Phase III Study of BBV154 Intranasal Vaccine in Healthy Volunteers

NCT05522335
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Phase
Phase 3
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Recruitment status
Unknown
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Participants
3,160
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Lead sponsor
Bharat Biotech International Limited
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Start date
2022-04-16
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Number of sites
14
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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)
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Acronym
Nasal154PH3
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Short title
Phase III Study of BBV154 Intranasal Vaccine in Healthy Volunteers
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Official title
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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Unknown
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Phase
Phase 3
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Study type
Interventional
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Completion date
2023-02-28
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First posted
2022-08-31
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Registry last updated
2022-08-31
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Primary completion date
2022-07-19
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Start date
2022-04-16
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Actual participants
3,160
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Participants
3,160
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Participant count basis
Actual
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Protocol amendments
0
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Randomisation ratio
1:1:1
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Number of sites
14
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Bharat Biotech International Limited
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05522335
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ClinicalTrials.gov ID
NCT05522335
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Geometric mean titres (GMTs

    Timeframe: baseline

    Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.

  2. Geometric mean titres (GMTs

    Timeframe: Day 28+2

    Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.

  3. Geometric mean titres (GMTs)

    Timeframe: Day 42±7

    Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays

  4. Geometric mean titres (GMTs)

    Timeframe: Day 90±7

    Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays

  5. Geometric mean titres (GMTs)

    Timeframe: Day 180±7.

    Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays

  6. solicited adverse events

    Timeframe: 7days

    The occurrence of solicited adverse events within seven days of vaccination

  7. unsolicited adverse events

    Timeframe: day 180

    The occurrence of any unsolicited adverse events up to day 180 from 1st dose vaccination.

  1. Geometric mean titers (GMTs)

    Timeframe: baseline

    salivary IgA (n=80), Serum IgA and IgG binding antibody titer by ELISA assays

  2. Geometric mean titers (GMTs)

    Timeframe: Day 28+2

    salivary IgA (n=80), Serum IgA and IgG binding antibody titer by ELISA assays

  3. Geometric mean titers (GMTs)

    Timeframe: Day 42±7

    salivary IgA (n=80), Serum IgA and IgG binding antibody titer by ELISA assays

  4. Geometric mean titers (GMTs)

    Timeframe: Day 90±7

    salivary IgA (n=80), Serum IgA and IgG binding antibody titer by ELISA assays

  5. Geometric mean titers (GMTs)

    Timeframe: Day 180±7

    salivary IgA (n=80), Serum IgA and IgG binding antibody titer by ELISA assays

  6. Geometric mean titres

    Timeframe: baseline

    Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.

  7. Geometric mean titres

    Timeframe: Day 28+2

    Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.

  8. Geometric mean titres

    Timeframe: Day 42±7

    Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.

  9. adverse event

    Timeframe: 180 Days

    The occurrence of adverse event of special interest (AESI).

  10. vaccine induced thrombosis and thrombocytopenia

    Timeframe: 180 Days

    The occurrence of the vaccine induced thrombosis and thrombocytopenia in participants reporting the respective symptoms and signs.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  1. Ability to provide written informed consent.

  2. Participants of either gender of age ≥18 years.

  3. 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).

  4. Expressed interest and availability to fulfill the study requirements.

  5. 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

  6. 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

  7. Participants must refrain from blood/plasma or any other bodily fluid donation from the time of first vaccination until 3 months after last vaccination

  8. Agrees not to participate in another clinical trial at any time during the study period.

  9. Agrees to remain in the study area for the entire duration of the study.

  10. Willing to allow storage and future use of biological samples (serum) for future research.

    -

  1. History of any other COVID-19 investigational/or licensed vaccination.
  2. 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).
  3. 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.
  4. Medical problems because of alcohol or illicit drug use during the past 12 months.
  5. 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.
  6. Receipt of any licensed vaccine (other than Covid-19 vaccine) within four weeks before enrolment in this study.
  7. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
  8. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study.
  9. 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.
  10. 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).
  11. Any history of anaphylaxis in relation to vaccination.
  12. History of any cancer.
  13. History of severe psychiatric conditions likely to affect participation in the study.
  14. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture).
  15. Any other serious chronic illness requiring immediate hospital specialist supervision.
  16. 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
clinicaltrials.gov

  • VIMS (Visakha Institute of Medical Sciences)Vizag, India
  • AIIMS (All India Institute of Medical Sciences)Patna, India
  • Redkar Hospital and Research centerDargalim, India
  • Aatman Hospital, AhmedabadAhmedabad, India
  • PGIMS (Pt. BD Sharma Postgraduate Institute of Medical Sciences)Rohtak, India
  • Jeevan Rekha Hospital, BelgaumBelagavi, India
  • Rajarajeshwari Medical College and HospitalKambīpura, India
  • Oyster and Pearl Hospitals (Phadnis Clinic Pvt Ltd)Pune, India
  • Acharya Vinobha Bhave Rural HospitalWardha, India
  • Maharaja Agrasen super specality Hospital, JaipurJaipur, India
  • Malla Reddy Narayana Multi Speciality HospitalHyderabad, India
  • NIMS (Nizam's Institute of Medical SciencesHyderabad, India
  • Rana HospitalGorakhpur, India
  • Prakhar HospitalKanpur, India
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • BBIL/BBV154-III/2022
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (1)