Phase 3 Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose
NCT05567471
Phase
Phase 3
Recruitment status
Completed
Participants
Lead sponsor
Bharat Biotech International Limited
Start date
2022-02-26
Number of sites
- Summary
- A total sample size of 875 healthy volunteers ages ≥18 years will be recruited in this study in the ratio of 2:1:2:1:1. Group 1: (BBV154 in COVAXIN recipients): In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine in form of drops (0.5 mL) via intranasal route, in individuals previously vaccinated with COVAXIN. Group 2: (BBV152(COVAXIN) in COVAXIN recipients): In this group, 125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVAXIN. Group 3: (BBV154 in COVISHIELD recipients) In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine, in individuals previously vaccinated with COVISHIELD. Group 4: (BBV152(COVAXIN) in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of BBV152 (COVAXIN) vaccine, in individuals previously vaccinated with COVISHIELD. Group 5: (COVISHIELD in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of Covishield vaccine, in individuals previously vaccinated with COVISHIELD.
- Short title
- Phase 3 Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose
- Official title
- Phase 3, Randomized, Multi-Centric, Open-labeled Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose in Participants Previously Vaccinated With EUA Vaccines
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2022-09-28
- First posted
- 2022-10-05
- Registry last updated
- 2022-10-05
- Primary completion date
- 2022-05-03
- Start date
- 2022-02-26
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Randomisation ratio
- 2:1:2:1
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Bharat Biotech International Limited
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05567471
- ClinicalTrials.gov ID
- NCT05567471
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- No masking
Sources for study design
Geometric mean titres 1
Timeframe: baseline
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.
Geometric mean titres 2
Timeframe: Day 28+2
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.
Geometric mean titres 3
Timeframe: Day 56 ± 7
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.
Geometric mean titres 4
Timeframe: Day 28+2
GMTs of serum IgG Abs by ELISA
Geometric mean titres 5
Timeframe: Day 56 ± 7
GMTs of serum IgA Abs by ELISA
Cell mediated immune response
Timeframe: Day 28+2
Vaccine induced T cell responses through cell mediated immune analysis
Cell mediated immune response
Timeframe: Day 56 ± 7
Vaccine induced B cell responses through cell mediated immune analysis
Geometric mean titres
Timeframe: Day 28+2
GMTs of secretary IgA Abs by ELISA.
Geometric mean titres (GMTs)
Timeframe: Day 56 ± 7
GMTs of secretary IgA Abs by ELISA.
adverse events reported
Timeframe: 7 days after vaccination
The occurrence of solicited adverse events
adverse events of special interest reported
Timeframe: throughout the study duration 7 months
The occurrence of adverse event of special interest (AESI).
vaccine induced thrombosis and thrombocytopenia
Timeframe: throughout the study duration 7 months
The occurrence of the vaccine induced thrombosis and thrombocytopenia in participants reporting the respective symptoms and signs.
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- Yes
- Ability to provide written informed consent.
- Participants of either gender of age ≥18 years.
- Received and completed COVID-19 vaccine under Emergency Use Authorization (EUA) dosing guidelines at least 6 ± 1 month (after receipt of second dose of EUA vaccine) prior to enrollment, confirmed by the electronic Covid-19 Certificate (CoWIN).
- 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 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 for future research
- Known history of COVID-19 infection.
- 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 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 vaccination.
- 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 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.
- Immunosuppression because 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 (nasal and 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.
Sources for eligibility
- All India Institute of Medical SciencesPatna, India
- ESIC Medical College and HospitalFaridabad, India
- Vagus Super Specilaity HospitalsBangalore, India
- Jeevan Rekha HospitalBelagavi, India
- Gillurkar Multispeciality HopistalNagpur, India
- St. Theresa HospitalHyderabad, India
- Rana Hospital Pvt LtdGorakhpur, India
- Prakhar Hospital Pvt LtdKanpur, India
- AIIMS, New DelhiNew Delhi, India
Sources for sites