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Single Ad26.COV2.S booster dose following two doses of BBIBP-CorV vaccine against SARS-CoV-2 infection in adults: Day 28 results of a phase 1/2 open-label trial
BACKGROUND: The inactivated COVID-19 whole-virus vaccine BBIBP-CorV has been extensively used worldwide. Heterologous boosting after primary vaccination can induce higher immune responses against SARS-CoV-2 than homologous boosting. The safety and immunogenicity after 28 days of a single Ad26.COV2.S...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The Author(s). Published by Elsevier Ltd.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10267503/ https://www.ncbi.nlm.nih.gov/pubmed/37344265 http://dx.doi.org/10.1016/j.vaccine.2023.06.043 |
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author | Muangnoicharoen, Sant Wiangcharoen, Rakpong Nanthapisal, Sira Kamolratakul, Supitcha Lawpoolsri, Saranath Jongkaewwattana, Anan Thitithanyanont, Arunee Luvira, Viravarn Chinwangso, Pailinrut Thanthamnu, Narumon Chantratita, Narisara Lim, Jacqueline Kyungah Anh Wartel, T. Excler, Jean-Louis Ryser, Martin F. Leong, Chloe Mak, Tippi K. Pitisuttithum, Punnee |
author_facet | Muangnoicharoen, Sant Wiangcharoen, Rakpong Nanthapisal, Sira Kamolratakul, Supitcha Lawpoolsri, Saranath Jongkaewwattana, Anan Thitithanyanont, Arunee Luvira, Viravarn Chinwangso, Pailinrut Thanthamnu, Narumon Chantratita, Narisara Lim, Jacqueline Kyungah Anh Wartel, T. Excler, Jean-Louis Ryser, Martin F. Leong, Chloe Mak, Tippi K. Pitisuttithum, Punnee |
author_sort | Muangnoicharoen, Sant |
collection | PubMed |
description | BACKGROUND: The inactivated COVID-19 whole-virus vaccine BBIBP-CorV has been extensively used worldwide. Heterologous boosting after primary vaccination can induce higher immune responses against SARS-CoV-2 than homologous boosting. The safety and immunogenicity after 28 days of a single Ad26.COV2.S booster dose given at different intervals after 2 doses of BBIBP-CorV are presented. METHODS: This open-label phase 1/2 trial was conducted in healthy adults in Thailand who had completed 2-dose primary vaccination with BBIBP-CorV. Participants received a single booster dose of Ad26.COV2.S (5 × 10(10) virus particles) 90–240 days (Group A1; n = 360) or 45–75 days (Group A2; n = 66) after the second BBIBP-CorV dose. Safety and immunogenicity were assessed over 28 days. Binding IgG antibodies to the full-length pre-fusion Spike and anti-nucleocapsid proteins of SARS-CoV-2 were measured by enzyme-linked immunosorbent assay. The SARS-CoV-2 pseudovirus neutralization assay and live virus microneutralization assay were used to quantify the neutralizing activity of antibodies against ancestral SARS-CoV-2 (Wuhan-Hu-1) and the delta (B.1.617.2) and omicron (B.1.1.529/BA.1 and BA.2) variants. The cell-mediated immune response was measured using a quantitative interferon (IFN)-γ release assay in whole blood. RESULTS: Solicited local and systemic adverse events (AEs) on days 0–7 were mostly mild, as were unsolicited vaccine-related AEs during days 0–28, with no serious AEs. On day 28, anti-Spike binding antibodies increased from baseline by 487- and 146-fold in Groups A1 and A2, and neutralizing antibodies against ancestral SARS-CoV-2 by 55- and 37-fold, respectively. Humoral responses were strongest against ancestral SARS-CoV-2, followed by the delta, then the omicron BA.2 and BA.1 variants. T-cell–produced interferon-γ increased approximately 10-fold in both groups. CONCLUSIONS: A single heterologous Ad26.COV2.S booster dose after two BBIBP-CorV doses was well tolerated and induced robust humoral and cell-mediated immune responses measured at day 28 in both interval groups. Clinical Trials Registration. NCT05109559. |
format | Online Article Text |
id | pubmed-10267503 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | The Author(s). Published by Elsevier Ltd. |
record_format | MEDLINE/PubMed |
spelling | pubmed-102675032023-06-15 Single Ad26.COV2.S booster dose following two doses of BBIBP-CorV vaccine against SARS-CoV-2 infection in adults: Day 28 results of a phase 1/2 open-label trial Muangnoicharoen, Sant Wiangcharoen, Rakpong Nanthapisal, Sira Kamolratakul, Supitcha Lawpoolsri, Saranath Jongkaewwattana, Anan Thitithanyanont, Arunee Luvira, Viravarn Chinwangso, Pailinrut Thanthamnu, Narumon Chantratita, Narisara Lim, Jacqueline Kyungah Anh Wartel, T. Excler, Jean-Louis Ryser, Martin F. Leong, Chloe Mak, Tippi K. Pitisuttithum, Punnee Vaccine Article BACKGROUND: The inactivated COVID-19 whole-virus vaccine BBIBP-CorV has been extensively used worldwide. Heterologous boosting after primary vaccination can induce higher immune responses against SARS-CoV-2 than homologous boosting. The safety and immunogenicity after 28 days of a single Ad26.COV2.S booster dose given at different intervals after 2 doses of BBIBP-CorV are presented. METHODS: This open-label phase 1/2 trial was conducted in healthy adults in Thailand who had completed 2-dose primary vaccination with BBIBP-CorV. Participants received a single booster dose of Ad26.COV2.S (5 × 10(10) virus particles) 90–240 days (Group A1; n = 360) or 45–75 days (Group A2; n = 66) after the second BBIBP-CorV dose. Safety and immunogenicity were assessed over 28 days. Binding IgG antibodies to the full-length pre-fusion Spike and anti-nucleocapsid proteins of SARS-CoV-2 were measured by enzyme-linked immunosorbent assay. The SARS-CoV-2 pseudovirus neutralization assay and live virus microneutralization assay were used to quantify the neutralizing activity of antibodies against ancestral SARS-CoV-2 (Wuhan-Hu-1) and the delta (B.1.617.2) and omicron (B.1.1.529/BA.1 and BA.2) variants. The cell-mediated immune response was measured using a quantitative interferon (IFN)-γ release assay in whole blood. RESULTS: Solicited local and systemic adverse events (AEs) on days 0–7 were mostly mild, as were unsolicited vaccine-related AEs during days 0–28, with no serious AEs. On day 28, anti-Spike binding antibodies increased from baseline by 487- and 146-fold in Groups A1 and A2, and neutralizing antibodies against ancestral SARS-CoV-2 by 55- and 37-fold, respectively. Humoral responses were strongest against ancestral SARS-CoV-2, followed by the delta, then the omicron BA.2 and BA.1 variants. T-cell–produced interferon-γ increased approximately 10-fold in both groups. CONCLUSIONS: A single heterologous Ad26.COV2.S booster dose after two BBIBP-CorV doses was well tolerated and induced robust humoral and cell-mediated immune responses measured at day 28 in both interval groups. Clinical Trials Registration. NCT05109559. The Author(s). Published by Elsevier Ltd. 2023-06-15 /pmc/articles/PMC10267503/ /pubmed/37344265 http://dx.doi.org/10.1016/j.vaccine.2023.06.043 Text en © 2023 The Author(s) 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 Muangnoicharoen, Sant Wiangcharoen, Rakpong Nanthapisal, Sira Kamolratakul, Supitcha Lawpoolsri, Saranath Jongkaewwattana, Anan Thitithanyanont, Arunee Luvira, Viravarn Chinwangso, Pailinrut Thanthamnu, Narumon Chantratita, Narisara Lim, Jacqueline Kyungah Anh Wartel, T. Excler, Jean-Louis Ryser, Martin F. Leong, Chloe Mak, Tippi K. Pitisuttithum, Punnee Single Ad26.COV2.S booster dose following two doses of BBIBP-CorV vaccine against SARS-CoV-2 infection in adults: Day 28 results of a phase 1/2 open-label trial |
title | Single Ad26.COV2.S booster dose following two doses of BBIBP-CorV vaccine against SARS-CoV-2 infection in adults: Day 28 results of a phase 1/2 open-label trial |
title_full | Single Ad26.COV2.S booster dose following two doses of BBIBP-CorV vaccine against SARS-CoV-2 infection in adults: Day 28 results of a phase 1/2 open-label trial |
title_fullStr | Single Ad26.COV2.S booster dose following two doses of BBIBP-CorV vaccine against SARS-CoV-2 infection in adults: Day 28 results of a phase 1/2 open-label trial |
title_full_unstemmed | Single Ad26.COV2.S booster dose following two doses of BBIBP-CorV vaccine against SARS-CoV-2 infection in adults: Day 28 results of a phase 1/2 open-label trial |
title_short | Single Ad26.COV2.S booster dose following two doses of BBIBP-CorV vaccine against SARS-CoV-2 infection in adults: Day 28 results of a phase 1/2 open-label trial |
title_sort | single ad26.cov2.s booster dose following two doses of bbibp-corv vaccine against sars-cov-2 infection in adults: day 28 results of a phase 1/2 open-label trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10267503/ https://www.ncbi.nlm.nih.gov/pubmed/37344265 http://dx.doi.org/10.1016/j.vaccine.2023.06.043 |
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