Immunogenicity and Safety of Adjuvanted SCB-2020S Vaccines in Adults

NCT04950751 | Withdrawn Phase 2 DMC

• 1 other identifier: CLO-SCB-2020-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase 2, randomized, controlled, observer-blind study to evaluate the immunogenicity and safety of different formulations of the investigational adjuvanted recombinant SARS-CoV-2 trimeric S-protein (from B.1.351 variant) subunit vaccine (SCB-2020S), when administered as 2-dose vaccination series 21 days apart to adults ≥ 18 years of age.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies to B.1.351 variant

  Days 36

• Proportion of subjects achieving seroconversion of SARS-CoV-2 neutralising antibodies to B.1.351 variant

  Seroconversion rate (percentage of participants with a ≥4-fold increase in titer from that at Day 1 (or from LLoQ if Day 1 titer \<LLoQ).

  Day 36

• Geometric mean fold rise (GMFR) of SARS-Cov-2 neutralising antibodies to B.1.351 variant

  Day 36/Day 1

Secondary Outcomes (19)

• Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies to Wuhan strain

  Day 36

• Proportion of subjects achieving seroconversion of SARS-CoV-2 neutralising antibodies to Wuhan strain

  Day 36

• Geometric mean fold rise (GMFR) of SARS-Cov-2 neutralising antibodies to Wuhan strain

  Day 36/Day 1

• Geometric mean titer (GMT) of antibody titers specific to SCB-2019 antigen

  Day 36

• Proportion of subjects achieving seroconversion of antibodies specific to SCB-2019

  Day 36

Study Arms (5)

SCB-2020S Standard Dose

EXPERIMENTAL

Day 1 and 22: standard dose SCB-2020S with CpG 1018/alum adjuvant

Biological: candidate vaccine, SCB-2020S

SCB-2020S Low Antigen Dose

EXPERIMENTAL

Day 1 and 22: low dose SCB-2020S with CpG 1018/alum adjuvant

Biological: candidate vaccine, SCB-2020S

SCB-2020S Low Adjuvant Dose

EXPERIMENTAL

Day 1 and 22: standard dose SCB-2020S with low dose CpG 1018/alum adjuvant

Biological: candidate vaccine, SCB-2020S

SCB-2020S Mixed Series

EXPERIMENTAL

Day 1 (Dose 1) standard dose SCB-2020S with CpG 1018/alum adjuvant and Day 22 Dose 2) standard dose SCB-2020S with alum adjuvant

Biological: candidate vaccine, SCB-2020S

SCB-2019

ACTIVE COMPARATOR

Day 1 and 22: standard dose SCB-2019 with CpG 1018/alum adjuvant

Biological: candidate vaccine, SCB-2020S

Interventions

candidate vaccine, SCB-2020S BIOLOGICAL

a recombinant SARS-Co-2 trimeric S-protein (from B.1.351 variant) subunit vaccine for COVID-19

SCB-2019; SCB-2020S Low Adjuvant Dose; SCB-2020S Low Antigen Dose; SCB-2020S Mixed Series; SCB-2020S Standard Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female ≥18 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. (\*A stable medical condition is defined as disease not requiring significant change or hospitalization for worsening disease during the 3 months before enrollment.)
• \. Female participants of childbearing potential may be enrolled in the study, if the participant has practiced adequate 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.

You may not qualify if:

• \. Individuals with body temperature \>37.5°C (axillary), or any acute illness at baseline (Day 1) or within 3 days prior to randomization. Participants meeting this criterion may be rescheduled within the relevant window. Febrile participants with minor illnesses can be enrolled at the discretion of the investigator.
• \. Individuals with laboratory-confirmed SARS-CoV-2 infection \[as defined by reverse transcriptase polymerase chain reaction (RT-PCR) assay or Rapid COVID Antigen Test or an equivalent at Visit 1\] or with history of COVID-19.
• \. Individuals seropositive at Baseline for SARS-CoV-2.
• Individuals who have received an investigational or authorized COVID-19 vaccine 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 \[e.g., anaphylaxis to any component of the study vaccines (CpG 1018, aluminum), or SCB-2020S/SCB-2019 components \].
• \. 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 21 days after the second vaccination.
• \. Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular 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.

Sponsors & Collaborators

• Clover Biopharmaceuticals AUS Pty: lead

MeSH Terms

Conditions

COVID-19

Interventions

SCB-2019 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 6, 2021
• Study Start: August 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: September 10, 2021

Record last verified: 2021-09