Corona Virus InfectionPhase 2BBV152BBV154NCT05639998
BBV152/BBV154 Heterologus Prime-Boost Study
A Phase 2 study testing COVAXIN(BBV152) and BBV154 Intranasal Vaccine in people with Corona Virus Infection, run by Bharat Biotech International Limited at 11 sites in India.
Trial summary
All participants will be assessed for immunogenicity and safety endpoints and provide a blood sample before the administration of the first dose of IP. Blood samples will be collected on days 0, 9 (Groups 1, 3 and 4), 28,37 (Groups 2 and 4), 56, 90 and 180 to assess the neutralizing antibody titer against the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- COVAXIN(BBV152) and BBV154 Intranasal Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 608 participants
- Where
- 11 sitesIndia
- Study dates
- 1 Sep 2021to 31 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent.
- Participants of either gender, ages between 18 years <65 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 fulfil 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 .
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- Participants must refrain from blood/plasma or any other bodily fluid donation from the time of first vaccination until 3 months after the 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 for future research
Who cannot join
- History of any other COVID-19 investigational/or licensed vaccination.
- History of cold, sneezing, nasal obstruction in the past 1 day.
- For women of childbearing potential, a 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-limited illness such as an upper respiratory infection or gastroenteritis within three days before 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.
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- 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 before vaccination in this study.
- Immunosuppression 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 (nasal and topical steroids are allowed).
- Any history of anaphylaxis concerning vaccination.
- History of any cancer.
- History of severe psychiatric severe 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 venipuncture.
- 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. Re-Vaccination Exclusion Criteria
- Pregnancy.
- Anaphylactic reaction following administration of the vaccine.
- Virologically confirmed cases of SARS-CoV-2 infection.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
India11 sites
Institute of Medical Sciences and SUM Hospital,Odisha
Bhubaneswar, Odisha
Institute of Liver and Biliary Sciences,New Delhi
Delhi
The INCLEN Trust International/Guru Nanak Hospital
Gurgaon, Haryana
Malla Reddy Narayana Multispeciality Hospital
Hyderabad, Telangana, 500010
Gleneagles Global Hospitals,Hyderabad
Hyderabad, Telangana
St Theresas Hospital
Hyderabad, Telangana
Prakhar Hospital Pvt Limited
Kanpur, Uttar Pradesh
JSS Medical College & Hospital
Mysore, Karnataka
Gillurkur Multispeciality Hospital
Nagpur, Maharashtra
All India Institute of Medical Scienecs
New Delhi, National Capital Territory of Delhi, 110029
The Medicity Hopsital
Rudrapur, Uttarakhand
About this study
Official title: Phase 2 Randomized, Multi-centric of Heterologus Prime-Boost Combination of SARS-CoV-2 Vaccines to Evaluate the Immunogenicity and Safety of BBV152 (COVAXIN®) With BBV154 (Adenoviral Intranasal COVID-19 Vaccine) in Healthy Volunteers
All participants will be assessed for immunogenicity and safety endpoints and provide a blood sample before the administration of the first dose of IP. Blood samples will be collected on days 0, 9 (Groups 1, 3 and 4), 28,37 (Groups 2 and 4), 56, 90 and 180 to assess the neutralizing antibody titer against the SARSCoV-2 virus. A subset of 160 Participants (40 participants from each group) will be assessed for immunogenicity analysis, among these subset 10mL of blood and 5mL of saliva will be collected on days 0, 9 (Groups 1, 3 and 4), 28, 37 (Groups 2 and 4), 56, 90 and 180 to assess cell-mediated immunity and mucosal immunogenicity.
Group 1 (COVAXIN® + COVAXIN®): In this group, 152 participants will be recruited who will receive COVAXIN® on day 0 and on day 28 via the intramuscular route.
Read more
Group 2 (COVAXIN® + BBV154): In this group, 152 participants will be recruited who will receive COVAXIN® (Intramuscular) on day 0 and BBV154 (Intranasal) day 28.
*Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® viaintramuscular route.
Group 3 (BBV154 + COVAXIN®): In this group, 152 participants will be recruited who will receive BBV154 (Intranasal) on day 0 and COVAXIN® (Intramuscular) on day 28.
*Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® via intramuscular route.
Group 4 (BBV154 + BBV154): In this group, 152 participants will be recruited who will receive BBV154 on day 0 and on day 28 via the intranasal route.
Read the detailed description
A Phase 2 randomized, multi-centric, Clinical Trial of Heterologus Prime-Boost Combination of SARS-CoV-2 Vaccines to evaluate the immunogenicity and safety of BBV152 (COVAXIN®) with BBV154 (Adenoviral Intranasal COVID-19 vaccine) in Healthy Volunteers.
This is a heterologus prime boost study, designed to evaluate the immunogenicity and safety of COVAXIN® with BBV154 and vice versa, amongthe four groups. A total of 608 subjects will be enrolled in the 1:1:1:1 ratio.
Group 1 (COVAXIN® + COVAXIN®): In this group, 152 participants will be recruited who will receive COVAXIN® on day 0 and on day 28 via the intramuscular route.
Group 2 (COVAXIN® + BBV154): In this group, 152 participants will be recruited who will receive COVAXIN® (Intramuscular) on day 0 and BBV154 (Intranasal) day 28.
*Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® viaintramuscular route
Group 3 (BBV154 + COVAXIN®): In this group, 152 participants will be recruited who will receive BBV154 (Intranasal) on day 0 and COVAXIN® (Intramuscular) on day 28.
*Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® via intramuscular route.
Group 4 (BBV154 + BBV154): In this group, 152 participants will be recruited who will receive BBV154 on day 0 and on day 28 via the intranasal route.
All participants will be assessed for immunogenicity and safety endpoints and provide a blood sample before the administration of the first dose of IP. Blood samples will be collected on days 0, 9 (Groups 1, 3 and 4), 28, 37 (Groups 2 and 4),56, 90 and 180 to assess the neutralizing antibody titer against the SARS-CoV-2 virus. A subset of 160 Participants (40 participants from each group) will be assessed for cell mediated and mucosal immunogenicity analysis, among these subset 10mL of blood and 5mL of saliva will be collected on days 0, 9 (Groups 1, 3 and 4), 28, 37 (Groups 2 and 4), 56, 90 and 180 to assess cell-mediated immunity and mucosal immunogenicity.
STUDY PROCEDURE
Visit 1(Day 0)
- If the participant is eligible (in good general health or stable pre-existing disease as per the discretion of the Principal investigator), a blood sample will be withdrawn before vaccination for all the participants.
- Safety Labs: An additional 15mL of blood will collected from half of the study population (76 from each group) to assess the safety at Day 0 and 56.
- A blood sample (5 mL) will be collected from all the participants for immunogenicity assessment. A study vaccine/comparator will be administered. Following vaccination, participants will remain at the study site for at least 30 minutes of observation to record any immediate adverse event.
- Additional 10 mL blood will be collected from subset of 160 participants (Group1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- A 5mL saliva sample will be collected from subset of 160 participants (Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- Vaccine will be administered.
- Diary cards will be distributed to the participants.
- Telephonic follow-up (1-7-days post-vaccination) for adverse event recording.
Visit 2 (Day 9+2):
- Study participants will return to the OPD for physical examination (general and systemic examination), and specific symptoms for COVID-19.
- A blood sample (5 mL) will be collected from all the participants for immunogenicity assessment.
- Subset of Study participants (Group 1, 3 and 4) will return to the OPD for vitals and physical examination (general and systemic examination), and specific symptoms for COVID-19.
- Additional 10 mL blood will be collected from subset of (Groups 1, 3 and 4)participants(Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- A 5mL saliva sample will be collected from subset of (Groups 1, 3 and 4) participants(Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
Visit 3 (Day 28 +2 ):
- Study participants will return to the OPD for vitals and physical examination (general and systemic examination), and specific symptoms for COVID-19.
- A blood sample (5 mL) will be collected from all the participants for immunogenicity assessment.
- Additional 10 mL blood will be collected from subset of 160 participants(Group1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- A 5mL saliva sample will be collected fromsubset of 160 participants(Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- Vaccine will be administered.
- Telephonic follow-up (1-7-days post-vaccination) for adverse event recording.
Visit 4 (Day 37±2):
- Study participants will return to the OPD for physical examination (general and systemic examination), and specific symptoms for COVID-19.
- A blood sample (5 mL) will be collected from all the participants for immunogenicity assessment.
- Subset of Study participants (Groups 2 and 4) will return to the OPD for vitals and physical examination (general and systemic examination), and specific symptoms for COVID-19.
- Additional 10 mL blood will be collected from subset of (Groups 2 and 4) participants (Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- A 5mL saliva sample will be collected from subset of (Groups 2 and 4) participants (Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
Visit 5 (Day 56+7):
- Study participants will return to the OPD for physical examination (general and systemic examination), and specific symptoms for COVID-19.
- Safety Labs: 15mL of blood will collected from half of the study population (76 from each group) to assess the safety.
- A blood sample (5 mL) will be collected from all the participants for immunogenicity assessment.
- Additional 10 mL blood will be collected from subset of 160 participants(Group1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- A 5mL saliva sample will be collected from subset of 160 participants (Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
Visit 6 (Day 90+7):
- Study participants will return to the OPD for physical examination (general and systemic examination), and specific symptoms for COVID-19.
- A blood sample (5 mL) will be collected from all the participants for immunogenicity assessment.
- Additional 10 mL blood will be collected from subset of 160 participants(Group1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- A 5mL saliva sample will be collected from subset of 160 participants(Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
Visit 7 (Day 180+7):
- Study participants will return to the OPD for physical examination (general and systemic examination), and specific symptoms for COVID-19.
- A blood sample (5 mL) will be collected from all the participants for immunogenicity assessment.
- Additional 10 mL blood will be collected from subset of 160 participants (Group1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- A 5mL saliva sample will be collected from subset of 160 participants (Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
DSMB \& report
An interim report based on the safety and immunogenicity of the vaccineswill be notified to the Data safety monitoring board and Central Drugs Standard Control Organization (CDSCO), India, for further progressing theclinical development of the vaccine. This interim report will contain a detailed analysis of the data based on the primary and secondary objectives through Day 56 (Immunogenicity \& Safety).
- Conditions
- Corona Virus Infection
- Being tested
- COVAXIN(BBV152), BBV154 Intranasal Vaccine
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVAXIN(BBV152)Biological
COVAXIN® on day 0 and on day 28 via the intramuscular route in GROUP 1. COVAXIN® (Intramuscular) on day 0 and BBV154 (Intranasal) day 28:GROUP 2
BBV154 Intranasal VaccineBiological
BBV154 (Intranasal) on day 0 and COVAXIN® (Intramuscular) on day 28: GROUP 3 BBV154 on day 0 and on day 28 via the intranasal route: GROUP 4
| Study group | Role | What they receive |
|---|---|---|
| Group 1(COVAXIN® + COVAXIN®) | Experimental | Group 1 (COVAXIN® + COVAXIN®):
In this group, 152 participants will be recruited who will receive COVAXIN® on day 0 and on day 28 via the intramuscular route Receives: Biological: COVAXIN(BBV152) |
| Group 2(COVAXIN® + BBV154) | Experimental | Group 2 (COVAXIN® + BBV154):
In this group, 152 participants will be recruited who will receive COVAXIN® (Intramuscular) on day 0 and BBV154 (Intranasal) day 28.
*Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® via intramuscular route Receives: Biological: COVAXIN(BBV152); Biological: BBV154 Intranasal Vaccine |
| Group 3(BBV154 + COVAXIN®) | Experimental | Group 3 (BBV154 + COVAXIN®):
In this group, 152 participants will be recruited who will receive BBV154 (Intranasal) on day 0 and COVAXIN® (Intramuscular) on day 28.
*Post 56 days of vaccination, participants with sero-conversion rate less than 3 folds will receive another dose of COVAXIN® via intramuscular route Receives: Biological: COVAXIN(BBV152); Biological: BBV154 Intranasal Vaccine |
| Group 4(BBV154 + BBV154) | Experimental | Group 4 (BBV154 + BBV154):
In this group, 152 participants will be recruited who will receive BBV154 on day 0 and on day 28 via the intranasal route. Receives: Biological: BBV154 Intranasal Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunogenicity
GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the four groups.
Measured: Day 0
immunogenicity
GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the four groups
Measured: Day 28+2
immunogenicity
GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the four groups.
Measured: Day56±7
immunogenicity
GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the four groups.
Measured: Day90±7
immunogenicity
GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the four groups.
Measured: Day180 ±7
Secondary outcomes (22)
reactogenicity
The occurrence of immediate adverse events
Measured: within 30 minutes post each vaccination
immediate adverse events
The occurrence of immediate adverse events
Measured: within 30 minutes post each vaccination
reactogenicity
The occurrence of solicited adverse events
Measured: within seven days of vaccination
solicited adverse events
The occurrence of solicited adverse events
Measured: within seven days of vaccination
reactogenicity
The occurrence of serious adverse events (SAEs)
Measured: throughout the study duration 7 Months
serious adverse events
The occurrence of serious adverse events (SAEs)
Measured: throughout the study duration 7 Months
reactogenicity
The occurrence of any unsolicited adverse events
Measured: Day 0 from the 1st dose vaccination
reactogenicity
The occurrence of any unsolicited adverse events
Measured: Day 9 +2
reactogenicity
The occurrence of any unsolicited adverse events
Measured: Day 28 +2
reactogenicity
The occurrence of any unsolicited adverse events
Measured: Day 37±2
reactogenicity
The occurrence of any unsolicited adverse events
Measured: Day 56+7
unsolicited adverse events
The occurrence of any unsolicited adverse events
Measured: Day 0 from the 1st dose vaccination
unsolicited adverse events
The occurrence of any unsolicited adverse events
Measured: Day 9 from the 1st dose vaccination
unsolicited adverse events
The occurrence of any unsolicited adverse events
Measured: Day 28 from the 1st dose vaccination
unsolicited adverse events
The occurrence of any unsolicited adverse events
Measured: Day 37 from the 1st dose vaccination
unsolicited adverse events
The occurrence of any unsolicited adverse events
Measured: Day 56 from the 1st dose vaccination
vaccine-induced Cell mediated immune response (Subset n=160)
Vaccine-induced cell-mediated immunogenicity and antigen-specific T-cell responses across the groups
Measured: day 9+2 (Group 1, 3 and 4)
vaccine-induced Cell mediated immune response (Subset n=160)
Vaccine-induced cell-mediated immunogenicity and antigen-specific T-cell responses across the groups
Measured: days 28+2
vaccine-induced Cell mediated immune response (Subset n=160)
Vaccine-induced cell-mediated immunogenicity and antigen-specific T-cell responses across the groups
Measured: 37±2 (Group 2 and 4)
vaccine-induced Cell mediated immune response (Subset n=160)
Vaccine-induced cell-mediated immunogenicity and antigen-specific T-cell responses across the groups
Measured: 56±7
vaccine-induced Cell mediated immune response (Subset n=160)
Vaccine-induced cell-mediated immunogenicity and antigen-specific T-cell responses across the groups
Measured: day 90±7
vaccine-induced Cell mediated immune response (Subset n=160)
Vaccine-induced cell-mediated immunogenicity and antigen-specific T-cell responses across the groups
Measured: Day 180±7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Sep 2021
- Primary completion1 Mar 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Group 1 (COVAXIN® + COVAXIN®): In this group, 152 participants will be recruited who will receive COVAXIN® on day 0 and on day 28 via the intramuscular route. Group 2 (COVAXIN® + BBV154): In this group, 152 participants will be recruited who will receive COVAXIN® (Intramuscular) on day 0 and BBV154 (Intranasal) day 28. Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® viaintramuscular route. Group 3 (BBV154 + COVAXIN®): In this group, 152 participants will be recruited who will receive BBV154 (Intranasal) on day 0 and COVAXIN® (Intramuscular) on day 28. Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® via intramuscular route. Group 4 (BBV154 + BBV154): In this group, 152 participants will be recruited who will receive BBV154 on day 0 and on day 28 via the intranasal route
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 608 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bharat Biotech International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639998
- Sponsor's protocol ID
- BBIL-BBV152/154-2021
- Acronym
- BBV152BBV154
- Status last verified
- Nov 2022
- First submitted
- 17 Aug 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized, Multi-centric of Heterologus Prime-Boost Combination of SARS-CoV-2 Vaccines to Evaluate the Immunogenicity and Safety of BBV152 (COVAXIN®) With BBV154 (Adenoviral Intranasal COVID-19 Vaccine) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05639998
- Acronym / sponsor ID
- BBV152BBV154 / BBIL-BBV152/154-2021
- Conditions
- Corona Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 608 participants (actual)
- Lead sponsor
- Bharat Biotech International LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All participants will be assessed for immunogenicity and safety endpoints and provide a blood sample before the administration of the first dose of IP. Blood samples will be collected on days 0, 9 (Groups 1, 3 and 4), 28,37 (Groups 2 and 4), 56, 90 and 180 to assess the neutralizing antibody titer against the SARSCoV-2 virus. A subset of 160 Participants (40 participants from each group) will be assessed for immunogenicity analysis, among these subset 10mL of blood and 5mL of saliva will be collected on days 0, 9 (Groups 1, 3 and 4), 28, 37 (Groups 2 and 4), 56, 90 and 180 to assess cell-mediated immunity and mucosal immunogenicity.
Group 1 (COVAXIN® + COVAXIN®): In this group, 152 participants will be recruited who will receive COVAXIN® on day 0 and on day 28 via the intramuscular route.
Group 2 (COVAXIN® + BBV154): In this group, 152 participants will be recruited who will receive COVAXIN® (Intramuscular) on day 0 and BBV154 (Intranasal) day 28.
*Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® viaintramuscular route.
Group 3 (BBV154 + COVAXIN®): In this group, 152 participants will be recruited who will receive BBV154 (Intranasal) on day 0 and COVAXIN® (Intramuscular) on day 28.
*Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® via intramuscular route.
Group 4 (BBV154 + BBV154): In this group, 152 participants will be recruited who will receive BBV154 on day 0 and on day 28 via the intranasal route.
Detailed description
A Phase 2 randomized, multi-centric, Clinical Trial of Heterologus Prime-Boost Combination of SARS-CoV-2 Vaccines to evaluate the immunogenicity and safety of BBV152 (COVAXIN®) with BBV154 (Adenoviral Intranasal COVID-19 vaccine) in Healthy Volunteers.
This is a heterologus prime boost study, designed to evaluate the immunogenicity and safety of COVAXIN® with BBV154 and vice versa, amongthe four groups. A total of 608 subjects will be enrolled in the 1:1:1:1 ratio.
Group 1 (COVAXIN® + COVAXIN®): In this group, 152 participants will be recruited who will receive COVAXIN® on day 0 and on day 28 via the intramuscular route.
Group 2 (COVAXIN® + BBV154): In this group, 152 participants will be recruited who will receive COVAXIN® (Intramuscular) on day 0 and BBV154 (Intranasal) day 28.
*Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® viaintramuscular route
Group 3 (BBV154 + COVAXIN®): In this group, 152 participants will be recruited who will receive BBV154 (Intranasal) on day 0 and COVAXIN® (Intramuscular) on day 28.
*Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® via intramuscular route.
Group 4 (BBV154 + BBV154): In this group, 152 participants will be recruited who will receive BBV154 on day 0 and on day 28 via the intranasal route.
All participants will be assessed for immunogenicity and safety endpoints and provide a blood sample before the administration of the first dose of IP. Blood samples will be collected on days 0, 9 (Groups 1, 3 and 4), 28, 37 (Groups 2 and 4),56, 90 and 180 to assess the neutralizing antibody titer against the SARS-CoV-2 virus. A subset of 160 Participants (40 participants from each group) will be assessed for cell mediated and mucosal immunogenicity analysis, among these subset 10mL of blood and 5mL of saliva will be collected on days 0, 9 (Groups 1, 3 and 4), 28, 37 (Groups 2 and 4), 56, 90 and 180 to assess cell-mediated immunity and mucosal immunogenicity.
STUDY PROCEDURE
Visit 1(Day 0)
- If the participant is eligible (in good general health or stable pre-existing disease as per the discretion of the Principal investigator), a blood sample will be withdrawn before vaccination for all the participants.
- Safety Labs: An additional 15mL of blood will collected from half of the study population (76 from each group) to assess the safety at Day 0 and 56.
- A blood sample (5 mL) will be collected from all the participants for immunogenicity assessment. A study vaccine/comparator will be administered. Following vaccination, participants will remain at the study site for at least 30 minutes of observation to record any immediate adverse event.
- Additional 10 mL blood will be collected from subset of 160 participants (Group1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- A 5mL saliva sample will be collected from subset of 160 participants (Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- Vaccine will be administered.
- Diary cards will be distributed to the participants.
- Telephonic follow-up (1-7-days post-vaccination) for adverse event recording.
Visit 2 (Day 9+2):
- Study participants will return to the OPD for physical examination (general and systemic examination), and specific symptoms for COVID-19.
- A blood sample (5 mL) will be collected from all the participants for immunogenicity assessment.
- Subset of Study participants (Group 1, 3 and 4) will return to the OPD for vitals and physical examination (general and systemic examination), and specific symptoms for COVID-19.
- Additional 10 mL blood will be collected from subset of (Groups 1, 3 and 4)participants(Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- A 5mL saliva sample will be collected from subset of (Groups 1, 3 and 4) participants(Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
Visit 3 (Day 28 +2 ):
- Study participants will return to the OPD for vitals and physical examination (general and systemic examination), and specific symptoms for COVID-19.
- A blood sample (5 mL) will be collected from all the participants for immunogenicity assessment.
- Additional 10 mL blood will be collected from subset of 160 participants(Group1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- A 5mL saliva sample will be collected fromsubset of 160 participants(Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- Vaccine will be administered.
- Telephonic follow-up (1-7-days post-vaccination) for adverse event recording.
Visit 4 (Day 37±2):
- Study participants will return to the OPD for physical examination (general and systemic examination), and specific symptoms for COVID-19.
- A blood sample (5 mL) will be collected from all the participants for immunogenicity assessment.
- Subset of Study participants (Groups 2 and 4) will return to the OPD for vitals and physical examination (general and systemic examination), and specific symptoms for COVID-19.
- Additional 10 mL blood will be collected from subset of (Groups 2 and 4) participants (Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- A 5mL saliva sample will be collected from subset of (Groups 2 and 4) participants (Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
Visit 5 (Day 56+7):
- Study participants will return to the OPD for physical examination (general and systemic examination), and specific symptoms for COVID-19.
- Safety Labs: 15mL of blood will collected from half of the study population (76 from each group) to assess the safety.
- A blood sample (5 mL) will be collected from all the participants for immunogenicity assessment.
- Additional 10 mL blood will be collected from subset of 160 participants(Group1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- A 5mL saliva sample will be collected from subset of 160 participants (Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
Visit 6 (Day 90+7):
- Study participants will return to the OPD for physical examination (general and systemic examination), and specific symptoms for COVID-19.
- A blood sample (5 mL) will be collected from all the participants for immunogenicity assessment.
- Additional 10 mL blood will be collected from subset of 160 participants(Group1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- A 5mL saliva sample will be collected from subset of 160 participants(Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
Visit 7 (Day 180+7):
- Study participants will return to the OPD for physical examination (general and systemic examination), and specific symptoms for COVID-19.
- A blood sample (5 mL) will be collected from all the participants for immunogenicity assessment.
- Additional 10 mL blood will be collected from subset of 160 participants (Group1:40, Group-2:40, Group 3: 40 and Group 4: 40).
- A 5mL saliva sample will be collected from subset of 160 participants (Group-1:40, Group-2:40, Group 3: 40 and Group 4: 40).
DSMB \& report
An interim report based on the safety and immunogenicity of the vaccineswill be notified to the Data safety monitoring board and Central Drugs Standard Control Organization (CDSCO), India, for further progressing theclinical development of the vaccine. This interim report will contain a detailed analysis of the data based on the primary and secondary objectives through Day 56 (Immunogenicity \& Safety).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Group 1 (COVAXIN® + COVAXIN®): In this group, 152 participants will be recruited who will receive COVAXIN® on day 0 and on day 28 via the intramuscular route. Group 2 (COVAXIN® + BBV154): In this group, 152 participants will be recruited who will receive COVAXIN® (Intramuscular) on day 0 and BBV154 (Intranasal) day 28. Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® viaintramuscular route. Group 3 (BBV154 + COVAXIN®): In this group, 152 participants will be recruited who will receive BBV154 (Intranasal) on day 0 and COVAXIN® (Intramuscular) on day 28. Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® via intramuscular route. Group 4 (BBV154 + BBV154): In this group, 152 participants will be recruited who will receive BBV154 on day 0 and on day 28 via the intranasal route
| Arm | Type | Receives |
|---|---|---|
| Group 1(COVAXIN® + COVAXIN®) | Experimental | Biological: COVAXIN(BBV152)Group 1 (COVAXIN® + COVAXIN®): In this group, 152 participants will be recruited who will receive COVAXIN® on day 0 and on day 28 via the intramuscular route |
| Group 2(COVAXIN® + BBV154) | Experimental | Biological: COVAXIN(BBV152), Biological: BBV154 Intranasal VaccineGroup 2 (COVAXIN® + BBV154): In this group, 152 participants will be recruited who will receive COVAXIN® (Intramuscular) on day 0 and BBV154 (Intranasal) day 28. *Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® via intramuscular route |
| Group 3(BBV154 + COVAXIN®) | Experimental | Biological: COVAXIN(BBV152), Biological: BBV154 Intranasal VaccineGroup 3 (BBV154 + COVAXIN®): In this group, 152 participants will be recruited who will receive BBV154 (Intranasal) on day 0 and COVAXIN® (Intramuscular) on day 28. *Post 56 days of vaccination, participants with sero-conversion rate less than 3 folds will receive another dose of COVAXIN® via intramuscular route |
| Group 4(BBV154 + BBV154) | Experimental | Biological: BBV154 Intranasal VaccineGroup 4 (BBV154 + BBV154): In this group, 152 participants will be recruited who will receive BBV154 on day 0 and on day 28 via the intranasal route. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ability to provide written informed consent.
- Participants of either gender, ages between 18 years <65 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 fulfil 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
Key exclusion criteria (20 listed)
- History of any other COVID-19 investigational/or licensed vaccination.
- History of cold, sneezing, nasal obstruction in the past 1 day.
- For women of childbearing potential, a 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-limited illness such as an upper respiratory infection or gastroenteritis within three days before each dose of vaccine.
- Medical problems because of alcohol or illicit drug use during the past 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVAXIN(BBV152)COVAXIN® on day 0 and on day 28 via the intramuscular route in GROUP 1. COVAXIN® (Intramuscular) on day 0 and BBV154 (Intranasal) day 28:GROUP 2 | Biological | Group 1(COVAXIN® + COVAXIN®), Group 2(COVAXIN® + BBV154), Group 3(BBV154 + COVAXIN®) |
| BBV154 Intranasal VaccineBBV154 (Intranasal) on day 0 and COVAXIN® (Intramuscular) on day 28: GROUP 3 BBV154 on day 0 and on day 28 via the intranasal route: GROUP 4 | Biological | Group 2(COVAXIN® + BBV154), Group 3(BBV154 + COVAXIN®), Group 4(BBV154 + BBV154) |
Primary outcome
immunogenicity
Time frame: Day 0
GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the four groups.
immunogenicity
Time frame: Day 28+2
GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the four groups
immunogenicity
Time frame: Day56±7
GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the four groups.
immunogenicity
Time frame: Day90±7
GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the four groups.
immunogenicity
Time frame: Day180 ±7
GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the four groups.
22 secondary outcomes
reactogenicity
Time frame: within 30 minutes post each vaccination
immediate adverse events
Time frame: within 30 minutes post each vaccination
reactogenicity
Time frame: within seven days of vaccination
solicited adverse events
Time frame: within seven days of vaccination
reactogenicity
Time frame: throughout the study duration 7 Months
serious adverse events
Time frame: throughout the study duration 7 Months
reactogenicity
Time frame: Day 0 from the 1st dose vaccination
reactogenicity
Time frame: Day 9 +2
reactogenicity
Time frame: Day 28 +2
reactogenicity
Time frame: Day 37±2
reactogenicity
Time frame: Day 56+7
unsolicited adverse events
Time frame: Day 0 from the 1st dose vaccination
unsolicited adverse events
Time frame: Day 9 from the 1st dose vaccination
unsolicited adverse events
Time frame: Day 28 from the 1st dose vaccination
unsolicited adverse events
Time frame: Day 37 from the 1st dose vaccination
unsolicited adverse events
Time frame: Day 56 from the 1st dose vaccination
vaccine-induced Cell mediated immune response (Subset n=160)
Time frame: day 9+2 (Group 1, 3 and 4)
vaccine-induced Cell mediated immune response (Subset n=160)
Time frame: days 28+2
vaccine-induced Cell mediated immune response (Subset n=160)
Time frame: 37±2 (Group 2 and 4)
vaccine-induced Cell mediated immune response (Subset n=160)
Time frame: 56±7
vaccine-induced Cell mediated immune response (Subset n=160)
Time frame: day 90±7
vaccine-induced Cell mediated immune response (Subset n=160)
Time frame: Day 180±7.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COVAXIN(BBV152) and BBV154 Intranasal Vaccine in people with Corona Virus Infection, run by Bharat Biotech International Limited at 11 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immunogenicity (time frame: Day 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.