COVID-19NCT05541289
Expanded Access Program of Whole, Inactivated COVID-19 Vaccine COVAXIN™ (BBV152) in Adults Aged 18 Years and Older
A study testing BBV152 in people with COVID-19, run by Ocugen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- BBV152
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Does not meet Inclusion/Exclusion criteria for the ongoing COVAXIN™ (BBV152), COVID-19 vaccine clinical trial(s).
- 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.
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- In relatively stable health based on site Investigator's judgment, as determined by medical history, physical examination, and the following criteria:
- 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.
- 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.
Who cannot join
- 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.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- History of heparin-induced thrombocytopenia (HIT) withing 90 days prior enrollment.
- Previous vaccination with any coronavirus vaccine within 6 months prior enrollment.
- 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).
- 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]).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Intermediate Size Expanded Access Program of Whole, Inactivated SARS-CoV-2 Vaccine COVAXIN™ (BBV152) in Adults Aged 18 Years and Older
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.
Read the 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).
- Conditions
- COVID-19
- Being tested
- BBV152
- Keywords
- Expanded Access, EAP, COVAXIN, BBV152
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBV152Biological
Also called COVAXIN
Single Arm; BBV152 (COVAXIN™)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Ocugen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541289
- Sponsor's protocol ID
- OCU-004EA
- Status last verified
- Sep 2022
- First submitted
- 9 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intermediate Size Expanded Access Program of Whole, Inactivated SARS-CoV-2 Vaccine COVAXIN™ (BBV152) in Adults Aged 18 Years and Older
- ClinicalTrials.gov ID
- NCT05541289
- Acronym / sponsor ID
- OCU-004EA
- Conditions
- COVID-19
- Keywords
- Expanded Access, EAP, COVAXIN, BBV152
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- OcugenIndustry (pharma, biotech, devices)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Does not meet Inclusion/Exclusion criteria for the ongoing COVAXIN™ (BBV152), COVID-19 vaccine clinical trial(s).
- 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.
Key exclusion criteria (8 listed)
- 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.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- History of heparin-induced thrombocytopenia (HIT) withing 90 days prior enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBV152Also: COVAXINSingle Arm; BBV152 (COVAXIN™) | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Non-Human Primate Efficacy Study Immunogenicity and protective efficacy of inactivated SARS-CoV-2 vaccine candidate, BBV152 in rhesus macaquesLink provided by the sponsor.
- Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomised, double-blind, controlled, phase 3 trialLink provided by the sponsor.
- Persistence of immunity and impact of third dose of inactivated COVID-19 vaccine against emerging variantsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BBV152 in people with COVID-19, run by Ocugen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.