Coronavirus Disease (COVID-19). Need for immunization against COVID-19
Conditions
Interventions
Intervention 1: Intervention group in the first cohort: In 6 cities (Isfahan, Babol, Bandar Abbas, Sari, Kerman and Hamedan) 80% of people (14,400 people) receive the intervention (vaccine) after rand
Sponsors
Pasture Institute of Iran
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Giving written informed consent Ability to comply with the vaccination plan, scheduled visits and lab tests Having general health and controlled underlying diseases Iranian citizenship Residing in the studied cities (Isfahan, Babol, Bandar Abbas, Zanjan, Kerman, Hamedan, Yazd and Sari) Both Genders Aged 18 to 80 years
Exclusion criteria
Exclusion criteria: Pregnant or lactating women or those who plan to become pregnant up to 3 months after the last dose of the vaccine Application of vaccines containing tetanus toxoid in the last 3 months History of blood /blood products transfusions such as immunoglobulin in the last three months Type 2 diabetes ( HbA1c higher than 7.5) Chronic liver disease (liver enzymes more than 5 times normal: ALT=150, AST=100) Subjects previously vaccinated against SARS-CoV-2. History of psychiatric disorders Uncontrolled asthma (having an asthma attack in the last three months). History of severe allergic reaction (anaphylaxis) to the vaccine throughout life History of smoking more than 20 cigarettes a day for more than twenty years Coagulation problems that contraindicate IM injection Previous vaccination with any coronavirus vaccine or participation in other COVID-19 vaccine trials Treatment with immunomodulators in the last 30 days Uncontrolled hypertension (cytological pressure more than 140, diastolic pressure more than 90 mm Hg) Fever or acute illness for 7 days before the injection or on the day of the injection Chronic kidney disease (GFR less than 30) All individuals who are in phase one priority of vaccination based on the National COVID-19 Vaccination Program (health workers can participate if they give consent) Subjects with tattoos in the deltoid region on both arms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effectiveness of the vaccine in preventing symptomatic Covid-19 infection. Timepoint: 2-dose regimen: Day 14 and 75 days after dose-2 injection; 2-dose + booster regimen: Day 14 after dose-2 injection and 90 days after booster. Method of measurement: Real Time PCR test results for COVID-19. | — |
Secondary
| Measure | Time frame |
|---|---|
| The effectiveness of the vaccine in preventing severe form of Covid-19. Timepoint: 2-dose regimen: Day 14 and 75 days after dose-2 injection; 2-dose + booster regimen: Day 14 after dose-2 injection and 90 days after booster. Method of measurement: Based on the patient's clinical condition, like respiratory symptoms such as dyspnea and tachypnea, SpO2 of lower than 90%, and lung involvement of more than 50%, or hospitalization.;The effectiveness of the vaccine in prevention of death from Covid-19. Timepoint: All cases of death due to COVID-19 will be detected: 2-dose regimen: Day 14 and 75 days after dose-2 injection; 2-dose + booster regimen: Day 14 after dose-2 injection and 90 days after the booster. Method of measurement: According to the diagnosis of the research physician and the DSMB team and based on the definition of the World Health Organization.;SARS-CoV-2 virus neutralization assay. Timepoint: Based on serum samples on day 0 and up to 1 month after receiving the last dose of vaccine in 10% of antibody positive volunteers. Method of measurement: Viral neutralization tests (VNTs).;Humoral safety will be studied on a subset of the population of Babol, Sari (under 2-dose regimen) and Zanjan (under 2-dose + booster regimen). Timepoint: The Humoral test will be done before and 1 month after receiving the last dose. Also, in Babol and Sari, an additional assessment will be done on days 5 and 28 of a 30% sample of subjects (900 people in each city). Method of measurement: EISA test.;The frequency of local and systemic events and mild, moderate , severe, critical adverse events and death will be recorded by the participants in the forms. Timepoint: The occurrence of side effects and adverse events will be monitored from Zero day to 5 months after the injection of the last dose. Method of measurement: Active and inactive monitoring from Zero day to 5 months after the injection of the last dose with the registration of adverse events in CIFs.;Evaluation | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Ehsan Mostafavi
Pasture Institute of Iran
Outcome results
None listed