Phase III Study of BBV154 Intranasal Vaccine in Healthy Volunteers

NCT05522335 | Unknown Phase 3 DMC

• 1 other identifier: BBIL/BBV154-III/2022
• Study Type: interventional
• Target: 3,160
• Locations: 1 country
• Sites: 14

Brief Summary

Group 1 (BBV154): In this group, 3000 participants will be recruited, randomized in 1:1:1 ratio receive 3 consecutive lots (Lot 1: 1000, Lot 2: 1000, Lot 3: 1000) of the BBV154 vaccine (0.5 mL each dose) on day 0 and day 28 via intranasal route. Group 2 (COVAXIN®): In this group, 160 participants will be recruited and administered with COVAXIN® vaccine on day 0 and on day 28 via intramuscular route. A total sample size of 3160 healthy volunteer's age's ≥18 years will be recruited in this study. BBV154-Subjects- Part 1 ( Immunogenicity Group)- First 640 Subjects BBV154-Subjects- Part 2 ( Safety Group)- (Remaining 2520 subjects) Visit 1: Baseline (Day 0) Visit 2 (Day 28+2) Visit 3 (Day 42 ± 7 days) Visit 4 (Day 90 ± 7 days) and Visit 5 (Day 180± 7 days)

Conditions

COVID-19 Respiratory Infection

Outcome Measures

Primary Outcomes (7)

• Geometric mean titres (GMTs

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

  baseline

• Geometric mean titres (GMTs

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

  Day 28+2

• Geometric mean titres (GMTs)

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

  Day 42±7

• Geometric mean titres (GMTs)

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

  Day 90±7

• Geometric mean titres (GMTs)

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

  Day 180±7.

• solicited adverse events

  The occurrence of solicited adverse events within seven days of vaccination

  7days

• unsolicited adverse events

  The occurrence of any unsolicited adverse events up to day 180 from 1st dose vaccination.

  day 180

Secondary Outcomes (10)

• Geometric mean titers (GMTs)

  baseline

• Geometric mean titers (GMTs)

  Day 28+2

• Geometric mean titers (GMTs)

  Day 42±7

• Geometric mean titers (GMTs)

  Day 90±7

• Geometric mean titers (GMTs)

  Day 180±7

Study Arms (4)

BBV154 Lot-1

ACTIVE COMPARATOR

Safety Group : In this group, 1000 participants will be recruited, receive BBV154 vaccine (0.5 mL each dose) on day 0 and day 28 via intranasal route and assess for the safety.

Biological: BBV154(Intranasal) & covaxin

BBV154 Lot-2

ACTIVE COMPARATOR

Safety Group : In this group, 1000 participants will be recruited, receive BBV154 vaccine (0.5 mL each dose) on day 0 and day 28 via intranasal route and assess for the safety.

Biological: BBV154(Intranasal) & covaxin

BBV154 Lot-3

ACTIVE COMPARATOR

Safety Group : In this group, 1000 participants will be recruited, receive BBV154 vaccine (0.5 mL each dose) on day 0 and day 28 via intranasal route and assess for the safety.

Biological: BBV154(Intranasal) & covaxin

COVAXIN®

ACTIVE COMPARATOR

Immunogenicity Group :In this group, 160 participants will be recruited, receive Covaxin vaccine (0.5 mL each dose) on day 0 and day 28 via intramuscular route and assess for the Immunogenicity.

Biological: BBV154(Intranasal) & covaxin

Interventions

BBV154(Intranasal) & covaxin BIOLOGICAL

Intervention Covaxin

BBV154 Lot-1; BBV154 Lot-2; BBV154 Lot-3; COVAXIN®

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.
• 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 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 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 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 (serum) for future research.

You may not qualify if:

• History of any other COVID-19 investigational/or licensed vaccination.
• 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 each dose 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 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 (other than Covid-19 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.
• Immunosuppressant 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 (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 (14)

VIMS (Visakha Institute of Medical Sciences)

Vizag, Andhrapradesh, 530040, India

Location

AIIMS (All India Institute of Medical Sciences)

Patna, Bihar, 801507, India

Location

Redkar Hospital and Research center

Dargalim, Goa, 403513, India

Location

Aatman Hospital, Ahmedabad

Ahmedabad, Gujarat, 380058, India

Location

PGIMS (Pt. BD Sharma Postgraduate Institute of Medical Sciences)

Rohtak, Haryana, 124001, India

Location

Jeevan Rekha Hospital, Belgaum

Belagavi, Karnataka, 590002, India

Location

Rajarajeshwari Medical College and Hospital

Kambīpura, Karnataka, 560074, India

Location

Oyster and Pearl Hospitals (Phadnis Clinic Pvt Ltd)

Pune, Maharashtra, 411005, India

Location

Acharya Vinobha Bhave Rural Hospital

Wardha, Maharashtra, 442004, India

Location

Maharaja Agrasen super specality Hospital, Jaipur

Jaipur, Rajasthan, 302039, India

Location

Malla Reddy Narayana Multi Speciality Hospital

Hyderabad, Telangana, 500015, India

Location

NIMS (Nizam's Institute of Medical Sciences

Hyderabad, Telangana, 500082, India

Location

Rana Hospital

Gorakhpur, Uttar Pradesh, 273001, India

Location

Prakhar Hospital

Kanpur, Uttar Pradesh, 208002, India

Location

Related Publications (2)

• Singh C, Verma S, Reddy P, Diamond MS, Curiel DT, Patel C, Jain MK, Redkar SV, Bhate AS, Gundappa V, Konatham R, Toppo L, Joshi AC, Kushwaha JS, Singh AP, Bawankule S, Ella R, Prasad S, Ganneru B, Chiteti SR, Kataram S, Vadrevu KM. Phase III Pivotal comparative clinical trial of intranasal (iNCOVACC) and intramuscular COVID 19 vaccine (Covaxin(R)). NPJ Vaccines. 2023 Aug 18;8(1):125. doi: 10.1038/s41541-023-00717-8.

  PMID: 37596281 DERIVED

• Nakahashi-Ouchida R, Fujihashi K, Kurashima Y, Yuki Y, Kiyono H. Nasal vaccines: solutions for respiratory infectious diseases. Trends Mol Med. 2023 Feb;29(2):124-140. doi: 10.1016/j.molmed.2022.10.009. Epub 2022 Nov 23.

  PMID: 36435633 DERIVED

MeSH Terms

Interventions

BBV152 COVID-19 vaccine

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: August 13, 2022
• First Posted: August 31, 2022
• Study Start: April 16, 2022
• Primary Completion: July 19, 2022
• Study Completion: February 28, 2023
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

IN (14)