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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05926440
• Other study ID #: CLO-SCB-2023-002
• Status: Withdrawn
• Phase: Phase 3
• Start date: August 17, 2023
• Est. completion date: August 17, 2023

Study information

• Verified date: August 2023
• Source: Clover Biopharmaceuticals AUS Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 17, 2023
• Est. primary completion date: August 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
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
SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection

Locations

Country	Name	City	State
Philippines	Health Index Multispecialty Clinic	Manila
Philippines	Manila Doctors Hospital	Manila
Philippines	Tropical Disease Foundation	Putatan

Sponsors (1)

Lead Sponsor	Collaborator
Clover Biopharmaceuticals AUS Pty Ltd

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron BA.5	GMT ratio	Day 15
Primary	To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5	GMT ratio	Day 15
Primary	Assess the reactogenicity of SCB-2023 vaccine compared to SCB-2019 vaccine	Proportion of participants with local and systemic AEs	Day 7
Primary	Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine	Proportion of participants with unsolicited AEs	Day 29
Primary	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	Up to 1 year post-vaccination
Secondary	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	Day 15
Secondary	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	Day 1, 15, 180
Secondary	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	Day 1, 15, 180
Secondary	Proportion of subjects with seroconversion by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5	SCRs	Day 1, 15, 180
Secondary	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	Day 1, 15, 180
Secondary	Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against SARS-CoV-2 variants of concern	GMTs	Day 1, 15
Secondary	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	Day 1, 15
Secondary	Proportion of subjects with seroconversion by virus neutralization assay against SARS-CoV-2 variants of concern	SCRs	Day 1, 15
Secondary	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	Day 1, 15