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Long-Term Results of Immunogenicity of Booster Vaccination against SARS-CoV-2 (Hybrid COV-RAPEL TR Study) in Turkiye: A Double-Blind, Randomized, Controlled, Multicenter Phase 2 Clinical Study
The immunogenicity of vaccines decreases over time, causing a need for booster doses. This study aimed to present the long-term (Day 84) immunogenicity results of the double-blind, randomized, controlled, phase II Hybrid COV-RAPEL TR Study (NCT04979949), in which the TURKOVAC or CoronaVac vaccines w...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10416156/ https://www.ncbi.nlm.nih.gov/pubmed/37515050 http://dx.doi.org/10.3390/vaccines11071234 |
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author | Ates, Ihsan Batirel, Ayse Aydin, Mehtap Karadag, Fatma Yilmaz Erden, Abdulsamet Kucuksahin, Orhan Armagan, Berkan Guven, Serdar Can Karakas, Ozlem Gokdemir, Selim Altunal, Lutfiye Nilsun Buber, Aslihan Ayse Gemcioglu, Emin Zengin, Oguzhan Inan, Osman Sahiner, Enes Seyda Korukluoglu, Gulay Sezer, Zafer Ozdarendeli, Aykut Omma, Ahmet Kara, Ates |
author_facet | Ates, Ihsan Batirel, Ayse Aydin, Mehtap Karadag, Fatma Yilmaz Erden, Abdulsamet Kucuksahin, Orhan Armagan, Berkan Guven, Serdar Can Karakas, Ozlem Gokdemir, Selim Altunal, Lutfiye Nilsun Buber, Aslihan Ayse Gemcioglu, Emin Zengin, Oguzhan Inan, Osman Sahiner, Enes Seyda Korukluoglu, Gulay Sezer, Zafer Ozdarendeli, Aykut Omma, Ahmet Kara, Ates |
author_sort | Ates, Ihsan |
collection | PubMed |
description | The immunogenicity of vaccines decreases over time, causing a need for booster doses. This study aimed to present the long-term (Day 84) immunogenicity results of the double-blind, randomized, controlled, phase II Hybrid COV-RAPEL TR Study (NCT04979949), in which the TURKOVAC or CoronaVac vaccines were used as a booster after the second dose of primary vaccination with CoronaVac. A total of 190 participants from the Hybrid COV-RAPEL TR Study, who had both Day 28 and Day 84 immunogenicity results, were included. The immunogenicity on Day 84, regarding the neutralizing antibody positivity (Wuhan and Delta variants) and anti-spike immunoglobulin (Ig) G (IgG) antibody positivity, was compared between TURKOVAC and CoronaVac vaccine arms according to sex and age groups. Overall, antibody positivity showed a slight decrease on Day 84 vs. Day 28, but was not different between TURKOVAC and CoronaVac arms either for sexes or for age groups. However, TURKOVAC produced better antibody response against the Delta variant than CoronaVac, while CoronaVac was superior over TURKOVAC regarding neutralizing antibody positivity in the 50–60 years age group, regardless of the variant. A single booster dose, after the completion of the primary vaccination, increases antibody positivity on Day 28 which persists until Day 84 with a slight decrease. However, an additional booster dose may be required thereafter, since the decrease in antibody titer may be faster over time. |
format | Online Article Text |
id | pubmed-10416156 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-104161562023-08-12 Long-Term Results of Immunogenicity of Booster Vaccination against SARS-CoV-2 (Hybrid COV-RAPEL TR Study) in Turkiye: A Double-Blind, Randomized, Controlled, Multicenter Phase 2 Clinical Study Ates, Ihsan Batirel, Ayse Aydin, Mehtap Karadag, Fatma Yilmaz Erden, Abdulsamet Kucuksahin, Orhan Armagan, Berkan Guven, Serdar Can Karakas, Ozlem Gokdemir, Selim Altunal, Lutfiye Nilsun Buber, Aslihan Ayse Gemcioglu, Emin Zengin, Oguzhan Inan, Osman Sahiner, Enes Seyda Korukluoglu, Gulay Sezer, Zafer Ozdarendeli, Aykut Omma, Ahmet Kara, Ates Vaccines (Basel) Article The immunogenicity of vaccines decreases over time, causing a need for booster doses. This study aimed to present the long-term (Day 84) immunogenicity results of the double-blind, randomized, controlled, phase II Hybrid COV-RAPEL TR Study (NCT04979949), in which the TURKOVAC or CoronaVac vaccines were used as a booster after the second dose of primary vaccination with CoronaVac. A total of 190 participants from the Hybrid COV-RAPEL TR Study, who had both Day 28 and Day 84 immunogenicity results, were included. The immunogenicity on Day 84, regarding the neutralizing antibody positivity (Wuhan and Delta variants) and anti-spike immunoglobulin (Ig) G (IgG) antibody positivity, was compared between TURKOVAC and CoronaVac vaccine arms according to sex and age groups. Overall, antibody positivity showed a slight decrease on Day 84 vs. Day 28, but was not different between TURKOVAC and CoronaVac arms either for sexes or for age groups. However, TURKOVAC produced better antibody response against the Delta variant than CoronaVac, while CoronaVac was superior over TURKOVAC regarding neutralizing antibody positivity in the 50–60 years age group, regardless of the variant. A single booster dose, after the completion of the primary vaccination, increases antibody positivity on Day 28 which persists until Day 84 with a slight decrease. However, an additional booster dose may be required thereafter, since the decrease in antibody titer may be faster over time. MDPI 2023-07-12 /pmc/articles/PMC10416156/ /pubmed/37515050 http://dx.doi.org/10.3390/vaccines11071234 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Ates, Ihsan Batirel, Ayse Aydin, Mehtap Karadag, Fatma Yilmaz Erden, Abdulsamet Kucuksahin, Orhan Armagan, Berkan Guven, Serdar Can Karakas, Ozlem Gokdemir, Selim Altunal, Lutfiye Nilsun Buber, Aslihan Ayse Gemcioglu, Emin Zengin, Oguzhan Inan, Osman Sahiner, Enes Seyda Korukluoglu, Gulay Sezer, Zafer Ozdarendeli, Aykut Omma, Ahmet Kara, Ates Long-Term Results of Immunogenicity of Booster Vaccination against SARS-CoV-2 (Hybrid COV-RAPEL TR Study) in Turkiye: A Double-Blind, Randomized, Controlled, Multicenter Phase 2 Clinical Study |
title | Long-Term Results of Immunogenicity of Booster Vaccination against SARS-CoV-2 (Hybrid COV-RAPEL TR Study) in Turkiye: A Double-Blind, Randomized, Controlled, Multicenter Phase 2 Clinical Study |
title_full | Long-Term Results of Immunogenicity of Booster Vaccination against SARS-CoV-2 (Hybrid COV-RAPEL TR Study) in Turkiye: A Double-Blind, Randomized, Controlled, Multicenter Phase 2 Clinical Study |
title_fullStr | Long-Term Results of Immunogenicity of Booster Vaccination against SARS-CoV-2 (Hybrid COV-RAPEL TR Study) in Turkiye: A Double-Blind, Randomized, Controlled, Multicenter Phase 2 Clinical Study |
title_full_unstemmed | Long-Term Results of Immunogenicity of Booster Vaccination against SARS-CoV-2 (Hybrid COV-RAPEL TR Study) in Turkiye: A Double-Blind, Randomized, Controlled, Multicenter Phase 2 Clinical Study |
title_short | Long-Term Results of Immunogenicity of Booster Vaccination against SARS-CoV-2 (Hybrid COV-RAPEL TR Study) in Turkiye: A Double-Blind, Randomized, Controlled, Multicenter Phase 2 Clinical Study |
title_sort | long-term results of immunogenicity of booster vaccination against sars-cov-2 (hybrid cov-rapel tr study) in turkiye: a double-blind, randomized, controlled, multicenter phase 2 clinical study |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10416156/ https://www.ncbi.nlm.nih.gov/pubmed/37515050 http://dx.doi.org/10.3390/vaccines11071234 |
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