SARS-CoV-2-mediated COVID-19 MedDRA version: 23.1 Level: LLT Classification code 10084465 Term: COVID-19 vaccination System Organ Class: 100000004865
Conditions
Sponsors
Clover Biopharmaceuticals AUS Pty Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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 enrollment. Note: The first 200 individuals enrolled in the Phase 2 part of the study should be healthy subjects 18 to 64 years or age without comorbidities associated with a high risk of severe COVID-19. 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. Male subjects must agree to employ acceptable contraception from the day of first dose of the study vaccine/placebo until 6 months after the last dose of the study vaccine/placebo and also refrain from donating sperm during this period. 6. Individuals (or their legally acceptable representative based on local regulations) willing and able to give an informed consent, prior to screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5500
Exclusion criteria
Exclusion criteria: 1. Individuals with laboratory-confirmed SARS-CoV-2 infection (e.g., a positive RT-PCR or Rapid COVID-19 antigen test). 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. If a short-term course of systemic corticosteroids have been administered for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 30 days before the first study vaccination. A unique dose of systemic steroids on a single day would be allowed, as well as inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. 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 (SCB-2019, CpG 1018 Adjuvant and Aluminum hydroxide/SCB-2019 components as outlined in the latest IB). 7. 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). 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 14 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. Participants meeting this criterion may be rescheduled within the relevant window. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Primary Efficacy Objective: Vaccine Efficacy Against RT-PCR-Confirmed COVID-19 of Any Severity: To demonstrate the efficacy of CpG 1018/Alum-adjuvanted SCB-2019 vaccine for the prevention of any RT-PCR-confirmed COVID-19 of any severity in subjects without evidence of prior SARS-CoV-2 infection. 2. Primary Safety and Reactogenicity Objective: To assess the safety and reactogenicity of CpG 1018/Alum-adjuvanted SCB-2019 vaccine compared to placebo. ;Secondary Objective: Secondary Efficacy Objectives: - Vaccine Efficacy Against Any RT-PCR Confirmed Moderate-to-Severe COVID-19 - Vaccine Efficacy Against Any Laboratory-Confirmed SARS-CoV-2 Infection - Vaccine Efficacy Against Any RT-PCR-Confirmed Severe COVID-19 - Vaccine Efficacy Against Any Laboratory-Confirmed Asymptomatic SARS-CoV-2 Infection - Vaccine Efficacy Against Burden of Disease (BOD) - Vaccine Efficacy Against Any RT-PCR-Confirmed COVID-19 of Any Severity, Associated with Hospitalization - Vaccine Efficacy by Evidence of Prior SARS-CoV-2 Infection and Risk of Severe COVID-19 - Vaccine Efficacy After the First Dose Secondary Immunogenicity Objectives: To assess the immunogenicity of CpG 1018/Alum-adjuvanted SCB 2019 vaccine in Phase 2 subjects To assess the immune response against Trimer Tag domain of SCB 2019 in Phase 2 subjects Secondary Safety Objective: To assess the immune response against Trimer Tag domain of SCB 2019 in Phase 2 subjects ;Primary end point(s): First occurrence of any RT-PCR-confirmed COVID-19 of any severity with onset at least 14 days after the second study vaccination in subjects without evidence of prior SARS-CoV-2 infection. Local and systemic solicited AEs reported within 7 days after each study vaccination (in Phase 2 subjects) Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 43 (in Phase 2 subjects) SAEs, AEs leading to early termination from the study, MAAEs, and AESIs during the entire study period (in all subjects).;Timepoint(s) of ev | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): First occurrence of RT-PCR confirmed moderate-to-severe COVID 19 (Refer to Case Definition) with onset at least 14 days after the second vaccination in subjects without evidence of prior SARS-CoV-2 infection Occurrence of any laboratory-confirmed SARS-CoV-2 infection (Refer to Case Definition) with onset at least 14 days after the second study vaccination in subjects without evidence of prior SARS-CoV-2 infection First occurrence of RT-PCR confirmed severe COVID 19 with onset at least 14 days after the second vaccination in subjects without evidence of prior SARS-CoV-2 infection Occurrence of laboratory-confirmed asymptomatic SARS-CoV-2 infection (Refer to Case Definition), with onset at least 14 days after the second vaccination in subjects without evidence of prior SARS-CoV-2 infection. Occurrence of any SARS-CoV-2 infection, any confirmed RT-PCR COVID-19 and any RT-PCR-confirmed severe COVID-19 with onset at least 14 days after the second vaccination in subjects without evidence of prior SARS-CoV-2 infection First occurrence of RT-PCR confirmed COVID 19 of any severity, associated with hospitalization, with onset at least 14 days after the second vaccination in subjects without evidence of prior SARS-CoV-2 infection. - First occurrence of RT-PCR confirmed COVID 19 of any severity, - First occurrence of RT-PCR-confirmed moderate-to-severe COVID-19, - First occurrence of RT-PCR confirmed severe COVID-19, - First occurrence of RT-PCR confirmed COVID 19 of any severity, associated with hospitalization, - Occurrence of any laboratory-confirmed SARS-CoV-2 infection, and - Occurrence of laboratory-confirmed asymptomatic SARS-CoV-2 infection, with onset at least 14 days after the second vaccination For Immunogenicity - VNA, ACE2-competitive ELISA, SCB-2019 binding antibody ELISA, For Safety- Trimer-Tag binding antibody as measured by ELISA assay;Timepoint(s) of evaluation of this end point: For Efficacy - First occurrence of any | — |
Countries
Belgium, Brazil, Colombia, Dominican Republic, Germany, Guatemala, Nepal, Panama, Philippines, Poland, South Africa
Contacts
Public ContactHtay Htay Han
Clover Biopharmaceuticals AUS Pty Ltd
Outcome results
None listed