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Trial record 3 of 4 for:    Covaxin

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05258669
Recruitment Status : Recruiting
First Posted : February 28, 2022
Last Update Posted : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
Ocugen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: BBV152 Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 randomization ratio
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: An unblinded pharmacist or another qualified individual will prepare and provide the syringe in a blinded manner to the study vaccine administrator (a trained and qualified study nurse, medical doctor, or otherwise qualified health care professional) who will perform the injection.
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : February 20, 2022
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : October 31, 2023


Arm Intervention/treatment
Active Comparator: BBV152
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 Name: 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 Name: Covaxin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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, Delta, and Omicron and ELISA Immunoglobulin G (IgG) Abs against Spike, Receptor-Binding Domain (RBD), and N protein in each treatment group, overall, and stratified by age group.
    • Geometric Mean Fold Rises (GMFR) as measured by MNT neutralizing antibodies against Wild-Type, Delta, and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in each treatment group, overall, and stratified by age group.

  2. 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, Delta, and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in each treatment group, overall, and stratified by age group.
    • Geometric Mean Fold Rises (GMFR) as measured by MNT nAbs against Wild-Type, Delta, and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in each treatment group, overall, and stratified by age group.

  3. 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)

  4. 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, Delta, and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in each treatment group, overall, and stratified by age group.

  5. 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, Delta, and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in each treatment group, overall, and stratified by age group.
    • Geometric Mean Fold Rises (GMFR) as measured by MNT neutralizing antibodies against Wild-Type, Delta, and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in each treatment group, overall, and stratified by age group.

  6. 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, Delta, and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in each treatment group, overall, and stratified by age group.
    • Geometric Mean Fold Rises (GMFR) as measured by MNT neutralizing antibodies against Wild-Type, Delta, and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in each treatment group, overall, and stratified by age group.

  7. 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)

  8. 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)

  9. 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).

  10. Evaluate the unsolicited adverse events. [ Time Frame: 28 days following each of vaccination ]
    Total count, duration, frequency of participants, and proportion of participants reporting unsolicited adverse events.

  11. 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.


Other Outcome Measures:
  1. Explore cell based immune response in a subset of participants following 28 days of BBV152 administration (1st dose and 2nd dose) [ Time Frame: Day 28 and Day 56 ]
    • Geometric Mean Titer (GMT) as measured by MNT neutralizing antibodies against Wild-Type, Delta, and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in each treatment group, overall, and stratified by age group.
    • Geometric Mean Fold Rises (GMFR) as measured by MNT neutralizing antibodies against Wild-Type, Delta, and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in each treatment group, overall, and stratified by age group.



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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 Participants must have received one documented dose of viral vector J&J/Janssen COVID-19 vaccine a minimum 60 days from their dose prior to enrollment, or Participants must have NO vaccination history of COVID-19 vaccine and no history of COVID-19 disease (self-report, on-site inquiry).
  6. Participants must agree not to take any vaccination 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). Effective treatment (to resolution) of an acute infection (e.g., urinary tract infection, cellulitis, otitis, or bronchitis) with an antibiotic within 45 days preceding Screening will not be considered a deviation from this inclusion criterion as long as the antibiotic therapy was completed at least one week prior to Screening and no signs or symptoms of the infection have been present since the completion of treatment. Any prescription change that is due to a change of health care provider or insurance company or that is made for reasons that do not reflect a change in disease status (e.g., financial considerations), as long as within the same general class of medication, will not be considered a deviation from this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site investigator, will not be considered a deviation from this inclusion criterion.
    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. If the results of the laboratory screening tests are outside the local laboratory normal reference ranges and additionally within the limits of toxicity Grade 1 according to the US FDA toxicity tables (i.e., for tests in the FDA table), the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the Investigator.

    Note: If laboratory screening tests are out of local laboratory normal ranges and deemed clinically significant, repeat of screening tests is permitted once during the screening period to assess eligibility.

  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.

14. 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 30.0 kg/m2 at Screening.

Exclusion Criteria:

  1. History of SARS-CoV-2, MERS infection (self-report, on-site inquiry).
  2. Presence of fever or other acute illness at the time of enrollment. Fever is defined as a body temperature ≥ 38.0°C/100.4°F. Participants meeting this criterion may be rescheduled when the fever has resolved and there have not been any symptoms for > 14 days (about 2 weeks) before enrollment.
  3. History or current clinically significant cardiac disease, such as 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. Have received any vaccine within 28 days (about 4 weeks) 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. Screening tests will not be repeated prior to subsequent dosing.
  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.

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): NCT05258669


Contacts
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Contact: Roshan George, MD 484 324-2346 roshan.george@ocugen.com
Contact: Radika Kumar, MD 484 324-2346 radika.kumar@ocugen.com

Locations
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United States, Florida
Clinical Site Partners Recruiting
Winter Park, Florida, United States, 332789
Contact: Regina Jones       rjones@clinicalsitepartners.com   
Principal Investigator: Jorge Monroy, MD         
United States, Georgia
IACT Health Not yet recruiting
Columbus, Georgia, United States, 31904
Contact: Anna Thweatt       anna.thwett@centricityresearch.com   
Principal Investigator: Joseph Surber         
Paul Bradley Meridian Research Not yet recruiting
Savannah, Georgia, United States, 31406
Contact: reagan deal       rdeal@mcrmed.com   
Principal Investigator: Paul Bradley         
United States, Nebraska
Jay Meyer Meridian Research Not yet recruiting
Lincoln, Nebraska, United States, 68510
Contact: Tiffany Mick       tmick@mcrmed.com   
Principal Investigator: Jay Meyer         
United States, Virginia
Meridian Research 3235 Academy Ave Not yet recruiting
Portsmouth, Virginia, United States, 237803
Contact: Eric Honeycutt       ehoneycutt@mcrmed.com   
Principal Investigator: Banu Myneni         
Sponsors and Collaborators
Ocugen
Investigators
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Study Director: Huma Qamar, MD, MPH, CMI Ocugen
Additional Information:
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Responsible Party: Ocugen
ClinicalTrials.gov Identifier: NCT05258669    
Other Study ID Numbers: OCU-002
First Posted: February 28, 2022    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases