Protocol summary
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Study aim
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Comparison of the safety and efficacy of Fakhravac and Sinopharm SARS-CoV-2 vaccines
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Design
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Randomized, double blind, controlled trial with parallel design on 41128 volunteers in 2 groups of 20564, double blind and randomized, using non-inferiority design.
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Settings and conduct
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1-SASAD Sports Complex, Shahid Fakhrizadeh Street, Sayad Shirazi Highway; 2-Mobile center
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age>18; Internet and smart mobile phone access; No current COVID-19 disease; No pregnancy; Signing the informed consent form; Exclusion criteria: Current acute or chronic symptomatic illness; Acute febrile illness; Lactation; Receiving COVID19 vaccine; Transfusion of any blood product or immunoglobulin; Long-term use of immunosuppressive drugs or systemic corticosteroids; Having cancer; Uncontrol serious psychiatric illnesses; Blood disorders; Continued use of anticoagulants; Current drug or alcohol abuse; Close contact with a person having confirmed COVID-19
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Intervention groups
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Intervention group: Two doses of Fakhravac vaccine in 3 wks interval; Control group: Two doses of Sinopharm vaccine
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Main outcome variables
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Primary: Occurrence of confirmed Covid-19 disease two weeks after second dose; Secondary: Occurrence of confirmed moderate or severe cases or death due to Covid-19 two weeks after the second dose; Occurrence of confirmed severe cases or death due to Covid-19 two weeks after the second dose; Abnormal vital signs and anaphylactic reactions immediately after vaccination; Local adverse events within the first week post-vaccination; Systemic adverse event within the first week post-vaccination; Serious Adverse Event/Reaction, Suspected Unexpected Serious Adverse Reaction, Medically Attended Adverse Events
General information
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Reason for update
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Addition of mobile centers; Addition of two non-random arms; Change in inclusion and exclusion criteria
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210206050259N3
Registration date:
2021-08-29, 1400/06/07
Registration timing:
prospective
Last update:
2021-12-20, 1400/09/29
Update count:
2
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Registration date
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2021-08-29, 1400/06/07
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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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2021-09-01, 1400/06/10
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Expected recruitment end date
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2021-11-21, 1400/08/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the safety and efficacy of Fakhravac and Sinopharm SARS-CoV-2 vaccines, in adults aged 18 and over; a phase III randomized, non-inferiority clinical trial
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Public title
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Comparison of the safety and efficacy of Fakhravac and Sinopharm SARS-CoV-2 vaccines, in adults aged 18 and over
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age > 18;
Having Iranian citizenship;
Internet and smart mobile access (him/herself or one of him/his family);
Living in and around the city where the trial takes place;
No current COVID-19 disease;
No pregnancy;
Using safe methods of contraception;
Signing the informed consent form.
Exclusion criteria:
Current acute or chronic symptomatic illness that requires ongoing medical or surgical care;
Acute febrile illness;
Lactation;
History of receiving COVID19 vaccine;
History of transfusion of any blood product or immunoglobulin within the 3 months before the study;
History of long-term use (14 successive days) of immunosuppressive drugs or systemic corticosteroids in the last 4 months leading up to the study;
History of diagnosis or treatment for HIV;
History of allergic diseases such as angioedema or anaphylactic reactions following the use of drugs, vaccines or food;
History of diagnosis or treatment for cancer (except basal cell carcinoma and Insitu cervical cancer);
History of uncontrolled serious psychiatric illnesses;
History of blood disorders (Blood Dyscrasias, coagulation disorders, platelet deficiency, etc);
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.;
Current drug or alcohol abuse (addiction);
Close contact with a definite case of COVID-19 up to two weeks prior to the day of receiving the first dose;
Chronic diseases that are not listed as exclusion criteria but are considered unstable within the last 4 weeks.
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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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3
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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:
41128
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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This study uses both randomized and non-randomized arms. Block randomization method with variable block sizes of 4 and 6 in STATA will be used to create the random sequence in randomized arms. For the purpose of concealment, a unique code will be assigned to each intervention the participants receive, and all subjects will be identified with this code until the end of the study (concealment code).
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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, the control group will receive the Sinopharm vaccine, which has different packaging (volume and shape) compared to FakhraVac. Therefore, implementation of blinding will be done by a person who will be responsible for this. This is the only person who will not be blind to the intervention given. Once the participant becomes eligible to receive the vaccine, a concealment/randomization code will be assigned to the volunteer and the vaccine type will be displayed on the screen of the vaccinator until the inoculation is confirmed. Non-randomized arms that were added to the study later on, are not blind.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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In addition to the randomized arms, two non-randomised and open label arms were added to the study. Participants will receive one of the FAKHRAVAC or Sinofarm vaccines by their own choice in these additional arms.
Ethics committees
1
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Ethics committee
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Approval date
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2021-08-24, 1400/06/02
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Ethics committee reference number
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IR.NREC.1400.006
Health conditions studied
1
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Description of health condition studied
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Respiratory Distress Syndrome due to SARS-CoV-2
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19, virus identified
Primary outcomes
1
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Description
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Occurrence of confirmed symptomatic Covid-19 disease two weeks after the second vaccine dose
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Timepoint
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Two weeks after the second dose of the vaccine up to 6 months
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Method of measurement
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Clinical assessments and PCR test
Secondary outcomes
1
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Description
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Occurrence of confirmed moderate, or severe illness or death due to Covid-19 infection two weeks after the second vaccine dose
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Timepoint
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Two weeks after the second vaccine dose up to 6 months
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Method of measurement
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Clinical assessments and PCR test
2
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Description
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Occurrence of confirmed severe cases or death due to Covid-19 infection two weeks after the second vaccine dose
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Timepoint
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Two weeks after the second vaccine dose up to 6 months
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Method of measurement
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Clinical assessments and PCR test
3
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Description
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Abnormal vital signs and anaphylactic reactions immediately after vaccination
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Timepoint
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In the first half an hour after each vaccine dose
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Method of measurement
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Temperature is measured using a digital thermometer. Respiratory rate will be counted by the research staff over one minute. Blood pressure and heart rate will be measured by a digital sphygmomanometer in a sitting position.
4
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Description
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Local adverse events within the first week post-vaccination
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Timepoint
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For the first 6 days after each vaccine dose
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Method of measurement
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Record daily symptoms using a mobile phone application
5
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Description
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Systemic adverse event within the first week post-vaccination
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Timepoint
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For the first 6 days after each vaccine dose
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Method of measurement
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Record daily symptoms using a mobile phone application
6
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Description
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Serious Adverse Event/Reaction(SAEs) , Suspected Unexpected Serious Adverse Reaction (SUSARs), Medically Attended Adverse Events (MAAEs)
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Timepoint
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Up to six months after the last dose of the vaccine
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Method of measurement
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adverse events will be assessed monthly up to 6 months
Intervention groups
1
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Description
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Intervention group: Two doses of 10 micro gram vaccine injected in the deltoid muscle (IM) at 21 days interval
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Category
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Prevention
2
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Description
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Control group: Two doses of Sinopharm vaccine injected in the deltoid muscle (IM) at 21 days interval
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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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Organization of Defensive Innovation and Research
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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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Other
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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Not applicable
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Title and more details about the data/document
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Deidentified IPD on study outcomes could be shared.
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When the data will become available and for how long
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After completion of the study and publication of the results, data could be shared for 2 years
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To whom data/document is available
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Data is available only to members of academic institutions within joint projects with MILAD Daru Nour Co
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Under which criteria data/document could be used
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Proposal should be presented to MILAD Daru Nour Co. A scientific Advisory committee to MILAD Daru Nour Co should confirm necessity and scientific validity of the proposed joint project
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From where data/document is obtainable
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You can contact Ms Kousar Naderi at k.naderi@strc.ac.ir
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What processes are involved for a request to access data/document
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Request for data will be made available within the approved joint projects
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Comments
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