Covid-19 Living Data

Trial NCT04979949
Publication Omma A, Hum Vaccines Immunother, 2022
Dates: 2021-07-12 to 2021-09-10
Funding: Public/non profit (Health Institutes of Türkiye (TUSEB))
Conflict of interest: no COI

Methods
	RCT
	Location : Multicenter / Turkiye Follow-up duration (months): 1
	3 mcg TURKOVAC (n = 108) 3 mcg (600 SU) CoronaVac (n = 114)
Inclusion criteria	Healthy or Having controlled underlying disease or mild-to-moderate comorbidities (comorbidities that did not cause end-organ damage) male or female adults aged 18–60 years who were vaccinated with two doses of CoronaVac vaccine and did not exceed the duration of at least 90 days and a maximum of 270 days from the second dose of vaccination.
Exclusion criteria	Receipt of any vaccine (registered or investigational) other than study vaccine within 30 days before and after each study vaccine (one week for authorized seasonal flu vaccine or pneumococcal vaccine) Having had COVID-19 after primary vaccination Prior or planned receipt of any other trial or licensed vaccine or product likely to affect the interpretation of trial data (e.g. adenovirus vector vaccines, any coronavirus vaccine) Being pregnant at the time of enrollment or planning to become pregnant within the first three months following vaccination Any confirmed or suspected immunosuppressive or immunodeficiency state History of allergic disease or reaction likely to be exacerbated by any component of the study vaccines Any history of anaphylaxis Current diagnosis or treatment of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder) Continued use of anticoagulants such as coumarins or new oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban) Presence of cerebral venous sinus thrombosis, antiphospholipid syndrome or a history of heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2) History of active or previous autoimmune neurological disorder (eg. multiple sclerosis, Guillain-Barre syndrome, transverse myelitis) (Bell's palsy is not an exclusion criterion) Presence of severe renal or hepatic impairment.
Interventions
	Intervention 1 IM dose of 3 mcg TURKOVAC (booster), between 90-270 days after second dose of prime with CoronaVac.
	Control 1 IM dose of 3 mcg (600 SU) CoronaVac (booster), between 90-270 days after second dose of prime with CoronaVac.
Participants
	Randomized 222 participants
	Characteristics of participants Type of participants: Adults N=222 150 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR
	Description of participants Adults including healthy or stable co-morbidities with no recent history of COVID-19 in 4 centres in Turkiye.
Primary outcome
	In the register 1) Incidence of adverse reactions [Time Frame: 7 days after vaccination]: Incidence of adverse reactions within 7 days of vaccination in all subjects. 2) Incidence of Serious Adverse Events (SAE) [Time Frame: 168 days after vaccination]: Incidence of Serious Adverse Events (SAE) in all subjects 168 days after vaccination.
	In the report Number, severity, and rate of volunteers experiencing AEs and serious AEs... incidence of adverse reactions within 7 days post-vaccination and the incidence of serious AEs up to day 28 post-vaccination
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: Yes Data accessibility: Anonymous participant data that support the findings of this study are available from the corresponding author upon reasonable request. Corresponding author Ahmet Omma: ahmetomma@gmail.com
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, the study registry and protocol were used in data extraction and risk of bias assessment. Preliminary analysis. The trial (n = 222) achieved its target sample size (n = 222). There is no change from the trial registration in the intervention and control treatments.