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Immunogenicity and Safety Study of SCB-2023 Vaccine as a Booster in Adults

Primary Purpose

COVID-19

Status
Withdrawn
Phase
Phase 3
Locations
Philippines
Study Type
Interventional
Intervention
SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Sponsored by
Clover Biopharmaceuticals AUS Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Health Index Multispecialty Clinic
  • Manila Doctors Hospital
  • Tropical Disease Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SCB-2023 arm

SCB-2019 arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron BA.5
GMT ratio
To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5
GMT ratio
Assess the reactogenicity of SCB-2023 vaccine compared to SCB-2019 vaccine
Proportion of participants with local and systemic AEs
Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine
Proportion of participants with unsolicited AEs
Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine
Proportion of participants with SAE, AEs leading to early termination from study, MAAEs, and AESIs

Secondary Outcome Measures

Non-inferiority with respect to ratio of the geometric mean of Omicron BA.5 titer in SCB-2023 recipients and SARS-CoV-2 Delta titers in SCB-2019 recipients, as measured by virus neutralization assay.
GMT ratio
Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5.
GMTs; GMFRs; SCRs; Proportion of participants with antibody titer ≥ LLoQ
Geometric mean fold rise elicited by SCB-2023 vaccine and SCB-2019 vaccines by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5
GMFRs
Proportion of subjects with seroconversion by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5
SCRs
Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5
Proportion of participants with antibody titer ≥ LLoQ
Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against SARS-CoV-2 variants of concern
GMTs
Geometric mean fold rise elicited by SCB-2023 vaccine and SCB-2019 vaccines by virus neutralization assay against SARS-CoV-2 variants of concern
GMFRs
Proportion of subjects with seroconversion by virus neutralization assay against SARS-CoV-2 variants of concern
SCRs
Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against SARS-CoV-2 variants of concern
Proportion of participants with antibody titer ≥ LLoQ

Full Information

First Posted
June 8, 2023
Last Updated
August 23, 2023
Sponsor
Clover Biopharmaceuticals AUS Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05926440
Brief Title
Immunogenicity and Safety Study of SCB-2023 Vaccine as a Booster in Adults
Official Title
Phase 3, Multi-center, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of SCB-2023 Vaccine Administered as a Booster Dose to Adults Who Previously Received COVID-19 Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
we has selected a new candidate vaccine which is monovalent.
Study Start Date
August 17, 2023 (Actual)
Primary Completion Date
August 17, 2023 (Actual)
Study Completion Date
August 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clover Biopharmaceuticals AUS Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCB-2023 arm
Arm Type
Experimental
Arm Description
Participants will receive one booster dose with SCB-2023 vaccine on Day 1
Arm Title
SCB-2019 arm
Arm Type
Active Comparator
Arm Description
Participants will receive one booster dose with SCB-2019 vaccine on Day 1
Intervention Type
Biological
Intervention Name(s)
SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Intervention Description
SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Intervention Type
Biological
Intervention Name(s)
SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Intervention Description
SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Primary Outcome Measure Information:
Title
To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron BA.5
Description
GMT ratio
Time Frame
Day 15
Title
To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5
Description
GMT ratio
Time Frame
Day 15
Title
Assess the reactogenicity of SCB-2023 vaccine compared to SCB-2019 vaccine
Description
Proportion of participants with local and systemic AEs
Time Frame
Day 7
Title
Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine
Description
Proportion of participants with unsolicited AEs
Time Frame
Day 29
Title
Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine
Description
Proportion of participants with SAE, AEs leading to early termination from study, MAAEs, and AESIs
Time Frame
Up to 1 year post-vaccination
Secondary Outcome Measure Information:
Title
Non-inferiority with respect to ratio of the geometric mean of Omicron BA.5 titer in SCB-2023 recipients and SARS-CoV-2 Delta titers in SCB-2019 recipients, as measured by virus neutralization assay.
Description
GMT ratio
Time Frame
Day 15
Title
Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5.
Description
GMTs; GMFRs; SCRs; Proportion of participants with antibody titer ≥ LLoQ
Time Frame
Day 1, 15, 180
Title
Geometric mean fold rise elicited by SCB-2023 vaccine and SCB-2019 vaccines by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5
Description
GMFRs
Time Frame
Day 1, 15, 180
Title
Proportion of subjects with seroconversion by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5
Description
SCRs
Time Frame
Day 1, 15, 180
Title
Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5
Description
Proportion of participants with antibody titer ≥ LLoQ
Time Frame
Day 1, 15, 180
Title
Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against SARS-CoV-2 variants of concern
Description
GMTs
Time Frame
Day 1, 15
Title
Geometric mean fold rise elicited by SCB-2023 vaccine and SCB-2019 vaccines by virus neutralization assay against SARS-CoV-2 variants of concern
Description
GMFRs
Time Frame
Day 1, 15
Title
Proportion of subjects with seroconversion by virus neutralization assay against SARS-CoV-2 variants of concern
Description
SCRs
Time Frame
Day 1, 15
Title
Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against SARS-CoV-2 variants of concern
Description
Proportion of participants with antibody titer ≥ LLoQ
Time Frame
Day 1, 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Health Index Multispecialty Clinic
City
Manila
Country
Philippines
Facility Name
Manila Doctors Hospital
City
Manila
Country
Philippines
Facility Name
Tropical Disease Foundation
City
Putatan
Country
Philippines

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity and Safety Study of SCB-2023 Vaccine as a Booster in Adults

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