SARS-CoV-2. COVID-19
Conditions
Interventions
Intervention 1: Intervention group 1: Vaccine at 5 µg/200µl dose
Participants in this group will receive two doses (IM) of RAZI recombinant spike protein vaccine 21 days apart followed by a 10 µg/200µl nasal spray 51 days after the first dose (day 0). Intervention
Participants in this group will receive two doses (IM) of Adjuvant by 50% v/v concentation produced in RAZI institute 21 days apart followed by another dose in the form of nasal spray at day 51 (count
Sponsors
Razi Vaccine and Serum Research Institute
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Having Iranian citizenship; Diploma or higher degree; Adults aged 18 - 55 years; Body mass index 17 to 35 kg/m2; Having good health based on clinical and laboratory criteria; Having sublingual temperature less than or equal to 37.2 ° C in the morning based on mercury thermometer; Negative IgG and IgM antibody titers for COVID-19 S antigen; Negative RT-PCR test for COVID-19; Negative IgG ELISA for HIV; Having heart rate between 60 and 100; Signed the informed consent form; The participant agrees to reduce the risk of developing of COVID-19; For females of childbearing age 18 to 49 years: not being pregnant based on the first day of the last menstrual period; For females of childbearing age 18 to 49 years: negative pregnancy test based on bHCG on the day of screening and the day of vaccination; For females of childbearing age 18 to 49 years: use at least one effective method of contraception (condoms, oral contraceptive pills, intrauterine device, Norplant capsule) and willing to continue using it up to three month after last vaccine dose; Unwillingness to have children and use effective methods of contraception up to three months after completion of vaccination (all participants). Confirmation by a psychiatrist that the participant's mental health and capacity allows him/her to make a decision regarding his/her participation in the trial.
Exclusion criteria
Exclusion criteria: Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care on the day of vaccination; Working in an occupation with a high risk of exposure to COVID-19 including medical staff, occupations with close contact with the client; Breastfeeding; Receipt any vaccine during the 30 days before the screening day; Received blood and/or any blood products and/or immunoglobulins within three months preceding the screening day; Any confirmed or suspected immunodeficient state; History of long-term use of immunosuppressive medication (defined as more than 14 continuous days) in the last 4 months leading up to screening day; Long-term use (defined as more than 14 continuous days) of systemic corticosteroids (equivalent to 10 mg or more daily prednisolone) within the past 4 months, except topical steroids; History of allergic diseases such as angioedema or anaphylactic reactions; History of any allergy to the drug or vaccine (defined as any clinical signs or symptom of itching at the injection site, urticaria in the body after injection, excessive redness at the injection site); History of autoimmune diseases (other than controlled autoimmune thyroid disease, stable celiac disease, mild psoriasis, vitiligo that does not require corticosteroid or immunosuppressive therapy); History of chemotherapy in the last 5 years; History of cancer in the last 5 years; History of serious psychiatric illnesses; History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, deficiency of blood factors); Suffering from chronic obstructive pulmonary disease such as asthma and COPD that diagnosed by a specialist and is/was under medication; Suffering from ischemic heart disease that is/was under medication by a specialist , history of cardiac interventions; Suffering from hypertension that is/was under medication by a specialist ; Suffering from diabetes that is/was under medication by a specialist ; History of chronic neurological diseases (including seizures and epilepsy); Any history of substance or alcohol abuse within the last 2 years; Any abnormality in the hematology or biochemical laboratory tests based on FDA toxicity score (grade >1) on the screening day; History of confirmed COVID-19; Acute febrile illness at the time of vaccination; History of acetaminophen allergy; Acute or chronic hepatitis B and C; Receiving prophylactic drug against tuberculosis; History of syncope with blood transfusion or blood observation; Splenectomy for any reason; Any close contact with a confirmed COVID-19 case within two weeks before the first dose of vaccine; History of SARS or MERS; Participate in any clinical trials (research) study other than this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abnormal vital signs and anaphylactic reactions before and immediately after vaccination: number and percentages of participants who develop abnormal vital signs within three hours of receiving the vaccine at each doses 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 three hours after each vaccination. Timepoint: Before vaccination and hourly for three hours after vaccination at each dose. Method of measurement: Clinical examination.;The number and percentage of ocal adverse events within the first week post-vaccination (including pain, tenderness, erythema / redness, swelling and stiffness, itching) that will be assessed based on the severity score, duration and peak intensity. Timepoint: Seven days after 1st and 2nd vaccination(Days 0-7 and 21-27)daily assessment. Method of measurement: Daily symptom registration cards will be given to patients at the time of vaccination and they will be asked to bring them with themselves on the next visit. These patients will be contacted daily during these seven days and the study staff will ensure that the cards are completed.;The number and percentage of systemic adverse event within the first week post-vaccination (including nausea and vomiting, diarrhea, headache, fatigue, muscle pain) that will be assessed based on the severity score, duration and peak intensity. Timepoint: Seven days after each vaccination step (Days 0-7 and 21-27 and 51-57) daily assessment. Method of measurement: Daily symptom registration cards will be given to patients at the time of vaccination and they will be asked | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and percentage of Severe Adverse event (SAEs). Timepoint: Monthly until sixth month after last vaccine dose. Method of measurement: These events will be collected monthly from the participants through face to face or telephone contacts. In case of Severe Adverse event identification in the participants, more information about the event will be collected and discussed at the DSMB meeting.;Number and percentage of Suspected Unexpected Serious Adverse Reaction(SUSAR ). Timepoint: Monthly until sixth month after last vaccine dose. Method of measurement: These events will be collected monthly from the participants through face to face or telephone contacts. In case of Suspected Unexpected Serious Adverse Reaction identification in the participants, more information about the event will be collected and discussed at the DSMB meeting.;Number and percentage of Medically Attended Adverse Events (MAAEs). Timepoint: Monthly until sixth month after last vaccine dose. Method of measurement: These events will be collected monthly from the participants through face to face or telephone contacts. In case of medically attended events identification in the participants, more information about the event will be collected and discussed at the DSMB meeting.;Number and percentage of Covid-19 disease occurrence two weeks after second vaccine dose. Timepoint: ?Any time between the 14 days after second vaccine dose and the end of study. Method of measurement: Diagnosis of Covid-19 disease will be based on Iran's Ministry of Health's guideline and a positive positive PCR test.;Serum levels of specific IgG antibodies against S, S1, S2, NTD, RBD components of SARS-CoV-2 spike protein antigen(s). "serum antibody level" will be assessed using geometric mean, as well as "serum fold rise" and "seroconversion rate " and will be compared between the two groups. Seroconversion rate is defined as the the proportion of the individuals whose serum IgG levels have two fold or more using the E | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Hossein Fallah Mehrabadi
Razi Vaccine and Serum Research Institute
Outcome results
None listed