Phase 3 Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose

NCT05567471 | Completed Phase 3

• 1 other identifier: BBIL/Booster/2021 Hetero
• Study Type: interventional
• Target: 875
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

COVID-19 Respiratory Infection

Outcome Measures

Primary Outcomes (3)

• Geometric mean titres 1

  Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.

  baseline

• Geometric mean titres 2

  Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.

  Day 28+2

• Geometric mean titres 3

  Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.

  Day 56 ± 7

Secondary Outcomes (9)

• Geometric mean titres 4

  Day 28+2

• Geometric mean titres 5

  Day 56 ± 7

• Cell mediated immune response

  Day 28+2

• Cell mediated immune response

  Day 56 ± 7

• Geometric mean titres

  Day 28+2

Study Arms (5)

Group 1(BBV154 in COVAXIN recipients)

ACTIVE COMPARATOR

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.

Biological: BBV154 Intranasal Vaccine

Group 2 (COVAXIN in COVAXIN recipients)

ACTIVE COMPARATOR

125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVAXIN.

Biological: Intramuscular vaccine COVAXIN

Group 3 (BBV154 in COVISHIELD recipients)

ACTIVE COMPARATOR

250 participants will be recruited and administered with a booster dose of BBV154 vaccine, in individuals previously vaccinated with COVISHIELD.

Biological: BBV154 Intranasal Vaccine

Group 4(COVAXIN in COVISHIELD recipients)

ACTIVE COMPARATOR

125 participants will be recruited and administered with a booster dose of BBV152 (COVAXIN) vaccine, in individuals previously vaccinated with COVISHIELD.

Biological: Intramuscular vaccine COVAXIN

Group 5 (COVISHIELD in COVISHIELD recipients)

ACTIVE COMPARATOR

125 participants will be recruited and administered with a booster dose of Covishield vaccine, in individuals previously vaccinated with COVISHIELD.

Biological: Covishield

Interventions

BBV154 Intranasal Vaccine BIOLOGICAL

Administered BBV154 vaccine in form of drops (0.5 mL) via intranasal route

Group 1(BBV154 in COVAXIN recipients); Group 3 (BBV154 in COVISHIELD recipients)

Intramuscular vaccine COVAXIN BIOLOGICAL

Administered BBV152 vaccine via intramuscular route

Group 2 (COVAXIN in COVAXIN recipients); Group 4(COVAXIN in COVISHIELD recipients)

Covishield BIOLOGICAL

Administered vaccine via intramuscular route

Group 5 (COVISHIELD in COVISHIELD recipients)

Eligibility Criteria

• Age: 18 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 of age ≥18 years.
• 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).
• Expressed interest and availability to fulfill 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 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:

• Known history of COVID-19 infection.
• 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).
• 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.
• 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 prior to vaccination in this study.
• 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.
• 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 in relation to vaccination.
• History of any cancer.
• History of severe psychiatric 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 venepuncture).
• Any other serious chronic illness requiring immediate hospital specialist supervision.

Sponsors & Collaborators

• Bharat Biotech International Limited: lead

Study Sites (9)

All India Institute of Medical Sciences

Patna, Bihar, 801507, India

Location

ESIC Medical College and Hospital

Faridabad, Haryana, 121001, India

Location

Vagus Super Specilaity Hospitals

Bangalore, Karnataka, 560003, India

Location

Jeevan Rekha Hospital

Belagavi, Karnataka, 590002, India

Location

Gillurkar Multispeciality Hopistal

Nagpur, Maharashtra, 440009, India

Location

St. Theresa Hospital

Hyderabad, Telangana, 500018, India

Location

Rana Hospital Pvt Ltd

Gorakhpur, Uttar Pradesh, 273001, India

Location

Prakhar Hospital Pvt Ltd

Kanpur, Uttar Pradesh, 208002, India

Location

AIIMS, New Delhi

New Delhi, 110029, India

Location

MeSH Terms

Interventions

ChAdOx1 nCoV-19

Intervention Hierarchy (Ancestors)

Vaccines, DNA; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines

Study Officials

• Dr. Sanjay Rai, MBBS,MD

  AIIMS, New Delhi

  PRINCIPAL INVESTIGATOR

• Dr Chandramani Singh, MBBS,MD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Dr Anil Kumar Pandey, MBBS,MD

  ESIC Medical College and Hospital Faridabad

  PRINCIPAL INVESTIGATOR

• Dr Chandrashekhar S Gillurkar, MBBS,MD

  Gillurkar Multispeciality Hopistal

  PRINCIPAL INVESTIGATOR

• Dr Amit Suresh Bhate, MBBS,MD

  Jeevan Rekha Hospital

  PRINCIPAL INVESTIGATOR

• Dr Jitendra Singh Kushwaha, MBBS,MD

  Prakhar Hospital Pvt Ltd

  PRINCIPAL INVESTIGATOR

• Dr Shivaraj K K, MBBS,MD

  Vagus Super Specilaity Hospitals

  PRINCIPAL INVESTIGATOR

• Dr A Venkateshwar Rao, MBBS,MD

  St. Theresa Hospital

  PRINCIPAL INVESTIGATOR

• Dr Ajeet Pratap Singh, MBBS,MD

  Rana Hospital Pvt Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 5, 2022
• Study Start: February 26, 2022
• Primary Completion: May 3, 2022
• Study Completion: September 28, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

IN (9)