SARS-CoV-2. U07.1
Conditions
Interventions
Intervention 1: Intervention group: One intransal dose of 10 microgram per 200 microliter of Razi Cov Pars recombinant protein vaccine. Intervention 2: Control group: One intransal dose of placebo.
Sponsors
Razi Vaccine and Serum Research Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Having Iranian citizenship or in the case of foreign nationals with a legal residence permit Age 18 years and older History of full vaccination with one of the following vaccines: Sinopharm, Razi Cov Pars, Pastocovac, Spikogen, AstraZeneca, Fakhra, or Barkat at least 5 months before the study 5 months interval between the last vaccine dose and the current study participation In the last six months, the person has not had a confirmed Covid-19 disease based on laboratory evidence or confirmed by a physician Signing a written informed consent form Using at least one reliable contraceptive method (condom, oral contraceptive pills, intrauterine contraceptive device, IUD, Norplant capsule) for women of reproductive age 18 to 49 years until 3 months after receiving the booster dose Negative pregnancy test (baby check) on the day of vaccination
Exclusion criteria
Exclusion criteria: History of allergic reactions after receiving any previous Covid-19 vaccines or any other drug or vaccine Having any acute or chronic illness requiring continuous ongoing medical or surgical care within the last months History of severe cardiovascular disease such as heart failure, or hospitalization due to heart disease within the last year Pregnancy declared by the participant based on the first day of the last menstrual period (LMP) Breastfeeding History of receiving any vaccine within 14 days of receiving the intranasal booster dose Received blood and/or any blood products and/or immunoglobulins within three months prior to the intranasal booster dose Diagnosed (suspected or confirmed) with immunocompromising illneses, 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 for more than 14 consecutive days with the exception of topical steroids within the last 4 months Recent diagnosis or treatment of cancers except basal cell carcinoma and In-situ cervical cancer History of uncontrolled serious psychiatric illnesses History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, or deficiency of blood clotting factors) History of chronic neurological diseases (including seizures and epilepsy) Current substance or alcohol abuse Acute febrile illness at the time of receiving the booster dose Splenectomy for any reason Close contact with a confirmed COVID-19 case within two weeks before participating in the current study 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 as prophylaxis is allowed Chronic unstable diseases in the last 4 weeks, including hospitalization due to surgery, deterioration of one of the organ system's function, a need to add new drugs or serious dose adjustments for existing drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum levels of specific IgG antibodies against S and RBD antigens. Timepoint: 2 weeks after the intranasal booster dose. Method of measurement: ELISA method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum levels of specific IgA antibody against RBD antigen. Timepoint: 2 weeks after the intranasal booster dose. Method of measurement: ELISA method.;Levels of specific IgG and IgA antibodies against S and RBD antigens in saliva and nasal mucosa. Timepoint: 2 weeks after the intranasal booster dose. Method of measurement: ELISA method.;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: Before vaccination and half an hour after vaccination. Method of measurement: Clinical examination.;The number and percentage of systemic adverse reactions 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: Daily, within the first week after intranasal booster dose. Method of measurement: Via mobile application, study staff will contact participants who fail to fill their application and complete a local adverse reaction form on their behalf.;Number and percentage of Severe Adverse events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSAR ) and Medically Attended Adverse Events (MAAEs) Up to one month after receiving the booster dose. Timepoint: Up to one month after the intranasal booster dose. Method of measurement: Active follow-up | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Hossein Fallah Mehrabadi
Razi Vaccine and Serum Research Institute
Outcome results
None listed