Immunogenicity and Safety Study of SCB-2019 Vaccine as a Booster to COVID-19 Vaccine in Adults

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

A Multi-center, Observer-blind, Randomized, Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019), Administered as a Booster Dose to Adults, Who Previously Received Primary Series of a COVID-19 Vaccine

The purpose of this study is to assess the immunogenicity and safety of the investigational SCB-2019 vaccine, administered as a booster dose, to adults who:

  • Received primary series with one of the selected authorized or investigational COVID-19 vaccines at least 3 months prior to enrollment.
  • Received primary series and a booster dose of CoronaVac at least 3 months prior to enrollment.

Study Overview

Status

Status

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

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1831

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 Locations

  • Philippines
    • Metro Manila
      • Las Piñas, Metro Manila, Philippines, 1741
        • Las Piñas Doctors Hospital
      • Manila, Metro Manila, Philippines, 1000
        • Manila Doctors Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male and female participants at least 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 primary vaccination series with one of the selected COVID-19 vaccines (Comirnaty, Vaxzevria, or CoronaVac) ≥3 months prior to enrollment; or received primary series and a booster dose (≥3 months after primary series) of CoronaVac, ≥3 months prior to enrollment.

Exclusion Criteria:

  • Individuals with fever >37.5°C (axillary), or any acute illness at baseline (Day 1) or within 3 days prior to randomization;
  • Individuals with laboratory-confirmed SARS-CoV-2 infection at Visit 1 (determined by positive Rapid Antigen Test or RT-PCR);
  • Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for primary series with Comirnaty, Vaxzevria, CoronaVac vaccines, or primary and booster dose of CoronaVac), or plan to receive COVID-19 vaccine during the study period;
  • Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines;
  • Individuals who have received any other investigational product within 30 days prior to Day 1 or intend to participate in another clinical study at any time during the conduct of this study.

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: Group 1a (primary series: Comirnaty)
participants will receive one dose of SCB-2019 vaccine on Day 1
Biological: Candidate vaccine, SCB-2019
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Active Comparator: Group 1b (primary series: Comirnaty)
participants will receive one dose of Comirnaty vaccine on Day 1
Biological: Comirnaty Vaccine
intramuscular injection
Experimental: Group 2a (primary series: Vaxzevria)
participants will receive one dose of SCB-2019 vaccine on Day 1
Biological: Candidate vaccine, SCB-2019
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Active Comparator: Group 2b (primary series: Vaxzevria)
participants will receive one dose of Vaxzevria vaccine on Day 1
Biological: Vaxzevria Vaccine
intramuscular injection
Experimental: Group 3a (primary series: CoronaVac)
participants will receive one dose of SCB-2019 vaccine on Day 1
Biological: Candidate vaccine, SCB-2019
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Active Comparator: Group 3b (primary series: CoronaVac)
participants will receive one dose of CoronaVac vaccine on Day 1
Biological: CoronaVac Vaccine
intramuscular injection
Experimental: Group 4a (primary series and booster dose CoronaVac)
participants will receive one dose of SCB-2019 vaccine on Day 1
Biological: Candidate vaccine, SCB-2019
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Active Comparator: Group 4b (primary series and booster dose CoronaVac)
participants will receive one dose of CoronaVac on Day 1;
Biological: CoronaVac Vaccine
intramuscular injection
Experimental: Group 4c (primary series and booster dose CoronaVac)
participants will receive a half dose of SCB-2019 vaccine on Day 1
Biological: Candidate vaccine, SCB-2019
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Experimental: Group 5a (primary series: CoronaVac)
participants will receive a dose of 2-vial presentation of SCB-2019 vaccine
Biological: Candidate vaccine, SCB-2019
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Experimental: Group 5b (primary series: CoronaVac)
participants will receive a dose of 3-vial presentation of SCB-2019 vaccine
Biological: Candidate vaccine, SCB-2019
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
Time Frame
GMT ratio of GMT SCB-2019 over GMT Comirnaty on Day 15
Time Frame: Day 15
Day 15
GMT ratio of GMT SCB-2019 over GMT COVID-19 Vaccine Janssen on Day 15
Time Frame: Day 15
Day 15
GMT ratio of GMT SCB-2019 over GMT CoronaVac Vaccine on Day 15
Time Frame: Day 15
Day 15
Local and systemic solicited AEs reported within 7 days after study vaccination
Time Frame: Up to 7 days after each vaccination
Up to 7 days after each vaccination
Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 29
Time Frame: Up to Day 29
Up to Day 29
SAEs, AEs leading to early termination from the study, MAAEs, and AESIs
Time Frame: Through study completion, an average of 6 Months
Through study completion, an average of 6 Months

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.
June 13, 2022

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.
June 6, 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.
June 6, 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).
January 10, 2022

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.
January 10, 2022

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.
January 12, 2022

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 24, 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-2019-015

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.

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