COVID-19. COVID-19, virus identified
Conditions
Interventions
intramuscular (deltoid muscle). Intervention 2: Intervention group: receiving 120 micrograms of RBD protein recombinant SARS-CoV-2 vaccine in days 0, 21, and 35
intramuscular (deltoid muscle). Intervention 3: Control group: the placebo group will receive an intramuscular injection (in the deltoid muscle) consisting of buffer and adjuvant only, on days 0, 21,
Sponsors
Bagheiat-allah University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 50 years old Healthy in terms of past medical history, physical examination, and laboratory data- Body mass index: 17-35 kg/m2 Willingness to participate in the study and complete follow-up Ability to comprehend study methodology Ability to comprehend and sign informed consent- Provision of consent to access medical documents in case of contracting COVID-19 For women: negative pregnancy screening Acceptance of contraception use from 21 days before randomization until six months after receiving the last vaccine dose Acceptance of not receiving blood product or bone marrow from randomization until three months after receiving last vaccine dose
Exclusion criteria
Exclusion criteria: Positive COVID-19 PCR test Positive antibodies against SARS-CoV-2 (IgG, IgM) History of infection with SARS-CoV-2 documented with RT-PCR test Close contact with COVID-19 infected individual in the past 14 days Isolation due to signs and symptoms that are suspicious of COVID-19 Fever (axillary temperature > 37° C), dry cough, fatigue, nasal congestion, rhinorrhea, sore throat, myalgia, diarrhea, dyspnea in the past 14 days Laboratory abnormalities in biochemistry profile, blood, and urine (including urea, creatinine, fasting blood sugar, Na, K, aspartate transaminase, alanine transaminase, alkaline phosphatase, total bilirubin, hemoglobin, leukocyte count, neutrophil count, lymphocyte count, platelet count, urine protein, urine glucose, blood cells in urine) History of severe allergic reactions or allergy to vaccine components (latex) Experience to severe allergic or allergic reactions to components of the recombinant RBD protein vaccine (latex sensitivity) Personal or family history of seizure, epilepsy, encephalopathy, psychiatric disorder Congenital malformations -History of neurologic diseases or seizure (except for febrile seizure at childhood) Growth disorders Genetic disorders Malnutrition Renal or liver abnormalities Uncontrolled hypertension (>140/90 mmHg) Heart failure with NYHA class =2 Recent exacerbations of cardiovascular disease include cardiovascular intervention, the addition of new cardiovascular drugs to control symptoms, or unstable angina. Chronic obstructive lung disease with GOLD score =2- Asthma Diabetic complications BMI > 35 kg/m2 History of malignancy in the past five years Exacerbation of chronic diseases in the past 7 days Immunodeficiency, lymphoma, leukemia, autoimmune diseases Thyroid disease or history of thyroidectomy without proper control Splenectomy or history of resection of solid organs Coagulation abnormalities Anti-tuberculosis treatment Positive HBSAg Positive HIV Ab Positive HCV Ab Receiving immunosuppressive therapy for 14 consecutive days in the past 3 months or need for such therapy in the following 6 months Receiving any off-label or investigational therapy for COVID-19 Receiving flu vaccine in the past 14 days or other vaccines in the past 4 weeks History of drug or alcohol abuse in the prior year Receiving immunoglobulin or blood products in the prior 3 months Receiving investigational drugs in the past 45 days Planning to receive other vaccines in the next month Severe psychiatric disorders interfering with participation in the trial Women with positive beta-HCG, pregnancy, or during breastfeeding, or plan to become pregnant during the study High risk occupation for COVID-19 exposure (health care workers) or with decision of investigators First degree family members of the trial personnel Any other reason that the investigators document making volunteers ineligible-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any immediate adverse reaction after inoculation. Timepoint: 30 min after injection. Method of measurement: close monitoring.;Any local adverse events. Timepoint: 0-7 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Any systemic adverse events. Timepoint: 0-7 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Any laboratory adverse events. Timepoint: 0-7 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Any serious adverse events. Timepoint: 0-7 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Any serious adverse event, medically attended adverse event, or adverse event of interest. Timepoint: 0-125 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System. | — |
Secondary
| Measure | Time frame |
|---|---|
| IgG antibody against RBD protein. Timepoint: in days 0, 7, 28, 35, 42, and 49 after injection of the first dose. Method of measurement: based on geometric means and seroconversion (at least fourfold increase in antibody titer).;IgG antibody level against RBD protein. Timepoint: in days 0, 7, 28, 35, 42, and 49 after injection of the first dose. Method of measurement: based on ELISA method and seroconversion rate (proportion of individuals with at least twofold and fourfold inreases) and seroresponse (proportion of individuals with an increase above the 95th percentile of placebo group titers).;Neutralizing antibodies. Timepoint: in days 0, 7, 28, 35, 42, and 49 after injection of the first dose. Method of measurement: based on geometric mean titers and ratios and seroconversion rate (proportion of individuals with at least twofold and fourfold inreases) and seroresponse (proportion of individuals with an increase above the 95th percentile of placebo group titers).;Cellular immunity response. Timepoint: in days 0, 7, 28, 35, 42, and 49 after injection of the first dose. Method of measurement: determining Th1 or Th2 dominance based on levels of IL-4? IL-10? IL-12? IL-13 ? INF? with ELISA measurement, and levels of CD3? CD4? CD8 with INF? based on flow cytometry measurement. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Hassan Abolghasemi
Bagheiat-allah University of Medical Sciences
Outcome results
None listed