BBV152/BBV154 Heterologus Prime-Boost Study

NCT05639998 | Completed Phase 2 DMC

• 1 other identifier: BBIL-BBV152/154-2021
• Study Type: interventional
• Target: 608
• Locations: 1 country
• Sites: 11

Brief 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 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.

Conditions

Corona Virus Infection

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (22)

• reactogenicity

  within 30 minutes post each vaccination

• immediate adverse events

  within 30 minutes post each vaccination

• reactogenicity

  within seven days of vaccination

• solicited adverse events

  within seven days of vaccination

• reactogenicity

  throughout the study duration 7 Months

Study Arms (4)

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

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

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

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.

Biological: BBV154 Intranasal Vaccine

Interventions

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

Group 1(COVAXIN® + COVAXIN®); Group 2(COVAXIN® + BBV154); Group 3(BBV154 + COVAXIN®)

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

Group 2(COVAXIN® + BBV154); Group 3(BBV154 + COVAXIN®); Group 4(BBV154 + BBV154)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Bharat Biotech International Limited: lead

Study Sites (11)

The INCLEN Trust International/Guru Nanak Hospital

Gurgaon, Haryana, India

Location

JSS Medical College & Hospital

Mysore, Karnataka, India

Location

Gillurkur Multispeciality Hospital

Nagpur, Maharashtra, India

Location

All India Institute of Medical Scienecs

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Institute of Medical Sciences and SUM Hospital,Odisha

Bhubaneswar, Odisha, India

Location

Malla Reddy Narayana Multispeciality Hospital

Hyderabad, Telangana, 500010, India

Location

Gleneagles Global Hospitals,Hyderabad

Hyderabad, Telangana, India

Location

St Theresas Hospital

Hyderabad, Telangana, India

Location

Prakhar Hospital Pvt Limited

Kanpur, Uttar Pradesh, India

Location

The Medicity Hopsital

Rudrapur, Uttarakhand, India

Location

Institute of Liver and Biliary Sciences,New Delhi

Delhi, India

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

BBV152 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: December 7, 2022
• Study Start: September 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: July 31, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-11

Locations

IN (11)