Immuno-bridging and Broadening Study of a Whole, Inactivated COVID-19 Vaccine BBV152 in Healthy Adults

March 24, 2023 updated by: Ocugen

A Phase 2/3, Observer-Blind, Immuno-bridging, and Broadening Study of a Whole, Inactivated Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Vaccine (BBV152) in Healthy Adults

A randomized, observer-blind, placebo-controlled immuno-bridging, and broadening study to demonstrate the equivalence of the immune response between participants enrolled in Phase 3 efficacy trial in India and demographically diverse healthy adult participants in the US which matched in age and vaccine formulation setting to whom those efficacy results are extrapolated; and to assess the broadening of the BBV152 in participants who previously received two shots of messenger ribonucleic acid (mRNA) COVID-19 vaccine at least 6 months earlier or one-shots of viral vector J&J/Janssen COVID-19 vaccine at least 2 months earlier. Safety and tolerability evaluation is a secondary endpoint.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants in stable health will be randomly assigned into one of four groups based on their age to receive either 6 µg of BBV152 or placebo in a 1:1 ratio. Each participant will receive 2 doses of the study vaccine by 0.5 mL intramuscular injection, the first on Day 0 and the second on Day 28. Data will be collected in an observer-blind manner.

Safety will be monitored by the Data and Safety Monitoring Board. The Data and Safety Monitoring Board will convene to perform safety reviews at 2 and 6 months and for immediate concerns regarding safety observations as needed.

Safety assessment will include monitoring solicited, unsolicited, serious, medically attended adverse events and potentially immune medicated medical conditions.

Since this is a bridging study, the maximum sample size of the data from the previous study will be 31 samples from the <65 years population and 358 with samples from the 18 to <65 years population.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85282
        • Recruiting
        • Voyage Medical
        • Contact:
        • Principal Investigator:
          • Ali Imran, MD
    • Florida
      • Miami, Florida, United States, 33135
        • Recruiting
        • Suncoast Research Group LLC
        • Principal Investigator:
          • Mark Kutner, MD
      • Miami, Florida, United States, 33122
        • Recruiting
        • Angels Clinical Institute
        • Contact:
        • Principal Investigator:
          • Yanely Pineiro, MD
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Palm Springs Community Health Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Reynold Martinez, MD
      • Winter Park, Florida, United States, 332789
    • Georgia
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Recruiting
        • Jay Meyer Meridian Research
        • Principal Investigator:
          • Jay Meyer
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75149
        • Recruiting
        • Prx Research
        • Principal Investigator:
          • Samer Nachawati, DO
        • Contact:
      • McKinney, Texas, United States, 75071
        • Recruiting
        • Wellness Clinical Research
        • Contact:
        • Principal Investigator:
          • Zahid Zafar, MD
    • Virginia
      • Portsmouth, Virginia, United States, 237803
        • Recruiting
        • Meridian Research 3235 Academy Ave
        • Principal Investigator:
          • Banu Myneni
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female participants ≥ 18 years of age at the time of informed consent.
  2. The participant is capable of providing signed informed consent.
  3. The participants who consent, are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations, and other study procedures.
  4. Have negative the Cue™ SARS-CoV-2 Test of anterior nasal specimens.
  5. Participants must have received two documented doses of mRNA vaccine a minimum of 180 days from their last dose prior to enrollment or One documented dose of viral vector J&J/Janssen COVID-19 vaccine a minimum 60 days from their dose prior to enrollment, or A documented dose of the booster shot of the mRNA COVID-19 vaccine (Comirnaty or Spikevax) a minimum of 150 days from their last dose prior to enrollment, or No vaccination history of COVID-19 vaccine and no history of COVID-19 disease (self-report, on-site inquiry).
  6. The participant must agree not to take the influenza vaccine until 30 days after the second dose of vaccination and not take any other vaccines for the entire duration of the study.

  7. Participants must be in relatively stable health based on the site Investigator's judgment, as determined by medical history, physical examination, and the following criteria:

    1. Stable health for age (defined as no new conditions per medical history, new medications in a different therapeutic class, or change in a daily dose of existing prescription medications within the 45 days preceding Screening).
    2. Participants may be on chronic or as-needed medications if, in the opinion of the Investigator, these pose no additional risk to participant safety or assessment of reactogenicity, and immunogenicity and their use is not for management of a worsening of medical diagnosis or condition.
  8. Participants are expected to be available for the duration of the study and can be contacted by telephone during study participation.
  9. Have a non-clinically significant 12-lead ECG
  10. Participants must be healthy based on clinical laboratory tests performed at screening.

  11. Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:

    • Has a negative urine pregnancy test at Screening and prior to each study dose
    • Has agreed to continue adequate contraception through 3 months following the second dose of the IP
    • Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 0)
    • Is not currently breastfeeding Adequate female contraception is defined as consistent and correct use of a Food and Drug Administration (FDA) approved contraceptive method in accordance with the product label.
  12. Male participants engaging in activity that could result in the pregnancy of sexual partners must agree to practice adequate contraception and refrain from sperm donation from the time of the first dose and through 6 months after the second dose.

Adequate contraception for male participants is defined as:

  • Monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above)

  • Use of barrier methods and spermicide Male participants with partners who have become pregnant prior to Screening are eligible to participate in the study.

    15. Have a body mass index (BMI) less than 35.0 kg/m2 at Screening.

Exclusion Criteria:

  1. History of COVID-19 disease (self-report, on-site inquiry).
  2. Presence of fever or other acute illness at the time of enrollment. Fever is defined as an oral temperature ≥ 38.0°C/100.4°F.
  3. History or current clinically significant cardiac disease, such as myocarditis, pericarditis, ventricular arrhythmia requiring therapy, uncontrolled hypertension, or any history of symptomatic congestive heart failure (CHF).
  4. Has significant renal, vascular, pulmonary, gastrointestinal, neurologic, hematologic, rheumatologic, oncologic, psychiatric disease, or immune-deficiency or other medical disorders not excluded by other exclusion criteria, which, in the opinion of the Investigator, may either put the individual at risk because of participation in the study or influence the safety or the volunteer's ability to participate in the study.
  5. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s).
  6. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  7. History of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus (e.g., rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythematosus)
  8. Has bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate intramuscular injection.
  9. Receipt of treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (equivalent to prednisone ≥ 10mg/day for the duration of ≥ two weeks), e.g., for cancer or an autoimmune disease, or planned receipt throughout the study period. If systemic corticosteroids have been administered short-term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days (about 4 weeks) before study intervention administration.
  10. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days (about 2 months) before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 days (about 3 months) before study intervention administration or planned receipt throughout the study.
  11. Has participated in an interventional clinical trial within the 4 weeks prior to randomization.
  12. Known sensitivity to any components of the study vaccine.
  13. The participant has received the influenza vaccine within 14 days prior to enrollment and any other vaccine within 28 days prior to randomization.
  14. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IP.
  15. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody. Participants who have been effectively treated for hepatitis C, as evidenced by a negative hepatitis C ribonucleic acid (RNA) confirmation test and who no longer require antiviral therapy, are eligible for participation.
  16. Known or suspected history of alcohol or Drug Enforcement Administration (DEA) Schedule 1 (including for cannabis, even where legal) or excessive intake of alcohol as judged by the Investigator. Benzodiazepines for anxiety disorders and stimulants for attention deficit hyperactivity disorder are not exclusionary if the participant has been on a stable dose for more than 3 months prior to Screening and each study dosing and if the participant can produce a valid, current prescription for the medication. Propoxyphene, opioids, or combinations containing these medications (including as used for opioid addiction) are not permitted regardless of prescription status. Note: A positive Screening urine drug screen may not be repeated.
  17. Donated blood products within the 4 weeks prior to randomization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: BBV152
Biological: BBV152
Each participant will receive 2 doses of the investigational product intramuscular injection of either 6 μg of BBV15 vaccine or placebo.
Other Names:
  • Covaxin
Placebo Comparator: Placebo
0.9% normal saline
Biological: BBV152
Each participant will receive 2 doses of the investigational product intramuscular injection of either 6 μg of BBV15 vaccine or placebo.
Other Names:
  • Covaxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare immune response measured by serum neutralizing antibodies against Wild-Type SARS-CoV-2 in US-based participants and age-matched controls participants who participated in the Phase 3 efficacy trial in India.
Time Frame: Vaccination days (Day 0 and Day 28), Day 56 and Day 84
Serum neutralizing antibodies against Wild-Type SARS-CoV-2 will be measured by Microneutralization Test (MNT) assay.
Vaccination days (Day 0 and Day 28), Day 56 and Day 84

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the change over time in immunogenicity of two doses of BBV152 measured by MNT neutralizing antibodies.
Time Frame: Day0, Day 28, Day 56 and Day 84
  • Geometric Mean Titer (GMT) as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA Immunoglobulin G (IgG) Abs against Spike, Receptor-Binding Domain (RBD), and N protein in BBV152 treatment group, overall, and stratified by age group.
  • Geometric Mean Fold Rises (GMFR) as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in BBV152 treatment group, overall, and stratified by age group.
  • Geometric Mean Titer, Geometric Mean Fold Rises, and Seroconversion rate as measured by MNT nAbs against Omicron at Day 0, Wild Type at Day 0 and Day 56 and ELISA IgG Abs against Spike, RBD, and N protein at Day 0, Day 28, Day 56, Day 84 in the placebo treatment group.
Day0, Day 28, Day 56 and Day 84
Evaluate the immunogenicity of two doses of BBV152 measured by MNT neutralizing antibodies.
Time Frame: Day 0, Day 28, Day 56 and Day 84
  • Geometric Mean Titer (GMT) as measured by MNT Neutralizing Antibodies (nAbs) against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in BBV152 treatment group, overall, and stratified by age group.
  • Geometric Mean Fold Rises (GMFR) as measured by MNT nAbs against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in each BBV152 treatment group, overall, and stratified by age group.
  • Geometric Mean Titer, Geometric Mean Fold Rises, and Seroconversion rate as measured by MNT nAbs against Omicron at Day 0, Wild Type at Day 0 and Day 56 and ELISA IgG Abs against Spike, RBD, and N protein at Day 0, Day 28, Day 56, Day 84 in the placebo treatment group.
Day 0, Day 28, Day 56 and Day 84
Evaluate the serious adverse events (SAEs)
Time Frame: 1 year
Total count, duration, frequency of participants, and proportion of participants reporting serious adverse events (SAEs)
1 year
Evaluate response rate of anti-SARS-CoV-2 IgG antibody seroconversion from negative to positive following 28 days of BBV152 administration
Time Frame: Day 0, Day 28, Day 56 and Day 84
  • Seroconversion rate, defined as 4-fold rise from day 0, at days 28, 56, and 84 as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in BBV152 treatment group, overall, and stratified by age group.
  • Seroconversion rate as measured by MNT nAbs against Omicron at Day 0, Wild Type at Day 0 and Day 56 and ELISA IgG Abs against Spike, RBD, and N protein at Day 0, Day 28, Day 56, Day 84 in the placebo treatment group.
Day 0, Day 28, Day 56 and Day 84
Evaluate the immunogenicity of the single dose of BBV152.
Time Frame: Day 0, Day 28, Day 56 and Day 84
  • Geometric Mean Titer (GMT) as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in BBV152 treatment group, overall, and stratified by age group.
  • Geometric Mean Fold Rises (GMFR) as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in BBV152 treatment group, overall, and stratified by age group.
  • Geometric Mean Titer, Geometric Mean Fold Rises, and Seroconversion rate as measured by MNT nAbs against Omicron at Day 0, Wild Type at Day 0 and Day 56 and ELISA IgG Abs against Spike, RBD, and N protein at Day 0, Day 28, Day 56, Day 84 in the placebo treatment group.
Day 0, Day 28, Day 56 and Day 84
Evaluate immune-broadening, as measured by MNT neutralizing antibodies, compare the sera taken from previously mRNA or viral vector vaccinated US-based participants with sera taken from previously mRNA or Viral Vector vaccinated placebo controls.
Time Frame: Day 0, Day 28, Day 56 and Day 84
  • Geometric Mean Titer (GMT) as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in BBV152 treatment group, overall, and stratified by age group.
  • Geometric Mean Fold Rises (GMFR) as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in BBV152 treatment group, overall, and stratified by age group.
  • Geometric Mean Titer, Geometric Mean Fold Rises, and Seroconversion rate as measured by MNT nAbs against Omicron at Day 0, Wild Type at Day 0 and Day 56 and ELISA IgG Abs against Spike, RBD, and N protein at Day 0, Day 28, Day 56, Day 84 in the placebo treatment group.
Day 0, Day 28, Day 56 and Day 84
Evaluate the medically attended adverse events (MAAEs).
Time Frame: 1 year
Total count, duration, frequency of participants, and proportion of participants reporting medically attended adverse events (MAAEs)
1 year
Evaluate potential immune-mediated medical conditions (PIMMCs).
Time Frame: 1 year
Total count, duration, frequency of participants, and proportion of participants reporting potential immune-mediated medical conditions (PIMMCs)
1 year
Evaluate the adverse events of special interest (AESI).
Time Frame: 1 year
Total count, duration, frequency of participants, and proportion of participants reporting adverse events of special interest (AESI).
1 year
Evaluate the unsolicited adverse events.
Time Frame: 28 days following the first vaccination and 1 year following the last dose of vaccination
Total count, duration, frequency of participants, and proportion of participants reporting unsolicited adverse events.
28 days following the first vaccination and 1 year following the last dose of vaccination
Evaluate the solicited adverse events.
Time Frame: for 7 days following each dose of vaccination
Total count, frequency of participants, and proportion of participants solicited local and systemic adverse events.
for 7 days following each dose of vaccination

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Explore cell based immune response in a subset of participants following 28 days of the second dose of BBV152 administration
Time Frame: D0 and Day 56
  • Geometric Mean Titer (GMT) as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA Immunoglobulin G (IgG) Abs against Spike, Receptor-Binding Domain (RBD), and N protein in the BBV152 treatment group and a subset of the placebo treatment group, overall, and stratified by age group.
  • Geometric Mean Fold Rises (GMFR) as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in the BBV152 treatment group and a subset of the placebo treatment group, overall, and stratified by age group.
D0 and Day 56
Explore the immunogenicity of one and two doses of BBV152 against future variants of concern.
Time Frame: Day0, D28, and Day 56
  • Geometric Mean Titer (GMT) as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA Immunoglobulin G (IgG) Abs against Spike, Receptor-Binding Domain (RBD), and N protein in BBV152 treatment group and a subset of the placebo treatment group, overall, and stratified by age group.
  • Geometric Mean Fold Rises (GMFR) as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in the BBV152 treatment group and a subset of the placebo treatment group, overall, and stratified by age group.
Day0, D28, and Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ocugen

Investigators

  • Study Director: Huma Qamar, MD, MPH, CMI, Ocugen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

October 31, 2023

Study Registration Dates

First Submitted

February 22, 2022

First Submitted That Met QC Criteria

February 25, 2022

First Posted (Actual)

February 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCU-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

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