Immuno-bridging and Broadening Study of a Whole, Inactivated COVID-19 Vaccine BBV152 in Healthy Adults

NCT05258669 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: OCU-002
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 10

Brief Summary

A randomized, observer-blind, placebo-controlled immuno-bridging, and broadening study to demonstrate the equivalence of the immune response between participants enrolled in Phase 3 efficacy trial in India and demographically diverse healthy adult participants in the US which matched in age and vaccine formulation setting to whom those efficacy results are extrapolated; and to assess the broadening of the BBV152 in participants who previously received two shots of messenger ribonucleic acid (mRNA) COVID-19 vaccine at least 6 months earlier or one-shots of viral vector J\&J/Janssen COVID-19 vaccine at least 2 months earlier. Safety and tolerability evaluation is a secondary endpoint.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Compare immune response measured by serum neutralizing antibodies against Wild-Type SARS-CoV-2 in US-based participants and age-matched controls participants who participated in the Phase 3 efficacy trial in India.

  Serum neutralizing antibodies against Wild-Type SARS-CoV-2 will be measured by Microneutralization Test (MNT) assay.

  Vaccination days (Day 0 and Day 28), Day 56 and Day 84

Secondary Outcomes (11)

• Evaluate the change over time in immunogenicity of two doses of BBV152 measured by MNT neutralizing antibodies.

  Day0, Day 28, Day 56 and Day 84

• Evaluate the immunogenicity of two doses of BBV152 measured by MNT neutralizing antibodies.

  Day 0, Day 28, Day 56 and Day 84

• Evaluate the serious adverse events (SAEs)

  1 year

• Evaluate response rate of anti-SARS-CoV-2 IgG antibody seroconversion from negative to positive following 28 days of BBV152 administration

  Day 0, Day 28, Day 56 and Day 84

• Evaluate the immunogenicity of the single dose of BBV152.

  Day 0, Day 28, Day 56 and Day 84

Other Outcomes (2)

• Explore cell based immune response in a subset of participants following 28 days of the second dose of BBV152 administration

  D0 and Day 56

• Explore the immunogenicity of one and two doses of BBV152 against future variants of concern.

  Day0, D28, and Day 56

Study Arms (2)

BBV152

ACTIVE COMPARATOR

BBV152

Biological: BBV152

Placebo

PLACEBO COMPARATOR

0.9% normal saline

Biological: BBV152

Interventions

BBV152 BIOLOGICAL

Each participant will receive 2 doses of the investigational product intramuscular injection of either 6 μg of BBV15 vaccine or placebo.

Also known as: Covaxin

BBV152; Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female participants ≥ 18 years of age at the time of informed consent.
• The participant is capable of providing signed informed consent.
• The participants who consent, are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations, and other study procedures.
• Have negative the Cue™ SARS-CoV-2 Test of anterior nasal specimens.
• Participants must have received two documented doses of mRNA vaccine a minimum of 180 days from their last dose prior to enrollment or One documented dose of viral vector J\&J/Janssen COVID-19 vaccine a minimum 60 days from their dose prior to enrollment, or A documented dose of the booster shot of the mRNA COVID-19 vaccine (Comirnaty or Spikevax) a minimum of 150 days from their last dose prior to enrollment, or No vaccination history of COVID-19 vaccine and no history of COVID-19 disease (self-report, on-site inquiry).
• The participant must agree not to take the influenza vaccine until 30 days after the second dose of vaccination and not take any other vaccines for the entire duration of the study.
• Participants must be in relatively stable health based on the site Investigator's judgment, as determined by medical history, physical examination, and the following criteria:
• Stable health for age (defined as no new conditions per medical history, new medications in a different therapeutic class, or change in a daily dose of existing prescription medications within the 45 days preceding Screening).
• Participants may be on chronic or as-needed medications if, in the opinion of the Investigator, these pose no additional risk to participant safety or assessment of reactogenicity, and immunogenicity and their use is not for management of a worsening of medical diagnosis or condition.
• Participants are expected to be available for the duration of the study and can be contacted by telephone during study participation.
• Have a non-clinically significant 12-lead ECG
• Participants must be healthy based on clinical laboratory tests performed at screening.
• Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
• Has a negative urine pregnancy test at Screening and prior to each study dose
• Has agreed to continue adequate contraception through 3 months following the second dose of the IP

You may not qualify if:

• History of COVID-19 disease (self-report, on-site inquiry).
• Presence of fever or other acute illness at the time of enrollment. Fever is defined as an oral temperature ≥ 38.0°C/100.4°F.
• History or current clinically significant cardiac disease, such as myocarditis, pericarditis, ventricular arrhythmia requiring therapy, uncontrolled hypertension, or any history of symptomatic congestive heart failure (CHF).
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s).
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• History of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus (e.g., rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythematosus)
• Has bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate intramuscular injection.
• Receipt of treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (equivalent to prednisone ≥ 10mg/day for the duration of ≥ two weeks), e.g., for cancer or an autoimmune disease, or planned receipt throughout the study period. If systemic corticosteroids have been administered short-term (\<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days (about 4 weeks) before study intervention administration.
• Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days (about 2 months) before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 days (about 3 months) before study intervention administration or planned receipt throughout the study.
• Has participated in an interventional clinical trial within the 4 weeks prior to randomization.
• Known sensitivity to any components of the study vaccine.
• The participant has received the influenza vaccine within 14 days prior to enrollment and any other vaccine within 28 days prior to randomization.
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IP.
• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody. Participants who have been effectively treated for hepatitis C, as evidenced by a negative hepatitis C ribonucleic acid (RNA) confirmation test and who no longer require antiviral therapy, are eligible for participation.
• Donated blood products within the 4 weeks prior to randomization.

Sponsors & Collaborators

• Ocugen: lead

Study Sites (10)

Voyage Medical

Tempe, Arizona, 85282, United States

RECRUITING

Angels Clinical Institute

Miami, Florida, 33122, United States

RECRUITING

Suncoast Research Group LLC

Miami, Florida, 33135, United States

RECRUITING

Palm Springs Community Health Center

Miami Lakes, Florida, 33016, United States

RECRUITING

Clinical Site Partners

Winter Park, Florida, 332789, United States

RECRUITING

IACT Health

Columbus, Georgia, 31904, United States

RECRUITING

Jay Meyer Meridian Research

Lincoln, Nebraska, 68510, United States

RECRUITING

PRX Research

Dallas, Texas, 75149, United States

RECRUITING

Wellness Clinical Research

McKinney, Texas, 75071, United States

RECRUITING

Meridian Research 3235 Academy Ave

Portsmouth, Virginia, 237803, United States

RECRUITING

Related Links

• Non-Human Primate Efficacy Study Immunogenicity and protective efficacy of inactivated SARS-CoV-2 vaccine candidate, BBV152 in rhesus macaques
• Neutralization of Brazil variant of concern P2 (B.1.1.28) Neutralization of B.1.1.28 P2 variant with sera of natural SARS-CoV-2 infection and recipients of BBV152 vaccine

MeSH Terms

Conditions

COVID-19

Interventions

BBV152 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Huma Qamar, MD, MPH, CMI

  Ocugen

  STUDY DIRECTOR

Central Study Contacts

Alice Cousens, RN,MBA

CONTACT

4844338665; Alice.Cousens@ocugen.com

Roshan George, MD, MPH

CONTACT

(845) 664-1505; roshan.george@ocugen.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An unblinded pharmacist or another qualified individual will prepare and provide the syringe in a blinded manner to the study vaccine administrator (a trained and qualified study nurse, medical doctor, or otherwise qualified health care professional) who will perform the injection.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 randomization ratio

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: February 28, 2022
• Study Start: February 20, 2022
• Primary Completion: September 1, 2023
• Study Completion: October 31, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)