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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...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The Authors. Published by Elsevier Ltd.
2023
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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). |
format | Online Article Text |
id | pubmed-9812825 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | The Authors. Published by Elsevier Ltd. |
record_format | MEDLINE/PubMed |
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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