Covid 19. COVID 19, virus identified
Conditions
Interventions
Intervention 1: Intervention Group: Injection of a dose of 80 micrograms of recombinant RBD protein vaccine intramuscularly (deltoid muscle) in 10000 participants in affiliated centers of Baqiyatallah
Sponsors
Bagheiat-allah University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age 18 years and older Candidates who have received two identical doses of the available vaccine (Sinopharm, CovIran Barakat, AstraZenka) and at least 3 months (at least 90 days) have passed since the second dose The candidate is able to fully understand the provisions of the informed consent form and sign it before entering the study
Exclusion criteria
Exclusion criteria: SARS CoV 2 infection (clinically significant or rtPCR document) Approved or suspected COVID 19 in the last two months Going through home quarantine due to suspicion of having an exposure to a patient with Corona History of severe allergic reactions Chronic kidney, liver and various malignancies Acute bacterial infection in the last 7 days Known cases of immunodeficiency, HIV, or autoimmune diseases Receiving immunosuppressive drugs or corticosteroids in the last 3 months Receiving immunoglobulin or blood products during the three months prior to vaccination Pregnant or Breastfeeding women or those who plan to become pregnant during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?The level of specific IgG antibody against RBD protein in days 0 and 21 after booster injection based on GMI, GMT and seroconversion rate (increase at least 4 times in antibody titer) in Shahid Soleimani Clinical Trial Center (sample of 300 people). Timepoint: in days 0 and 21 after booster injection. Method of measurement: The level of specific IgG antibody against RBD protein ibased on GMI, GMT and seroconversion rate (increase at least 4 times in antibody titer) .;Cellular immune response to booster dose based on measurement of IL 4 and INF? levels using ELISA method on days 0 and 21 after injection (subgroup of 90 people). Timepoint: in days 0 and 21 after booster injection. Method of measurement: Cellular immune response to booster dose based on measurement of IL 4 and INF? levels using ELISA method .;Measurement of neutralizing antibody level by neutralization test method Virus (subgroup of 90 people). Timepoint: in days 0 and 21 after booster injection. Method of measurement: Measurement of neutralizing antibody level by neutralization test method Virus. | — |
Secondary
| Measure | Time frame |
|---|---|
| Any reaction within 30 minutes after booster dose injection. Timepoint: within 30 minutes after booster dose injection. Method of measurement: ?Data collection and recording by the nurse or physician based on the participating condition within 30 minutes after injection at the vaccination site.;Occurrence of local adverse event (s) (pain, redness, stiffness, swelling, skin rash, burning and itching) or systemic (fever, headache, chills, diarrhea) Vomiting, muscle pain, joint pain, shortness of breath, fatigue, allergic reactions, etc.) based on the severity, duration and maximum severity of the complication within 3 and 7 days after injection of the booster dose. Timepoint: within 3 and 7 days after injection of the booster dose. Method of measurement: ?Experts contact participants and record possible side effects.;Incidence of adverse event (s) Systemic (fever, headache, chills, diarrhea, vomiting, muscle aches, joint pain, shortness of breath,fatigue, allergic reactions, etc.) based on the severity, duration and maximum severity of the complication within 28 days after booster dose. Timepoint: within 28 days after booster dose. Method of measurement: ?Experts contact participants and record possible side effects.;Incidence of adverse event (s) Systemic (fever, headache, chills, diarrhea, vomiting, muscle aches, joint pain, shortness of breath, fatigue, allergic reactions, etc.) based on the severity, duration and maximum severity of the complication within 60 days after booster dose as a complementary outcome. Timepoint: within 60 days after booster dose. Method of measurement: ?Experts contact participants and record possible side effects.;Level of IgG antibody specific against RBD protein in 3 and 6 months after booster dose injection and seroconversion rate (increase at least 4 times in antibody titer) in the vaccine group in Shahid Soleimani Clinical Trial Center (group of 200 people) as a complementary outcome. Timepoint: in 3 and 6 months after booster dose | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Hassan Abolghasemi
Bagheiat-allah University of Medical Sciences
Outcome results
None listed