We did a double-blind, randomised, placebo-controlled, case-driven phase 3 clinical trial to assess the safety and efficacy of the inactivated SARS-CoV-2 vaccine CoronaVac among volunteers in Turkey.

Volunteers aged 18–59 years with no history of COVID-19 were screened for eligibility. Exclusion criteria included (but were not limited to) positive PCR and total antibody tests for SARS-CoV-2; pregnancy, breastfeeding; known allergy to components of the study vaccine or placebo; recent (within the past 6 months) or planned use of immunosuppressive therapy, or use of immunoglobulins or any blood products within the past 3 months; asplenia; history of bleeding disorder; alcohol or drug abuse; and any confirmed or suspected autoimmune or immunodeficiency disease. The study protocol containing the full list of eligibility criteria is available online.10

Participants were recruited in two consecutive cohorts (K1 and K2) at 24 centres (appendix p 8) in Turkey between Sept 15, 2020, and Jan 6, 2021. K1 included actively working health-care workers such as doctors, nurses, and technicians working in health-care facilities, including but not confined to COVID-19 areas, and was launched to closely observe the safety of the vaccine before proceeding with the community. K2 included subjects representing the community in addition to health-care workers included in K1.

During the study, the Ministry of Health gave an emergency use authorisation for CoronaVac on Jan 13, 2021, and started an immediate vaccination programme initially for health-care workers and later for the public, prioritising older adults (aged ≥65 years). Although recruitment of volunteers was ongoing at this time, to comply with the principles of the Declaration of Helsinki regarding using a placebo for human subjects in medical research, the ethics committee suggested discontinuing the masking and injection of participants in the placebo group. Consequently, the placebo recipients were offered vaccines, first in K1 and later in K2.

The study protocol was approved by the clinical research ethics board of Hacettepe University (approval number 2020/10-26, July 16, 2020). The entire study protocol was published previously and is available on the Hacettepe University Vaccine Institute website.10 Signed informed consent was obtained from participants before screening.

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