Immunogenicity and Safety Study of Monovalent Omicron XBB.1.5 Vaccine as a Booster in Adults

NCT06567457 | Withdrawn Phase 3 DMC

• 1 other identifier: CLO-SCB-2023B-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the immunogenicity and safety of SCB-2023B monovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

• GMT ratio

  Demonstrate that SCB-2023B vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5

  Day 15

• Assess the reactogenicity of SCB-2023B vaccine compared to SCB-2019 vaccine

  Proportion of participants with local and systemic AEs

  Day 7

• Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine

  Proportion of participants with unsolicited AEs

  Day 29

• Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine

  Proportion of participants with SAE, AEs leading to early termination from study, MAAEs, and AESIs

  Up to 1 year post-vaccination

Secondary Outcomes (9)

• Non-inferiority of the Omicron XBB.1.5 immune response elicited by SCB-2023B vaccine versus SARS-CoV-2 Delta titers in a subset of naïve participants of the CLO-SCB-2019-003 clinical study (virus neutralization assay)

  Day 15

• GMTs

  Day 1, 15, 180

• GMFRs

  Day 1, 15, 180

• SCRs

  Day 1, 15, 180

• Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron XBB1.5

  Day 1, 15, 180

Study Arms (2)

SCB-2023B

EXPERIMENTAL

Participants will receive one booster dose with SCB-2023B vaccine on Day 1

Biological: SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19

SCB-2019

ACTIVE COMPARATOR

Participants will receive one booster dose with SCB-2019 vaccine on Day 1

Biological: SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19

Interventions

SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19 BIOLOGICAL

intramuscular injection

SCB-2023B

SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19 BIOLOGICAL

intramuscular injection

SCB-2019

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 ≥18 years of age.
• Individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.
• Individuals willing and able to give an informed consent, prior to screening.
• Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.
• Individuals who received three doses of inactivated COVID-19 vaccine

You may not qualify if:

• Body temperature \>37.8°C (axillary), or any acute illness at baseline.
• Confirmed SARS-CoV-2 infectionor with known history of COVID-19.
• Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for inactivated COVID-19 vaccine).
• Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
• Any progressive unstable or uncontrolled clinical conditions.
• Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period.
• History of severe adverse reaction associated with a vaccine or severe allergic reaction.
• History of malignancy within 1 year before screening.
• Individuals who have received any other investigational product.
• Individuals who have received any other licensed vaccines within 14 days prior to enrollment.
• Treatment with Rituximab or any other anti-CD20 monoclonal antibodies.
• Known bleeding disorder that would, in the opinion of the investigator, contraindicate i.m. injection.
• Administration of intravenous immunoglobulins and/or any blood products.
• Any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant.

Sponsors & Collaborators

• Clover Biopharmaceuticals AUS Pty: lead

MeSH Terms

Conditions

COVID-19

Interventions

SCB-2019 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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 22, 2024
• Study Start: October 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08