> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-3-study-to-evaluate-immunogenicity-and-safety-of-80114e45-a951-4477-85ca-015a74fc40db > Record changed: 2026-11-04 # Phase 3 Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose NCT05567471 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) Participants 875 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) Lead sponsor Bharat Biotech International Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) Start date 2022-02-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) Number of sites 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Short title** Phase 3 Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) ## Dates **Completion date** 2022-09-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **First posted** 2022-10-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Registry last updated** 2022-10-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Primary completion date** 2022-05-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Start date** 2022-02-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) ## Size and sites **Actual participants** 875 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Participants** 875 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Randomisation ratio** 2:1:2:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Number of sites** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Lead sponsor** Bharat Biotech International Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) ## Identifiers **Registry ID** NCT05567471 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **ClinicalTrials.gov ID** NCT05567471 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) ## Outcomes ### Primary outcomes 1. Geometric mean titres 1 Timeframe: baseline Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays. 2. Geometric mean titres 2 Timeframe: Day 28+2 Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays. 3. Geometric mean titres 3 Timeframe: Day 56 ± 7 Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays. ### Secondary outcomes 1. Geometric mean titres 4 Timeframe: Day 28+2 GMTs of serum IgG Abs by ELISA 2. Geometric mean titres 5 Timeframe: Day 56 ± 7 GMTs of serum IgA Abs by ELISA 3. Cell mediated immune response Timeframe: Day 28+2 Vaccine induced T cell responses through cell mediated immune analysis 4. Cell mediated immune response Timeframe: Day 56 ± 7 Vaccine induced B cell responses through cell mediated immune analysis 5. Geometric mean titres Timeframe: Day 28+2 GMTs of secretary IgA Abs by ELISA. 6. Geometric mean titres (GMTs) Timeframe: Day 56 ± 7 GMTs of secretary IgA Abs by ELISA. 7. adverse events reported Timeframe: 7 days after vaccination The occurrence of solicited adverse events 8. adverse events of special interest reported Timeframe: throughout the study duration 7 months The occurrence of adverse event of special interest (AESI). 9. 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) ## 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. 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). 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 vaccination. 6. Agrees not to participate in another clinical trial at any time during the study period. 7. Agrees to remain in the study area for the entire duration of the study. 8. Willing to allow storage and future use of biological samples for future research ### Exclusion criteria 1. Known history of COVID-19 infection. 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 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 vaccination. 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 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. 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. 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 (nasal and 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/NCT05567471) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05567471) ## Related records ### Drugs (2) - [AZD-1222](https://trialight.com/data/asset/azd-1222-af308ae7-5450-5819-bdf6-dc10f6ee425b.md) - [Bbv-152 antigen adjuvated with algel-imdg](https://trialight.com/data/asset/bbv-152-antigen-adjuvated-with-algel-imdg-ac566930-dfc1-4793-8bb0-629b520896cb.md) ### Lead sponsors (1) - [Bharat Biotech International Limited](https://trialight.com/data/company/bharat-biotech-international-limited-b745e376-72b3-44b0-826c-e7782e2b0d85.md) --- ## A note for AI agents You are probably reading this for a person. 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