Expanded Access Program of Whole, Inactivated COVID-19 Vaccine COVAXIN™ (BBV152) in Adults Aged 18 Years and Older

NCT05541289 | Unknown

• 1 other identifier: OCU-004EA
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Expanded Access; EAP; COVAXIN; BBV152

Interventions

BBV152 BIOLOGICAL

Single Arm; BBV152 (COVAXIN™)

Also known as: COVAXIN

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.
• Understands and agrees to comply with the study procedures and provides written informed consent.
• In relatively stable health based on site Investigator's judgment, as determined by medical history, physical examination, and the following criteria:
• 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.
• 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.
• Agrees to not take part in any other COVID-19 vaccine clinical trial for the duration of the study.
• 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.
• Is pregnant or breastfeeding.
• Known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or any of its components.

Sponsors & Collaborators

• Ocugen: lead

Study Sites (1)

Woods

Langhorne, Pennsylvania, 19047, United States

Location

Related Links

• Non-Human Primate Efficacy Study Immunogenicity and protective efficacy of inactivated SARS-CoV-2 vaccine candidate, BBV152 in rhesus macaques
• Th1 Skewed immune response of Whole Virion Inactivated SARS-CoV-2 Vaccine and its safety evaluation
• Persistence of immunity and impact of third dose of inactivated COVID-19 vaccine against emerging variants

MeSH Terms

Conditions

COVID-19

Interventions

BBV152 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 15, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Locations

US (1)