Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06194318




Registration number
NCT06194318
Ethics application status
Date submitted
17/11/2023
Date registered
8/01/2024
Date last updated
22/02/2024

Titles & IDs
Public title
First-in-human Safety and Immunogenicity Study of SCB-1019 in Healthy Adults
Scientific title
A Phase 1, Placebo-controlled, Randomized, Observer-blind, First-in-human Study to Describe the Safety, Reactogenicity and Immunogenicity of SCB-1019 in Healthy Adults
Secondary ID [1] 0 0
CLO-SCB-1019-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infection 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Candidate vaccine, SCB-1019
Treatment: Other - placebo

Experimental: group 1 (SCB-1019 90µg with Alum; young adults) - 4 young adults (18-59 years old) will receive low dose SCB-1019 (90µg, with Alum) at Day 1

Placebo comparator: group 2 (Placebo; young adults) - 2 young adults (18-59 years old) will receive Placebo at Day 1

Experimental: group 3 (SCB-1019 360µg with Alum; young adults) - 4 young adults (18-59 years old) will receive high dose SCB-1019 (360µg, with Alum) at Day 1

Placebo comparator: group 4 (Placebo; young adults) - 2 young adults (18-59 years old) will receive Placebo at Day 1

Experimental: group 5 (SCB-1019 90µg without Alum; older adults) - 10 older adults (60-85 years old) will receive low dose SCB-1019 (90µg, without Alum) at Day 1

Experimental: group 6 (SCB-1019 90µg with Alum; older adults) - 10 older adults (60-85 years old) will receive low dose SCB-1019 (90µg, with Alum) at Day 1

Placebo comparator: group 7 (Placebo; older adults) - 4 older adults (60-85 years old) will receive Placebo at Day 1

Experimental: group 8 (SCB-1019 360µg without Alum; older adults) - 10 older adults (60-85 years old) will receive high dose SCB-1019 (360µg, without Alum) at Day 1

Experimental: group 9 (SCB-1019 360µg with Alum; older adults) - 10 older adults (60-85 years old) will receive high dose SCB-1019 (360µg, with Alum) at Day 1

Placebo comparator: group 10 (Placebo; older adults) - 4 older adults (60-85 years old) will receive Placebo at Day 1


Treatment: Other: Candidate vaccine, SCB-1019
The SCB-1019 vaccine contains RSV F protein subunits from the two dominant circulating strains, A strain (SCB-1019A) and B strain (SCB-1019B). SCB-1019A and SCB-1019B are recombinant RSV F-Trimer proteins engineered by fusing the ectodomain of RSV F protein with Trimer-Tag™

Treatment: Other: placebo
placebo
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the reactogenicity of SCB-1019 vaccine
Timepoint [1] 0 0
Within 7 days after vaccination
Primary outcome [2] 0 0
Evaluate the unsolicited AEs of SCB-1019 vaccine
Timepoint [2] 0 0
Within 28 days after vaccination
Primary outcome [3] 0 0
Evaluate the SAEs, AESIs, MAAEs, AEs leading to early termination from the study of SCB-1019 vaccine
Timepoint [3] 0 0
Throughout the study period, from enrollment to 6 months follow up
Primary outcome [4] 0 0
Evaluate the safety and tolerability in hematology parameters of SCB-1019 vaccine
Timepoint [4] 0 0
Screening and Day 8
Primary outcome [5] 0 0
Evaluate the safety and tolerability in biochemistry parameters of SCB-1019 vaccine
Timepoint [5] 0 0
Screening and Day 8
Primary outcome [6] 0 0
Evaluate the safety and tolerability in coagulation parameters of SCB-1019 vaccine
Timepoint [6] 0 0
Screening and Day 8

Eligibility
Key inclusion criteria
* Male and female participants 18 to 59 years of age (Part 1) and 60 to 85 years of age (Part 2) at the screening visit.
* Individuals willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
* Individuals willing and able to give an informed consent, prior to screening.
* Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included (a stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment).
* Female of childbearing potential willing to use a highly effective contraceptive method from 30 days before until 90 days after vaccination and have a negative pregnancy test on the day of vaccination; males able to father children and willing to use a highly effective contractive method from vaccination up to 90 days after vaccination, and agree to refrain from donating sperm during this period.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Acute disease or fever (=38°C) at time of vaccination. Participants with a minor illness (mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. For participants with minor illness and/or fever at the time of vaccination, Visit 1 may be rescheduled within the allowed time-window.
* History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.
* Previous vaccination with an RSV vaccine at any time before vaccination (Day 1), or planned receipt during the study of a non-study RSV vaccine.
* Receipt of any other licensed vaccines within 14 days before vaccination (Day 1) or planned receipt of any vaccine up to 28 days after study vaccination (Day 29).
* Receipt of any other investigational product within 30 days before vaccination (Day 1) or intention to participate in another clinical study at any time during the conduct of this study.
* Any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant.
* Receipt of intravenous immunoglobulins and/or any blood products within 60 days before vaccination (Day 1) or planned administration during the study period.
* Individuals with positive test result for hepatitis B surface antigen, hepatitis C virus antibody, and/or human immunodeficiency virus types 1 or 2 antibodies at screening.
* Immunocompromised with known or suspected immunodeficiency, as determined by medical history and/or laboratory/physical examination (no laboratory testing required).
* Receipt of any immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g. for cancer, organ transplantation or autoimmune disease, within three months prior to vaccination or planned receipt during the study. If a short-term course of systemic corticosteroids (<14 days) has 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 28 days before study vaccination. Inhaled/nebulized, intraarticular, intrabursal, or topical (skin or eye) corticosteroids are permitted.
* Treatment with rituximab or any other anti-CD20 monoclonal antibodies within nine months prior to vaccination or planned during the study period.
* History of malignancy within one year before vaccination (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix which has been cured, or other malignancies with minimal risk of recurrence).
* Any screening safety laboratory values (hematology, biochemistry, coagulation, and urinalysis) that meet the definition of a =Grade 1 abnormality (according to the toxicity grading)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Southern AustraliaWA
Recruitment hospital [1] 0 0
Fusion Clinical Research - Adelaide
Recruitment hospital [2] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
5067 - Adelaide
Recruitment postcode(s) [2] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Clover Biopharmaceuticals AUS Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Rook, MD
Address 0 0
CMAX Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
xuesong pei, MD
Address 0 0
Country 0 0
Phone 0 0
18515445890
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06194318