| Autor: |
Tanriover, Mine Durusu, Aydin, Ozlem Altuntas, Guner, Rahmet, Yildiz, Orhan, Celik, Ilhami, Doganay, Hamdi Levent, Kose, Sukran, Akhan, Sila, Akalin, Emin Halis, Sezer, Zafer, Ozdarendeli, Aykut, Unal, Serhat |
| Předmět: |
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| Zdroj: |
Vaccines; Nov2022, Vol. 10 Issue 11, p1865, 17p |
| 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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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