Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Controlled Phase 2/3 Study of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Vaccine (SCB-2019) for the Prevention of COVID-19 (SCB-2019)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04672395
Recruitment Status : Not yet recruiting
First Posted : December 17, 2020
Last Update Posted : February 9, 2021
Sponsor:
Collaborators:
Coalition for Epidemic Preparedness Innovations
International Vaccine Institute
Information provided by (Responsible Party):
Clover Biopharmaceuticals AUS Pty Ltd

Tracking Information
First Submitted Date  ICMJE December 16, 2020
First Posted Date  ICMJE December 17, 2020
Last Update Posted Date February 9, 2021
Estimated Study Start Date  ICMJE March 2021
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2021)
  • Number of Participants with a First Occurrence of COVID-19 of Any Severity Starting 14 Days after Second Dose of SCB-2019 [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 8 (7 days after first dose) and up to Day 29 (7 days after second dose) ]
  • Number of Participants with Unsolicited AEs [ Time Frame: Up to Day 43 (21 days after each dose) ]
  • Number of Participants with Serious Adverse Events (SAEs), or Medically Attended AEs (MAAEs), or AEs Leading to Early Termination, or Adverse Events of Special Interest (AESIs) [ Time Frame: Up to Day 389 (1 year after second dose) ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2020)
  • Number of Participants with a First Occurrence of COVID-19 of Any Severity Starting 14 Days after Second Dose of SCB-2019 [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Number of Participants with a First Occurrence of Moderate-to-Severe COVID-19 Starting 14 Days after Second Dose of SCB-2019 [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 8 (7 days after first dose) and up to Day 29 (7 days after second dose) ]
  • Number of Participants with Unsolicited AEs [ Time Frame: Up to Day 43 (21 days after each dose) ]
  • Number of Participants with Serious Adverse Events (SAEs), or Medically Attended AEs (MAAEs), or AEs Leading to Early Termination, or Adverse Events of Special Interest (AESIs) [ Time Frame: Up to Day 389 (1 year after second dose) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2021)
  • Number of Participants with a First Occurrence of Moderate-to-Severe COVID-19 Starting 14 Days after Second Dose of SCB-2019 [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Number of Participants with First Occurrence of Any Laboratory-Confirmed SARS-CoV-2 infection Starting 14 Days after Second Dose of SCB-2019 or Placebo [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of SCB-2019 or Placebo [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Number of Participants with First Occurrence of Any Laboratory-Confirmed Asymptomatic SARS-CoV-2 infection Starting 14 Days after Second Dose of SCB-2019 or Placebo [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Burden of Disease Score of COVID-19 or SARS-CoV-2 Infection Cases Starting 14 Days after Second Dose of SCB-2019 or Placebo [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Number of Participants with a First Occurrence of COVID-19 of Any Severity, Associated with Hospitalization, Starting 14 Days after Second Dose of SCB-2019 or Placebo [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of SCB-2019 or Placebo, regardless of evidence of prior SARS-CoV-2 Infection [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of SCB-2019 or Placebo, regardless of risk of severe COVID-19 [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Number of Participants with a First Occurrence of COVID-19 Starting 14 days after First Dose of SCB-2019 or Placebo [ Time Frame: Day 15 up to Day 389 (1 year after second dose) ]
  • Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) [ Time Frame: Day 1, Day 22, Day 35, Day 205, and Day 389 ]
  • Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb [ Time Frame: Day 1, Day 22, Day 35, Day 205, and Day 389 ]
  • Number of Participants with Seroconversion for SARS-CoV-2 Specific nAb [ Time Frame: Day 22, and Day 35 ]
  • Geometric Mean Titer (GMT) of SARS-CoV-2 antibodies competing for binding of S protein to the human ACE2 receptor [ Time Frame: Day 1, Day 22, Day 35, Day 205, and Day 389 ]
  • Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 antibodies competing for binding of S protein to the human ACE2 receptor [ Time Frame: Day 1, Day 22, Day 35, Day 205, and Day 389 ]
  • Number of Participants with Seroconversion for of SARS-CoV-2 antibodies competing for binding of S protein to the human ACE2 receptor [ Time Frame: Day 22, and Day 35 ]
  • Geometric Mean Titer (GMT) of SCB-2019 binding antibody [ Time Frame: Day 1, Day 22, Day 35, Day 205, and Day 389 ]
  • Geometric Mean Fold Rise (GMFR) of SCB-2019 binding antibody [ Time Frame: Day 1, Day 22, Day 35, Day 205, and Day 389 ]
  • Number of Participants with Seroconversion for SCB-2019 binding antibody [ Time Frame: Day 22, and Day 35 ]
  • Geometric Mean Titer (GMT) of Trimer-Tag binding antibody [ Time Frame: Day 1, Day 22, Day 35, Day 205, and Day 389 ]
  • Geometric Mean Fold Rise (GMFR) of Trimer-Tag binding antibody [ Time Frame: Day 1, Day 22, Day 35, Day 205, and Day 389 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2020)
  • Number of Participants with First Occurrence of Any Laboratory-Confirmed SARS-CoV-2 infection Starting 14 Days after Second Dose of SCB-2019 or Placebo [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of SCB-2019 or Placebo [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Number of Participants with First Occurrence of Any Laboratory-Confirmed Asymptomatic SARS-CoV-2 infection Starting 14 Days after Second Dose of SCB-2019 or Placebo [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Burden of Disease Score of COVID-19 or SARS-CoV-2 Infection Cases Starting 14 Days after Second Dose of SCB-2019 or Placebo [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Number of Participants with a First Occurrence of COVID-19 of Any Severity, Associated with Hospitalization, Starting 14 Days after Second Dose of SCB-2019 or Placebo [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of SCB-2019 or Placebo, regardless of evidence of prior SARS-CoV-2 Infection [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of SCB-2019 or Placebo, regardless of risk of severe COVID-19 [ Time Frame: Day 36 up to Day 389 (1 year after second dose) ]
  • Number of Participants with a First Occurrence of COVID-19 Starting 14 days after First Dose of SCB-2019 or Placebo [ Time Frame: Day 15 up to Day 389 (1 year after second dose) ]
  • Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) [ Time Frame: Day 1, Day 22, Day 35, Day 205, and Day 389 ]
  • Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb [ Time Frame: Day 1, Day 22, Day 35, Day 205, and Day 389 ]
  • Number of Participants with Seroconversion for SARS-CoV-2 Specific nAb [ Time Frame: Day 22, and Day 35 ]
  • Geometric Mean Titer (GMT) of SARS-CoV-2 antibodies competing for binding of S protein to the human ACE2 receptor [ Time Frame: Day 1, Day 22, Day 35, Day 205, and Day 389 ]
  • Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 antibodies competing for binding of S protein to the human ACE2 receptor [ Time Frame: Day 1, Day 22, Day 35, Day 205, and Day 389 ]
  • Number of Participants with Seroconversion for of SARS-CoV-2 antibodies competing for binding of S protein to the human ACE2 receptor [ Time Frame: Day 22, and Day 35 ]
  • Geometric Mean Titer (GMT) of SCB-2019 binding antibody [ Time Frame: Day 1, Day 22, Day 35, Day 205, and Day 389 ]
  • Geometric Mean Fold Rise (GMFR) of SCB-2019 binding antibody [ Time Frame: Day 1, Day 22, Day 35, Day 205, and Day 389 ]
  • Number of Participants with Seroconversion for SCB-2019 binding antibody [ Time Frame: Day 22, and Day 35 ]
  • Geometric Mean Titer (GMT) of Trimer-Tag binding antibody [ Time Frame: Day 1, Day 22, Day 35, Day 205, and Day 389 ]
  • Geometric Mean Fold Rise (GMFR) of Trimer-Tag binding antibody [ Time Frame: Day 1, Day 22, Day 35, Day 205, and Day 389 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Controlled Phase 2/3 Study of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Vaccine (SCB-2019) for the Prevention of COVID-19
Official Title  ICMJE A Double-Blind, Randomized, Controlled, Phase 2/3 Study to Evaluate the Efficacy, Immunogenicity, and Safety of SCB 2019, a Recombinant SARS-CoV-2 Trimeric S Protein Subunit Vaccine for the Prevention of COVID-19 in Participants Aged 18 Years and Older
Brief Summary The purpose of this double-blind, randomized, controlled study is to evaluate the efficacy, immunogenicity, reactogenicity and safety of an adjuvanted recombinant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) trimeric spike (S)-protein subunit vaccine (SCB-2019) for the prevention of SARS-CoV-2-mediated COVID-19 in adult subjects 18 years of age and above.
Detailed Description This study will assess the efficacy against COVID-19 and SARS-CoV-2 infection, immunogenicity, reactogenicity, and safety of CpG 1018/Alum-adjuvated SCB-2019 vaccine. The COVID-19 pandemic has resulted in high morbidity and mortality, caused major disruption to healthcare systems, and has had significant socioeconomic impacts. Currently, only limited treatment options are available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID-19 prevention would have significant public health impact.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Each subject will receive 2 doses of their assigned treatment, on Days 1 and 22. The treatment will be administered IM in the deltoid region of the upper arm.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: CpG 1018/Alum-adjuvanted SCB-2019 vaccine
    Group 1: Participants will receive 1 intramuscular (IM) injection of 30 microgram (ug) SCB-2019 with CpG 1018/Alum adjuvant on Day 1 and on Day 22
  • Biological: Placebo; 0.9% saline
    Group 2: Participants will receive 1 IM injection of SCB-2019-matching placebo on Day 1 and on Day 22
Study Arms  ICMJE
  • Experimental: Group 1
    CpG 1018/Alum-adjuvanted SCB-2019 vaccine
    Intervention: Biological: CpG 1018/Alum-adjuvanted SCB-2019 vaccine
  • Placebo Comparator: Group 2
    0.9% sodium chloride
    Intervention: Biological: Placebo; 0.9% saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 4, 2021)
22000
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2020)
34000
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or females ≥18 years of age, inclusive.
  2. Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, the electronic completion of the COVID-19 ePRO and other study procedures.
  3. Healthy adults or adults with pre-existing medical conditions who are in stable condition.

    A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrolment

  4. Female subjects are eligible to participate in the study if not pregnant, not breastfeeding, and at least 1 of the following criteria apply:

    • Women of childbearing potential (WOCBP) must have a negative urine pregnancy test prior to each vaccination. A confirmatory serum pregnancy test may be conducted at the Investigator's discretion. They must be using a highly effective licensed method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions during the study until 90 days after the second vaccination.

  5. Individuals (or their legally acceptable representative based on local regulations) willing and able to give an informed consent, prior to screening

Exclusion Criteria:

  1. Individuals with laboratory-confirmed SARS-CoV-2 infection (e.g., a positive result for the Rapid COVID-19 antigen test) or a known history of SARS-CoV-2 infection.
  2. Individuals with behavioral or cognitive impairment (including drug and alcohol abuse) in the opinion of the Investigator.
  3. Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillian-Barré syndrome.
  4. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or planned receipt during the study period.
  5. Individuals who are pregnant, or breastfeeding, or planning to become pregnant during the study period.
  6. 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 vaccine
  7. Individuals who have a history of malignancy within 1 year before screening
  8. Individuals who have received any other investigational product within 30 days prior to Day 1 or intent to participate in another clinical study at any time during the conduct of this study.
  9. Individuals who have received previous vaccination with any coronavirus vaccine.
  10. Individuals who have received any other licensed vaccines within 28 days prior to enrollment in this study or who are planning to receive any vaccine up to 14 days after the second vaccination.
  11. Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular injection.
  12. Individuals who received any blood/plasma products or immunoglobulins within 60 days prior to Day 1 or plan to receive it during the study period.
  13. Individuals with any condition that, in the opinion of the Investigator, may increase the risk of study participation or interfere with the assessment of the primary study objectives
  14. Individuals with fever >37.8°C (≥100.04°F; irrespective of method), or any acute illness at baseline (Day 1) or within 3 days of randomization.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Vincent Mwangi, MD +1 847-691-8580 Vincent.mwangi@cloverbiopharma.com
Contact: Pilar Rubio, MD +57 314-857-0960 Pilar.Rubio@cloverbiopharma.com
Listed Location Countries  ICMJE Belgium,   Brazil,   Colombia,   Dominican Republic,   Germany,   Nepal,   Panama,   Philippines,   Poland,   South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04672395
Other Study ID Numbers  ICMJE CLO-SCB-2019-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clover Biopharmaceuticals AUS Pty Ltd
Study Sponsor  ICMJE Clover Biopharmaceuticals AUS Pty Ltd
Collaborators  ICMJE
  • Coalition for Epidemic Preparedness Innovations
  • International Vaccine Institute
Investigators  ICMJE
Study Chair: Igor Smolenov, MD, PhD Clover Biopharmaceuticals AUS Pty Ltd
PRS Account Clover Biopharmaceuticals AUS Pty Ltd
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP