- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04471519
Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COVID-19 in Healthy Volunteers (BBV152)
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
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.
Study Overview
Status
Conditions
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.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Goa, India, 403513
- Redkar Hospital and Research Centre
-
-
Andhra Pradesh
-
Visakhapatnam, Andhra Pradesh, India, 560037
- King George Hospital
-
-
Bihar
-
Patna, Bihar, India, 801507
- All India Institute of Medical Sciences
-
-
Haryana
-
Rohtak, Haryana, India, 124001
- Pt BD SHARMA,PGIMS/UHS
-
-
Karnataka
-
Belgaum, Karnataka, India, 590019
- Jeevan Rekha Hospital
-
-
Maharastra
-
Nagpur, Maharastra, India, 440009
- Gillukar Multispeciality Hospital
-
-
New Delhi
-
Delhi, New Delhi, India, 110029
- All India Institute of Medical Sciences
-
-
Orissa
-
Bhubaneswar, Orissa, India, 751003
- Institute of Medical Sciences and SUM Hospital
-
-
Tamilnadu
-
Chennai, Tamilnadu, India, 603211
- SRM Hospital & Research center
-
-
Telangana
-
Hyderabad, Telangana, India, 500082
- Nizam's Institute of Medical Sciences
-
-
Uttar Pradesh
-
Gorakhpur, Uttar Pradesh, India, 273013
- Rana Hospital and Trauma Center
-
Kanpur, Uttar Pradesh, India, 208002
- Prakhar Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Phase 1:
Inclusion Criteria
- Ability to provide written informed consent.
- Participants of either gender of age between ≥18 to ≤55 years.
- 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).
- Expressed interest and availability to fulfill the study requirements.
- 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
- 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
- Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination
- Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination
- Agrees not to participate in another clinical trial at any time during the study period.
- Agrees to remain in the study area for the entire duration of the study.
- Willing to allow storage and future use of biological samples for future research.
Exclusion Criteria
- History of any other COVID-19 investigational vaccination.
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.)
- Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method.
- Health care workers.
- 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).
- 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.
- Medical problems as a result of alcohol or illicit drug use during the past 12 months.
- 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.
- Receipt of any licensed vaccine within four weeks before enrolment in this study.
- Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
- Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study.
- 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.
- 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).
- Any history of hereditary angioedema or idiopathic angioedema.
- Any history of anaphylaxis in relation to vaccination.
- Any history of albumin-intolerance.
- Pregnancy, lactation, or willingness/intention to become pregnant during the study.
- History of any cancer.
- History of psychiatric severe conditions likely to affect participation in the study.
- A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture.
- Any other serious chronic illness requiring hospital specialist supervision.
- Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma.
- Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness
- Morbidly obese (BMI≥35 kg/m2) or underweight (BMI ≤18 kg/m2).
- Living in the same household of any COVID-19 positive person.
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
- Pregnancy.
- Anaphylactic reaction following administration of the investigational vaccine.
- Virologically confirmed cases of COVID-19
Phase 2:
Inclusion Criteria
- Ability to provide written informed consent (Audio video consent for vulnerable subjects).
- Participants of either gender of age between ≥12 to ≤ 65 years.
- 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).
- Expressed interest and availability to fulfill the study requirements.
- 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.
- 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
- Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination
- Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination.
- Agrees to remain in the study area for the entire duration of the study.
- Willing to allow storage and future use of biological samples for future research.
Exclusion Criteria
- History of any other COVID-19 investigational vaccination.
- Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method.
- Health care workers.
- Positive urine pregnancy test (within 24 hours of administering each dose of vaccine).
- 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.
- Medical problems as a result of alcohol or illicit drug use during the past 12 months.
- 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.
- Receipt of any licensed vaccine within four weeks before enrolment in this study.
- Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
- Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study.
- 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.
- 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).
- Any history of hereditary angioedema or idiopathic angioedema.
- Any history of anaphylaxis in relation to vaccination.
- Any history of albumin-intolerance.
- Pregnancy, lactation, or willingness/intention to become pregnant during the study.
- History of any cancer.
- History of psychiatric severe conditions likely to affect participation in the study.
- A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture.
- Any other serious chronic illness requiring hospital specialist supervision.
- Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma.
- Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness
- Morbidly obese (BMI≥35 kg/m2) or underweight (BMI ≤18 kg/m2).
- Living in the same household of any COVID-19 positive person.
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
- Pregnancy.
- Anaphylactic reaction following administration of the investigational vaccine.
- Virologically confirmed cases of COVID-19.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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
|
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
|
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
|
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.
|
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.
|
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
|
0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 1: Occurrence of adverse events and Serious Adverse events
Time Frame: Through study completion, an average of 6 months
|
Safety
|
Through study completion, an average of 6 months
|
Phase 2: Evaluation of Neutralizing Antibody Titers
Time Frame: Through study completion, an average of 6 months
|
Pre- and Post-vaccination immune response
|
Through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 1: Evaluation of Neutralizing Antibody Titers
Time Frame: Through study completion, an average of 6 months
|
Pre- and Post-vaccination immune response
|
Through study completion, an average of 6 months
|
Phase 2: Occurrence of adverse events and Serious Adverse events
Time Frame: Through study completion, an average of 6 months
|
Safety
|
Through study completion, an average of 6 months
|
Phase 2: Evaluation of Neutralizing Antibody Titers
Time Frame: Through study completion, an average of 6 months
|
Post-vaccination immune responses comparing two-dose and three dose regimens
|
Through study completion, an average of 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- 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
Publications and helpful links
General Publications
- Vadrevu KM, Ganneru B, Reddy S, Jogdand H, Raju D, Sapkal G, Yadav P, Reddy P, Verma S, Singh C, Redkar SV, Gillurkar CS, Kushwaha JS, Mohapatra S, Bhate A, Rai SK, Ella R, Abraham P, Prasad S, Ella K. Persistence of immunity and impact of third dose of inactivated COVID-19 vaccine against emerging variants. Sci Rep. 2022 Jul 14;12(1):12038. doi: 10.1038/s41598-022-16097-3.
- Ella R, Reddy S, Jogdand H, Sarangi V, Ganneru B, Prasad S, Das D, Raju D, Praturi U, Sapkal G, Yadav P, Reddy P, Verma S, Singh C, Redkar SV, Gillurkar CS, Kushwaha JS, Mohapatra S, Bhate A, Rai S, Panda S, Abraham P, Gupta N, Ella K, Bhargava B, Vadrevu KM. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 trial. Lancet Infect Dis. 2021 Jul;21(7):950-961. doi: 10.1016/S1473-3099(21)00070-0. Epub 2021 Mar 8.
- Yadav PD, Ella R, Kumar S, Patil DR, Mohandas S, Shete AM, Vadrevu KM, Bhati G, Sapkal G, Kaushal H, Patil S, Jain R, Deshpande G, Gupta N, Agarwal K, Gokhale M, Mathapati B, Metkari S, Mote C, Nyayanit D, Patil DY, Sai Prasad BS, Suryawanshi A, Kadam M, Kumar A, Daigude S, Gopale S, Majumdar T, Mali D, Sarkale P, Baradkar S, Gawande P, Joshi Y, Fulari S, Dighe H, Sharma S, Gunjikar R, Kumar A, Kalele K, Srinivas VK, Gangakhedkar RR, Ella KM, Abraham P, Panda S, Bhargava B. Immunogenicity and protective efficacy of inactivated SARS-CoV-2 vaccine candidate, BBV152 in rhesus macaques. Nat Commun. 2021 Mar 2;12(1):1386. doi: 10.1038/s41467-021-21639-w.
- Ella R, Vadrevu KM, Jogdand H, Prasad S, Reddy S, Sarangi V, Ganneru B, Sapkal G, Yadav P, Abraham P, Panda S, Gupta N, Reddy P, Verma S, Kumar Rai S, Singh C, Redkar SV, Gillurkar CS, Kushwaha JS, Mohapatra S, Rao V, Guleria R, Ella K, Bhargava B. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial. Lancet Infect Dis. 2021 May;21(5):637-646. doi: 10.1016/S1473-3099(20)30942-7. Epub 2021 Jan 21. Erratum In: Lancet Infect Dis. 2021 Apr;21(4):e81.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BBIL/BBV152-A/2020
- Protocol No:BBIL/BBV152-A/2020 (Other Identifier: Bharat Biotech International Ltd)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece
Clinical Trials on BBV152A - Phase I
-
KK Women's and Children's HospitalNational University Hospital, Singapore; Singapore General HospitalRecruitingLymphoblastic Leukemia, Acute, Childhood | Lymphoblastic Leukemia | Lymphoblastic Leukemia, Acute Adult | Lymphoblastic Leukemia in Children | CARSingapore
-
European Institute of OncologyRecruiting
-
Centre Georges Francois LeclercNot yet recruiting
-
Scripps Clinic Cancer CenterThreshold PharmaceuticalsUnknownHepatocellular CarcinomaUnited States
-
Riphah International UniversityRecruitingCoronary Artery StenosisPakistan
-
University of OregonNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)CompletedHealth Behavior | Health Care UtilizationUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingSmall Cell Lung Carcinoma | Small Cell Lung CancerUnited States
-
AtlasMedx, IncorporatedActive, not recruitingBreast Cancer | Pancreatic Cancer | Ovarian Cancer | Prostate Cancer | Homologous Recombination Deficiency | Advanced Malignant NeoplasmUnited States
-
Vanderbilt University Medical CenterNational Center for AIDS/STD Control and Prevention, China CDCCompleted