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

August 23, 2023 updated by: Clover Biopharmaceuticals AUS Pty Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Philippines
      • Manila, Philippines
        • Manila Doctors Hospital
      • Manila, Philippines
        • Health Index Multispecialty Clinic
      • Putatan, Philippines
        • Tropical Disease Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SCB-2023 arm
Participants will receive one booster dose with SCB-2023 vaccine on Day 1
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
Active Comparator: SCB-2019 arm
Participants will receive one booster dose with SCB-2019 vaccine on Day 1
Biological: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron BA.5
Time Frame: Day 15
GMT ratio
Day 15
To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5
Time Frame: Day 15
GMT ratio
Day 15
Assess the reactogenicity of SCB-2023 vaccine compared to SCB-2019 vaccine
Time Frame: Day 7
Proportion of participants with local and systemic AEs
Day 7
Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine
Time Frame: Day 29
Proportion of participants with unsolicited AEs
Day 29
Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine
Time Frame: Up to 1 year post-vaccination
Proportion of participants with SAE, AEs leading to early termination from study, MAAEs, and AESIs
Up to 1 year post-vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Day 15
GMT ratio
Day 15
Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5.
Time Frame: Day 1, 15, 180
GMTs; GMFRs; SCRs; Proportion of participants with antibody titer ≥ LLoQ
Day 1, 15, 180
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
Time Frame: Day 1, 15, 180
GMFRs
Day 1, 15, 180
Proportion of subjects with seroconversion by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5
Time Frame: Day 1, 15, 180
SCRs
Day 1, 15, 180
Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5
Time Frame: Day 1, 15, 180
Proportion of participants with antibody titer ≥ LLoQ
Day 1, 15, 180
Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against SARS-CoV-2 variants of concern
Time Frame: Day 1, 15
GMTs
Day 1, 15
Geometric mean fold rise elicited by SCB-2023 vaccine and SCB-2019 vaccines by virus neutralization assay against SARS-CoV-2 variants of concern
Time Frame: Day 1, 15
GMFRs
Day 1, 15
Proportion of subjects with seroconversion by virus neutralization assay against SARS-CoV-2 variants of concern
Time Frame: Day 1, 15
SCRs
Day 1, 15
Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against SARS-CoV-2 variants of concern
Time Frame: Day 1, 15
Proportion of participants with antibody titer ≥ LLoQ
Day 1, 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clover Biopharmaceuticals AUS Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLO-SCB-2023-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings