Immuno-bridging and Broadening Study of a Whole, Inactivated COVID-19 Vaccine BBV152 in Healthy Adults
NCT ID: NCT05258669
Last Updated: 2023-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
400 participants
INTERVENTIONAL
2022-02-20
2023-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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BBV152
BBV152
BBV152
Each participant will receive 2 doses of the investigational product intramuscular injection of either 6 μg of BBV15 vaccine or placebo.
Placebo
0.9% normal saline
BBV152
Each participant will receive 2 doses of the investigational product intramuscular injection of either 6 μg of BBV15 vaccine or placebo.
Interventions
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BBV152
Each participant will receive 2 doses of the investigational product intramuscular injection of either 6 μg of BBV15 vaccine or placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
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.
18 Years
ALL
Yes
Sponsors
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Ocugen
INDUSTRY
Responsible Party
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Principal Investigators
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Huma Qamar, MD, MPH, CMI
Role: STUDY_DIRECTOR
Ocugen
Locations
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Voyage Medical
Tempe, Arizona, United States
Angels Clinical Institute
Miami, Florida, United States
Suncoast Research Group LLC
Miami, Florida, United States
Palm Springs Community Health Center
Miami Lakes, Florida, United States
Clinical Site Partners
Winter Park, Florida, United States
IACT Health
Columbus, Georgia, United States
Jay Meyer Meridian Research
Lincoln, Nebraska, United States
PRX Research
Dallas, Texas, United States
Wellness Clinical Research
McKinney, Texas, United States
Meridian Research 3235 Academy Ave
Portsmouth, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Non-Human Primate Efficacy Study Immunogenicity and protective efficacy of inactivated SARS-CoV-2 vaccine candidate, BBV152 in rhesus macaques
Other Identifiers
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OCU-002
Identifier Type: -
Identifier Source: org_study_id
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