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

NCT ID: NCT06567457

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2024-10-31

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.

Detailed Description

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

SCB-2019

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BIOLOGICAL

intramuscular injection

SCB-2023B

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

intramuscular injection

Interventions

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

intramuscular injection

Intervention Type: BIOLOGICAL

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

intramuscular injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clover Biopharmaceuticals AUS Pty

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CLO-SCB-2023B-002

Identifier Type: -

Identifier Source: org_study_id