Booster Vaccination Against COVID-19

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 222

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Turkovac	Turkovac	Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.
CoronaVac	CoronaVac	Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.

Primary Outcome Measures

Name	Time	Method
Incidence of Serious Adverse Events (SAE)	168 days after vaccination	Incidence of Serious Adverse Events (SAE) in all subjects 168 days after vaccination
Incidence of adverse reactions	7 days after vaccination	Incidence of adverse reactions within 7 days of vaccination in all subjects

Secondary Outcome Measures

Name	Time	Method
Neutralizing antibody and anti-spike protein immunoglobulin G	On days 0, 28 and 84	Amount of SARS-CoV2 anti-spike protein immunoglobulin G and SARS-CoV2 neutralizing antibody amount

Trial Locations

Locations (4)

Ankara City Hospital Internal Medicine Clinic

🇹🇷

Ankara, Turkey

T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases

🇹🇷

Istanbul, Turkey

Sancaktepe Martyr Professor Dr. İlhan Varank Training and Research Hospital Infectious Diseases and Clinical Microbiology Clinic

🇹🇷

Istanbul, Turkey

Ümraniye Training and Research Hospital Infectious Diseases

🇹🇷

Istanbul, Turkey

Booster Vaccination Against COVID-19

Recruitment & Eligibility

Study & Design

Trial Locations

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