<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20210620051639N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-23</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Phase 3 Clinical Trial to evaluate the Immunogenicity and Safety of Covid19 Recombinant RBD Protein Vaccine (Noora Vaccine)  as a Booster Vaccine after injection of existing Vaccines in IRAN</public_title>
      <acronym></acronym>
      <scientific_title>Phase 3 Clinical Trial to evaluate the Immunogenicity and Safety of Covid19 Recombinant RBD Protein Vaccine (Noora Vaccine)  as a Booster Vaccine after injection of existing Vaccines in IRAN</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60796</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, Randomization process in immunogenicity assessment section is performed one step before the onset of recruitment. For this purpose, 60 random block sequences with size 6 will be produced so that for every 4 volunteers receiving the recombinant vaccine, 2 volunteers will receive placebo.
There is no randomization process in the safety assessment section which will be performed before and after, Blinding description: The blinding process in the immunogenicity assessment section of this study, which will be performed on a sample size of 300 people, is performed in a double-blind manner. For this purpose, the placebo is exactly the same as the vaccine and is prepared by the manufacturer with the same volume, color and other specifications and will be labeled by an independent group based on randomization codes. Obviously, the researchers, the evaluation team of the volunteers, the vaccinators and the volunteers will be completely unaware of the type of product received.
In the safety assessment section (on a sample size of 10000 people), the study will be open labeled and the blinding process will not be used.</study_design>
      <phase>3</phase>
      <hc_freetext>Covid 19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: Injection of a dose of 80 micrograms of recombinant RBD protein vaccine intramuscularly (deltoid muscle) in 10000 participants in affiliated centers of Baqiyatallah Hospital and 200 participants in Shahid Soleimani Clinical Trial Center. Intervention 2: Control group: Injection of a placebo intramuscularly (deltoid muscle) in 100 participants in Shahid Soleimani Clinical Trial Center.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is not a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Hassan Abolghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical Sciences, Shahid Nosrati alley, Shiekh Bahaei st., Mollasadra st,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915371</zip>
        <telephone>+98 21 8216 2440</telephone>
        <email>H.abolghasemi.ha@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hassan Abolghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical Sciences, Shahid Nosrati alley, Shiekh Bahaei st., Mollasadra st,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915371</zip>
        <telephone>+98 21 8216 2440</telephone>
        <email>H.abolghasemi.ha@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 years and older
Candidates who have received two identical doses of the available vaccine (Sinopharm, CovIran Barakat, AstraZenka) and at least 3 months (at least 90 days) have passed since the second dose
The candidate is able to fully understand the provisions of the informed consent form and sign it before entering the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>SARS CoV 2 infection (clinically significant or rtPCR document)
Approved or suspected COVID 19 in the last two months
Going through home quarantine due to suspicion of having an exposure to a patient with Corona
History of severe allergic reactions
Chronic kidney, liver and various malignancies
Acute bacterial infection in the last 7 days
Known cases of immunodeficiency, HIV, or autoimmune diseases
Receiving immunosuppressive drugs or corticosteroids in the last 3 months
Receiving immunoglobulin or blood products during the three months prior to vaccination
Pregnant or Breastfeeding women or those who plan to become pregnant during the study period</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID 19, virus identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: Injection of a dose of 80 micrograms of recombinant RBD protein vaccine intramuscularly (deltoid muscle) in 10000 participants in affiliated centers of Baqiyatallah Hospital and 200 participants in Shahid Soleimani Clinical Trial Center</i_keyword>
      <i_keyword>Control group: Injection of a placebo intramuscularly (deltoid muscle) in 100 participants in Shahid Soleimani Clinical Trial Center</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>ّThe level of specific IgG antibody against RBD protein in days 0 and 21 after booster injection based on GMI, GMT and seroconversion rate (increase at least 4 times in antibody titer) in Shahid Soleimani Clinical Trial Center (sample of 300 people). Timepoint: in days 0 and 21 after booster injection. Method of measurement: The level of specific IgG antibody against RBD protein ibased on GMI, GMT and seroconversion rate (increase at least 4 times in antibody titer) .</prim_outcome>
      <prim_outcome>Cellular immune response to booster dose based on measurement of IL 4 and INFγ levels using ELISA method on days 0 and 21 after injection (subgroup of 90 people). Timepoint: in days 0 and 21 after booster injection. Method of measurement: Cellular immune response to booster dose based on measurement of IL 4 and INFγ levels using ELISA method .</prim_outcome>
      <prim_outcome>Measurement of neutralizing antibody level by neutralization test method Virus (subgroup of 90 people). Timepoint: in days 0 and 21 after booster injection. Method of measurement: Measurement of neutralizing antibody level by neutralization test method Virus.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Any reaction within 30 minutes after booster dose injection. Timepoint: within 30 minutes after booster dose injection. Method of measurement: ِData collection and recording by the nurse or physician based on the participating condition within 30 minutes after injection at the vaccination site.</sec_outcome>
      <sec_outcome>Occurrence of local adverse event (s) (pain, redness, stiffness, swelling, skin rash, burning and itching) or systemic (fever, headache, chills, diarrhea) Vomiting, muscle pain, joint pain, shortness of breath, fatigue, allergic reactions, etc.) based on the severity, duration and maximum severity of the complication within 3 and 7 days after injection of the booster dose. Timepoint: within 3 and 7 days after injection of the booster dose. Method of measurement: ٍExperts contact participants and record possible side effects.</sec_outcome>
      <sec_outcome>Incidence of adverse event (s) Systemic (fever, headache, chills, diarrhea, vomiting, muscle aches, joint pain, shortness of breath,fatigue, allergic reactions, etc.) based on the severity, duration and maximum severity of the complication within 28 days after booster dose. Timepoint: within 28 days after booster dose. Method of measurement: ٍExperts contact participants and record possible side effects.</sec_outcome>
      <sec_outcome>Incidence of adverse event (s) Systemic (fever, headache, chills, diarrhea, vomiting, muscle aches, joint pain, shortness of breath, fatigue, allergic reactions, etc.) based on the severity, duration and maximum severity of the complication within 60 days after booster dose as a complementary outcome. Timepoint: within 60 days after booster dose. Method of measurement: ٍExperts contact participants and record possible side effects.</sec_outcome>
      <sec_outcome>Level of IgG antibody specific against RBD protein in 3 and 6 months after booster dose injection and seroconversion rate (increase at least 4 times in antibody titer) in the vaccine group in Shahid Soleimani Clinical Trial Center (group of 200 people) as a complementary outcome. Timepoint: in 3 and 6 months after booster dose injection. Method of measurement: collecting blood samples of vaccine participants (200 people) in Shahid Soleimani Trial Center.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-22</approval_date>
        <contact_name>National Research Ethics Committee</contact_name>
        <contact_address>13th floor, Block A, Ministry of health, Simaye Iran street, Shahrake ghods Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
