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IRCT20210620051639N1 IRCT 2021-06-25 Bagheiat-allah University of Medical Sciences Safety and immunogenicity of COVID-19 RBD protein recombinant vaccine (AmitisGen): phase I study. A randomized, double-blinded, placebo-controlled phase I clinical trial to evaluate the safety and immunogenicity of three dose regimens of COVID-19 RBD protein recombinant vaccine (AmitisGen; 80µg and 120µg) in a healthy population 2021-06-25 anticipated 70 Complete https://irct.ir/trial/56987 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: A random sequence of length 70 (the size of the sample size) is generated by the online system (SealedEnvelope.com). For this purpose, 10 random blocks with size 7 are produced, in each block, 3 people are given the low-dose vaccine, 3 people are given high-dose vaccine and 1 person is assigned to the placebo group. The generated codes are pasted on the vaccine vials before the start of the study and are assigned to the candidates during the study by the study software, Blinding description: Each vaccine dose is in a separate vial with an identifier code. Vaccine boxes and vials are identical in shape, color, and smell, making participants, investigators, and outcome adjudicators all blinded to the randomized intervention. After injection of each vaccine, the abbreviated ID of the participant and the date will be written on the outside box and a label with the same ID will be added to the trial file. Study personnel who are in charge of vaccine injection check all relevant IDs before injection. During the study, all vaccine packages will be archived. 1 COVID-19. Intervention 1: Intervention group: receiving 80 micrograms of RBD protein recombinant SARS-CoV-2 vaccine in days 0, 21, and 35; 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, and 35. No - There is not a plan to make this available Justification or reason for not sharing IPD is No plans to release patient data
public Dr. Hassan Abolghasemi
Baqiyatallah University of Medical Sciences, Shahid Nosrati alley, Shiekh Bahaei st., Mollasadra st,
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8216 2440 H.abolghasemi.ha@gmail.com Bagheiat-allah University of Medical Sciences scientific Dr. Hassan Abolghasemi
Baqiyatallah University of Medical Sciences, Shahid Nosrati alley, Sheikh Bahaei st., Mollasadra st,
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8216 2440 H.abolghasemi.ha@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) 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 18 years 50 years Both 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- U07.1 COVID-19, virus identified Prevention Prevention Placebo Intervention group: receiving 80 micrograms of RBD protein recombinant SARS-CoV-2 vaccine in days 0, 21, and 35; intramuscular (deltoid muscle) Intervention group: receiving 120 micrograms of RBD protein recombinant SARS-CoV-2 vaccine in days 0, 21, and 35; intramuscular (deltoid muscle) Control group: the placebo group will receive an intramuscular injection (in the deltoid muscle) consisting of buffer and adjuvant only, on days 0, 21, and 35 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. 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 و INFγ with ELISA measurement, and levels of CD3، CD4، CD8 with INFγ based on flow cytometry measurement. Bagheiat-allah University of Medical Sciences Approved 2021-06-23 Reserch ethics committees of national research committee 13th floor, Block A, Ministry of health, Simaye Iran street, Shahrake ghods Tehran Tehran Iran (Islamic Republic of)