NCT05522335UnknownPhase 3
A Phase III Randomized Open Label Multi-center Study to Compare Immunogenicity and Safety of BBV154 With COVAXIN®, and to Assess Lot to Lot Consistency of BBV154 in Healthy Volunteers
Bharat Biotech International Limited28 sites in 1 country3,160 target enrollmentStarted: April 16, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 3,160
- Locations
- 28
- Primary Endpoint
- Geometric mean titres (GMTs
Study Overview
Brief Summary
Group 1 (BBV154): In this group, 3000 participants will be recruited, randomized in 1:1:1 ratio receive 3 consecutive lots (Lot 1: 1000, Lot 2: 1000, Lot 3: 1000) of the BBV154 vaccine (0.5 mL each dose) on day 0 and day 28 via intranasal route. Group 2 (COVAXIN®): In this group, 160 participants will be recruited and administered with COVAXIN® vaccine on day 0 and on day 28 via intramuscular route.
A total sample size of 3160 healthy volunteer's age's ≥18 years will be recruited in this study. BBV154-Subjects- Part 1 ( Immunogenicity Group)- First 640 Subjects BBV154-Subjects- Part 2 ( Safety Group)- (Remaining 2520 subjects) Visit 1: Baseline (Day 0) Visit 2 (Day 28+2) Visit 3 (Day 42 ± 7 days) Visit 4 (Day 90 ± 7 days) and Visit 5 (Day 180± 7 days)
Detailed Description
Sample Collection:
- Pregnancy test will be conducted by using rapid test kit.
- Immunogenicity analysis: A total of 5 ml of blood is collected on Day 0, Day 28+2, Day 42±7, Day 90±7 and Day 180±7 (Subset of 640, 160 from each lot and control group). Sera will collect from the blood sample and stored as 3 aliquots at -20°C.
- A saliva sample (5 mL) and an additional blood sample (10mL) will be collected on Day 0, Day 28+2, Day 42±7, Day 90±7 and Day 180±7 (Subset of 80, 60 from Group 1(20 from each lot) and 20 from Group 2).
- Saliva will be collected by Passive droll method using Falcon tube.
Sample Size:
A total sample size of 3160 healthy volunteer's age's ≥18 years will be recruited in this study.
Randomization:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Ability to provide written informed consent.
- •Participants of either gender of age ≥18 years.
- •Good general health as determined by the discretion of investigator (vital signs (heart rate ≥60 to≤100 bpm; blood pressure systolic ≥90 mm Hg and <140 mm Hg; diastolic ≥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical history, and physical examination).
- •Expressed interest and availability to fulfill the study requirements.
- •For a female participant of child-bearing potential, planning to avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least four weeks after the last vaccination
- •Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination
- •Participants must refrain from blood/plasma or any other bodily fluid donation from the time of first vaccination until 3 months after last vaccination
- •Agrees not to participate in another clinical trial at any time during the study period.
- •Agrees to remain in the study area for the entire duration of the study.
- •Willing to allow storage and future use of biological samples (serum) for future research.
Exclusion Criteria
- •History of any other COVID-19 investigational/or licensed vaccination.
- •For women of child bearing potential, a positive serum pregnancy test (during screening within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of administering each dose of vaccine).
- •Temperature >38.0°C (100.4°F) or symptoms of an acute self limiting illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine.
- •Medical problems because of alcohol or illicit drug use during the past 12 months.
- •Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrolment or expects to receive an investigational agent during the study period.
- •Receipt of any licensed vaccine (other than Covid-19 vaccine) within four weeks before enrolment in this study.
- •Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
- •Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study.
- •Immunosuppressant as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
- •Long-term use (> 2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (Topical steroids are allowed).
- •Any history of anaphylaxis in relation to vaccination.
- •History of any cancer.
- •History of severe psychiatric conditions likely to affect participation in the study.
- •A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture).
- •Any other serious chronic illness requiring immediate hospital specialist supervision.
- •Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol. -
Outcomes
Primary Outcomes
Geometric mean titres (GMTs
Time Frame: Day 28+2
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.
Geometric mean titres (GMTs)
Time Frame: Day 180±7.
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays
solicited adverse events
Time Frame: 7days
The occurrence of solicited adverse events within seven days of vaccination
unsolicited adverse events
Time Frame: day 180
The occurrence of any unsolicited adverse events up to day 180 from 1st dose vaccination.
Secondary Outcomes
- Geometric mean titers (GMTs)(Day 180±7)
- Geometric mean titres(Day 42±7)
- adverse event(180 Days)
- vaccine induced thrombosis and thrombocytopenia(180 Days)
Investigators
Study Sites (28)
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