Covid-19 Living Data

Trial NCT04942405
Publication Tanriover M, Vaccines, 2022
Dates: 2021-06-22 to 2022-01-07
Funding: Public/non profit (This research was funded, and the investigational products for the study were provided by The Health Institutes of Turkey (TUSEB).)
Conflict of interest: Yes

Methods
	RCT
	Location : Multicenter / Turkey Follow-up duration (months): *
	TURKOVAC (n = 642) CoronaVac (n = 648)
Inclusion criteria	Volunteers 18–55 years of age with no COVID-19 history who consented to participate agreed to comply with all study visits, procedures, contraceptive requirements were medically stable.
Exclusion criteria	Acute illness or fever within 48 h before or use of antipyretic/analgesic medication within 24 h before planned administration of vaccine pregnancy or breastfeeding known history of SARS-CoV-2 infection current positive (polymerase chain reaction (PCR)-based viral RNA detection) or past positive (serological testing or PCR-based viral RNA detection) diagnostic test result for SARS-CoV-2 prior administration of an investigational or approved coronavirus vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19 cardiac diseases uncontrolled hypertension history of coronary artery disease at early ages in their first-degree relatives (presence of coronary artery disease before age 55 in men and before age 65 in women) body mass index >= 40 kg/m2 autoimmune disease severe allergic reaction to any licensed or investigational vaccine or to any of the constituents of CoronaVac or TURKOVAC bleeding disorders immunosuppressive or immunodeficient state (including human immunodeficiency virus), asplenia, recurrent severe infections receipt or plan of receipt of a licensed, live replicating vaccine within 28 days before or after first study vaccination or a licensed inactivated or non-replicating vaccine within 14 days before or after first study vaccination immunosuppressive therapy within 6 months prior to screening, or planned receipt throughout the study receipt of systemic Igs or blood products within 3 months prior to screening or plans to receive such products during the study.
Interventions
	Intervention 2 IM doses of 3 mcg of TURKOVAC, 28 days apart
	Control 2 IM doses of 3 mcg of CoronaVac, 28 days apart
Participants
	Randomized 1290 participants
	Characteristics of participants Type of participants: Healthy adults N=1290 665 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR
	Description of participants Adults including healthy and with stable co-morbidities with no history of COVID-19 in 8 centres in Türkiye.
Primary outcome
	In the register Protection Indexes of Two Vaccine Doses For Symptomatic COVID-19. [Time Frame: 2 weeks after the second dose of vaccination]: To evaluate the efficacy of two-dose regimen of TURKOVAC and two-dose regimen of CoronaVac vaccines for Real Time-PCR confirmed symptomatic COVID-19 disease.
	In the report Protection rates of two doses of TURKOVAC and two doses of CoronaVac against RT-PCR-confirmed symptomatic COVID-19 at least 14 days after the second vaccination dose.
Documents available	Protocol NR Statistical plan * Data-sharing stated: Yes Data accessibility: Proposals should be submitted to the sponsor, Health Institutes of Türkiye, who holds all the financial and intellectual rights of the study and the study vaccine TURKOVAC. Corresponding author Serhat Unal: sunal@hacettepe.edu.tr
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the published article and its supplement, the study registry was used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. Preliminary analysis with data cut-off date of February 23, 2022. Authors stated, "The study was closed to recruitment far before reaching the targeted sample size as the primary outcome was attained, TURKOVAC was granted EUA, and the vaccine was integrated as an option for community vaccine roll-out." The primary outcome in the article reflects that in the registry. There is no change from the trial registration in the intervention and control treatments.