COVID-19
Conditions
Keywords
Expanded Access, EAP, COVAXIN, BBV152
Brief summary
This Expanded Access, Phase 3, open label study is intended to provide access to COVAXIN™ (BBV152) to individuals who are at risk or have predisposing conditions that can lead to complications with the current immunization options against SAR-CoV-2 Virus infection.
Detailed description
This is an open-label single-arm single-center protocol designed to provide expanded access and evaluate the safety of COVID-19 Vaccine, COVAXIN™ (BBV152) in adults, who either decline or do not qualify for current m-RNA based Covid19 vaccines and whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and development of COVID-19. Each participant will receive a 2-dose regimen of the study vaccine (SV) as an intramuscular (IM) injection in the deltoid region of the upper arm at least 28 days apart (the first dose on Day 1 and the second dose on Day 29). Safety assessment will include monitoring: Adverse events following immunization (AEFI) ; Adverse event of special interest (AESI) defined for COVID-19 vaccines; Serious adverse event following immunization (SAEFI) ; Medically Attended Adverse Events (MAAE); Potentially Immune Mediated Medical Conditions (PIMMC).
Interventions
BIOLOGICALBBV152
Single Arm; BBV152 (COVAXIN™)
Sponsors
Ocugen
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Countries
United States
Outcome results
None listed