SARS-CoV-2. COVID-19
Conditions
Interventions
Intervention 1: Intervention group 1: Participants in this group will receive one doses (IM) of RAZI recombinant spike protein vaccine (day 0). Intervention 2: Intervention group 2: Participants in th
Sponsors
Razi Vaccine and Serum Research Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Having Iranian citizenship; Age 18 years and older; Having history of full vaccination with Sinopharm vaccine (two doses) 75 to 195 days from the last vaccination; Signing an informed consent form; For females of childbearing age 18 to 49 years: use of at least one effective method of contraception (condom, oral contraceptive pills, intrauterine device, norplant capsule) and willing to continue up to two month after the booster dose.
Exclusion criteria
Exclusion criteria: History of allergy to drugs or vaccines (e.g urticaria and fever); Any current or new diagnosis of acute or chronic illness requiring continuous ongoing medical care; Severe cardiovascular disease; Breastfeeding; History of receiving any vaccine within 14 days before receiving the booster dose; History of diseases resulting in immunosuppression (suspected and definite); History of long-term use of immunosuppressive drugs, including history of long-term use of systemic corticosteroids (equivalent to 10 mg or more daily prednisolone) with the exception of topical steroids (more than 14 consecutive days) within the past 4 months; History of uncontrolled serious psychiatric illnesses; History of chronic neurological diseases (including seizures and epilepsy)? Acute febrile illness at the time of booster vaccine injection; Splenectomy for any reason; Close contact with a confirmed COVID-19 case within two weeks before the booster dose; Continued use of anticoagulants such as coumarin and related anticoagulants (such as warfarin) or new oral anticoagulants / antiplatelet agents. Note: Less than 325 mg of aspirin per day is allowed as prophylaxis; Recent diagnosis or treatment of cancers except basal cell carcinoma and In-situ cervical cancer; Received blood and/or any blood products and/or immunoglobulins within three months preceding the booster dose; History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, or deficiency of blood clotting factors); Current substance or alcohol abuse; Pregnancy based on the participant's statement and the time of the first day of the last menstrual period and negative pregnancy test (baby check) on the day of vaccination; History of COVID -19 based on laboratory or clinical evidence after primary vaccination; Chronic unstable diseases in the last 4 weeks, including hospitalization due to surgery, deterioration of one organ function, the need to add new drugs or serious dose adjustments to existing drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutralizing antibody activity. Timepoint: On day zero, two weeks, 3 and 6 months after the booster dose injection. Method of measurement: SARS-CoV-2 virus neutralizing antibody titter measured in bio-safety level III lab using conventional method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum levels of specific IgG antibodies against S1, RBD antigens. Timepoint: On day zero, two weeks, 3 and 6 months after the booster dose vaccine. Method of measurement: ELISA method.;The cell-mediated immunity will be evaluated by counting the number of CD3, CD4 and CD8 cells and joint calculation of CD3 and CD4 and CD3 and CD8 . IFN-?, TNF-a, and interleukins 2, 4, 6, and 17 will also be measured. It will be will be assessed in 20 members of the selected group. Summary of the measures performed in this section are as follows: 1- Assessment of CD4 to CD8 cell proportions after stimulation of PBMC (Peripheral Blood Mononuclear Cells) by inactivated virus and recombinant spike protein using flow cytometry 2- Assessment of specific proliferation of PBMC cells stimulated by inactivated virus and recombinant spike protein using flow cytometry 3 - Assessment of TH1 and TH2 specific cellular immunity after PBMC stimulation in vaccinated individuals with recombinant spike protein to determine the levels of interferon-gamma, interleukin-4, tumor necrosis factor-alpha and interleukin 6 using ELISpot and ELISA kit. Timepoint: On day zero, two weeks, 3 and 6 months after the booster dose vaccine. Method of measurement: Immunologic lab tests.;Abnormal vital signs and anaphylactic reactions before and immediately after vaccination: number and percentages of participants who develop abnormal vital signs within half an hour of receiving the vaccine will be recorded. Abnormal vital signs include temperature, respiratory rate, heart rate, systolic and diastolic blood pressure. Anaphylaxis is defined as an immediate systemic hypersensitivity simultaneously involving two systems. Anaphylactic reactions include: erythema, pruritus, urticaria and angioedema, bronchospasm, laryngeal edema, dizziness, hypotension, nausea, shortness of breath, wheezing, arrhythmia, cyanosis, vomiting, diarrhea, abdominal pain and will be checked up to half an hour after vaccine booster dose. Timepoint: Be | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Hossein Fallah Mehrabadi
Razi Vaccine and Serum Research Institute
Outcome results
None listed