| Autor: |
Tanriover MD; Department of Internal Medicine, Hacettepe University Faculty of Medicine, 06230 Ankara, Türkiye.; Vaccine Institute, Hacettepe University, 06230 Ankara, Türkiye., Aydin OA; Department of Infectious Diseases and Clinical Microbiology, University of Health Sciences, Başaksehir Cam and Sakura City Hospital, 34480 Istanbul, Türkiye., Guner R; Infectious Diseases and Clinical Microbiology Clinic, Ankara Yildirim Beyazit University, Ankara City Hospital, 06800 Ankara, Türkiye., Yildiz O; Department of Infectious Diseases and Clinical Microbiology, Erciyes University Faculty of Medicine, 38030 Kayseri, Türkiye., Celik I; Department of Infectious Diseases and Clinical Microbiology, Kayseri City Training and Research Hospital, 38080 Kayseri, Türkiye., Doganay HL; Department of Gastroenterology, Medical Park Pendik Hospital, 34899 Istanbul, Türkiye.; Department of Internal Medicine, Bahcesehir University School of Medicine, 34734 Istanbul, Türkiye., Kose S; Infectious Diseases Clinic, University of Health Sciences, Izmir Tepecik Training and Research Hospital, 35020 Izmir, Türkiye., Akhan S; Department of Infectious Diseases and Clinical Microbiology, Kocaeli University Faculty of Medicine, 41001 Kocaeli, Türkiye., Akalin EH; Department of Infectious Diseases and Clinical Microbiology, Bursa Uludag University Faculty of Medicine, 16059 Bursa, Türkiye., Sezer Z; Department of Medical Pharmacology, Erciyes University Faculty of Medicine, 38030 Kayseri, Türkiye., Ozdarendeli A; Department of Microbiology, Erciyes University Faculty of Medicine, 38030 Kayseri, Türkiye.; Vaccine Research, Development and Application Centre (ERAGEM), Erciyes University, 38280 Kayseri, Türkiye., Unal S; Vaccine Institute, Hacettepe University, 06230 Ankara, Türkiye.; Department of Infectious Diseases and Clinical Microbiology, Hacettepe University Faculty of Medicine, 06230 Ankara, Türkiye., On Behalf Of The Turkovac Study Group |
| Abstrakt: |
We present the interim results of the efficacy, immunogenicity, and safety of the two-dose schedules of TURKOVAC versus CoronaVac. This was a randomized, observer-blinded, non-inferiority trial (NCT04942405). Volunteers were 18-55 years old and randomized at a 1:1 ratio to receive either TURKOVAC or CoronaVac at Day 0 and Day 28, both of which are 3 μg/0.5 mL of inactivated severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) adsorbed to aluminum hydroxide. The primary efficacy outcome was the prevention of polymerase chain reaction (PCR)-confirmed symptomatic coronavirus disease 2019 (COVID-19) at least 14 days after the second dose in the modified per-protocol (mPP) group. Safety analyses were performed in the modified intention-to-treat (mITT) group. Between 22 June 2021 and 7 January 2022, 1290 participants were randomized. The mITT group consisted of 915 participants, and the mPP group consisted of 732 participants. During a median follow-up of 90 (IQR 86-90) days, the relative risk reduction with TURKOVAC compared to CoronaVac was 41.03% (95% CI 12.95-60.06) for preventing PCR-confirmed symptomatic COVID-19. The incidences of adverse events (AEs) overall were 58.8% in TURKOVAC and 49.7% in CoronaVac arms ( p = 0.006), with no fatalities or grade four AEs. TURKOVAC was non-inferior to CoronaVac in terms of efficacy and demonstrated a good safety and tolerability profile. |
