History
# Registration date Revision Id
2 2021-06-14, 1400/03/24 187662
1 2021-04-24, 1400/02/04 180000
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  • Protocol summary

    In a double blind randomized trial, 24,000 adults, aged between 18 and 80 years old (in 8 cities) will assign to the vaccine and placebo groups (4:1 ratio). People will be assigned to two subgroups: under 65 years, 65 and older . The intervention in 6 cities, will be performed with two doses of vaccine and in 2 cities with three doses of vaccine.
    In a double blind randomized trial, 24,000 adults, aged between 18 and 80 years old (in 8 cities) will assign to the vaccine and placebo groups (4:1 ratio). The intervention in 6 cities, will be performed with two doses of vaccine and in 2 cities with three doses of vaccine.
    طی یک کارآزمایی تصادفی دوسوکور(فاز سه) 24،000 نفر در محدوه سنی 18 تا 80 سال از 8 شهر، با تخصیص تصادفی (نسبت 4: 1) به گروه های اصلی واکسن و دارونما تقسیم می شوند. افراد از هر شهر به دو زیر گروه شامل: افراد 65 سال و بالاتر، افراد کمتر از 65 سال تخصیص داده خواهند شد. مداخله در 6 شهر با دو دوز و در 2 شهر با سه دوز واکسن انجام خواهد شد.
    طی یک کارآزمایی تصادفی دوسوکور(فاز سه) 24،000 نفر در محدوه سنی 18 تا 80 سال از 8 شهر، با تخصیص تصادفی (نسبت 4: 1) به گروه های اصلی واکسن و دارونما تقسیم می شوند. مداخله در 6 شهر با دو دوز و در 2 شهر با سه دوز واکسن انجام خواهد شد.
    This study will be conducted in 8 centers from 7 provinces. During the study, efficacy, safety and immunogenicity of two doses of Soberana 02 vaccine and two doses of Soberana 02 with one dose of Soberana 01 will evaluate in comparison with the control group. Researchers and volunteers are not aware of the product prescription for each individuals.
    This study will be conducted in 8 centers from 7 provinces. During the study, efficacy, safety and immunogenicity of two doses of Soberana 02 vaccine and two doses of Soberana 02 with one dose of Soberana plus will evaluate in comparison with the control group. Researchers and volunteers are not aware of the product prescription for each individuals.
    این مطالعه در 8 مرکز از 7 استان انجام خواهد شد. طی مطالعه کارآیی، ایمنی و ایمنی زایی دو دوز واکسن سوبرانای 2 و دو دوز سوبرانای 2 به همراه یک دوز بوستر سوبرانای 1در مقایسه با گروه کنترل ارزیابی می شود. محققان و داوطلبان از تجویز محصول برای هر فرد مطلع نیستند.
    این مطالعه در 8 مرکز از 7 استان انجام خواهد شد. طی مطالعه کارآیی، ایمنی و ایمنی زایی دو دوز واکسن سوبرانای 2 و دو دوز سوبرانای 2 به همراه یک دوز بوستر سوبرانا-پلاس در مقایسه با گروه کنترل ارزیابی می شود. محققان و داوطلبان از تجویز محصول برای هر فرد مطلع نیستند.
    Inclusion informed consent, 18-80 years, male and female, Iranian citizens, healthy adults/adults with controlled underlying diseases, able to comply with schedule, subjects from 8 selected cities Exclusion Fever or infectious disease (recently),mental diseases, sever allergies, complicated diseases (uncontrolled: asthma, hypertension, renal, liver and hart diseases), application of tetanus vaccines (recently), vaccination against SARS-CoV-2, use of immunomodulators, tattoos on arms, participation in COVID-19 vaccine trials, Blood transfusion and its products (recently), Coagulation problems, heavy smoker
    Inclusion informed consent, 18-80 years, male and female, Iranian citizens, healthy adults/adults with controlled underlying diseases, able to comply with schedule, subjects from 8 cities Exclusion Fever or infectious disease (recently),mental diseases, sever allergies, complicated diseases (asthma, hypertension, renal, liver and hart diseases), application of tetanus vaccines (recently), vaccination against SARS-CoV-2, use of immunomodulators, tattoos on arms, participation in COVID-19 vaccine trials, Blood transfusion and its products (recently), Coagulation problems, heavy smoker-First priority groups for vaccination
    ورود رضایتنامه کتبی ، سن 18 تا 80 سال، زن و مرد، تابعیت ایرانی،افراد سالم/ با بیماری زمینه ای کنترل شده، امکان دنبال نمودن برنامه،افراد مقیم 8 شهر منتخب عدم ورود تب یا بیماری عفونی طی 7 روز قبل از واکسیناسیون، بیماری های اعصاب و روان، سابقه حساسیت شدید، استفاده از واکسن حاوی سم کزاز، افراد واکسینه شده علیه کووید 19، درمان با داروهای سیستم ایمنی(اخیرا)، افراد دارای خالکوبی ناحیه دلتوئید دو بازو، مشکلات انعقادی، سابقه تزریق واکسن کووید 19،مشارکت در سایر کارآزمایی های واکسن کووید 19، تزریق خون و فراورده های آن (اخیرا)، مصرف سیگار (بیش از 20 نخ روزانه بیش از 20 سال)
    ورود: رضایت آگاهانه؛ توان تبعیت از برنامه؛ سلامت عمومی؛ بیماریهای کنترل شده؛ تابعیت ایرانی؛ مقیم یکی از شهرهای مطالعه؛ زن یا مرد؛ 18 تا 80 سال عدم ورود فاز 1 اولویت واکسیناسیون کشوری؛ بارداری؛ شیردهی؛ قصد بارداری تا 3 ماه پس از آخرین دوز واکسن؛ تزریق توکسوئید کزاز 3 ماه پیش از مطالعه؛ پرفشاری خون کنترل نشده؛ دریافت فراورده های خونی در سه ماه گذشته؛ هموگلوبین ایوانسی> 5/7؛ GFR < 30؛ 150ALT≥؛ 100AST≥؛ حمله آسم در 3 ماه گذشته؛ سابقه واکنش آلرژیک شدید به واکسن؛ اختلالات روانپزشکی؛ مصرف سیگار> ۲۰ نخ/روز برای >20 سال؛ مشکلات انعقادی مخل تزریق عضلانی؛ سابقه واکسیناسیون کووید-19؛ درمان با ایمنومودولیتورها 1 ماه پیش از واکسیناسیون؛ تب/بیماری حاد 7 روز قبل از واکسیناسیون
    Cohort 1: 25 µg of RBD-TT, IM, 0 - 28 Cohort 2: 25 µg of RBD-TT, IM, 0 - 28 + a booster dose (Soberana 01), 56 Placebo groups (in each cohort):Aluminum hydroxide, IM, 0.5 mL, 0 - 28
    Cohort 1: 25 µg of RBD-TT, IM, 0 - 28 Cohort 2: 25 µg of RBD-TT, IM, 0 - 28 + a booster dose (Soberana Plus), 56 Placebo groups (in each cohort):Aluminum hydroxide, IM, 0.5 mL, 0 - 28
    گروه مداخله کوهورت1: 25 میکروگرم (RBD-TT) سوبرانا 2 ،عضلانی، روزهای 0 و 28 گروه مداخله کوهورت2: 25 میکروگرم (RBD-TT) سوبرانا 2 ،عضلانی، روزهای 0 و 28+ یک دوز تقویت کننده(50 میکروگرم از ژل هیدروکسید آلومینیوم d-RBD + آلومینیوم) در روز 56 گروه های دارونما: ، 0.5 میلی لیتر ،عضلانی، روزهای 0 - 28
    مداخله کوهورت1: 25 میکروگرم (RBD-TT) سوبرانا 2 ،عضلانی، روزهای 0 و 28 مداخله کوهورت2: 25 میکروگرم (RBD-TT) سوبرانا 2 ،عضلانی، روزهای 0 و 28+ یک دوز تقویت کننده(50 میکروگرم از ژل هیدروکسید آلومینیوم d-RBD + آلومینیوم) در روز 56 گروه های دارونما: ، 0.5 میلی لیتر ،عضلانی، روزهای 0 - 28
  • General information

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    Due to the small number of volunteers who were above 65 years (as they have had access to COVID-19 vaccine from the national health system), the 10% limit for recruitment of the above 65 years age group was removed from the protocol upon approval of the DSMB. As per the request of the DSMB committee, new sample size is estimated for the cellular immunity assessment. Accordingly, the following fields in the IRCT were updated: - Secondary outcome variable section> description of the third outcome variable> the sample size for cellular immunity assessment is changed to 130 people. - Abstract section > Study Design section: e 10% limit for recruitment of the above 65 years age group is removed.
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    به دلیل کم بودن تعداد نمونه در گروه سنی بالای 65 سال (به دلیل توزیع واکسن برای این گروه سنی توسط سیستم بهداشتی) سقف ده درصدی حجم نمونه از گروه سنی بالای 65 سال با تایید کمیته DSMB برداشته شد. براساس پیشنهاد کمیته DSMB حجم نمونه جداگانه برای ارزیابی ایمنی سلولی محاسبه گردید. براین اساس، فیلدهای زیر در سامانه به روزرسانی گردید: - در بخش متغیر پیامد ثانویه در شرح متغیر پیامد سوم تعداد افراد مورد ارزیابی ایمنی سلولی به ۱۳۰ نفر تغییر کرد. - در بخش چکیده پروتکل در قسمت طراحی، محدودیت 10 درصدی حجم نمونه برای زیر گروه سنی بالای ۶۵ سال حذف شد.
    Pregnant or lactating women or those who plan to become pregnant up to 3 months after the last dose of the vaccine
    Application of vaccines containing tetanus toxoid in the last 3 months
    History of blood /blood products transfusions such as immunoglobulin in the last three months
    Type 2 diabetes ( HbA1c higher than 7.5)
    Chronic liver disease (liver enzymes more than 5 times normal: ALT≥150, AST≥100) Subjects previously vaccinated against SARS-CoV-2.
    History of psychiatric disorders
    Uncontrolled asthma (having an asthma attack in the last three months).
    History of severe allergic reaction (anaphylaxis) to the vaccine throughout life
    History of smoking more than 20 cigarettes a day for more than twenty years
    Coagulation problems that contraindicate IM injection
    Previous vaccination with any coronavirus vaccine or participation in other COVID-19 vaccine trials
    Treatment with immunomodulators in the last 30 days
    Uncontrolled hypertension (cytological pressure more than 140, diastolic pressure more than 90 mm Hg)
    Fever or acute illness for 7 days before the injection or on the day of the injection
    Chronic kidney disease (GFR less than 30)
    All individuals who are in phase one priority of vaccination based on the National COVID-19 Vaccination Program
    Subjects with tattoos in the deltoid region on both arms
    Pregnant or lactating women or those who plan to become pregnant up to 3 months after the last dose of the vaccine
    Application of vaccines containing tetanus toxoid in the last 3 months
    History of blood /blood products transfusions such as immunoglobulin in the last three months
    Type 2 diabetes ( HbA1c higher than 7.5)
    Chronic liver disease (liver enzymes more than 5 times normal: ALT≥150, AST≥100) Subjects previously vaccinated against SARS-CoV-2.
    History of psychiatric disorders
    Uncontrolled asthma (having an asthma attack in the last three months).
    History of severe allergic reaction (anaphylaxis) to the vaccine throughout life
    History of smoking more than 20 cigarettes a day for more than twenty years
    Coagulation problems that contraindicate IM injection
    Previous vaccination with any coronavirus vaccine or participation in other COVID-19 vaccine trials
    Treatment with immunomodulators in the last 30 days
    Uncontrolled hypertension (cytological pressure more than 140, diastolic pressure more than 90 mm Hg)
    Fever or acute illness for 7 days before the injection or on the day of the injection
    Chronic kidney disease (GFR less than 30)
    All individuals who are in phase one priority of vaccination based on the National COVID-19 Vaccination Program
    Subjects with tattoos in the deltoid region on both arms
    Individuals in priority of the first phase of national vaccination (health workers can participate if they give consent)
    زنان باردار یا شیرده یا کسانی که قصد بارداری تا 3 ماه پس از تزریق آخرین دوز واکسن را دارند
    سابقه تزریق واکسن حاوی توکسین کزاز طی 3 ماه پیش از ورود به مطالعه
    سابقه دریافت خون یا فراورده های خونی مثل ایمنوگلوبولین در سه ماه گذشته
    دارای دیابت نوع 2 (هموگلوبین اوانسی بالای 7 و نیم)
    دارای بیماری مزمن کبدی (آنزیم های کبدی بیشتر از 5 برابر حد نرمال: ALT≥150,AST≥100 )
    دارای سابقه اختلالات روانپزشکی
    دارای آسم کنترل نشده (در سه ماه گذشته حمله آسمی داشته است)
    سابقه واکنش آلرژیک شدید (آنافیلاکسی) به واکسن در طول عمر فرد
    سابقه مصرف سیگار بیش از ۲۰ نخ در روز برای بیش از بیست سال
    مشکلات انعقادی که با تزریق عضلانی کنترا اندیکاسیون داشته باشد
    داشتن سابقه واکسیناسیون علیه کووید-19 یا سابقه شرکت در سایر کارآزمایی های واکسن کووید-19
    سابقه درمان با داروهای تضعیف کننده سیستم ایمنی 1 ماه پیش از تزریق واکسن کاندید
    دارای فشار خون بالای کنترل نشده (فشار سیتولیک بیش از 140، دیاستولیک بیش از 90 میلی متر جیوه)
    داشتن تب یا بیماری حاد در طی 7 روز قبل از تزریق و یا در روز تزریق
    دارای بیماری مزمن کلیوی (GFR کمتر از 30)
    کلیه افرادی که در فاز 1 اولویت واکسیناسیون بر اساس برنامه ملی استقرار و گسترش واکسیناسیون کرونا هستند
    افراد دارای خالکوبی در ناحیه دلتوئید بر روی هر دو بازو
    زنان باردار یا شیرده یا کسانی که قصد بارداری تا 3 ماه پس از تزریق آخرین دوز واکسن را دارند
    سابقه تزریق واکسن حاوی توکسین کزاز طی 3 ماه پیش از ورود به مطالعه
    سابقه دریافت خون یا فراورده های خونی مثل ایمنوگلوبولین در سه ماه گذشته
    دارای دیابت نوع 2 (هموگلوبین اوانسی بالای 7 و نیم)
    دارای بیماری مزمن کبدی (آنزیم های کبدی بیشتر از 5 برابر حد نرمال: ALT≥150,AST≥100 )
    دارای سابقه اختلالات روانپزشکی
    دارای آسم کنترل نشده (در سه ماه گذشته حمله آسمی داشته است)
    سابقه واکنش آلرژیک شدید (آنافیلاکسی) به واکسن در طول عمر فرد
    سابقه مصرف سیگار بیش از ۲۰ نخ در روز برای بیش از بیست سال
    مشکلات انعقادی که با تزریق عضلانی کنترا اندیکاسیون داشته باشد
    داشتن سابقه واکسیناسیون علیه کووید-19 یا سابقه شرکت در سایر کارآزمایی های واکسن کووید-19
    سابقه درمان با داروهای تضعیف کننده سیستم ایمنی 1 ماه پیش از تزریق واکسن کاندید
    دارای فشار خون بالای کنترل نشده (فشار سیتولیک بیش از 140، دیاستولیک بیش از 90 میلی متر جیوه)
    داشتن تب یا بیماری حاد در طی 7 روز قبل از تزریق و یا در روز تزریق
    دارای بیماری مزمن کلیوی (GFR کمتر از 30)
    کلیه افرادی که در فاز 1 اولویت واکسیناسیون بر اساس برنامه ملی استقرار و گسترش واکسیناسیون کرونا هستند
    افراد دارای خالکوبی در ناحیه دلتوئید بر روی هر دو بازو
    افراد در اولویت فاز اول واکسیناسیون(کارکنان حوزه بهداشت و درمان درصورت داشتن رضایت می توانند شرکت کنند)
  • Secondary outcomes

    #1
    The frequency of local and systemic events and mild, moderate and severe adverse events will be recorded by the participants in the forms.
    The frequency of local and systemic events and mild, moderate , severe, critical adverse events and death will be recorded by the participants in the forms.
    فراوانی رخدادهای موضعی و سیستمیک پیش بینی شده و ناخواسته ی خفیف، متوسط و شدید توسط شرکت کنندگان در برگه ثبت عوارض ثبت خواهد شد.
    فراوانی رخدادهای موضعی و سیستمیک پیش بینی شده و ناخواسته ی خفیف، متوسط، شدید، بحرانی و مرگ توسط شرکت کنندگان در برگه ثبت عوارض ثبت خواهد شد.
    #2
    Evaluation of Cellular safety will be performed on 30 people in one of the cities of Babol or Sari (depending of logistic status).
    Evaluation of Cellular safety will be performed on 130 people in one of the cities of Babol or Sari (depending of logistic status).
    ارزیابی ایمنی سلولی، در یکی از شهرهای بابل یا ساری (بسته به شرایط شهر از نظر لوجستیک ) بر روی 30 نفر انجام می شود.
    ارزیابی ایمنی سلولی، در یکی از شهرهای بابل یا ساری (بسته به شرایط شهر از نظر لوجستیک ) بر روی 130 نفر انجام می شود.
  • Intervention groups

    #1
    گروه مداخله در کوهورت اول: در 6 شهر (اصفهان، بابل، بندرعباس، ساری، کرمان و همدان) 80 درصد افراد (14400 نفر) پس از تخصیص تصادفی، کاندید واکسن را دریافت میکنند . مداخله تزریق عضلانی کاندید واکسن با کنژوکاسیون 25 میکروگرم RBD به توکسیون کزاز در یک برنامه 2 دوزه (روزهای 0 و 28) می باشد. این واکسن ساخت انستیتو واکسن سازی فینلای کوبا است.
    گروه مداخله در کوهورت اول: در 6 شهر (اصفهان، بابل، بندرعباس، ساری، کرمان و همدان) 80 درصد افراد (14400 نفر) پس از تخصیص تصادفی، کاندید واکسن را دریافت میکنند . مداخله تزریق عضلانی کاندید واکسن با کنژوکاسیون 25 میکروگرم RBD به توکسین کزاز در یک برنامه 2 دوزه (روزهای 0 و 28) می باشد. این واکسن ساخت انستیتو واکسن سازی فینلای کوبا است.
    #2
    Intervention group in the second cohort: In two cities (Zanjan and Yazd) 80% of people (4800 people) receive the intervention (vaccine) after random allocation. The intervention includes: a 2-dose program + a booster dose (days 0, 28, 56). The booster dose of the candidate vaccine is Subrana 01 (50 micrograms d-RBD +, IM 0.5 ml). This vaccine is made by the Finlay Institute of Vaccines.
    Intervention group in the second cohort: In two cities (Zanjan and Yazd) 80% of people (4800 people) receive the intervention (vaccine) after random allocation. The intervention includes: a 2-dose program + a booster dose (days 0, 28, 56). The booster dose of the candidate vaccine is Sobrana Plus (50 micrograms d-RBD +, IM 0.5 ml). This vaccine is made by the Finlay Institute of Vaccines.
    گروه مداخله در کوهورت دوم: در دو شهر (زنجان و یزد) 80 درصد افراد (4800 نفر) پس از تخصیص تصادفی، مداخله مربوطه را دریافت میکنند . مداخله شامل یک برنامه 2 دوزه + یک دوز بوستر (روزهای 0، 28، 56) می باشد. دوز بوستر کاندید واکسن سوبرانا-1 (50 میکروگرم d-RBD + , IM 5/0 میلی-لیتر) می باشد. این واکسن ساخت انستیتو واکسن سازی فینلای کوبا است.
    گروه مداخله در کوهورت دوم: در دو شهر (زنجان و یزد) 80 درصد افراد (4800 نفر) پس از تخصیص تصادفی، مداخله مربوطه را دریافت میکنند . مداخله شامل یک برنامه 2 دوزه + یک دوز بوستر (روزهای 0، 28، 56) می باشد. دوز بوستر کاندید واکسن سوبرانا-پلاس (50 میکروگرم d-RBD + , IM 5/0 میلی-لیتر) می باشد. این واکسن ساخت انستیتو واکسن سازی فینلای کوبا است.
  • Recruitment centers

    #1
    Name of recruitment center - English: Isfahan University of Medical Sciences and Health Services
    Name of recruitment center - Persian: دانشگاه علوم پزشکی و خدمات بهداشتی و درمانی اصفهان
    Full name of responsible person - English: Dr. Morteza Pourahmad
    Full name of responsible person - Persian: دکتر مرتضی پوراحمد
    Street address - English: Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Central Headquarters
    Street address - Persian: اصفهان، خیابان هزار جریب، دانشگاه علوم پزشکی و خدمات بهداشتی درمانی استان اصفهان ،‌ستاد مرکزی
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: ۷۳۴۶۱-۸۱۷۴۶
    Phone: +98 31 3668 0048
    Fax:
    Email: mortezapourahmad@yahoo.com
    Web page address:
    Name of recruitment center - English: Shahid Nilforuzadeh Hall, on the campus of Isfahan University of Medical Sciences
    Name of recruitment center - Persian: سالن شهید نیلفروش زاده، واقع در پردیس دانشگاه علوم پزشکی اصفهان
    Full name of responsible person - English: Dr. Morteza Pourahmad
    Full name of responsible person - Persian: دکتر مرتضی پوراحمد
    Street address - English: Hezar Jerib St., Isfahan University of Medical Sciences and Health Services
    Street address - Persian: اصفهان، خیابان هزار جریب، دانشگاه علوم پزشکی و خدمات بهداشتی درمانی استان اصفهان
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: ۷۳۴۶۱-۸۱۷۴۶
    Phone: +98 31 3668 0048
    Fax:
    Email: mortezapourahmad@yahoo.com
    Web page address:
    #2
    Name of recruitment center - English: Babol University of Medical Sciences and Health Services
    Name of recruitment center - Persian: دانشگاه علوم پزشکی و خدمات بهداشتی و درمانی بابل
    Full name of responsible person - English: Dr. Mostafa Javanian
    Full name of responsible person - Persian: دکتر مصطفی جوانیان
    Street address - English: Ganj Afrooz St., Babol University of Medical Sciences, Babol, Mazandaran
    Street address - Persian: مازندران، بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: ۴۷۷۴۵-۴۷۱۷۶
    Phone: +98 11 3219 9592
    Fax:
    Email: sfjalali42@yahoo.com
    Web page address:
    Name of recruitment center - English: Sport Hall of Babol University of Medical Sciences and Health Services
    Name of recruitment center - Persian: سالن ورزشی دانشگاه علوم پزشکی و خدمات بهداشتی و درمانی بابل
    Full name of responsible person - English: Dr. Mostafa Javanian
    Full name of responsible person - Persian: دکتر مصطفی جوانیان
    Street address - English: Ganj Afrooz St., Babol University of Medical Sciences, Babol, Mazandaran
    Street address - Persian: مازندران، بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: ۴۷۷۴۵-۴۷۱۷۶
    Phone: +98 11 3219 9592
    Fax:
    Email: sfjalali42@yahoo.com
    Web page address:
    #3
    Name of recruitment center - English: Hormozgan University of Medical Sciences and Health Services
    Name of recruitment center - Persian: دانشگاه علوم پزشکی و خدمات بهداشتی و درمانی هرمزگان
    Full name of responsible person - English: Dr.Hossein Farshidi
    Full name of responsible person - Persian: دکتر حسین فرشیدی
    Street address - English: Shahid Chamran Boulevard, Bandar Abbas, Hormozgan
    Street address - Persian: هرمزگان، بندرعباس،بلوار شهيد چمران
    City - English: Bandar Abass
    City - Persian: بندرعباس
    Province: Hormozgan
    Country: Iran (Islamic Republic of)
    Postal code: 7919693116
    Phone: +98 76 3371 0371
    Fax:
    Email: Traznahan@yahoo.com
    Web page address:
    Name of recruitment center - English: Behvarz Training Center
    Name of recruitment center - Persian: مرکز آموزشگاه بهورزی
    Full name of responsible person - English: Dr.Hossein Farshidi
    Full name of responsible person - Persian: دکتر حسین فرشیدی
    Street address - English: Payambar Azam Town, Hormoz Boulevard, Green Tree Site Phase 2
    Street address - Persian: شهرک پیامبر اعظم، بلوار هرمز، سایت درخت سبز فاز2
    City - English: Bandar Abass
    City - Persian: بندرعباس
    Province: Hormozgan
    Country: Iran (Islamic Republic of)
    Postal code: 7919693116
    Phone: +98 76 3371 0371
    Fax:
    Email: Traznahan@yahoo.com
    Web page address:
    #4
    Name of recruitment center - English: Mazandaran University of Medical Sciences and Health Services
    Name of recruitment center - Persian: دانشگاه علوم پزشکی و خدمات بهداشتی و درمانی مازندران
    Full name of responsible person - English: Dr. Roya Ghasemian
    Full name of responsible person - Persian: دکتر رویا قاسمیان
    Street address - English: Imam Square, Joybar Three Ways, beginning of Valiasr Highway, Mazandaran University of Medical Sciences, Sari
    Street address - Persian: ساری، میدان امام (ره) سه راه جویبار، ابتدای بزرگراه ولیعصر (عج)، ستاد مرکزی دانشگاه علوم پزشکی مازندران
    City - English: Mazandaran
    City - Persian: مازندران
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 4815733971
    Phone: +98 11 3304 4000
    Fax:
    Email: roya31gh@gmail.com
    Web page address:
    Name of recruitment center - English: School of Nursing and Midwifery, Mazandaran University of Medical Sciences
    Name of recruitment center - Persian: دانشکده پرستاری و مامایی دانشگاه علوم پزشکی مازندران
    Full name of responsible person - English: Dr. Roya Ghasemian
    Full name of responsible person - Persian: دکتر رویا قاسمیان
    Street address - English: Imam Square, Joybar Three Ways, beginning of Valiasr Highway, Mazandaran University of Medical Sciences, Sari
    Street address - Persian: ساری، میدان امام (ره) سه راه جویبار، ابتدای بزرگراه ولیعصر (عج)، ستاد مرکزی دانشگاه علوم پزشکی مازندران
    City - English: Mazandaran
    City - Persian: مازندران
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 4815733971
    Phone: +98 11 3304 4000
    Fax:
    Email: roya31gh@gmail.com
    Web page address:
    #5
    Name of recruitment center - English: Zanjan University of Medical Sciences and Health Services
    Name of recruitment center - Persian: دانشگاه علوم پزشکی و خدمات بهداشتی و درمانی زنجان
    Full name of responsible person - English: Dr. Samad Ghodrati
    Full name of responsible person - Persian: دکتر صمد قدرتی
    Street address - English: Dr. Yousef Sabouti Blvd., Zanjan, Dr. Yousef Sabouti Blvd., Zanjan University of Medical Sciences
    Street address - Persian: زنجان، بلوار دکتر یوسف ثبوتی، پردیس دانشگاه علوم پزشکی زنجان
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: 4513956184
    Phone: +98 24 3301 8100
    Fax:
    Email: ghodrati@zums.ac.ir
    Web page address:
    Name of recruitment center - English: Corona Vaccine Clinical Trial Center, Zanjan University of Medical Sciences
    Name of recruitment center - Persian: مرکز کارآزمایی بالینی واکسن کرونا دانشگاه علوم پزشکی زنجان
    Full name of responsible person - English: Dr. Samad Ghodrati
    Full name of responsible person - Persian: دکتر صمد قدرتی
    Street address - English: Amirkabir crossroads, next to Zanjan county health center
    Street address - Persian: چهارراه امیرکبیر، جنب مرکز بهداشت شهرستان زنجان
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: 4513956184
    Phone: +98 24 3315 6201
    Fax:
    Email: ghodrati@zums.ac.ir
    Web page address:
    #6
    Name of recruitment center - English: Kerman University of Medical Sciences and Health Services
    Name of recruitment center - Persian: دانشگاه علوم پزشکی و خدمات بهداشتی و درمانی کرمان
    Full name of responsible person - English: Dr. Iman Ghasemzadeh
    Full name of responsible person - Persian: دکتر ایمان قاسم زاده
    Street address - English: The beginning of Haft Bagh Alavi axis, Kerman University of Medical Sciences campus, Kerman
    Street address - Persian: کرمان، ابتدای محور هفت باغ علوی ، پردیس دانشگاه علوم پزشکی کرمان
    City - English: Kerman
    City - Persian: کرمان
    Province: Kerman
    Country: Iran (Islamic Republic of)
    Postal code: 76169-13555
    Phone: +98 34 3132 5700
    Fax:
    Email: imanaten@gmail.com
    Web page address:
    Name of recruitment center - English: Health Technology Incubator of Kerman University of Medical Sciences
    Name of recruitment center - Persian: مرکز رشد و فناوری دانشگاه علوم پزشکی کرمان
    Full name of responsible person - English: Dr. Iman Ghasemzadeh
    Full name of responsible person - Persian: دکتر ایمان قاسم زاده
    Street address - English: Kerman Health Technology, between Farhangian interchange & Amirkabir interchange, Jomhouri blvd
    Street address - Persian: بلوار جمهوری اسلامی، بين چهارراه فرهنگيان و چهار راه اميركبير، ضلع شمالي بلوار
    City - English: Kerman
    City - Persian: کرمان
    Province: Kerman
    Country: Iran (Islamic Republic of)
    Postal code: 76188-66749
    Phone: +98 34 3211 4534
    Fax:
    Email: imanaten@gmail.com
    Web page address:
    #7
    Name of recruitment center - English: Hamadan University of Medical Sciences and Health Services
    Name of recruitment center - Persian: دانشگاه علوم پزشکی و خدمات بهداشتی و درمانی همدان
    Full name of responsible person - English: Dr. Fariba Keramat
    Full name of responsible person - Persian: دکتر فریبا کرامت
    Street address - English: Shahid Fahmideh St., in front of the People's Park of the Educational Complex of Hamadan University of Medical Sciences and Health Services, Hamadan
    Street address - Persian: همدان، خیابان شهید فهمیده، روبروی بوستان مردم، دانشگاه علوم پزشکی و خدمات درمانی همدان
    City - English: Hamedan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 6517838678
    Phone: +98 81 3525 0182
    Fax:
    Email: faribakeramat@yahoo.com
    Web page address:
    Name of recruitment center - English: Shahid Soleimani Sports Hall, Hamadan University of Medical Sciences and Health Services
    Name of recruitment center - Persian: سالن ورزشی شهید سلیمانی، دانشگاه علوم پزشکی و خدمات بهداشتی و درمانی همدان
    Full name of responsible person - English: Dr. Fariba Keramat
    Full name of responsible person - Persian: دکتر فریبا کرامت
    Street address - English: Palestine Square, Shahid Soleimani Sports Hall
    Street address - Persian: میدان فلسطین، سالن ورزشی شهید سلیمانی
    City - English: Hamedan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 6517838678
    Phone: +98 81 3525 0182
    Fax:
    Email: faribakeramat@yahoo.com
    Web page address:
    #8
    Name of recruitment center - English: Yazd University of Medical Sciences and Health Services
    Name of recruitment center - Persian: دانشگاه علوم پزشکی و خدمات بهداشتی و درمانی یزد
    Full name of responsible person - English: Dr. Mohammadreza Mirjalili
    Full name of responsible person - Persian: دکتر محمدرضا میرجلیلی
    Street address - English: Bahonar Square, Shahid Sadoughi Boulevard, Yazd University of Medical Sciences, Yazd
    Street address - Persian: یزد، میدان باهنر – بلوار شهید صدوقی – دانشگاه علوم پزشکی یزد
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916978477
    Phone: +98 35 3725 8474
    Fax:
    Email: Dr.mirjalili@ssu.ac.ir
    Web page address:
    Name of recruitment center - English: Akbari Health Center
    Name of recruitment center - Persian: مرکز بهداشت اکبری
    Full name of responsible person - English: Dr. Mohammadreza Mirjalili
    Full name of responsible person - Persian: دکتر محمدرضا میرجلیلی
    Street address - English: Safaieh, Imam Hassan Square, Shahid Karimi Street, in front of Safaieh Hotel
    Street address - Persian: صفائيه، ميدان امام حسن (ع)، خيابان شهيد كريمي، روبوروي هتل صفائيه.
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916978477
    Phone: +98 35 3725 8474
    Fax:
    Email: Dr.mirjalili@ssu.ac.ir
    Web page address:

Protocol summary

Study aim
Evaluation of efficacy, safety and immunogenicity of recombinant protein vaccine in the prevention of symptomatic infection, severe disease and death due to SARS - CoV-2, in the population aged 18-80 years
Design
In a double blind randomized trial, 24,000 adults, aged between 18 and 80 years old (in 8 cities) will assign to the vaccine and placebo groups (4:1 ratio). The intervention in 6 cities, will be performed with two doses of vaccine and in 2 cities with three doses of vaccine.
Settings and conduct
This study will be conducted in 8 centers from 7 provinces. During the study, efficacy, safety and immunogenicity of two doses of Soberana 02 vaccine and two doses of Soberana 02 with one dose of Soberana plus will evaluate in comparison with the control group. Researchers and volunteers are not aware of the product prescription for each individuals.
Participants/Inclusion and exclusion criteria
Inclusion informed consent, 18-80 years, male and female, Iranian citizens, healthy adults/adults with controlled underlying diseases, able to comply with schedule, subjects from 8 cities Exclusion Fever or infectious disease (recently),mental diseases, sever allergies, complicated diseases (asthma, hypertension, renal, liver and hart diseases), application of tetanus vaccines (recently), vaccination against SARS-CoV-2, use of immunomodulators, tattoos on arms, participation in COVID-19 vaccine trials, Blood transfusion and its products (recently), Coagulation problems, heavy smoker-First priority groups for vaccination
Intervention groups
Cohort 1: 25 µg of RBD-TT, IM, 0 - 28 Cohort 2: 25 µg of RBD-TT, IM, 0 - 28 + a booster dose (Soberana Plus), 56 Placebo groups (in each cohort):Aluminum hydroxide, IM, 0.5 mL, 0 - 28
Main outcome variables
PCR-confirmed of Covid-19 starting 14 days after the last dose of each scheme in the population

General information

Reason for update
Due to the small number of volunteers who were above 65 years (as they have had access to COVID-19 vaccine from the national health system), the 10% limit for recruitment of the above 65 years age group was removed from the protocol upon approval of the DSMB. As per the request of the DSMB committee, new sample size is estimated for the cellular immunity assessment. Accordingly, the following fields in the IRCT were updated: - Secondary outcome variable section> description of the third outcome variable> the sample size for cellular immunity assessment is changed to 130 people. - Abstract section > Study Design section: e 10% limit for recruitment of the above 65 years age group is removed.
Acronym
IRCT registration information
IRCT registration number: IRCT20210303050558N1
Registration date: 2021-04-24, 1400/02/04
Registration timing: prospective

Last update: 2021-06-23, 1400/04/02
Update count: 1
Registration date
2021-04-24, 1400/02/04
Registrant information
Name
Ehsan Mostafavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6411 2121
Email address
mostafaviehsan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-25, 1400/02/05
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy, safety, and immunogenicity of Soberana recombinant vaccine (product of Finlay Institute) based on RBD protein subunit of Sars-Cov-2 in a 2-dose regimen with and without a booster dose: a double-blind, randomized, placebo-controlled phase III clinical trial in the Iranian population of 18-80 years
Public title
Efficacy, safety and immunogenicity of Soberana 02 vaccine (product of Finlay Institute): a double-blind, randomized, placebo-controlled phase III clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Giving written informed consent Ability to comply with the vaccination plan, scheduled visits and lab tests Having general health and controlled underlying diseases Iranian citizenship Residing in the studied cities (Isfahan, Babol, Bandar Abbas, Zanjan, Kerman, Hamedan, Yazd and Sari) Both Genders Aged 18 to 80 years
Exclusion criteria:
Pregnant or lactating women or those who plan to become pregnant up to 3 months after the last dose of the vaccine Application of vaccines containing tetanus toxoid in the last 3 months History of blood /blood products transfusions such as immunoglobulin in the last three months Type 2 diabetes ( HbA1c higher than 7.5) Chronic liver disease (liver enzymes more than 5 times normal: ALT≥150, AST≥100) Subjects previously vaccinated against SARS-CoV-2. History of psychiatric disorders Uncontrolled asthma (having an asthma attack in the last three months). History of severe allergic reaction (anaphylaxis) to the vaccine throughout life History of smoking more than 20 cigarettes a day for more than twenty years Coagulation problems that contraindicate IM injection Previous vaccination with any coronavirus vaccine or participation in other COVID-19 vaccine trials Treatment with immunomodulators in the last 30 days Uncontrolled hypertension (cytological pressure more than 140, diastolic pressure more than 90 mm Hg) Fever or acute illness for 7 days before the injection or on the day of the injection Chronic kidney disease (GFR less than 30) All individuals who are in phase one priority of vaccination based on the National COVID-19 Vaccination Program Subjects with tattoos in the deltoid region on both arms Individuals in priority of the first phase of national vaccination (health workers can participate if they give consent)
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 24000
Randomization (investigator's opinion)
Randomized
Randomization description
The random chain will be defined in the system before the start of the study and the list of randomized treatment groups and the corresponding codes will be delivered to the Food and Drug Administration. Random codes and the type of intervention will be assigned to the candidates based on this list, the details of which are given in the following sections. The random chain in this study will be based on the stratified block randomization method. Stratified randomization will be based on studied cities and the randomization unit is individual participants. Random blocks are a common method for constructing and allocating interventions in clinical trials in which the sample size is divided into a number of blocks of a certain size and in each block the ratio of intervention and control groups in the study is observed. Using this method, it is possible to ensure that the ratio of the intervention group to the control is observed at any time during the study. In the present study, the sample size of 24,000 people in 8 study centres (3000 people in each centre) has been determined. Each centre also has 500 codes in excess of the study size to meet the extraordinary needs of the study (for example, the decision to increase the sample size in one of the centres). The size of the blocks is 25. Therefore, for each centre, 3500 codes in 140 random blocks will be considered, in each of which there are 20 intervention codes and 5 control codes. Each intervention or control code has a unique block ID in the form of a UUID, a 1-digit code for the study centre, a block code from 1 to 140 for labeling vial-holding blocks, and a volunteer code. The volunteer code consists of 5 digits, the first digit of which is the code of the study centre and 4 digits after 1 to 3000 and is therefore unique in the study. Random chain construction is done through a program written specifically for this study. Random chain construction will be performed through a randomization program using the Python 3.8.2 programming language, which was written specifically for this study. In this program, first the total sample size, number of centers, block size, number and ratio of interventions as well as the intervention label are defined. The program then calculates the required number of blocks for each center based on its sample size and block size and creates random chains for each block. In summary, in this method, first a list of intervention and control codes in a block will be made by observing the ratio of the groups. The ordering of the indices is done using a random process in which one of the indices is selected at each stage using a uniform distribution, added in the final order and removed from the unselected indices. This process is repeated for each block.
Blinding (investigator's opinion)
Double blinded
Blinding description
The unique codes of the volunteers are delivered to the preparation group and a label with the volunteer code is inserted on each vial. None of the people working in the preparation department will be in contact with those are involved in the site. Therefore, at the time of delivery of the vial block to the centres, the study colleagues will not be able to distinguish between the drug vial and the placebo. The suspensions in the vaccine and placebo vials are milky white and are similar in color and clarity. Moreover, vaccine and placebo vials are offered in similar appearance, they are inseparable, and packaging and are placed in boxes of 25. Each box will contain the block number and serial numbers of the vaccine/placebo inside. According to this process, participants, vaccinators, researchers, and outcome assessors will be blind. Vaccinators check the unique code information assigned to the candidate with the code on the vaccine/placebo vial before injection. During the study, all consumed vials will be archived and maintained.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Committee for Ethics in Biomedical Research
Street address
Sima-Ye-Iran St, Shahrak Gharb, Ministry o Health, Treatment and Medical Education
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2021-04-17, 1400/01/28
Ethics committee reference number
IR.NREC.1400.001

Health conditions studied

1

Description of health condition studied
Coronavirus Disease (COVID-19)
ICD-10 code
U11
ICD-10 code description
Need for immunization against COVID-19

Primary outcomes

1

Description
The effectiveness of the vaccine in preventing symptomatic Covid-19 infection
Timepoint
The incidence of symptomatic Covid-19 that occurs from day 14 after the second injection will be compared in the vaccine and placebo groups. Positive cases will be evaluated before this time period and will be evaluated in stratification analyzes.
Method of measurement
PCR test results for COVID-19

2

Description
The effectiveness of the vaccine in preventing severe form of Covid-19
Timepoint
All cases of severe infection will be detected from day 14 after injection of the last dose to 4 and 6 months from start of the injection (respectively in 2-dose and 2-dose + booster regimens).
Method of measurement
Positive results of Covid-19 PCR test and clinical condition of the patient that the hospitalized patient will need to receive oxygen through non-invasive respiratory ventilation (NIV) or high oxygen flow or the patient will need intubation.

3

Description
The effectiveness of the vaccine in death from Covid-19
Timepoint
All cases of death due to COVID-19 will be detected from day 14 after injection of the last dose to 4 and 6 months from start of the injection (respectively in 2-dose and 2-dose + booster regimens).
Method of measurement
Positive results of Covid-19 PCR test and according to the diagnosis of the research physician and the DSMB team and based on the definition of the World Health Organization

Secondary outcomes

1

Description
Humoral safety will be studied on a subset of the population of Babol, Sari (under 2-dose regimen) and Zanjan (under 2-dose + booster regimen).
Timepoint
The Humoral test will be done before and 1 month after receiving the last dose. Also, in Babol and Sari, an additional assessment will be done on days 5 and 28 of a 30% sample of subjects (900 people in each city).
Method of measurement
Anti-S-RBD antibody test

2

Description
The frequency of local and systemic events and mild, moderate , severe, critical adverse events and death will be recorded by the participants in the forms.
Timepoint
The occurrence of side effects and adverse events will be monitored from Zero day to 5 months after the injection of the last dose.
Method of measurement
Active and inactive monitoring from Zero day to 5 months after the injection of the last dose with the registration of adverse events in CIFs

3

Description
Evaluation of Cellular safety will be performed on 130 people in one of the cities of Babol or Sari (depending of logistic status).
Timepoint
Cell immunoassay will be performed at the same time as the humoral tests.
Method of measurement
Interferon Gamma Release Assay

Intervention groups

1

Description
Intervention group in the first cohort: In 6 cities (Isfahan, Babol, Bandar Abbas, Sari, Kerman and Hamedan) 80% of people (14,400 people) receive the intervention (vaccine) after random allocation. Intervention is included intramuscular injection of vaccine candidates with conjugation of 25 μg RBD to tetanus toxin in a 2-dose program (days 0 and 28). This vaccine is made by the Finlay Institute of Vaccines.
Category
Prevention

2

Description
Control group in the first cohort: In 6 cities (Isfahan, Babol, Bandar Abbas, Sari, Kerman and Hamedan) 20% of people (3600 people) receive a placebo after random allocation. The intervention involves an intramuscular injection of a dose of aluminum hydroxide on days 0 and 28. This placebo is made by the Finlay Institute of Vaccines.
Category
Placebo

3

Description
Intervention group in the second cohort: In two cities (Zanjan and Yazd) 80% of people (4800 people) receive the intervention (vaccine) after random allocation. The intervention includes: a 2-dose program + a booster dose (days 0, 28, 56). The booster dose of the candidate vaccine is Sobrana Plus (50 micrograms d-RBD +, IM 0.5 ml). This vaccine is made by the Finlay Institute of Vaccines.
Category
Prevention

4

Description
Control group in the second cohort: In 2 cities (Zanjan and Yazd) 20% of people (1200 people) receive a placebo after random allocation. The intervention involves an intramuscular injection of a dose of aluminum hydroxide on days 0, 28 and 56. This placebo is made by the Finlay Institute of Vaccines.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Nilforuzadeh Hall, on the campus of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Morteza Pourahmad
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
mortezapourahmad@yahoo.com

2

Recruitment center
Name of recruitment center
Sport Hall of Babol University of Medical Sciences and Health Services
Full name of responsible person
Dr. Mostafa Javanian
Street address
Ganj Afrooz St., Babol University of Medical Sciences, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۷۴۵-۴۷۱۷۶
Phone
+98 11 3219 9592
Email
sfjalali42@yahoo.com

3

Recruitment center
Name of recruitment center
Behvarz Training Center
Full name of responsible person
Dr.Hossein Farshidi
Street address
Payambar Azam Town, Hormoz Boulevard, Green Tree Site Phase 2
City
Bandar Abass
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0371
Email
Traznahan@yahoo.com

4

Recruitment center
Name of recruitment center
School of Nursing and Midwifery, Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Roya Ghasemian
Street address
Imam Square, Joybar Three Ways, beginning of Valiasr Highway, Mazandaran University of Medical Sciences, Sari
City
Mazandaran
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
roya31gh@gmail.com

5

Recruitment center
Name of recruitment center
Corona Vaccine Clinical Trial Center, Zanjan University of Medical Sciences
Full name of responsible person
Dr. Samad Ghodrati
Street address
Amirkabir crossroads, next to Zanjan county health center
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3315 6201
Email
ghodrati@zums.ac.ir

6

Recruitment center
Name of recruitment center
Health Technology Incubator of Kerman University of Medical Sciences
Full name of responsible person
Dr. Iman Ghasemzadeh
Street address
Kerman Health Technology, between Farhangian interchange & Amirkabir interchange, Jomhouri blvd
City
Kerman
Province
Kerman
Postal code
76188-66749
Phone
+98 34 3211 4534
Email
imanaten@gmail.com

7

Recruitment center
Name of recruitment center
Shahid Soleimani Sports Hall, Hamadan University of Medical Sciences and Health Services
Full name of responsible person
Dr. Fariba Keramat
Street address
Palestine Square, Shahid Soleimani Sports Hall
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3525 0182
Email
faribakeramat@yahoo.com

8

Recruitment center
Name of recruitment center
Akbari Health Center
Full name of responsible person
Dr. Mohammadreza Mirjalili
Street address
Safaieh, Imam Hassan Square, Shahid Karimi Street, in front of Safaieh Hotel
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3725 8474
Email
Dr.mirjalili@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pasture Institute of Iran
Full name of responsible person
Dr Alireza Biglari
Street address
No. 69, 12 Farvardin St., Tehran
City
Tehran
Province
Tehran
Postal code
1316943551
Phone
+98 21 6695 4321
Email
biglari63@hotmail.com
Web page address
http://fa.pasteur.ac.ir/
Grant name
Pasteur institute of Iran
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pasture Institute of Iran
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Pasture Institute of Iran
Full name of responsible person
Dr. Ehsan Mostafavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Epidemiology
Street address
No. 69, 12 Farvardin St., Tehran
City
Tehran
Province
Tehran
Postal code
1316943551
Phone
+98 21 6411 2121
Email
mostafaviehsan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hamid Emadi Kuchak
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Enghela street, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1467664961
Phone
+98 21 8897 3372
Email
emadiham@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Pasture Institute of Iran
Full name of responsible person
Dr. Sana Eybpoosh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Epidemiology
Street address
No. 69, 12 Farvardin St., Tehran
City
Tehran
Province
Tehran
Postal code
1316943551
Phone
+98 21 6411 2121
Email
mostafaviehsan@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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