Clinical trial NCT05863429: Observational National Vaccine Study
Official title: Observational Study to Evaluate the Effectiveness, Immunogenicity and Safety of Inactivated COVID-19 Vaccine (TURKOVAC) Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Infection
Keywords: COVID-19
Effectiveness
Immunogenicity
Safety
Observational
Lead sponsor: Health Institutes of Turkey
Sponsor class: OTHER_GOV
First posted: 2023-05-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults aged 18 years and older

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subjects who meet all of the following criteria will be included in the study:

  1. Individuals aged 18 and over,
  2. Individuals who have never had a COVID-19 vaccine before OR who have received COVID-19 mRNA or inactivated vaccines in the primary vaccination and have selected TURKOVAC as the booster dose (3rd dose and 4th dose),
  3. Individuals who have not had COVID-19 during the last trimester,
  4. Only for subjects who will receive 4th dose of vaccine: Those who have received the third dose of TURKOVAC vaccine and those who have spent at least 90 days since the third dose,
  5. Individuals who agree to provide blood samples and verifiable identification information (in accordance with local regulations), who may be contacted by the investigator during the study and who may come into contact with the investigator,
  6. Individuals who will be able to voluntarily understand and sign informed consent,
  7. Individuals who accept phone calls to be made to them for the purpose of collecting safety-related data.

Exclusion Criteria:

* Subjects who meet one of the following criteria will be excluded from the study.

  1. For subjects who will receive primary vaccination: Individuals who have received any vaccine and/or flu vaccine within 14 days prior to the COVID-19 vaccine.
  2. Individuals who have chosen a vaccine other than TURKOVAC as a booster dose.

Primary outcomes:
measure: Incidence of adverse reactions
timeFrame: 3 - 7 days after vaccination
measure: Incidence of Serious Adverse Events (SAE)
timeFrame: 365 days after vaccination
Secondary outcomes:
measure: Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels
timeFrame: 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)
Other outcomes:
measure: Microneutralization levels
timeFrame: 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)
measure: Determine the confirmed COVID-19 case rates
timeFrame: At least 14 days after the second dose of TURKOVAC vaccine
measure: Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels and microneutralization levels
timeFrame: Before the fourth dose of TURKOVAC vaccine is given and on the 28th (±2 days) day following the booster dose of vaccine
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital Internal Medicine Clinic
city: Bolu
country: Turkey
facility: T.R. Ministry of Health Abant Izzet Baysal University Training and Research Hospital
city: Eskişehir
country: Turkey
facility: Eskişehir City Hospital Internal Medicine
city: Istanbul
country: Turkey
facility: T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases
city: Kayseri
country: Turkey
facility: Kayseri City Training and Research Hospital, Department of Infectious Diseases and Clinical Microbiology
city: Kayseri
country: Turkey
facility: Erciyes University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
city: Kocaeli
country: Turkey
facility: Health Sciences University Derince Training and Research Hospital
city: Trabzon
country: Turkey
facility: Health Sciences University Kanuni Training and Research Hospital Infectious Diseases and Clinical Microbiology
Study officials:
affiliation: Assoc. Prof.
name: İhsan Ateş, Assoc. Prof.
role: STUDY_DIRECTOR
References: