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IRCT20201214049709N6 IRCT 2022-11-29 Razi Vaccine and Serum Research Institute Immunogenicity and Safety of intranasal Razi Cov Pars as a booster dose Immunogenicity and Safety of intranasal Razi Cov Pars as a booster dose in adult population; randomised, double blind, placebo controlled clinical trial 2022-12-03 anticipated 206 Complete https://irct.ir/trial/67073 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, stratified block randomization method with variable block sizes of 4 and 6 were used to assign each participant to the intervention groups. The rand() function of Excel software were used to generate the random sequence within each block. After determining the allocated intervention, a non-repetitive eight-digit random code was assigned to each participant.This random code is a compilation of strata number, the number assigned to each participant and the "RIB" character and study participants will be identified by these codes during the study. Each strata includes participants that have received one of the seven vaccines (Sinopharm, Razi Cov Pars, Pastocovac, Spikogen, AstraZeneca, Fakhra, or Barkat) used as part of Iranian National Vaccination program as their primary vaccination, Blinding description: In this study, blinding will be achieved by using placebo which is the adjuvant only preparation identical in volume, appearance and packaging to the vaccine and will be used intranasally the same as the vaccine. In this study participants and all the research team members are unaware of the type of intervention. The study epidemiologist will keep the key to the random codes and will unblind any particular participant or participants if necessary. N/A SARS-CoV-2. 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. Yes - There is a plan to make this available What will be shared: Deidentified IPD related to outcome will be shared When: The access period will begin once the study is complete and the main results have been published in peer reviewed journals. To whom: The data that have been published in peer reviewed journals, will be available just for academic researchers. Conditions: The proposed study protocol should be submitted to RAZI vaccine and serum research institute and approved by its scientific and technical committee. Where to obtain: After publishing the article researchers can submit their request to Dr. Mohammad Hossein Fallah at the following email address (mhf2480@yahoo.com ). How to obtain: Data will be made availabe after consideration and approval by the relevant authorities from Razi Vaccine and Serum Research Institute. Comments:
public Mohammad Hossein Fallah Mehrabadi
Hesarak, Shahid Beheshti Street, Karaj
Karaj Iran (Islamic Republic of) 3197619751 +98 26 3457 0038 mhf2480@yahoo.com Razi Vaccine and Serum Research Institute scientific Iran University of Medical Sciences
Corner of Mansouri, Niayesh, Satarkhan Av, Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 21 6435 1000 kalantari.s@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 COVID-19 U07.1 Prevention Prevention Intervention group: One intransal dose of 10 microgram per 200 microliter of Razi Cov Pars recombinant protein vaccine Control group: One intransal dose of placebo Serum levels of specific IgG antibodies against S and RBD antigens. Timepoint: 2 weeks after the intranasal booster dose. Method of measurement: ELISA method. 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 on a weekly basis will be done by phone. Report of an adverse event could also be made via the mobile application. There will be a physician available 24/7 in the follow up center and all the reported events will be recorded and followed up by the staff in the center. Razi Vaccine and Serum Research Institute Approved 2022-11-26 National Research Ethics Committee Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)