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

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 scheduledvisits, treatment plans, laboratory tests, lifestyle considerations, and other studyprocedures.
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 180days from their last dose prior to enrollment or One documented dose of viral vectorJ&J/Janssen COVID-19 vaccine a minimum 60 days from their dose prior to enrollment, orA documented dose of the booster shot of the mRNA COVID-19 vaccine (Comirnaty orSpikevax) a minimum of 150 days from their last dose prior to enrollment, or Novaccination 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 thesecond dose of vaccination and not take any other vaccines for the entire duration ofthe study.
7. Participants must be in relatively stable health based on the site Investigator'sjudgment, as determined by medical history, physical examination, and the followingcriteria:
8. Stable health for age (defined as no new conditions per medical history, newmedications in a different therapeutic class, or change in a daily dose ofexisting prescription medications within the 45 days preceding Screening).
9. Participants may be on chronic or as-needed medications if, in the opinion of theInvestigator, these pose no additional risk to participant safety or assessmentof reactogenicity, and immunogenicity and their use is not for management of aworsening of medical diagnosis or condition.
10. Participants are expected to be available for the duration of the study and can becontacted by telephone during study participation.
11. Have a non-clinically significant 12-lead ECG
12. Participants must be healthy based on clinical laboratory tests performed atscreening.
13. Female participants of childbearing potential may be enrolled in the study if theparticipant 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 thesecond dose of the IP
• Has practiced adequate contraception or has abstained from all activities thatcould result in pregnancy for at least 28 days prior to the first dose (Day 0)
• Is not currently breastfeeding Adequate female contraception is defined asconsistent and correct use of a Food and Drug Administration (FDA) approvedcontraceptive method in accordance with the product label.

12. Male participants engaging in activity that could result in the pregnancy of sexualpartners must agree to practice adequate contraception and refrain from sperm donationfrom 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 hormonalcontraception (described above)
• Use of barrier methods and spermicide Male participants with partners who have becomepregnant 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 definedas 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, orany 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 medicaldisorders not excluded by other exclusion criteria, which, in the opinion of theInvestigator, may either put the individual at risk because of participation in thestudy 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 allergicreaction (e.g., anaphylaxis) to any component of the study intervention(s).
6. Immunocompromised individuals with known or suspected immunodeficiency, as determinedby history and/or laboratory/physical examination.
7. History of autoimmune disease or an active autoimmune disease requiring therapeuticintervention, including but not limited to systemic lupus erythematosus (e.g.,rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriaticarthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythematosus)
8. Has bleeding diathesis or condition associated with prolonged bleeding that would, inthe opinion of the Investigator, contraindicate intramuscular injection.
9. Receipt of treatment with immunosuppressive therapy, including cytotoxic agents orsystemic corticosteroids (equivalent to prednisone ≥ 10mg/day for the duration of ≥two weeks), e.g., for cancer or an autoimmune disease, or planned receipt throughoutthe study period. If systemic corticosteroids have been administered short-term (<14days) for treatment of an acute illness, participants should not be enrolled in thestudy until corticosteroid therapy has been discontinued for at least 28 days (about 4weeks) before study intervention administration.
10. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60days (about 2 months) before study intervention administration, or receipt of anypassive antibody therapy specific to COVID-19 from 90 days (about 3 months) beforestudy intervention administration or planned receipt throughout the study.
11. Has participated in an interventional clinical trial within the 4 weeks prior torandomization.
12. Known sensitivity to any components of the study vaccine.
13. The participant has received the influenza vaccine within 14 days prior to enrollmentand any other vaccine within 28 days prior to randomization.
14. Any clinically significant illness, medical/surgical procedure, or trauma within 4weeks of the first administration of IP.
15. Any positive result on screening for serum hepatitis B surface antigen, hepatitis Cantibody, and human immunodeficiency virus (HIV) antibody. Participants who have beeneffectively treated for hepatitis C, as evidenced by a negative hepatitis Cribonucleic 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 alcoholas judged by the Investigator. Benzodiazepines for anxiety disorders and stimulantsfor attention deficit hyperactivity disorder are not exclusionary if the participanthas been on a stable dose for more than 3 months prior to Screening and each studydosing and if the participant can produce a valid, current prescription for themedication. Propoxyphene, opioids, or combinations containing these medications (including as used for opioid addiction) are not permitted regardless of prescriptionstatus. Note: A positive Screening urine drug screen may not be repeated.
17. Donated blood products within the 4 weeks prior to randomization.