<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04471519</url>
  </required_header>
  <id_info>
    <org_study_id>BBIL/BBV152-A/2020</org_study_id>
    <secondary_id>Protocol No:BBIL/BBV152-A/2020</secondary_id>
    <nct_id>NCT04471519</nct_id>
  </id_info>
  <brief_title>Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COVID-19 in Healthy Volunteers</brief_title>
  <acronym>BBV152</acronym>
  <official_title>An Adaptive Phase 1, Followed by Phase 2 Randomized, Double-blind, Multicenter Study to Evaluate the Safety, Reactogenicity, Tolerability, and Immunogenicity of BBV152 in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bharat Biotech International Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Indian Council of Medical Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bharat Biotech International Limited</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Double blind, Multi-Centre study to evaluate the safety, reactogenicity, tolerability, and&#xD;
      immunogenicity of three investigational vaccine groups and one placebo group in healthy&#xD;
      volunteers who receive two intramuscular doses of BBV152 vaccine formulations and placebo. A&#xD;
      total sample size of 755 healthy volunteers, with 375 and 380 volunteers in phase 1 and 2&#xD;
      studies, respectively.&#xD;
&#xD;
      A protocol amendment was made to evaluate a boosting regimen at the 6-month interval in the&#xD;
      Phase 2 trial. At 6 months post-dose 2, participants who received the 6ug Algel-IMDG&#xD;
      allocation were randomized equally to receive a third dose of BBV152 (6ug Algel-IMDG) or&#xD;
      placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 1 study&#xD;
&#xD;
      The study is designed to evaluate the safety, reactogenicity, tolerability, and&#xD;
      immunogenicity of Four arms of healthy volunteers who receive two intramuscular doses of&#xD;
      BBV152 vaccine formulations or Placebo. A total no of 375 subjects will be enrolled in 4:1&#xD;
      ratio.&#xD;
&#xD;
      This study will be conducted in a dose escalatory manner with a two-dose regimen fourteen&#xD;
      days apart.&#xD;
&#xD;
      Phase 2 study&#xD;
&#xD;
      The study is designed to evaluate the safety, reactogenicity, tolerability, and&#xD;
      immunogenicity of two arms of healthy volunteers who will receive two intramuscular doses of&#xD;
      BBV152 vaccine formulations (BBV152-A &amp; BBV152-B) in a 1:1 ratio with dosage schedule on Day&#xD;
      0 and Day 28.&#xD;
&#xD;
      A protocol amendment was made to evaluate a boosting regimen at the 6-month interval in the&#xD;
      Phase 2 trial. At 6 months post-dose 2, participants who received the 6ug Algel-IMDG&#xD;
      allocation were randomized equally to receive a third dose of BBV152 (6ug Algel-IMDG) or&#xD;
      placebo. The investigator, participant and Sponsor were blinded to the allocation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 1: Occurrence of adverse events and Serious Adverse events</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
    <description>Safety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Evaluation of Neutralizing Antibody Titers</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
    <description>Pre- and Post-vaccination immune response</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase 1: Evaluation of Neutralizing Antibody Titers</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
    <description>Pre- and Post-vaccination immune response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Occurrence of adverse events and Serious Adverse events</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
    <description>Safety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Evaluation of Neutralizing Antibody Titers</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
    <description>Post-vaccination immune responses comparing two-dose and three dose regimens</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">755</enrollment>
  <condition>COVID-19</condition>
  <condition>SARS-CoV-2 Infection</condition>
  <arm_group>
    <arm_group_label>BBV152A - Phase I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine [BBV152A], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BBV152B - Phase I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine [BBV152B], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BBV152C - Phase I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine [BBV152C], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo - Phase I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0.5 mL of Placebo will be administered intramuscularly twice at Day 0 and Day 14.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BBV152A - Phase II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine [BBV152A], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 28.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BBV152B - Phase II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine [BBV152B], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 28</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BBV152A - Phase I</intervention_name>
    <description>0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14</description>
    <arm_group_label>BBV152A - Phase I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BBV152B - Phase I</intervention_name>
    <description>0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14</description>
    <arm_group_label>BBV152B - Phase I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BBV152C - Phase I</intervention_name>
    <description>0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14</description>
    <arm_group_label>BBV152C - Phase I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo - Phase I</intervention_name>
    <description>0.5 ml of the Placebo will be administered intramuscularly twice at Day 0 and Day 14</description>
    <arm_group_label>Placebo - Phase I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BBV152A - Phase II</intervention_name>
    <description>0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28</description>
    <arm_group_label>BBV152A - Phase II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BBV152B - Phase II</intervention_name>
    <description>0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28</description>
    <arm_group_label>BBV152B - Phase II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Phase 1:&#xD;
&#xD;
        Inclusion Criteria&#xD;
&#xD;
          1. Ability to provide written informed consent.&#xD;
&#xD;
          2. Participants of either gender of age between ≥18 to ≤55 years.&#xD;
&#xD;
          3. Good general health as determined by the discretion of investigator (vital signs&#xD;
             (heart rate ≥60 to≤100 bpm; blood pressure systolic ≥90 mm Hg and &lt;140 mm Hg;&#xD;
             diastolic ≥ 60 mm Hg and &lt;90 mm Hg; oral temperature &lt;100.4ºF), medical history, and&#xD;
             physical examination).&#xD;
&#xD;
          4. Expressed interest and availability to fulfill the study requirements.&#xD;
&#xD;
          5. For a female participant of child-bearing potential, planning to avoid becoming&#xD;
             pregnant (use of an effective method of contraception or abstinence) from the time of&#xD;
             study enrolment until at least four weeks after the last vaccination&#xD;
&#xD;
          6. Male subjects of reproductive potential: Use of condoms to ensure effective&#xD;
             contraception with the female partner from first vaccination until 3 months after last&#xD;
             vaccination&#xD;
&#xD;
          7. Male subjects agree to refrain from sperm donation from the time of first vaccination&#xD;
             until 3 months after last vaccination&#xD;
&#xD;
          8. Participants must refrain from blood or plasma donation from the time of first&#xD;
             vaccination until 3 months after last vaccination&#xD;
&#xD;
          9. Agrees not to participate in another clinical trial at any time during the study&#xD;
             period.&#xD;
&#xD;
         10. Agrees to remain in the study area for the entire duration of the study.&#xD;
&#xD;
         11. Willing to allow storage and future use of biological samples for future research.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. History of any other COVID-19 investigational vaccination.&#xD;
&#xD;
          2. Unacceptable laboratory abnormality from screening (prior to first vaccination) or&#xD;
             safety testing, as listed below [Abnormal Complete Blood Count (CBC), Random blood&#xD;
             sugar level, Renal function test (serum urea and Creatinine), liver function tests,&#xD;
             urine analysis report, Positive serology for hepatitis C or HIV antibody or hepatitis&#xD;
             B surface antigen].&#xD;
&#xD;
             (Subjects will be informed if their results are positive for hepatitis C, HIV 1 &amp; 2&#xD;
             antibody or hepatitis B surface antigen (HBsAg) and will be referred to a primary care&#xD;
             provider for follow up of these abnormal laboratory tests.)&#xD;
&#xD;
          3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method.&#xD;
&#xD;
          4. Health care workers.&#xD;
&#xD;
          5. For women, a positive serum pregnancy test (during screening within 45 days of&#xD;
             enrolment) or positive urine pregnancy test (within 24 hours of administering each&#xD;
             dose of vaccine).&#xD;
&#xD;
          6. Temperature &gt;38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an&#xD;
             upper respiratory infection or gastroenteritis within three days prior to each dose of&#xD;
             vaccine.&#xD;
&#xD;
          7. Medical problems as a result of alcohol or illicit drug use during the past 12 months.&#xD;
&#xD;
          8. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before&#xD;
             enrollment or expects to receive an investigational agent during the study period.&#xD;
&#xD;
          9. Receipt of any licensed vaccine within four weeks before enrolment in this study.&#xD;
&#xD;
         10. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic&#xD;
             reaction and history of allergies in the past.&#xD;
&#xD;
         11. Receipt of immunoglobulin or other blood products within the three months prior to&#xD;
             vaccination in this study.&#xD;
&#xD;
         12. Immunosuppression as a result of an underlying illness or treatment with&#xD;
             immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation&#xD;
             therapy within the preceding 36 months.&#xD;
&#xD;
         13. Long-term use (&gt; 2 weeks) of oral or parenteral steroids (glucocorticoids) or&#xD;
             high-dose inhaled steroids (&gt;800 mcg/day of beclomethasone dipropionate or equivalent)&#xD;
             within the preceding six months (nasal and topical steroids are allowed).&#xD;
&#xD;
         14. Any history of hereditary angioedema or idiopathic angioedema.&#xD;
&#xD;
         15. Any history of anaphylaxis in relation to vaccination.&#xD;
&#xD;
         16. Any history of albumin-intolerance.&#xD;
&#xD;
         17. Pregnancy, lactation, or willingness/intention to become pregnant during the study.&#xD;
&#xD;
         18. History of any cancer.&#xD;
&#xD;
         19. History of psychiatric severe conditions likely to affect participation in the study.&#xD;
&#xD;
         20. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or&#xD;
             prior history of significant bleeding or bruising following IM injections or&#xD;
             venepuncture.&#xD;
&#xD;
         21. Any other serious chronic illness requiring hospital specialist supervision.&#xD;
&#xD;
         22. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including&#xD;
             mild asthma.&#xD;
&#xD;
         23. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal&#xD;
             disease, endocrine disorder, and neurological illness&#xD;
&#xD;
         24. Morbidly obese (BMI≥35 kg/m2) or underweight (BMI ≤18 kg/m2).&#xD;
&#xD;
         25. Living in the same household of any COVID-19 positive person.&#xD;
&#xD;
         26. Any other condition that in the opinion of the investigator would jeopardize the&#xD;
             safety or rights of a volunteer participating in the trial or would render the subject&#xD;
             unable to comply with the protocol.&#xD;
&#xD;
             Re-Vaccination Exclusion Criteria&#xD;
&#xD;
         27. Pregnancy.&#xD;
&#xD;
         28. Anaphylactic reaction following administration of the investigational vaccine.&#xD;
&#xD;
         29. Virologically confirmed cases of COVID-19&#xD;
&#xD;
        Phase 2:&#xD;
&#xD;
        Inclusion Criteria&#xD;
&#xD;
          1. Ability to provide written informed consent (Audio video consent for vulnerable&#xD;
             subjects).&#xD;
&#xD;
          2. Participants of either gender of age between ≥12 to ≤ 65 years.&#xD;
&#xD;
          3. Good general health as determined by the discretion of investigator (vital signs&#xD;
             (heart rate ≥60 to≤100 bpm; blood pressure systolic ≥90 mm Hg and &lt;140 mm Hg;&#xD;
             diastolic ≥ 60 mm Hg and &lt;90 mm Hg; oral temperature &lt;100.4ºF), medical history, and&#xD;
             physical examination).&#xD;
&#xD;
          4. Expressed interest and availability to fulfill the study requirements.&#xD;
&#xD;
          5. For a female participant of child-bearing potential, avoid becoming pregnant (use of&#xD;
             an effective method of contraception or abstinence) from the time of study enrolment&#xD;
             until at least four weeks after the last vaccination and agrees not to participate in&#xD;
             another clinical trial at any time during the study period.&#xD;
&#xD;
          6. Male subjects of reproductive potential: Use of condoms to ensure effective&#xD;
             contraception with the female partner from first vaccination until 3 months after last&#xD;
             vaccination&#xD;
&#xD;
          7. Male subjects agree to refrain from sperm donation from the time of first vaccination&#xD;
             until 3 months after last vaccination&#xD;
&#xD;
          8. Participants must refrain from blood or plasma donation from the time of first&#xD;
             vaccination until 3 months after last vaccination.&#xD;
&#xD;
          9. Agrees to remain in the study area for the entire duration of the study.&#xD;
&#xD;
         10. Willing to allow storage and future use of biological samples for future research.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. History of any other COVID-19 investigational vaccination.&#xD;
&#xD;
          2. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method.&#xD;
&#xD;
          3. Health care workers.&#xD;
&#xD;
          4. Positive urine pregnancy test (within 24 hours of administering each dose of vaccine).&#xD;
&#xD;
          5. Temperature &gt; 38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an&#xD;
             upper respiratory infection or gastroenteritis within three days prior to each dose of&#xD;
             vaccine.&#xD;
&#xD;
          6. Medical problems as a result of alcohol or illicit drug use during the past 12 months.&#xD;
&#xD;
          7. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before&#xD;
             enrolment or expects to receive an investigational agent during the study period.&#xD;
&#xD;
          8. Receipt of any licensed vaccine within four weeks before enrolment in this study.&#xD;
&#xD;
          9. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic&#xD;
             reaction and history of allergies in the past.&#xD;
&#xD;
         10. Receipt of immunoglobulin or other blood products within the three months prior to&#xD;
             vaccination in this study.&#xD;
&#xD;
         11. Immunosuppression as a result of an underlying illness or treatment with&#xD;
             immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation&#xD;
             therapy within the preceding 36 months.&#xD;
&#xD;
         12. Long-term use (&gt; 2 weeks) of oral or parenteral steroids (glucocorticoids) or&#xD;
             high-dose inhaled steroids (&gt;800 mcg/day of beclomethasone dipropionate or equivalent)&#xD;
             within the preceding six months (nasal and topical steroids are allowed).&#xD;
&#xD;
         13. Any history of hereditary angioedema or idiopathic angioedema.&#xD;
&#xD;
         14. Any history of anaphylaxis in relation to vaccination.&#xD;
&#xD;
         15. Any history of albumin-intolerance.&#xD;
&#xD;
         16. Pregnancy, lactation, or willingness/intention to become pregnant during the study.&#xD;
&#xD;
         17. History of any cancer.&#xD;
&#xD;
         18. History of psychiatric severe conditions likely to affect participation in the study.&#xD;
&#xD;
         19. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or&#xD;
             prior history of significant bleeding or bruising following IM injections or&#xD;
             venepuncture.&#xD;
&#xD;
         20. Any other serious chronic illness requiring hospital specialist supervision.&#xD;
&#xD;
         21. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including&#xD;
             mild asthma.&#xD;
&#xD;
         22. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal&#xD;
             disease, endocrine disorder, and neurological illness&#xD;
&#xD;
         23. Morbidly obese (BMI≥35 kg/m2) or underweight (BMI ≤18 kg/m2).&#xD;
&#xD;
         24. Living in the same household of any COVID-19 positive person.&#xD;
&#xD;
         25. Any other condition that in the opinion of the investigator would jeopardize the&#xD;
             safety or rights of a volunteer participating in the trial or would render the subject&#xD;
             unable to comply with the protocol.&#xD;
&#xD;
             Re-Vaccination Exclusion Criteria&#xD;
&#xD;
         26. Pregnancy.&#xD;
&#xD;
         27. Anaphylactic reaction following administration of the investigational vaccine.&#xD;
&#xD;
         28. Virologically confirmed cases of COVID-19.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Savita Verma, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>PGIMS, Rohtak</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Sanjay Kumar Rai, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>All India Institute of Medical Sciences, Delhi</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Chandramani Singh, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>All India Institute of Medical Sciences, Patna</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Ajeeth Pratap Singh, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rana Hospital and Trauma Centre, Gorakhpur</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Satyajit Mohapatra, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SRM Hospital and Research Centre, Chennai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Prabhakar Reddy, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nizams Institute of Medical Sciences, Hyderabad</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Venkata Rao, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IMS &amp; SUM Hospital, Orissa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Jitendra Kushwaha, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prakhar Hospital, Kanpur</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Sagar Vivek Redkar, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Redkar Hospital and Research Center, Goa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Amit Bhate, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jeevan Rekha Hospital, Belguam</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Chadrashekar Gillukar, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gillukar Multispeciality Hospital, Nagpur</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr Vasudev R, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King George Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King George Hospital</name>
      <address>
        <city>Visakhapatnam</city>
        <state>Andhra Pradesh</state>
        <zip>560037</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>All India Institute of Medical Sciences</name>
      <address>
        <city>Patna</city>
        <state>Bihar</state>
        <zip>801507</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pt BD SHARMA,PGIMS/UHS</name>
      <address>
        <city>Rohtak</city>
        <state>Haryana</state>
        <zip>124001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeevan Rekha Hospital</name>
      <address>
        <city>Belgaum</city>
        <state>Karnataka</state>
        <zip>590019</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gillukar Multispeciality Hospital</name>
      <address>
        <city>Nagpur</city>
        <state>Maharastra</state>
        <zip>440009</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>All India Institute of Medical Sciences</name>
      <address>
        <city>Delhi</city>
        <state>New Delhi</state>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Medical Sciences and SUM Hospital</name>
      <address>
        <city>Bhubaneswar</city>
        <state>Orissa</state>
        <zip>751003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SRM Hospital &amp; Research center</name>
      <address>
        <city>Chennai</city>
        <state>Tamilnadu</state>
        <zip>603211</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nizam's Institute of Medical Sciences</name>
      <address>
        <city>Hyderabad</city>
        <state>Telangana</state>
        <zip>500082</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rana Hospital and Trauma Center</name>
      <address>
        <city>Gorakhpur</city>
        <state>Uttar Pradesh</state>
        <zip>273013</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prakhar Hospital</name>
      <address>
        <city>Kanpur</city>
        <state>Uttar Pradesh</state>
        <zip>208002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Redkar Hospital and Research Centre</name>
      <address>
        <city>Goa</city>
        <zip>403513</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>August 17, 2022</last_update_submitted>
  <last_update_submitted_qc>August 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BBV152</keyword>
  <keyword>COVID-19 vaccine</keyword>
  <keyword>inactivated vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04471519
org study id: BBIL/BBV152-A/2020
secondary id: Protocol No:BBIL/BBV152-A/2020
nct id: NCT04471519
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Double blind, Multi-Centre study to evaluate the safety, reactogenicity, tolerability, and
      immunogenicity of three investigational vaccine groups and one placebo group in healthy
      volunteers who receive two intramuscular doses of BBV152 vaccine formulations and placebo. A
      total sample size of 755 healthy volunteers, with 375 and 380 volunteers in phase 1 and 2
      studies, respectively.

      A protocol amendment was made to evaluate a boosting regimen at the 6-month interval in the
      Phase 2 trial. At 6 months post-dose 2, participants who received the 6ug Algel-IMDG
      allocation were randomized equally to receive a third dose of BBV152 (6ug Algel-IMDG) or
      placebo.
Phase 1 study

      The study is designed to evaluate the safety, reactogenicity, tolerability, and
      immunogenicity of Four arms of healthy volunteers who receive two intramuscular doses of
      BBV152 vaccine formulations or Placebo. A total no of 375 subjects will be enrolled in 4:1
      ratio.

      This study will be conducted in a dose escalatory manner with a two-dose regimen fourteen
      days apart.

      Phase 2 study

      The study is designed to evaluate the safety, reactogenicity, tolerability, and
      immunogenicity of two arms of healthy volunteers who will receive two intramuscular doses of
      BBV152 vaccine formulations (BBV152-A & BBV152-B) in a 1:1 ratio with dosage schedule on Day
      0 and Day 28.

      A protocol amendment was made to evaluate a boosting regimen at the 6-month interval in the
      Phase 2 trial. At 6 months post-dose 2, participants who received the 6ug Algel-IMDG
      allocation were randomized equally to receive a third dose of BBV152 (6ug Algel-IMDG) or
      placebo. The investigator, participant and Sponsor were blinded to the allocation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Phase 1: Occurrence of adverse events and Serious Adverse events
time frame: Through study completion, an average of 6 months
description: Safety
measure: Phase 2: Evaluation of Neutralizing Antibody Titers
time frame: Through study completion, an average of 6 months
description: Pre- and Post-vaccination immune response
measure: Phase 1: Evaluation of Neutralizing Antibody Titers
time frame: Through study completion, an average of 6 months
description: Pre- and Post-vaccination immune response
measure: Phase 2: Occurrence of adverse events and Serious Adverse events
time frame: Through study completion, an average of 6 months
description: Safety
measure: Phase 2: Evaluation of Neutralizing Antibody Titers
time frame: Through study completion, an average of 6 months
description: Post-vaccination immune responses comparing two-dose and three dose regimens
arm group label: BBV152A - Phase I
arm group type: Experimental
description: 0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine [BBV152A], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 14
arm group label: BBV152B - Phase I
arm group type: Experimental
description: 0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine [BBV152B], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 14
arm group label: BBV152C - Phase I
arm group type: Experimental
description: 0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine [BBV152C], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 14
arm group label: Placebo - Phase I
arm group type: Active Comparator
description: 0.5 mL of Placebo will be administered intramuscularly twice at Day 0 and Day 14.
arm group label: BBV152A - Phase II
arm group type: Experimental
description: 0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine [BBV152A], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 28.
arm group label: BBV152B - Phase II
arm group type: Experimental
description: 0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine [BBV152B], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 28
intervention type: Biological
intervention name: BBV152A - Phase I
description: 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14
arm group label: BBV152A - Phase I
intervention type: Biological
intervention name: BBV152B - Phase I
description: 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14
arm group label: BBV152B - Phase I
intervention type: Biological
intervention name: BBV152C - Phase I
description: 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14
arm group label: BBV152C - Phase I
intervention type: Biological
intervention name: Placebo - Phase I
description: 0.5 ml of the Placebo will be administered intramuscularly twice at Day 0 and Day 14
arm group label: Placebo - Phase I
intervention type: Biological
intervention name: BBV152A - Phase II
description: 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28
arm group label: BBV152A - Phase II
intervention type: Biological
intervention name: BBV152B - Phase II
description: 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28
arm group label: BBV152B - Phase II
criteria: 
gender: All
minimum age: 12 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Savita Verma, MBBS, MD
role: Principal Investigator
affiliation: PGIMS, Rohtak
last name: Dr. Sanjay Kumar Rai, MBBS, MD
role: Principal Investigator
affiliation: All India Institute of Medical Sciences, Delhi
last name: Dr. Chandramani Singh, MBBS, MD
role: Principal Investigator
affiliation: All India Institute of Medical Sciences, Patna
last name: Dr. Ajeeth Pratap Singh, MBBS, MD
role: Principal Investigator
affiliation: Rana Hospital and Trauma Centre, Gorakhpur
last name: Dr. Satyajit Mohapatra, MBBS, MD
role: Principal Investigator
affiliation: SRM Hospital and Research Centre, Chennai
last name: Dr. Prabhakar Reddy, MBBS, MD
role: Principal Investigator
affiliation: Nizams Institute of Medical Sciences, Hyderabad
last name: Dr. Venkata Rao, MBBS, MD
role: Principal Investigator
affiliation: IMS & SUM Hospital, Orissa
last name: Dr. Jitendra Kushwaha, MBBS, MD
role: Principal Investigator
affiliation: Prakhar Hospital, Kanpur
last name: Dr. Sagar Vivek Redkar, MBBS, MD
role: Principal Investigator
affiliation: Redkar Hospital and Research Center, Goa
last name: Dr. Amit Bhate, MBBS, MD
role: Principal Investigator
affiliation: Jeevan Rekha Hospital, Belguam
last name: Dr. Chadrashekar Gillukar, MBBS, MD
role: Principal Investigator
affiliation: Gillukar Multispeciality Hospital, Nagpur
last name: Dr Vasudev R, MBBS, MD
role: Principal Investigator
affiliation: King George Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: India
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No