A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety and Immunogenicity of SCB 2019, a Recombinant SARS-CoV-2 Trimeric S Protein Subunit Vaccine for COVID-19 in Healthy Volunteers.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Clover Biopharmaceuticals AUS Pty Ltd
- Enrollment
- 166
- Locations
- 1
- Primary Endpoint
- Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a randomized, double blind, placebo controlled, first-in-human (FIH) study to assess safety, reactogenicity, and immunogenicity of SCB-2019 at multiple dose levels, administered as 2 injections IM in healthy subjects. Each study vaccine dose level will be evaluated with and without adjuvant.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adult male or females, ≥18 years of age at Screening:
- •For the adult group: 18 to 54 years, inclusive, and
- •For the elderly group: 55 to 75 years, inclusive.
- •Individuals who are willing and able to give an informed consent, prior to Screening.
- •Individuals who are able to comply with study requirements.
- •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 must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to each vaccination. They must be using a highly effective licensed method of birth control for 30 days prior to the first dose of the study vaccine/placebo and must agree to continue such precautions during the study until 60 days after the second dose of the study vaccine/placebo.
- •Women not of childbearing potential, defined as surgically sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (no menses for 12 months and follicle-stimulating hormone \[FSH\] in the postmenopausal range).
- •Male subjects must agree to employ acceptable contraception from the day of first dose of the study vaccine/placebo until 90 days after the second dose of the study vaccine/placebo and also refrain from donating sperm during this period.
- •General good health based on medical history, physical examination, cardiac health evaluation, and clinical laboratory evaluations. Participants in the elderly population who have medically stable, well-controlled co-morbidities may be enrolled at the discretion of the Investigator.
Exclusion Criteria
- •Individuals with any positive test for SARS-CoV-2 infection, including but not limited to RT-PCR, at Screening (excluding the SARS-CoV-2 seropositive treatment group \[Treatment Groups 16 to 18\]).
- •Individuals with positive serology test results for SARS-CoV-2 at Screening (excluding the SARS-CoV-2 seropositive treatment group \[Treatment Groups 16 to 18\]).
- •Individuals with behavioral or cognitive impairment in the opinion of the Investigator.
- •Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillian-Barré syndrome.
- •Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study.
- •Individuals with known or suspected impairment of the immune system, such as:
- •Use of systemic (oral or parenteral) corticosteroids for ≥14 consecutive days within 60 days prior to Day
- •Use of inhaled, intranasal, or topical corticosteroids is allowed.Note: Systemic (oral or parenteral) corticosteroids are also prohibited for 3 weeks after the second dose of the study vaccine/placebo.
- •Receipt of cancer chemotherapy within 5 years prior to Day
- •Receipt of immunostimulants or immunosuppressants within 60 days prior to Day
Outcomes
Primary Outcomes
Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)
Time Frame: Day 1 to Day 184
To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
As assessed by serum anti-SCB-2019 IgG antibody titers
Time Frame: Day 1 to Day 184
Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).
Mean change from Baseline in safety laboratory measures (include hematology, coagulation panel, and serum chemistry)
Time Frame: Day 1 to Day 50
To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
Incidence of solicited adverse events (AEs) after vaccination
Time Frame: 7 days after the first or second vaccination.
To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
Incidence of unsolicited AEs after vaccination
Time Frame: Day 1 to Day 50
To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
Secondary Outcomes
- Antibody kinetics of each SCB 2019 vaccine formulation after first and second doses(Day 1 to Day 184)
- Immunogenicity(serum anti SARS-CoV-2 neutralizing antibody titers (cell based) )(Day 1 to Day 184)
- Immunogenicity( serum anti SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based) )(Day 1 to Day 184)
- Immunogenicity(serum anti SARS-CoV-2 whole virus antibody titers)(Day 1 to Day 184)