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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.
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)
Visit 2 (Day 9+2):
Visit 3 (Day 28 +2 ):
Visit 4 (Day 37±2):
Visit 5 (Day 56+7):
Visit 6 (Day 90+7):
Visit 7 (Day 180+7):
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| immunogenicity | GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the four groups. | Day 0 |
| immunogenicity | GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the four groups | Day 28+2 |
| immunogenicity | GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the four groups. | Day56±7 |
| immunogenicity | GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the four groups. | Day90±7 |
| immunogenicity | GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb's) by MNT/PRNT assays across the four groups. | Day180 ±7 |
| Measure | Description | Time Frame |
|---|---|---|
| reactogenicity | The occurrence of immediate adverse events | within 30 minutes post each vaccination |
| immediate adverse events | The occurrence of immediate adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The INCLEN Trust International/Guru Nanak Hospital | Gurgaon | Haryana | India | |||
| JSS Medical College & Hospital |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C000722386 | BBV152 COVID-19 vaccine |
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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
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| BBV154 Intranasal Vaccine | Biological | 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 |
|
| within 30 minutes post each vaccination |
| reactogenicity | The occurrence of solicited adverse events | within seven days of vaccination |
| solicited adverse events | The occurrence of solicited adverse events | within seven days of vaccination |
| reactogenicity | The occurrence of serious adverse events (SAEs) | throughout the study duration 7 Months |
| serious adverse events | The occurrence of serious adverse events (SAEs) | throughout the study duration 7 Months |
| reactogenicity | The occurrence of any unsolicited adverse events | Day 0 from the 1st dose vaccination |
| reactogenicity | The occurrence of any unsolicited adverse events | Day 9 +2 |
| reactogenicity | The occurrence of any unsolicited adverse events | Day 28 +2 |
| reactogenicity | The occurrence of any unsolicited adverse events | Day 37±2 |
| reactogenicity | The occurrence of any unsolicited adverse events | Day 56+7 |
| unsolicited adverse events | The occurrence of any unsolicited adverse events | Day 0 from the 1st dose vaccination |
| unsolicited adverse events | The occurrence of any unsolicited adverse events | Day 9 from the 1st dose vaccination |
| unsolicited adverse events | The occurrence of any unsolicited adverse events | Day 28 from the 1st dose vaccination |
| unsolicited adverse events | The occurrence of any unsolicited adverse events | Day 37 from the 1st dose vaccination |
| unsolicited adverse events | The occurrence of any unsolicited adverse events | 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 | 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 | 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 | 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 | 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 | 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 | Day 180±7. |
| Mysore |
| Karnataka |
| India |
| Gillurkur Multispeciality Hospital | Nagpur | Maharashtra | India |
| All India Institute of Medical Scienecs | New Delhi | National Capital Territory of Delhi | 110029 | India |
| Institute of Medical Sciences and SUM Hospital,Odisha | Bhubaneswar | Odisha | India |
| Malla Reddy Narayana Multispeciality Hospital | Hyderabad | Telangana | 500010 | India |
| Gleneagles Global Hospitals,Hyderabad | Hyderabad | Telangana | India |
| St Theresas Hospital | Hyderabad | Telangana | India |
| Prakhar Hospital Pvt Limited | Kanpur | Uttar Pradesh | India |
| The Medicity Hopsital | Rudrapur | Uttarakhand | India |
| Institute of Liver and Biliary Sciences,New Delhi | Delhi | India |
| D007239 |
| Infections |