| Eligibility |
Inclusion Criteria:
1. Does not meet Inclusion/Exclusion criteria for the ongoing COVAXIN™ (BBV152), COVID-19
vaccine clinical trial(s).
2. Either:
Has history of myocarditis or pericarditis occurred after any dose of mRNA COVID-19
vaccine OR Has a history of autoimmune disease or an active autoimmune disease
requiring therapeutic intervention, including but not limited to systemic lupus
erythematosus (e.g., Guillain-Barré Syndrome, rheumatoid arthritis, polyarticular
juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple
sclerosis, systemic lupus erythematous).
OR Unwilling to or unable to be vaccinated with the currently available vaccines due
to contraindications - possible side effects such as myocarditis, pericarditis,
Guillain-Barré syndrome or thromboembolic events , treating physician discretion or
any other personal preference.
3. Adults, = 18 years of age at time of consent, who based on the Investigator's
discretion are at high risk of SARS-CoV-2 infection, defined as adults whose locations
or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and
development of COVID-19.
4. Understands and agrees to comply with the study procedures and provides written
informed consent.
5. In relatively stable health based on site Investigator's judgment, as determined by
medical history, physical examination, and the following criteria:
6. Stable health for age (defined as no new conditions per medical history, new
medications in a different therapeutic class, or change in 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 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.
7. Participants may be on chronic or as needed medications if, in the opinion of the
Investigator, these pose no additional risk to participant safety and their use is not
for management of a worsening of medical diagnosis or condition.
8. Female participants of childbearing potential may be enrolled in the study if the
participant fulfills all the following criteria:
- Have a negative pregnancy test at Baseline and prior to each study dose.
- Have agreed to continue adequate contraception during the study and for 3 months
following the second dose of the study vaccine.
- 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.
9. Agrees to not take part in any other COVID-19 vaccine clinical trial for the duration
of the study.
Exclusion Criteria:
1. Is acutely ill or febrile 72 hours prior to or at Baseline. 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 has not been any symptoms for > 14 days before
enrollment.
2. Is pregnant or breastfeeding.
3. Known or suspected allergy or history of anaphylaxis, urticaria, or other significant
adverse reaction to the vaccine or any of its components.
4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection.
5. History of heparin-induced thrombocytopenia (HIT) withing 90 days prior enrollment.
6. Previous vaccination with any coronavirus vaccine within 6 months prior enrollment.
7. Has received systemic immunosuppressants or immune-modifying drugs for >14 days in
total within 6 months prior to Baseline (for corticosteroids =20 milligram (mg)/day of
prednisone equivalent).
8. Immunosuppressive or immunodeficient state, asplenia, recurrent severe infections
(HIV-positive participants with CD4 count =350 cells/mm3 and an undetectable HIV viral
load within the past year [low level variations from 50-500 viral copies which do not
lead to changes in antiretroviral therapy [ART] are permitted]).
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