COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04979949

Ahmet Omma, Assoc. Prof.

ahmetomma@hotmail.com

2021-07-28

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: - signed informed consent - healthy male or female aged 18 - 60 years (including both groups) - subjects who were vaccinated with coronavac for 2 doses and who had a minimum of 90 days and a maximum of 270 days after the second dose - subjects may have a controlled or moderate comorbidity - female subjects of childbearing potential should be willing to ensure that they or their partner use effective birth control methods continuously from 1 month before and up to 3 months after vaccination - subjects agreed to comply with all study requirements - subjects are willing to share their medical history with their physician and allow access to all medical records when relevant to study procedures - subjects are willing to agree to abstain from donating blood during the study

subjects meeting any of the following criteria will be excluded from the study: administration of any vaccine (registered or investigational) other than study intervention within 30 days before and after each study vaccine (one week for authorized seasonal flu vaccine or pneumococcal vaccine) positive for covid-19 after primary vaccination pre-or planned use of another vaccine or product likely to affect the study (e.g. adenovirus vectored vaccines, any coronavirus vaccine) subjects who were pregnant at the time of enrollment or who plan to become pregnant within the first 3 months following vaccination and who are breastfeeding subjects with fever (above 38°c) at the time of vaccination and/or up to 72 hours before administration of immunoglobulins and/or any blood product within 3 months prior to vaccination any confirmed or suspected immunosuppressive or immunodeficiency state; asplenia; recurrent severe infections and use of immunosuppressants (less than ≤14 days) in the last 6 months, excluding topical steroids or short-term oral steroids possible history of allergic disease or reaction (e.g. to the active substance) by any component of the study vaccines any history of anaphylaxis current cancer diagnosis or treatment (excluding basal cell carcinoma of the skin and cervical carcinoma in situ) history of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture continued use of anticoagulants such as coumarins and related anticoagulants (i.e. warfarin) or new oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban) cerebral venous sinus thrombosis, antiphospholipid syndrome, or a history of heparin-induced thrombocytopenia and thrombosis (hitt or hit type 2). suspected or known current alcohol or drug addiction any other significant disease, disorder or finding that could significantly increase the subject's risk for participation in the study, affect the subject's ability to participate in the study, or impair the interpretation of study data; severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, kidney disease, endocrine disorder, and neurological disease (mild/moderate well-controlled comorbidities are permitted) history of active or previous autoimmune neurological disorders (e.g. multiple sclerosis, guillain-barre syndrome, transverse myelitis) (bell's palsy will not be an exclusion criterion) subjects with severe renal impairment or liver failure subjects who will undergo scheduled elective surgery during the study subjects with a life expectancy of less than 6 months subject who participated in another clinical trial study involving an investigational product in the past 12 weeks in case of clinical necessity, a covid-19 pcr (polymerase chain reaction) test will be requested from the subjects, and subjects who are positive will be excluded from the study known history of sars-cov-2 infection acute respiratory disease (moderate or severe illness with or without fever) (subjects may be screened again after acute condition has resolved) fever (oral temperature > 37.8°c) (subjects can be enrolled again after acute condition improves) insufficient level of turkish to perform the informed consent, except where briefing by an independent witness can be provided and is available

2

Health Institutes of Turkey

18

60

Turkey

Healthy volunteers

N/A

222

Incidence of adverse reactions;Incidence of Serious Adverse Events (SAE)

None

Phase 2

[{"arm_notes": "1; after the second dose of the first course of CoronaVac vaccine.", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1; after the second dose of the first course of CoronaVac vaccine.", "treatment_id": 1322, "treatment_name": "Turkovac vaccine", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]