Booster Vaccination Against COVID-19

Study Overview
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Brief Summary
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A booster dose of vaccine (Turkovac or CoronaVac) will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.

Detailed Description
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To determine the safety and immunogenicity of booster doses of vaccine against SARS-CoV2 after a minimum of 90 days and a maximum of 270 days after the 2nd dose of a homologous 2 dose primary regimen. It is planned to recruit 111 subjects for 2 vaccines (Turkovac and CoronaVac). There will be a total of 222 subjects.

Official Title
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Double-Blind, Randomized, Controlled, Multi-Centered, Phase 2 Clinical Trial to Determine the Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2

Conditions
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COVID-19, Sars-CoV-2 Infection

Intervention / Treatment
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* Biological: CoronaVac
* Biological: Turkovac


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-Blind, Randomized, Controlled, Multi-Center Phase 2 Clinical Trial to Determine Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2 (Hybrid COV-Rapel TR)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CoronaVac<br>Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose. | Biological: CoronaVac<br>* One dose vaccine will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.<br>|
| Experimental: Turkovac<br>Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose. | Biological: Turkovac<br>* One dose vaccine will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse reactions | Incidence of adverse reactions within 7 days of vaccination in all subjects | 7 days after vaccination | 
| Incidence of Serious Adverse Events (SAE) | Incidence of Serious Adverse Events (SAE) in all subjects 168 days after vaccination | 168 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutralizing antibody and anti-spike protein immunoglobulin G | Amount of SARS-CoV2 anti-spike protein immunoglobulin G and SARS-CoV2 neutralizing antibody amount | On days 0, 28 and 84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Booster, COVID-19, SARS-CoV-2 Vaccine, Efficacy, Immunogenicity, Safety