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Safety, reactogenicity, and immunogenicity of Ad26.COV2.S: Results of a phase 1, randomized, double-blind, placebo-controlled COVID-19 vaccine trial in Japan

BACKGROUND: This study evaluated safety, reactogenicity, and immunogenicity of a 2-month homologous booster regimen of Ad26.COV2.S in Japanese adults. METHODS: In this multicenter, placebo-controlled, Phase 1 trial, adults (Cohort 1, aged 20–55 years, N = 125; Cohort 2, aged ≥ 65 years, N = 125) wer...

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Autores principales: Tsuchiya, Yumi, Tamura, Hiroshi, Fujii, Koji, Numaguchi, Hirotaka, Toyoizumi, Kiichiro, Liu, Tina, Le Gars, Mathieu, Cárdenas, Vicky, Eto, Takashi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Authors. Published by Elsevier Ltd. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9812825/
https://www.ncbi.nlm.nih.gov/pubmed/36732164
http://dx.doi.org/10.1016/j.vaccine.2023.01.006
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author Tsuchiya, Yumi
Tamura, Hiroshi
Fujii, Koji
Numaguchi, Hirotaka
Toyoizumi, Kiichiro
Liu, Tina
Le Gars, Mathieu
Cárdenas, Vicky
Eto, Takashi
author_facet Tsuchiya, Yumi
Tamura, Hiroshi
Fujii, Koji
Numaguchi, Hirotaka
Toyoizumi, Kiichiro
Liu, Tina
Le Gars, Mathieu
Cárdenas, Vicky
Eto, Takashi
author_sort Tsuchiya, Yumi
collection PubMed
description BACKGROUND: This study evaluated safety, reactogenicity, and immunogenicity of a 2-month homologous booster regimen of Ad26.COV2.S in Japanese adults. METHODS: In this multicenter, placebo-controlled, Phase 1 trial, adults (Cohort 1, aged 20–55 years, N = 125; Cohort 2, aged ≥ 65 years, N = 125) were randomized 2:2:1 to receive Ad26.COV2.S 5 × 10(10) viral particles (vp), Ad26.COV2.S 1 × 10(11) vp, or placebo, followed by a homologous booster 56 days later. Safety, reactogenicity, and immunogenicity were assessed. RESULTS: Two hundred participants received Ad26.COV2.S and 50 received placebo. The most frequent solicited local adverse event (AE) was vaccination-site pain, and the most frequent solicited systemic AEs were fatigue, myalgia, and headache. After primary vaccination, neutralizing and binding antibody levels increased through Day 57 (post-prime) in both cohorts. Fourteen days after boosting (Day 71), neutralizing antibody geometric mean titers (GMTs) had almost reached their peak value in Cohort 1 (5 × 10(10) vp: GMT = 1049; 1 × 10(11) vp: GMT = 1470) and peaked in Cohort 2 (504; 651); at Day 85, GMTs had declined minimally in Cohort 2. For both cohorts, binding antibody levels peaked at Day 71 with minimal decline at Day 85. CONCLUSION: A single dose and homologous Ad26.COV2.S booster increased antibody responses with an acceptable safety profile in Japanese adults (ClinicalTrials.gov Identifier: NCT04509947).
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spelling pubmed-98128252023-01-05 Safety, reactogenicity, and immunogenicity of Ad26.COV2.S: Results of a phase 1, randomized, double-blind, placebo-controlled COVID-19 vaccine trial in Japan Tsuchiya, Yumi Tamura, Hiroshi Fujii, Koji Numaguchi, Hirotaka Toyoizumi, Kiichiro Liu, Tina Le Gars, Mathieu Cárdenas, Vicky Eto, Takashi Vaccine Article BACKGROUND: This study evaluated safety, reactogenicity, and immunogenicity of a 2-month homologous booster regimen of Ad26.COV2.S in Japanese adults. METHODS: In this multicenter, placebo-controlled, Phase 1 trial, adults (Cohort 1, aged 20–55 years, N = 125; Cohort 2, aged ≥ 65 years, N = 125) were randomized 2:2:1 to receive Ad26.COV2.S 5 × 10(10) viral particles (vp), Ad26.COV2.S 1 × 10(11) vp, or placebo, followed by a homologous booster 56 days later. Safety, reactogenicity, and immunogenicity were assessed. RESULTS: Two hundred participants received Ad26.COV2.S and 50 received placebo. The most frequent solicited local adverse event (AE) was vaccination-site pain, and the most frequent solicited systemic AEs were fatigue, myalgia, and headache. After primary vaccination, neutralizing and binding antibody levels increased through Day 57 (post-prime) in both cohorts. Fourteen days after boosting (Day 71), neutralizing antibody geometric mean titers (GMTs) had almost reached their peak value in Cohort 1 (5 × 10(10) vp: GMT = 1049; 1 × 10(11) vp: GMT = 1470) and peaked in Cohort 2 (504; 651); at Day 85, GMTs had declined minimally in Cohort 2. For both cohorts, binding antibody levels peaked at Day 71 with minimal decline at Day 85. CONCLUSION: A single dose and homologous Ad26.COV2.S booster increased antibody responses with an acceptable safety profile in Japanese adults (ClinicalTrials.gov Identifier: NCT04509947). The Authors. Published by Elsevier Ltd. 2023-02-24 2023-01-05 /pmc/articles/PMC9812825/ /pubmed/36732164 http://dx.doi.org/10.1016/j.vaccine.2023.01.006 Text en © 2023 The Authors Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Tsuchiya, Yumi
Tamura, Hiroshi
Fujii, Koji
Numaguchi, Hirotaka
Toyoizumi, Kiichiro
Liu, Tina
Le Gars, Mathieu
Cárdenas, Vicky
Eto, Takashi
Safety, reactogenicity, and immunogenicity of Ad26.COV2.S: Results of a phase 1, randomized, double-blind, placebo-controlled COVID-19 vaccine trial in Japan
title Safety, reactogenicity, and immunogenicity of Ad26.COV2.S: Results of a phase 1, randomized, double-blind, placebo-controlled COVID-19 vaccine trial in Japan
title_full Safety, reactogenicity, and immunogenicity of Ad26.COV2.S: Results of a phase 1, randomized, double-blind, placebo-controlled COVID-19 vaccine trial in Japan
title_fullStr Safety, reactogenicity, and immunogenicity of Ad26.COV2.S: Results of a phase 1, randomized, double-blind, placebo-controlled COVID-19 vaccine trial in Japan
title_full_unstemmed Safety, reactogenicity, and immunogenicity of Ad26.COV2.S: Results of a phase 1, randomized, double-blind, placebo-controlled COVID-19 vaccine trial in Japan
title_short Safety, reactogenicity, and immunogenicity of Ad26.COV2.S: Results of a phase 1, randomized, double-blind, placebo-controlled COVID-19 vaccine trial in Japan
title_sort safety, reactogenicity, and immunogenicity of ad26.cov2.s: results of a phase 1, randomized, double-blind, placebo-controlled covid-19 vaccine trial in japan
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9812825/
https://www.ncbi.nlm.nih.gov/pubmed/36732164
http://dx.doi.org/10.1016/j.vaccine.2023.01.006
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