Enweonye, Laura Campora, Pierre Beukelaers, Nathan Segall, Thomas C Heineman, Anne E Schuind, Lidia Oostvogels

Article Affiliation:

Ana Strezova

Abstract:

BACKGROUND: This study evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) and the reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine (Tdap) when co-administered in adults aged≥50 years.

METHODS: In this open label, multi-center study (NCT02052596), participants were randomized 1:1 to the Co-Administration group (RZV dose 1 and Tdap at Day 0 [D0], RZV dose 2 at Month 2 [M2]) or Control group (Tdap at D0, RZV dose 1 at M2, RZV dose 2 at M4). Co-primary objectives were evaluation of the vaccine response rate (VRR) to RZV in the Co-Administration group, and demonstration of non-inferiority of the humoral responses to RZV and Tdap in the Co-Administration compared to Control group. Reactogenicity and safety of RZV and Tdap were also assessed.

RESULTS: VRR to RZV was 97.8% in the Co-Administration group. The non-inferiority criterion was met for the humoral response to RZV and for 4 Tdap antigens, but was not met for the Tdap antigen pertactin. Occurrences of solicited, unsolicited and serious adverse events, and potential immune-mediated diseases were similar between groups.

CONCLUSIONS: Co-administration of RZV and Tdap did not interfere with the humoral immune response to RZV or 4 of the 5 Tdap antigens. No safety concerns were identified.

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