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To assess the long-term safety of TURKOVAC in individuals who have not previously received the COVID-19 vaccine or who have received their primary vaccination with inactivated or mRNA vaccine, or who have received their primary vaccination with similarly inactivated or mRNA vaccine and who subsequently received the first dose or second dose of booster vaccine, who meet the inclusion/exclusion criteria of the study.
The primary objective of the study was to evaluate the long-term safety of TURKOVAC in individuals who had never received a COVID-19 vaccine before, or who received their primary vaccination with inactivated or mRNA vaccine, or who received their primary vaccination with similarly inactivated or mRNA vaccine, and who subsequently received a first dose or second dose of booster vaccine, in individuals who met the inclusion/exclusion criteria of the study. The secondary objective of the study was to evaluate the immunogenicity of TURKOVAC in individuals who meet the inclusion/exclusion criteria of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals who have never been vaccinated against COVID-19 | Individuals who have never been vaccinated against COVID-19 and who have applied to the study centers to be vaccinated with TURKOVAC within the scope of the routine vaccination program. |
| |
| Previously primary vaccinated individuals |
|
| |
| Individuals who have only received TURKOVAC vaccine before | Only individuals who have previously been vaccinated of TURKOVAC will also be invited to be included in the study retrospectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taking biological samples (blood) and keeping records with phone calls | Biological | Within the scope of the study, no intervention will be made to the participants. According to the vaccination program implemented in Turkey, subjects who apply to the study centers for TURKOVAC vaccine will be invited to the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions | Incidence of adverse reactions in all subjects within 3 - 7 days after vaccination (phone call). | 3 - 7 days after vaccination |
| Incidence of Serious Adverse Events (SAE) | Incidence of Serious Adverse Events (SAE) up to 365 days after vaccination in all subjects | 365 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels | Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels (from subjects available) immediately before the first dose of TURKOVAC vaccine (day 0) and on the following days of 28 (±2 days), 48 (±5 days), 84 (±5 days), and 168 (±10 days) | Immediately before the first dose of TURKOVAC vaccine (day 0) and on the following days of 28 (±2 days), 48 (±5 days), 84 (±5 days), and 168 (±10 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Microneutralization levels | Microneutralization levels (from subjects available) immediately before the first dose of TURKOVAC vaccine (day 0) and on the following days 28 (±2 days), 48 (±5 days), 84 (±5 days), and 168 (±10 days) | Immediately before the first dose of TURKOVAC vaccine (day 0) and on the following days 28 (±2 days), 48 (±5 days), 84 (±5 days), and 168 (±10 days) |
Inclusion Criteria:
Subjects who meet all of the following criteria will be included in the study:
Exclusion Criteria:
Subjects who meet one of the following criteria will be excluded from the study.
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Healthy adults aged 18 years and older
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| Name | Affiliation | Role |
|---|---|---|
| İhsan Ateş, Assoc. Prof. | Assoc. Prof. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara City Hospital Internal Medicine Clinic | Ankara | 06800 | Turkey (Türkiye) | |||
| T.R. Ministry of Health Abant Izzet Baysal University Training and Research Hospital |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood samples from volunteers who accepted the study will be used to evaluate the long-term safety and immunogenicity of the TURKOVAC vaccine.
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| Determine the confirmed COVID-19 case rates | To determine the confirmed COVID-19 case rates by symptomatic RT-PCR at least 14 days after the second dose of TURKOVAC vaccine | At least 14 days after the second dose of TURKOVAC vaccine |
| Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels and microneutralization levels | Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels and microneutralization levels (from subjects available) just before the fourth dose of TURKOVAC vaccine is given and on the 28th (±2 days) day following the booster dose of vaccine | Before the fourth dose of TURKOVAC vaccine is given and on the 28th (±2 days) day following the booster dose of vaccine |
| Bolu |
| 14280 |
| Turkey (Türkiye) |
| Eskişehir City Hospital Internal Medicine | Eskişehir | 26080 | Turkey (Türkiye) |
| T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases | Istanbul | 34865 | Turkey (Türkiye) |
| Kayseri City Training and Research Hospital, Department of Infectious Diseases and Clinical Microbiology | Kayseri | 38080 | Turkey (Türkiye) |
| Erciyes University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology | Kayseri | 38280 | Turkey (Türkiye) |
| Health Sciences University Derince Training and Research Hospital | Kocaeli | 41310 | Turkey (Türkiye) |
| Health Sciences University Kanuni Training and Research Hospital Infectious Diseases and Clinical Microbiology | Trabzon | Turkey (Türkiye) |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |