PMID- 36366373
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221222
IS  - 2076-393X (Print)
IS  - 2076-393X (Electronic)
IS  - 2076-393X (Linking)
VI  - 10
IP  - 11
DP  - 2022 Nov 4
TI  - 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.
LID - 10.3390/vaccines10111865 [doi]
LID - 1865
AB  - 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 mug/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.
FAU - Tanriover, Mine Durusu
AU  - Tanriover MD
AUID- ORCID: 0000-0001-9565-4389
AD  - Department of Internal Medicine, Hacettepe University Faculty of Medicine, 06230 
      Ankara, Turkiye.
AD  - Vaccine Institute, Hacettepe University, 06230 Ankara, Turkiye.
FAU - Aydin, Ozlem Altuntas
AU  - Aydin OA
AD  - Department of Infectious Diseases and Clinical Microbiology, University of Health 
      Sciences, Basaksehir Cam and Sakura City Hospital, 34480 Istanbul, Turkiye.
FAU - Guner, Rahmet
AU  - Guner R
AD  - Infectious Diseases and Clinical Microbiology Clinic, Ankara Yildirim Beyazit 
      University, Ankara City Hospital, 06800 Ankara, Turkiye.
FAU - Yildiz, Orhan
AU  - Yildiz O
AD  - Department of Infectious Diseases and Clinical Microbiology, Erciyes University 
      Faculty of Medicine, 38030 Kayseri, Turkiye.
FAU - Celik, Ilhami
AU  - Celik I
AUID- ORCID: 0000-0002-2604-3776
AD  - Department of Infectious Diseases and Clinical Microbiology, Kayseri City 
      Training and Research Hospital, 38080 Kayseri, Turkiye.
FAU - Doganay, Hamdi Levent
AU  - Doganay HL
AD  - Department of Gastroenterology, Medical Park Pendik Hospital, 34899 Istanbul, 
      Turkiye.
AD  - Department of Internal Medicine, Bahcesehir University School of Medicine, 34734 
      Istanbul, Turkiye.
FAU - Kose, Sukran
AU  - Kose S
AD  - Infectious Diseases Clinic, University of Health Sciences, Izmir Tepecik Training 
      and Research Hospital, 35020 Izmir, Turkiye.
FAU - Akhan, Sila
AU  - Akhan S
AD  - Department of Infectious Diseases and Clinical Microbiology, Kocaeli University 
      Faculty of Medicine, 41001 Kocaeli, Turkiye.
FAU - Akalin, Emin Halis
AU  - Akalin EH
AUID- ORCID: 0000-0001-7530-1279
AD  - Department of Infectious Diseases and Clinical Microbiology, Bursa Uludag 
      University Faculty of Medicine, 16059 Bursa, Turkiye.
FAU - Sezer, Zafer
AU  - Sezer Z
AD  - Department of Medical Pharmacology, Erciyes University Faculty of Medicine, 38030 
      Kayseri, Turkiye.
FAU - Ozdarendeli, Aykut
AU  - Ozdarendeli A
AD  - Department of Microbiology, Erciyes University Faculty of Medicine, 38030 
      Kayseri, Turkiye.
AD  - Vaccine Research, Development and Application Centre (ERAGEM), Erciyes 
      University, 38280 Kayseri, Turkiye.
FAU - Unal, Serhat
AU  - Unal S
AUID- ORCID: 0000-0003-1184-4711
AD  - Vaccine Institute, Hacettepe University, 06230 Ankara, Turkiye.
AD  - Department of Infectious Diseases and Clinical Microbiology, Hacettepe University 
      Faculty of Medicine, 06230 Ankara, Turkiye.
FAU - On Behalf Of The Turkovac Study Group
AU  - On Behalf Of The Turkovac Study Group
LA  - eng
GR  - TSB-11568-VAC-COV-TUR-F3.01/THE HEALTH INSTITUTES OF TURKIYE (TUSEB)./
PT  - Journal Article
DEP - 20221104
PL  - Switzerland
TA  - Vaccines (Basel)
JT  - Vaccines
JID - 101629355
PMC - PMC9698857
OTO - NOTNLM
OT  - COVID-19
OT  - CoronaVac
OT  - SARS-CoV-2 vaccines
OT  - TURKOVAC
OT  - efficacy
OT  - safety
OT  - vaccination
OT  - vaccine
OT  - vaccine immunogenicity
COIS- Aykut Ozdarendeli is the named inventor on patent applications covering 
      inactivated COVID-19 vaccine development. All remaining authors declare no 
      competing interests.
EDAT- 2022/11/12 06:00
MHDA- 2022/11/12 06:01
PMCR- 2022/11/04
CRDT- 2022/11/11 01:55
PHST- 2022/10/04 00:00 [received]
PHST- 2022/10/27 00:00 [revised]
PHST- 2022/11/01 00:00 [accepted]
PHST- 2022/11/11 01:55 [entrez]
PHST- 2022/11/12 06:00 [pubmed]
PHST- 2022/11/12 06:01 [medline]
PHST- 2022/11/04 00:00 [pmc-release]
AID - vaccines10111865 [pii]
AID - vaccines-10-01865 [pii]
AID - 10.3390/vaccines10111865 [doi]
PST - epublish
SO  - Vaccines (Basel). 2022 Nov 4;10(11):1865. doi: 10.3390/vaccines10111865.