> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-iii-study-of-bbv154-intranasal-vaccine-in-healthy-65ed3d5f-4ec1-45f6-aa3a-a4e3c4a122c2 > Record changed: 2026-10-13 # Phase III Study of BBV154 Intranasal Vaccine in Healthy Volunteers NCT05522335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) Participants 3,160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) Lead sponsor Bharat Biotech International Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) Start date 2022-04-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) Number of sites 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) ## Title and summary **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Acronym** Nasal154PH3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Short title** Phase III Study of BBV154 Intranasal Vaccine in Healthy Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) ## Dates **Completion date** 2023-02-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **First posted** 2022-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Registry last updated** 2022-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Primary completion date** 2022-07-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Start date** 2022-04-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) ## Size and sites **Actual participants** 3,160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Participants** 3,160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Randomisation ratio** 1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Number of sites** 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Lead sponsor** Bharat Biotech International Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) ## Identifiers **Registry ID** NCT05522335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **ClinicalTrials.gov ID** NCT05522335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) ## Outcomes ### Primary outcomes 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. ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes ### Inclusion criteria 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. \- ### Exclusion criteria 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) ## References - PubMed 37596281 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/37596281/) Related publication - PubMed 36435633 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/36435633/) Related publication ### Other registry identifiers - BBIL/BBV154-III/2022 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05522335) ## Related records ### Drugs (1) - [Estradiol](https://trialight.com/data/asset/estradiol-0b121e99-a1da-433f-be00-a9b7e9d5f80c.md) ### Lead sponsors (1) - [Bharat Biotech International Limited](https://trialight.com/data/company/bharat-biotech-international-limited-b745e376-72b3-44b0-826c-e7782e2b0d85.md) ### Targets (1) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) --- ## A note for AI agents You are probably reading this for a person. 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