Safety and immunogenicity of inactive vaccines as booster doses for COVID-19 in Türkiye: A randomized trial
Protective neutralizing antibody titers reduce in time after COVID-19 vaccinations, as in individuals who have had COVID-19. This study aimed to evaluate the safety and immunogenicity of CoronaVac and TURKOVAC vaccines used as a booster dose after CoronaVac primary vaccination. This double-blind, ra...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2022-11-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2022.2122503 |
| _version_ | 1827806414856257536 |
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| author | Ahmet Omma Ayse Batirel Mehtap Aydin Fatma Yilmaz Karadag Abdulsamet Erden Orhan Kucuksahin Berkan Armagan Serdar Can Güven Ozlem Karakas Selim Gokdemir Lutfiye Nilsun Altunal Aslihan Ayse Buber Emin Gemcioglu Oguzhan Zengin Osman Inan Enes Seyda Sahiner Gulay Korukluoglu Zafer Sezer Aykut Ozdarendeli Ates Kara Ihsan Ates |
| author_facet | Ahmet Omma Ayse Batirel Mehtap Aydin Fatma Yilmaz Karadag Abdulsamet Erden Orhan Kucuksahin Berkan Armagan Serdar Can Güven Ozlem Karakas Selim Gokdemir Lutfiye Nilsun Altunal Aslihan Ayse Buber Emin Gemcioglu Oguzhan Zengin Osman Inan Enes Seyda Sahiner Gulay Korukluoglu Zafer Sezer Aykut Ozdarendeli Ates Kara Ihsan Ates |
| author_sort | Ahmet Omma |
| collection | DOAJ |
| description | Protective neutralizing antibody titers reduce in time after COVID-19 vaccinations, as in individuals who have had COVID-19. This study aimed to evaluate the safety and immunogenicity of CoronaVac and TURKOVAC vaccines used as a booster dose after CoronaVac primary vaccination. This double-blind, randomized, controlled, phase II, multicenter study included healthy male and female adults (18–60 years) who were vaccinated with two doses of CoronaVac vaccine and did not exceed the duration of at least 90 days and a maximum of 270 days from the second dose of vaccination. Among 236 eligible volunteers, 222 were recruited for randomization between July 12, 2021 and September 10, 2021; 108 and 114 were randomized to the TURKOVAC and CoronaVac arms, respectively. The primary endpoint was adverse events (AEs) (ClinicalTrials.gov; Identifier: NCT04979949). On day 28, at the neutralizing antibody threshold of 1/6, the positivity rate reached 100% from 46.2% to 98.2% from 52.6% in the TURKOVAC and CoronaVac arms, respectively, against the Wuhan variant and the positivity rate reached 80.6% from 8.7% in the TURKOVAC arm vs. 71.9% from 14.0% in the CoronaVac arm against the Delta variant. IgG spike antibody positivity rate increased from 57.3% to 98.1% and from 57.9% to 97.4% in the TURKOVAC and CoronaVac arms, respectively. The TURKOVAC and CoronaVac arms were comparable regarding the frequency of overall AEs. Both vaccines administered as booster yielded higher antibody titers with acceptable safety profiles. |
| first_indexed | 2024-03-11T21:40:47Z |
| format | Article |
| id | doaj.art-8c21a7499126460eb2a45f3715e4845c |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T21:40:47Z |
| publishDate | 2022-11-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-8c21a7499126460eb2a45f3715e4845c2023-09-26T13:19:09ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2022-11-0118610.1080/21645515.2022.21225032122503Safety and immunogenicity of inactive vaccines as booster doses for COVID-19 in Türkiye: A randomized trialAhmet Omma0Ayse Batirel1Mehtap Aydin2Fatma Yilmaz Karadag3Abdulsamet Erden4Orhan Kucuksahin5Berkan Armagan6Serdar Can Güven7Ozlem Karakas8Selim Gokdemir9Lutfiye Nilsun Altunal10Aslihan Ayse Buber11Emin Gemcioglu12Oguzhan Zengin13Osman Inan14Enes Seyda Sahiner15Gulay Korukluoglu16Zafer Sezer17Aykut Ozdarendeli18Ates Kara19Ihsan Ates20Ankara City HospitalUniversity of Health Sciences, International Medical School, Kartal Dr. Lutfi Kirdar City HospitalUniversity of Health Sciences, Umraniye Training and Research HospitalUniversity of Health Sciences, Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research HospitalAnkara City HospitalDivision of Rheumatology, Yıldırım Beyazıt University School of MedicineAnkara City HospitalAnkara City HospitalAnkara City HospitalUniversity of Health Sciences, Kartal Dr. Lutfi Kirdar City HospitalUniversity of Health Sciences, Umraniye Training and Research HospitalUniversity of Health Sciences, Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research HospitalUniversity of Health Sciences Ankara City HospitalUniversity of Health Sciences Ankara City HospitalUniversity of Health Sciences Ankara City HospitalUniversity of Health Sciences Ankara City HospitalGeneral Directorate of Public HealthMedical Faculty, Erciyes UniversityErciyes UniversityHacettepe UniversityUniversity of Health Sciences Ankara City HospitalProtective neutralizing antibody titers reduce in time after COVID-19 vaccinations, as in individuals who have had COVID-19. This study aimed to evaluate the safety and immunogenicity of CoronaVac and TURKOVAC vaccines used as a booster dose after CoronaVac primary vaccination. This double-blind, randomized, controlled, phase II, multicenter study included healthy male and female adults (18–60 years) who were vaccinated with two doses of CoronaVac vaccine and did not exceed the duration of at least 90 days and a maximum of 270 days from the second dose of vaccination. Among 236 eligible volunteers, 222 were recruited for randomization between July 12, 2021 and September 10, 2021; 108 and 114 were randomized to the TURKOVAC and CoronaVac arms, respectively. The primary endpoint was adverse events (AEs) (ClinicalTrials.gov; Identifier: NCT04979949). On day 28, at the neutralizing antibody threshold of 1/6, the positivity rate reached 100% from 46.2% to 98.2% from 52.6% in the TURKOVAC and CoronaVac arms, respectively, against the Wuhan variant and the positivity rate reached 80.6% from 8.7% in the TURKOVAC arm vs. 71.9% from 14.0% in the CoronaVac arm against the Delta variant. IgG spike antibody positivity rate increased from 57.3% to 98.1% and from 57.9% to 97.4% in the TURKOVAC and CoronaVac arms, respectively. The TURKOVAC and CoronaVac arms were comparable regarding the frequency of overall AEs. Both vaccines administered as booster yielded higher antibody titers with acceptable safety profiles.http://dx.doi.org/10.1080/21645515.2022.2122503booster vaccinecoronavaccovid-19inactiveturkovac |
| spellingShingle | Ahmet Omma Ayse Batirel Mehtap Aydin Fatma Yilmaz Karadag Abdulsamet Erden Orhan Kucuksahin Berkan Armagan Serdar Can Güven Ozlem Karakas Selim Gokdemir Lutfiye Nilsun Altunal Aslihan Ayse Buber Emin Gemcioglu Oguzhan Zengin Osman Inan Enes Seyda Sahiner Gulay Korukluoglu Zafer Sezer Aykut Ozdarendeli Ates Kara Ihsan Ates Safety and immunogenicity of inactive vaccines as booster doses for COVID-19 in Türkiye: A randomized trial Human Vaccines & Immunotherapeutics booster vaccine coronavac covid-19 inactive turkovac |
| title | Safety and immunogenicity of inactive vaccines as booster doses for COVID-19 in Türkiye: A randomized trial |
| title_full | Safety and immunogenicity of inactive vaccines as booster doses for COVID-19 in Türkiye: A randomized trial |
| title_fullStr | Safety and immunogenicity of inactive vaccines as booster doses for COVID-19 in Türkiye: A randomized trial |
| title_full_unstemmed | Safety and immunogenicity of inactive vaccines as booster doses for COVID-19 in Türkiye: A randomized trial |
| title_short | Safety and immunogenicity of inactive vaccines as booster doses for COVID-19 in Türkiye: A randomized trial |
| title_sort | safety and immunogenicity of inactive vaccines as booster doses for covid 19 in turkiye a randomized trial |
| topic | booster vaccine coronavac covid-19 inactive turkovac |
| url | http://dx.doi.org/10.1080/21645515.2022.2122503 |
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