Safety and Immunogenicity Dose-finding Study of Adjuvanted SCB-2020S Vaccine in Adults

June 30, 2023 updated by: Clover Biopharmaceuticals AUS Pty Ltd

A Phase 1, Observer-blind, Randomized, Controlled, Dose-finding Study to Evaluate the Safety and Immunogenicity of Clover Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2020S) in Adults 18 to 75 Years of Age

This is a phase 1 study to assess the safety and immunogenicity of different formulations of the investigational adjuvanted recombinant SARS-CoV-2 trimeric S-protein (from beta variant) subunit vaccine (SCB-2020S vaccine), when administered as 2 dose vaccination series 21 days apart to adults ≥18 to ≤75 years of age.

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.
153

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 1

Contacts and Locations

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

Study Locations

  • South Africa
      • Bloemfontein, South Africa
        • Josha Research
      • Pretoria, South Africa
        • Global Clinical Trials (Pty) Ltd
      • Soweto, South Africa
        • Wits Vaccines and Infectious Diseases Analytics (VIDA) Research Unit

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female 18 to 75 years of age
  • Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures
  • Individuals are 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.
  • Female participants of childbearing potential may be enrolled in the study, if the participant has practiced highly effective method of contraception for 30 days prior to vaccination and has a negative pregnancy test on the day of vaccination and has agreed to continue adequate contraception for 3 months after the last vaccination
  • Male participants must agree to employ acceptable contraception from the day of the first dose of the study vaccine until 6 months after the last dose of the study vaccine and also refrain from donating sperm during this period

Exclusion Criteria:

  • Individuals with body temperature >37.8°C (axillary), or any acute illness at baseline (Day 1) or within 3 days prior to randomization.
  • Body mass index at screening >30 kg/m2
  • Individuals with laboratory-confirmed SARS-CoV-2 infection [as defined by reverse transcriptase polymerase chain reaction (RT-PCR) assay or Rapid COVID Antigen Test or an equivalent] at the screening visit or with known history of COVID-19 within 6 months prior to Day 1
  • Individuals who have received an investigational or authorized COVID-19 vaccine within 6 months prior to Day 1, or plan to receive COVID-19 vaccine during the study period
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease [e.g., malignancy, human immunodeficiency virus (HIV) infection] or immunosuppressive/cytotoxic therapy (e.g., systemic corticosteroids, medications used for cancer chemotherapy, organ transplantation or to treat autoimmune disorders) within 3 months prior to Day 1.
  • Individuals with 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
  • Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction, e.g., anaphylaxis to any components of the study vaccines
  • Individuals who have a history of malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix which have been cured, or other malignancies with minimal risk of recurrence).
  • 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
  • Individuals who have received any other licensed vaccines within 14 days prior to enrollment in this study or who are planning to receive any vaccine up to 28 days after the second vaccination
  • Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate i.m. injection
  • Individuals who have received treatment with rituximab or any other anti-CD20 monoclonal antibodies within 9 months prior to Day 1 or planned during the study period
  • Administration of intravenous immunoglobulins and/or any blood products within 3 months prior to enrollment or planned administration during the study period
  • Individuals with positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at Screening
  • Individuals with safety laboratory test results (hematology, biochemistry, and coagulation) with a toxicity score of Grade ≥2 at Screening.
  • The participant has a reported or documented history of alcohol abuse or drug addiction (excluding nonprescription health supplements and herbal remedies) within 1 year before the planned day of dose administration
  • The participant has a positive test result for drugs of abuse at Screening
  • Individuals with 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: Standard dose SCB-2020S with CpG/alum adjuvant
Day 1 and 22 standard dose of SCB-2020S with CpG/alum adjuvant
Biological: Candidate vaccine, SCB-2020S
a recombinant SARS-CoV-2 trimeric S-protein (from beta variant) subunit vaccine for COVID-19
Other: CpG/alum adjuvant
CpG/alum adjuvant
Experimental: Low dose SCB-2020S with low dose squalene based adjuvant
Day 1 and 22 low dose of SCB-2020S with low dose squalene based adjuvant
Biological: Candidate vaccine, SCB-2020S
a recombinant SARS-CoV-2 trimeric S-protein (from beta variant) subunit vaccine for COVID-19
Other: Squalene based adjuvant
Squalene based adjuvant
Experimental: Low dose SCB-2020S with standard dose squalene based adjuvant
Day 1 and 22 low dose of SCB-2020S with standard dose squalene based adjuvant
Biological: Candidate vaccine, SCB-2020S
a recombinant SARS-CoV-2 trimeric S-protein (from beta variant) subunit vaccine for COVID-19
Other: Squalene based adjuvant
Squalene based adjuvant
Experimental: Standard dose SCB-2020S with low dose squalene based adjuvant
Day 1 and 22 standard dose of SCB-2020S with low dose squalene based adjuvant
Biological: Candidate vaccine, SCB-2020S
a recombinant SARS-CoV-2 trimeric S-protein (from beta variant) subunit vaccine for COVID-19
Other: Squalene based adjuvant
Squalene based adjuvant
Experimental: Standard dose SCB-2020S with standard dose squalene based adjuvant
Day 1 and 22 standard dose of SCB-2020S with standard dose squalene based adjuvant
Biological: Candidate vaccine, SCB-2020S
a recombinant SARS-CoV-2 trimeric S-protein (from beta variant) subunit vaccine for COVID-19
Other: Squalene based adjuvant
Squalene based adjuvant
Active Comparator: Standard dose SCB-2019 with CpG/alum adjuvant
Day 1 and 22 standard dose of SCB-20219 with standard CpG/alum adjuvant
Biological: Candidate vaccine, SCB-2019
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19
Other: CpG/alum adjuvant
CpG/alum adjuvant

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
Number of participants with local and systemic adverse events (AEs) after vaccination with SCB-2020S vaccine.
Time Frame: 7 days after each dose
Proportion of subjects with solicited local and systemic adverse events
7 days after each dose
Number of participants with unsolicited AEs after vacccination with SCB-2020S vaccine
Time Frame: Up to 28 days after the last vaccination
Proportion of subjects with unsolicited adverse events
Up to 28 days after the last vaccination
Number of participants with MAAEs, SAEs, AESIs and AEs leading to discontinuation from study.
Time Frame: Up to 1 year after the last vaccination
Proportion of participants with any adverse events in this category.
Up to 1 year after the last vaccination
Number of participants with abnormal results in hematology parameters (hemoglobin, platelet count, red blood cell count, total and differential white blood cell count).
Time Frame: up to Day 29
Proportion of participants with abnormal results in hematology parameters.
up to Day 29
Number of participants with abnormal results in biochemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, creatinine, total protein).
Time Frame: up to Day 29
Proportion of participants with abnormal results in biochemistry parameters.
up to Day 29
Number of participants with abnormal results in coagulation parameters (activated partial thromboplastin, prothrombin time).
Time Frame: up to Day 29
Proportion of participants with abnormal results in coagulation parameters.
up to Day 29

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
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody (nAb)
Time Frame: Day 1, 22, 36, 90, 205 and 389
Day 1, 22, 36, 90, 205 and 389
Proportion of participants achieving seroconversion for SARS-CoV-2 nAb
Time Frame: Day 22, 36, 90, 205 and 389
Day 22, 36, 90, 205 and 389
Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb
Time Frame: Day 22, 36, 90, 205 and 389
Day 22, 36, 90, 205 and 389
Proportion of participants with nAb above a certain threshold
Time Frame: Day 1, 22, 36, 90, 205 and 389
Day 1, 22, 36, 90, 205 and 389
GMT of SCB-2019 Binding Antibody
Time Frame: Day 1, 22, 36, 90, 205 and 389
Day 1, 22, 36, 90, 205 and 389
Proportion of participants achieving seroconversion for SCB-2019 binding antibody
Time Frame: Day 22, 36, 90, 205 and 389
SCR is the percentage of participants with a ≥4-fold increase in titer from that at Day 1 (or from LLoQ if Day 1 titer <LLoQ).
Day 22, 36, 90, 205 and 389
GMFR of SCB-2019 binding antibody
Time Frame: Day 22, 36, 90, 205 and 389
Day 22, 36, 90, 205 and 389
SCB-2019 binding antibody above lower limit of quantification.
Time Frame: Day 1, 22, 36, 90, 205 and 389
Day 1, 22, 36, 90, 205 and 389

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.
May 30, 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.
September 23, 2022

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.
April 23, 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).
December 24, 2021

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 27, 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.
February 8, 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.
July 3, 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.
June 30, 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.
June 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-2020S-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.

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