Clinical trial NCT06567457: Immunogenicity and Safety Study of Monovalent Omicron XBB.1.5 Vaccine as a Booster in Adults
Official title: Phase 3, Multi-center, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Monovalent Omicron XBB.1.5 Vaccine Administered as a Booster Dose to Adults Who Previously Received COVID-19 Vaccine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: Clover Biopharmaceuticals, Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: GMT ratio
timeFrame: Day 15
measure: Assess the reactogenicity of SCB-2023B vaccine compared to SCB-2019 vaccine
timeFrame: Day 7
measure: Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine
timeFrame: Day 29
measure: Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine
timeFrame: Up to 1 year post-vaccination
Secondary outcomes:
measure: 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)
timeFrame: Day 15
measure: GMTs
timeFrame: Day 1, 15, 180
measure: GMFRs
timeFrame: Day 1, 15, 180
measure: SCRs
timeFrame: Day 1, 15, 180
measure: Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron XBB1.5
timeFrame: Day 1, 15, 180
measure: GMTs
timeFrame: Day 1, 15
measure: GMFRs
timeFrame: Day 1, 15
measure: SCRs
timeFrame: Day 1, 15
measure: Proportion of subjects with antibody titer >=LLOQ
timeFrame: Day 1, 15
Other outcomes:
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Study officials:
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