Protocol summary
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Study aim
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Immunogenicity and Safety of intranasal Razi Cov Pars as a booster dose in adult population
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Design
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This is a randomized double blind placebo controlled parallel group clinical trial. In this study we explore the immunogenicity of intranasal Razi Cov Pars as a booster dose. Stratified block randomization will be used. The type of the vaccine in the primary vaccination will be used to define the strata. An adjuvant only preparation will be used as placebo.
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Settings and conduct
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Razi Vaccine and Serum Research Institute Beheshti Ave, Hesarak, Karaj, Alborz Province
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Participants/Inclusion and exclusion criteria
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Main inclusion criteria: Age 18 years and older, Minimum 5 and maximum 9 months interval from the last vaccine dose, no history of confirmed Covid-19 illness during the first 5 months. Major 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 month
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Intervention groups
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Intervention group: One intranasal dose of 10 microgram per 200 micro liter of Razi Cov Pars recombinant protein vaccine; Control group: One intranasal dose of placebo
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Main outcome variables
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Serum levels of specific IgG antibodies against S and RBD antigens two weeks after the intranasal booster dose by ELISA method, Serum levels of specific IgA antibodies against RBD antigen, levels of specific IgG/IgA antibodies against S and RBD in saliva and nasal mucosa, Abnormal vital signs and anaphylactic reactions before and immediately after vaccination; The number and percentage of systemic adverse reactions within the first week post-vaccination, 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.
General information
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Reason for update
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reporting actual start and end dates and completion date, amending inclusion criteria
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201214049709N6
Registration date:
2022-11-29, 1401/09/08
Registration timing:
prospective
Last update:
2024-01-22, 1402/11/02
Update count:
2
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Registration date
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2022-11-29, 1401/09/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-12-03, 1401/09/12
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Expected recruitment end date
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2023-02-27, 1401/12/08
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Actual recruitment start date
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2023-01-03, 1401/10/13
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Actual recruitment end date
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2023-02-22, 1401/12/03
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Trial completion date
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2023-04-08, 1402/01/19
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Scientific title
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Immunogenicity and Safety of intranasal Razi Cov Pars as a booster dose in adult population; randomised, double blind, placebo controlled clinical trial
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Public title
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Immunogenicity and Safety of intranasal Razi Cov Pars as a booster dose
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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:
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
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
206
Actual sample size reached:
193
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-11-26, 1401/09/05
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Ethics committee reference number
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IR.NREC.1401.004
Health conditions studied
1
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Description of health condition studied
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SARS-CoV-2
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ICD-10 code
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COVID-19
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ICD-10 code description
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U07.1
Primary outcomes
1
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Description
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Serum levels of specific IgG antibodies against S and RBD antigens
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Timepoint
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2 weeks after the intranasal booster dose
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Method of measurement
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ELISA method
Secondary outcomes
1
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Description
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Serum levels of specific IgA antibody against RBD antigen
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Timepoint
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2 weeks after the intranasal booster dose
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Method of measurement
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ELISA method
2
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Description
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levels of specific IgG and IgA antibodies against S and RBD antigens in saliva and nasal mucosa.
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Timepoint
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2 weeks after the intranasal booster dose
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Method of measurement
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ELISA method
3
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Description
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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.
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Timepoint
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Before vaccination and half an hour after vaccination
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Method of measurement
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Clinical examination
4
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Description
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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.
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Timepoint
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Daily, within the first week after intranasal booster dose
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Method of measurement
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Via mobile application, study staff will contact participants who fail to fill their application and complete a local adverse reaction form on their behalf.
5
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Description
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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.
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Timepoint
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Up to one month after the intranasal booster dose
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Method of measurement
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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.
Intervention groups
1
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Description
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Intervention group: One intransal dose of 10 microgram per 200 microliter of Razi Cov Pars recombinant protein vaccine
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Category
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Prevention
2
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Description
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Control group: One intransal dose of placebo
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Razi Vaccine and Serum Research Institute
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Deidentified IPD related to outcome will be shared
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When the data will become available and for how long
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The access period will begin once the study is complete and the main results have been published in peer reviewed journals.
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To whom data/document is available
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The data that have been published in peer reviewed journals, will be available just for academic researchers.
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Under which criteria data/document could be used
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The proposed study protocol should be submitted to RAZI vaccine and serum research institute and approved by its scientific and technical committee.
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From where data/document is obtainable
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After publishing the article researchers can submit their request to Dr. Mohammad Hossein Fallah at the following email address (mhf2480@yahoo.com ).
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What processes are involved for a request to access data/document
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Data will be made availabe after consideration and approval by the relevant authorities from Razi Vaccine and Serum Research Institute.
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Comments
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