COVID-19Phase 1/2BBV152NCT04471519
Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COVID-19 in Healthy Volunteers
A Phase 1/2 study testing BBV152A - Phase I, BBV152B - Phase I and BBV152C - Phase I in people with COVID-19 and SARS-CoV-2 Infection, run by Bharat Biotech International Limited at 12 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection
- What is being tested?
- BBV152A - Phase I, BBV152B - Phase I and BBV152C - Phase I
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 755 participants
- Where
- 12 sitesIndia
- Study dates
- 15 Jul 2020to 30 Jun 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
- 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.
Who cannot join
- 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).
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- 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:
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites
Jeevan Rekha Hospital
Belagavi, Karnataka, 590019
Institute of Medical Sciences and SUM Hospital
Bhubaneswar, Odisha, 751003
SRM Hospital & Research center
Chennai, Tamil Nadu, 603211
All India Institute of Medical Sciences
Delhi, New Delhi, 110029
Redkar Hospital and Research Centre
Goa, 403513
Rana Hospital and Trauma Center
Gorakhpur, Uttar Pradesh, 273013
Nizam's Institute of Medical Sciences
Hyderabad, Telangana, 500082
Prakhar Hospital
Kanpur, Uttar Pradesh, 208002
Gillukar Multispeciality Hospital
Nagpur, Maharashtra, 440009
All India Institute of Medical Sciences
Patna, Bihar, 801507
Pt BD SHARMA,PGIMS/UHS
Rohtak, Haryana, 124001
King George Hospital
Visakhapatnam, Andhra Pradesh, 560037
About this study
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
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.
Read the 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.
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Being tested
- BBV152A - Phase I, BBV152B - Phase I, BBV152C - Phase I, Placebo - Phase I, BBV152A - Phase II
- Keywords
- BBV152, COVID-19 vaccine, inactivated vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBV152A - Phase IBiological
0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14
BBV152B - Phase IBiological
0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14
BBV152C - Phase IBiological
0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14
Placebo - Phase IBiological
0.5 ml of the Placebo will be administered intramuscularly twice at Day 0 and Day 14
BBV152A - Phase IIBiological
0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28
BBV152B - Phase IIBiological
0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28
| Study group | Role | What they receive |
|---|---|---|
| BBV152A - Phase I | Experimental | 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 Receives: Biological: BBV152A - Phase I |
| BBV152B - Phase I | Experimental | 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 Receives: Biological: BBV152B - Phase I |
| BBV152C - Phase I | Experimental | 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 Receives: Biological: BBV152C - Phase I |
| Placebo - Phase I | Active comparator | 0.5 mL of Placebo will be administered intramuscularly twice at Day 0 and Day 14. Receives: Biological: Placebo - Phase I |
| BBV152A - Phase II | Experimental | 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. Receives: Biological: BBV152A - Phase II |
| BBV152B - Phase II | Experimental | 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 Receives: Biological: BBV152B - Phase II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Occurrence of adverse events and Serious Adverse events
Safety
Measured: Through study completion, an average of 6 months
Phase 2: Evaluation of Neutralizing Antibody Titers
Pre- and Post-vaccination immune response
Measured: Through study completion, an average of 6 months
Secondary outcomes (3)
Phase 1: Evaluation of Neutralizing Antibody Titers
Pre- and Post-vaccination immune response
Measured: Through study completion, an average of 6 months
Phase 2: Occurrence of adverse events and Serious Adverse events
Safety
Measured: Through study completion, an average of 6 months
Phase 2: Evaluation of Neutralizing Antibody Titers
Post-vaccination immune responses comparing two-dose and three dose regimens
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start15 Jul 2020
- Primary completion31 Jul 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 755 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bharat Biotech International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Sponsor
- Investigators
- Dr. Savita Verma, MBBS, MD, Principal investigator, PGIMS, RohtakDr. Sanjay Kumar Rai, MBBS, MD, Principal investigator, All India Institute of Medical Sciences, DelhiDr. Chandramani Singh, MBBS, MD, Principal investigator, All India Institute of Medical SciencesDr. Ajeeth Pratap Singh, MBBS, MD, Principal investigator, Rana Hospital and Trauma Centre, GorakhpurDr. Satyajit Mohapatra, MBBS, MD, Principal investigator, SRM Hospital and Research Centre, ChennaiDr. Prabhakar Reddy, MBBS, MD, Principal investigator, Nizams Institute of Medical Sciences, HyderabadDr. Venkata Rao, MBBS, MD, Principal investigator, IMS & SUM Hospital, OrissaDr. Jitendra Kushwaha, MBBS, MD, Principal investigator, Prakhar Hospital, Kanpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471519
- Sponsor's protocol ID
- BBIL/BBV152-A/2020
- Other IDs
- Protocol No:BBIL/BBV152-A/2020
- Acronym
- BBV152
- Status last verified
- Aug 2022
- First submitted
- 11 Jul 2020
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35835822Ella 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.
PubMed 33705727Yadav 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.
PubMed 33654090Ella 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.
PubMed 33485468
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04471519
- Acronym / sponsor ID
- BBV152 / BBIL/BBV152-A/2020
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Keywords
- BBV152, COVID-19 vaccine, inactivated vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 755 participants (actual)
- Lead sponsor
- Bharat Biotech International LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Indian Council of Medical Research
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BBV152A - Phase I | Experimental | Biological: BBV152A - Phase I0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine [BBV152A], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 14 |
| BBV152B - Phase I | Experimental | Biological: BBV152B - Phase I0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine [BBV152B], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 14 |
| BBV152C - Phase I | Experimental | Biological: BBV152C - Phase I0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine [BBV152C], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 14 |
| Placebo - Phase I | Active comparator | Biological: Placebo - Phase I0.5 mL of Placebo will be administered intramuscularly twice at Day 0 and Day 14. |
| BBV152A - Phase II | Experimental | Biological: BBV152A - Phase II0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine [BBV152A], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 28. |
| BBV152B - Phase II | Experimental | Biological: BBV152B - Phase II0.5 mL of Whole Virion Inactivated SARS-CoV-2 Vaccine [BBV152B], is a liquid vaccine administered intramuscularly twice at Day 0 and Day 28 |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (61 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBV152A - Phase I0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14 | Biological | BBV152A - Phase I |
| BBV152B - Phase I0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14 | Biological | BBV152B - Phase I |
| BBV152C - Phase I0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14 | Biological | BBV152C - Phase I |
| Placebo - Phase I0.5 ml of the Placebo will be administered intramuscularly twice at Day 0 and Day 14 | Biological | Placebo - Phase I |
| BBV152A - Phase II0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28 | Biological | BBV152A - Phase II |
| BBV152B - Phase II0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28 | Biological | BBV152B - Phase II |
Primary outcome
Phase 1: Occurrence of adverse events and Serious Adverse events
Time frame: Through study completion, an average of 6 months
Safety
Phase 2: Evaluation of Neutralizing Antibody Titers
Time frame: Through study completion, an average of 6 months
Pre- and Post-vaccination immune response
3 secondary outcomes
Phase 1: Evaluation of Neutralizing Antibody Titers
Time frame: 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
Phase 2: Evaluation of Neutralizing Antibody Titers
Time frame: Through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Derived from this study: PubMed 35835822Vadrevu 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.
- Derived from this study: PubMed 33705727Ella 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.
- Derived from this study: PubMed 33654090Yadav 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.
- Derived from this study: PubMed 33485468Ella 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Savita Verma, MBBS, MD principal investigator
PGIMS, Rohtak
Dr. Sanjay Kumar Rai, MBBS, MD principal investigator
All India Institute of Medical Sciences, Delhi
Dr. Chandramani Singh, MBBS, MD principal investigator
All India Institute of Medical Sciences
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BBV152A - Phase I, BBV152B - Phase I and BBV152C - Phase I in people with COVID-19 and SARS-CoV-2 Infection, run by Bharat Biotech International Limited at 12 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 61 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Occurrence of adverse events and Serious Adverse events (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04471519, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.