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

This is an interventional prevention trial for COVID-19 Read More

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 4 months 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). 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 35.0 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 an oral 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. The participant has received the influenza vaccine less than 4 months 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. 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.