Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey

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dc.authoridCinar, Gule/0000-0002-7635-8848
dc.authoridSingil, Sarp/0000-0002-4280-925X
dc.authoridAzap, Alpay/0000-0001-5035-055X
dc.authoridAksu, Kurtuluş/0000-0001-6195-1158
dc.authoridEmre, Salih/0000-0003-4216-5287
dc.authoridYILDIZ, JALE/0000-0002-4950-570X
dc.authoridKoca Kalkan, İlkay/0000-0002-9788-1056
dc.authorwosidCinar, Gule/ABA-2413-2020
dc.authorwosidSingil, Sarp/JAC-2738-2023
dc.authorwosidAzap, Alpay/KMA-1874-2024
dc.authorwosidAksu, Kurtuluş/AAD-9192-2022
dc.authorwosidEmre, Salih/HGC-3199-2022
dc.authorwosidYILDIZ, JALE/JFT-0291-2023
dc.authorwosidKoca Kalkan, İlkay/ACR-0995-2022
dc.contributor.authorTanriover, Mine Durusu
dc.contributor.authorDoganay, Hamdi Levent
dc.contributor.authorAkova, Murat
dc.contributor.authorGuner, Hatice Rahmet
dc.contributor.authorAzap, Alpay
dc.contributor.authorAkhan, Sila
dc.contributor.authorKose, Sukran
dc.date.accessioned2024-08-04T20:50:24Z
dc.date.available2024-08-04T20:50:24Z
dc.date.issued2021
dc.departmentİnönü Üniversitesien_US
dc.description.abstractBackground CoronaVac, an inactivated whole-virion SARS-CoV-2 vaccine, has been shown to be well tolerated with a good safety profile in individuals aged 18 years and older in phase 1/2 trials, and provided a good humoral response against SARS-CoV-2. We present the interim efficacy and safety results of a phase 3 clinical trial of CoronaVac in Turkey. Methods This was a double-blind, randomised, placebo-controlled phase 3 trial. Volunteers aged 18-59 years with no history of COVID-19 and with negative PCR and antibody test results for SARS-CoV-2 were enrolled at 24 centres in Turkey. Exclusion criteria included (but were not limited to) immunosuppressive therapy (including steroids) within the past 6 months, bleeding disorders, asplenia, and receipt of any blood products or immunoglobulins within the past 3 months. The K1 cohort consisted of health-care workers (randomised in a 1:1 ratio), and individuals other than health-care workers were also recruited into the K2 cohort (randomised in a 2:1 ratio) using an interactive web response system. The study vaccine was 3 mu g inactivated SARS-CoV-2 virion adsorbed to aluminium hydroxide in a 0.5 mL aqueous suspension. Participants received either vaccine or placebo (consisting of all vaccine components except inactivated virus) intramuscularly on days 0 and 14. The primary efficacy outcome was the prevention of PCR-confirmed symptomatic COVID-19 at least 14 days after the second dose in the per protocol population. Safety analyses were done in the intention-to-treat population. This study is registered with ClinicalTrials.gov (NCT04582344) and is active but no longer recruiting. Findings Among 11 303 volunteers screened between Sept 14, 2020, and Jan 5, 2021, 10 218 were randomly allocated. After exclusion of four participants from the vaccine group because of protocol deviations, the intention-to-treat group consisted of 10 214 participants (6646 [65.1%] in the vaccine group and 3568 [34.9%] in the placebo group) and the per protocol group consisted of 10 029 participants (6559 [65.4%] and 3470 [34.6%]) who received two doses of vaccine or placebo. During a median follow-up period of 43 days (IQR 36-48), nine cases of PCR-confirmed symptomatic COVID-19 were reported in the vaccine group (31.7 cases [14.6-59.3] per 1000 person-years) and 32 cases were reported in the placebo group (192.3 cases [135.7-261.1] per 1000 person-years) 14 days or more after the second dose, yielding a vaccine efficacy of 83.5% (95% CI 65.4-92.1; p<0.0001). The frequencies of any adverse events were 1259 (18.9%) in the vaccine group and 603 (16.9%) in the placebo group (p=0.0108) with no fatalities or grade 4 adverse events. The most common systemic adverse event was fatigue (546 [8.2%] participants in the vaccine group and 248 [7.0%] the placebo group, p=0.0228). Injection-site pain was the most frequent local adverse event (157 [2.4%] in the vaccine group and 40 [1.1%] in the placebo group, p<0.0001). Interpretation CoronaVac has high efficacy against PCR-confirmed symptomatic COVID-19 with a good safety and tolerability profile. Copyright (C) 2021 Elsevier Ltd. All rights reserved.en_US
dc.description.sponsorshipTUSEBen_US
dc.description.sponsorshipWe are grateful to all participants who volunteered to be part of this study and to all members of the clinical research teams of the participating sites. We thank TUSEB for funding the study and Omega-CRO for the statistical analyses and production of figures, and providing the study protocol. We also thank the members of the data and safety monitoring board for their contributions in the safe execution of this study.en_US
dc.identifier.doi10.1016/S0140-6736(21)01429-X
dc.identifier.endpage222en_US
dc.identifier.issn0140-6736
dc.identifier.issn1474-547X
dc.identifier.issue10296en_US
dc.identifier.pmid34246358en_US
dc.identifier.scopus2-s2.0-85110110235en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage213en_US
dc.identifier.urihttps://doi.org/10.1016/S0140-6736(21)01429-X
dc.identifier.urihttps://hdl.handle.net/11616/100040
dc.identifier.volume398en_US
dc.identifier.wosWOS:000674291900021en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherElsevier Science Incen_US
dc.relation.ispartofLanceten_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subject[No Keywords]en_US
dc.titleEfficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkeyen_US
dc.typeArticleen_US

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