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Trial record 1 of 4 for:    bharat | covid-19
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Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COVID-19 in Healthy Volunteers (BBV152)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04471519
Recruitment Status : Active, not recruiting
First Posted : July 15, 2020
Last Update Posted : October 1, 2020
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by (Responsible Party):
Bharat Biotech International Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Infection Biological: BBV152A - Phase I Biological: BBV152B - Phase I Biological: BBV152C - Phase I Biological: Placebo - Phase I Biological: BBV152A - Phase II Biological: BBV152B - Phase II Phase 1 Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 755 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : July 13, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
Experimental: BBV152A - Phase I
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
Biological: BBV152A - Phase I
0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14

Experimental: BBV152B - Phase I
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
Biological: BBV152B - Phase I
0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14

Experimental: BBV152C - Phase I
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
Biological: BBV152C - Phase I
0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14

Active Comparator: Placebo - Phase I
0.5 mL of Placebo will be administered intramuscularly twice at Day 0 and Day 14.
Biological: Placebo - Phase I
0.5 ml of the Placebo will be administered intramuscularly twice at Day 0 and Day 14

Experimental: BBV152A - Phase II
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.
Biological: BBV152A - Phase II
0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28

Experimental: BBV152B - Phase II
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
Biological: BBV152B - Phase II
0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28




Primary Outcome Measures :
  1. Phase 1: Occurrence of adverse events and Serious Adverse events [ Time Frame: Through study completion, an average of 6 months ]
    Safety

  2. Phase 2: Evaluation of Neutralizing Antibody Titers [ Time Frame: Through study completion, an average of 6 months ]
    Pre- and Post-vaccination immune response


Secondary Outcome Measures :
  1. Phase 1: Evaluation of Neutralizing Antibody Titers [ Time Frame: Through study completion, an average of 6 months ]
    Pre- and Post-vaccination immune response

  2. Phase 2: Occurrence of adverse events and Serious Adverse events [ Time Frame: Through study completion, an average of 6 months ]
    Safety



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Phase 1:

Inclusion Criteria

  1. Ability to provide written informed consent.
  2. Participants of either gender of age between ≥18 to ≤55 years.
  3. Good general health as determined by the discretion of investigator (vital signs (heart rate ≥60 to≤100 bpm; blood pressure systolic ≥90 mm Hg and <140 mm Hg; diastolic ≥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical history, and physical examination).
  4. Expressed interest and availability to fulfill the study requirements.
  5. For a female participant of child-bearing potential, planning to avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least four weeks after the last vaccination
  6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination
  7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination
  8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination
  9. Agrees not to participate in another clinical trial at any time during the study period.
  10. Agrees to remain in the study area for the entire duration of the study.
  11. Willing to allow storage and future use of biological samples for future research.

Exclusion Criteria

  1. History of any other COVID-19 investigational vaccination.
  2. Unacceptable laboratory abnormality from screening (prior to first vaccination) or safety testing, as listed below [Abnormal Complete Blood Count (CBC), Random blood sugar level, Renal function test (serum urea and Creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen].

    (Subjects will be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody or hepatitis B surface antigen (HBsAg) and will be referred to a primary care provider for follow up of these abnormal laboratory tests.)

  3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method.
  4. Health care workers.
  5. For women, a positive serum pregnancy test (during screening within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of administering each dose of vaccine).
  6. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine.
  7. Medical problems as a result of alcohol or illicit drug use during the past 12 months.
  8. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrollment or expects to receive an investigational agent during the study period.
  9. Receipt of any licensed vaccine within four weeks before enrolment in this study.
  10. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
  11. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study.
  12. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
  13. Long-term use (> 2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed).
  14. Any history of hereditary angioedema or idiopathic angioedema.
  15. Any history of anaphylaxis in relation to vaccination.
  16. Any history of albumin-intolerance.
  17. Pregnancy, lactation, or willingness/intention to become pregnant during the study.
  18. History of any cancer.
  19. History of psychiatric severe conditions likely to affect participation in the study.
  20. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture.
  21. Any other serious chronic illness requiring hospital specialist supervision.
  22. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma.
  23. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness
  24. Morbidly obese (BMI≥35 kg/m2) or underweight (BMI ≤18 kg/m2).
  25. Living in the same household of any COVID-19 positive person.
  26. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.

    Re-Vaccination Exclusion Criteria

  27. Pregnancy.
  28. Anaphylactic reaction following administration of the investigational vaccine.
  29. Virologically confirmed cases of COVID-19

Phase 2:

Inclusion Criteria

  1. Ability to provide written informed consent (Audio video consent for vulnerable subjects).
  2. Participants of either gender of age between ≥12 to ≤ 65 years.
  3. Good general health as determined by the discretion of investigator (vital signs (heart rate ≥60 to≤100 bpm; blood pressure systolic ≥90 mm Hg and <140 mm Hg; diastolic ≥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical history, and physical examination).
  4. Expressed interest and availability to fulfill the study requirements.
  5. For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least four weeks after the last vaccination and agrees not to participate in another clinical trial at any time during the study period.
  6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination
  7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination
  8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination.
  9. Agrees to remain in the study area for the entire duration of the study.
  10. Willing to allow storage and future use of biological samples for future research.

Exclusion Criteria

  1. History of any other COVID-19 investigational vaccination.
  2. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method.
  3. Health care workers.
  4. Positive urine pregnancy test (within 24 hours of administering each dose of vaccine).
  5. Temperature > 38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine.
  6. Medical problems as a result of alcohol or illicit drug use during the past 12 months.
  7. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrolment or expects to receive an investigational agent during the study period.
  8. Receipt of any licensed vaccine within four weeks before enrolment in this study.
  9. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
  10. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study.
  11. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
  12. Long-term use (> 2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed).
  13. Any history of hereditary angioedema or idiopathic angioedema.
  14. Any history of anaphylaxis in relation to vaccination.
  15. Any history of albumin-intolerance.
  16. Pregnancy, lactation, or willingness/intention to become pregnant during the study.
  17. History of any cancer.
  18. History of psychiatric severe conditions likely to affect participation in the study.
  19. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture.
  20. Any other serious chronic illness requiring hospital specialist supervision.
  21. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma.
  22. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness
  23. Morbidly obese (BMI≥35 kg/m2) or underweight (BMI ≤18 kg/m2).
  24. Living in the same household of any COVID-19 positive person.
  25. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.

    Re-Vaccination Exclusion Criteria

  26. Pregnancy.
  27. Anaphylactic reaction following administration of the investigational vaccine.
  28. Virologically confirmed cases of COVID-19.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04471519


Locations
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India
King George Hospital
Visakhapatnam, Andhra Pradesh, India, 560037
All India Institute of Medical Sciences
Patna, Bihar, India, 801507
Pt BD SHARMA,PGIMS/UHS
Rohtak, Haryana, India, 124001
Jeevan Rekha Hospital
Belgaum, Karnataka, India, 590019
Gillukar Multispeciality Hospital
Nagpur, Maharastra, India, 440009
All India Institute of Medical Sciences
Delhi, New Delhi, India, 110029
Institute of Medical Sciences and SUM Hospital
Bhubaneswar, Orissa, India, 751003
SRM Hospital & Research center
Chennai, Tamilnadu, India, 603211
Nizam's Institute of Medical Sciences
Hyderabad, Telangana, India, 500082
Rana Hospital and Trauma Center
Gorakhpur, Uttar Pradesh, India, 273013
Prakhar Hospital
Kanpur, Uttar Pradesh, India, 208002
Redkar Hospital and Research Centre
Goa, India, 403513
Sponsors and Collaborators
Bharat Biotech International Limited
Indian Council of Medical Research
Investigators
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Principal Investigator: Dr. Savita Verma, MBBS, MD PGIMS, Rohtak
Principal Investigator: Dr. Sanjay Kumar Rai, MBBS, MD All India Institute of Medical Sciences, Delhi
Principal Investigator: Dr. Chandramani Singh, MBBS, MD All India Institute of Medical Sciences, Patna
Principal Investigator: Dr. Ajeeth Pratap Singh, MBBS, MD Rana Hospital and Trauma Centre, Gorakhpur
Principal Investigator: Dr. Satyajit Mohapatra, MBBS, MD SRM Hospital and Research Centre, Chennai
Principal Investigator: Dr. Prabhakar Reddy, MBBS, MD Nizams Institute of Medical Sciences, Hyderabad
Principal Investigator: Dr. Venkata Rao, MBBS, MD IMS & SUM Hospital, Orissa
Principal Investigator: Dr. Jitendra Kushwaha, MBBS, MD Prakhar Hospital, Kanpur
Principal Investigator: Dr. Sagar Vivek Redkar, MBBS, MD Redkar Hospital and Research Center, Goa
Principal Investigator: Dr. Amit Bhate, MBBS, MD Jeevan Rekha Hospital, Belguam
Principal Investigator: Dr. Chadrashekar Gillukar, MBBS, MD Gillukar Multispeciality Hospital, Nagpur
Principal Investigator: Dr Vasudev R, MBBS, MD King George Hospital
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Responsible Party: Bharat Biotech International Limited
ClinicalTrials.gov Identifier: NCT04471519    
Other Study ID Numbers: BBIL/BBV152-A/2020
Protocol No:BBIL/BBV152-A/2020 ( Other Identifier: Bharat Biotech International Ltd )
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bharat Biotech International Limited:
BBV152
COVID-19 vaccine
inactivated vaccine