Phase 3 immunogenicity and safety study of a tick-borne encephalitis vaccine in healthy Japanese participants 1 year of age and older.

Autor: Yonekawa M; Ohigesenseino Kodomo Clinic, Sapporo, Hokkaido, Japan. Electronic address: ohige_kodomoclinic@me.com., Watanabe T; Watanabe Pediatric Allergy Clinic, Sapporo, Hokkaido, Japan., Kogawara O; Vaccine Research, Pfizer R&D Japan, Tokyo, Japan., Yoshii C; Vaccine Research, Pfizer R&D Japan, Tokyo, Japan., Yamaji M; Vaccine Research, Pfizer R&D Japan, Tokyo, Japan., Aizawa M; Vaccine Research, Pfizer R&D Japan, Tokyo, Japan., Erber W; Medical Development and Scientific/Clinical Affairs, Pfizer Vaccines, Vienna, Austria., Ito S; Vaccine Medical Affairs, Pfizer Japan Inc, Tokyo, Japan., Jug B; QC Logistics, Pfizer Manufacturing Austria GmbH, Orth an der Donau, Austria., Koelch D; Vaccines Analytical Development, Pfizer, Orth, Austria., de Solom R; Pfizer Australia, Sydney, NSW, Australia., Lockhart SP; Vaccine Research and Development, Pfizer Ltd, Hurley, UK.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2024 May 10; Vol. 42 (13), pp. 3180-3189. Date of Electronic Publication: 2024 Apr 12.
DOI: 10.1016/j.vaccine.2024.03.071
Abstrakt: Background: Tick-borne encephalitis (TBE) virus infects the central nervous system and may lead to severe neurological complications or death. This study assessed immunogenicity, safety, and tolerability of TBE vaccine in Japanese participants 1 year of age and older.
Methods: This phase 3, multicenter, single-arm, open-label study was conducted in Japanese adult (≥ 16 years) and pediatric (1-< 16 years) populations. Participants received a single 0.5-mL (adult) or 0.25-mL (pediatric) dose of TBE vaccine at each of 3 visits. The primary endpoint was the proportion of participants who were seropositive (neutralization test [NT] titer ≥ 1:10) 4 weeks after Dose 3. Secondary and exploratory endpoints included NT seropositivity rates 4 weeks after Dose 2, immunoglobulin G (IgG) seropositivity 4 weeks after Doses 2 and 3, NT geometric mean titers (GMTs), IgG geometric mean concentrations (GMCs), and geometric mean fold rises. Primary safety endpoints were frequencies of local reactions, systemic events, adverse events (AEs), and serious AEs.
Results: Among 100 adult and 65 pediatric participants, 99.0 % and 100.0 % completed the study, respectively. NT seropositivity was achieved in 98.0 % adult and 100.0 % pediatric participants after Dose 3; seropositivity after Dose 2 was 93.0 % and 92.3 %, respectively. In both age groups, IgG seropositivity was ≥ 90.0 % and ≥ 96.0 % after Doses 2 and 3, respectively; GMTs and GMCs were highest 4 weeks after Dose 3. Reactogenicity events were generally mild to moderate in severity and short-lived. AEs were reported by 15.0 % (adult) and 43.1 % (pediatric) of participants. No life-threatening AEs, AEs leading to discontinuation, immediate AEs, related AEs, or deaths were reported. No serious AEs were considered related to TBE vaccine.
Conclusions: TBE vaccine elicited robust immune responses in Japanese participants 1 year of age and older. The 3-dose regimen was safe and well tolerated, and findings were consistent with the known safety profile of this TBE vaccine.
Clinicaltrials: gov: NCT04648241.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Motoharu Yonekawa received funding from Pfizer for this study. Tohru Watanabe received funding from Pfizer for this study. Osamu Kogawara, Chihiro Yoshii, Masako Yamaji, Masakazu Aizawa, Wilhelm Erber, Shuhei Ito, Bogdan Jug, Doris Koelch, Richard de Solom, and Stephen P. Lockhart received salary from their current or former employment at Pfizer and may hold Pfizer stock or stock options.
(Copyright © 2024. Published by Elsevier India Pvt Ltd.)
Databáze: MEDLINE
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