A randomized, observer-blind, placebo-controlled immuno-bridging, and broadening study todemonstrate the equivalence of the immune response between participants enrolled in Phase3 efficacy trial in India and demographically diverse healthy adult participants in theUS which matched in age and vaccine formulation setting to whom those efficacy resultsare extrapolated; and to assess the broadening of the BBV152 in participants whopreviously received two shots of messenger ribonucleic acid (mRNA) COVID-19 vaccine atleast 6 months earlier or one-shots of viral vector J&J/Janssen COVID-19 vaccine at least2 months earlier. Safety and tolerability evaluation is a secondary endpoint.
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.
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
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.
Voyage Medical
Tempe, Arizona, United States
Palm Springs Community Health Center
Miami Lakes, Florida, United States
Angels Clinical Institute
Miami, Florida, United States
Suncoast Research Group LLC
Miami, 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
Alice Cousens, RN,MBA
4844338665
Alice.Cousens@ocugen.com
Roshan George, MD, MPH
(845) 664-1505
roshan.george@ocugen.com
Huma Qamar, MD, MPH, CMI, Study Director
Ocugen