Efficacy, Immunogenicity, and Safety of the Two-Dose Schedules of TURKOVAC versus CoronaVac in Healthy Subjects: A Randomized, Observer-Blinded, Non-Inferiority Phase III Trial

• Published in: Vaccines (Basel) Vol. 10; no. 11; p. 1865
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 01.11.2022; MDPI
• Subjects: Aluminum; Aluminum hydroxide; Antigens; Cardiovascular disease; Clinical trials; Coronary vessels; CoronaVac; Coronaviruses; COVID-19; COVID-19 vaccines; Developing countries; Disease transmission; Effectiveness; efficacy; Evaluation; Immunogenicity; LDCs; Licenses; Polymerase chain reaction; Risk management; Safety; Safety analysis; Schedules; Severe acute respiratory syndrome coronavirus 2; Transgenic animals; TURKOVAC; Underserved populations; vaccine; Vein & artery diseases; Viral diseases; Turkey; Beijing China; Ireland; China; COVID-19; vaccine; vaccine immunogenicity; TURKOVAC; SARS-CoV-2 vaccines; safety; CoronaVac; efficacy; vaccination
• ISSN: 2076-393X; 2076-393X
• DOI: 10.3390/vaccines10111865

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.