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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06666179




Registration number
NCT06666179
Ethics application status
Date submitted
29/10/2024
Date registered
30/10/2024

Titles & IDs
Public title
Safety and Immunogenicity Study of SCB-1019T in Children
Scientific title
A Phase 1, Placebo-controlled, Randomized, Observer-blind Study to Describe the Safety, Reactogenicity and Immunogenicity of a Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) in Children 2 to <6 Years of Age
Secondary ID [1] 0 0
CLO-SCB-1019-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
RSV 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 - SCB-1019T 90 µg
Treatment: Other - SCB-1019T 90 µg + Alum
Treatment: Other - SCB-1019T 180 µg
Treatment: Other - SCB-1019T 180 µg + Alum
Other interventions - Placebo

Experimental: Group 1 (SCB-1019T 90 µg) - 24 children (2-\<6 years of age) will receive low-dose unadjuvanted SCB-1019T (90 µg) at Day 1

Experimental: Group 2 (SCB-1019T 90 µg + Alum) - 24 children (2-\<6 years of age) will receive low-dose alum-adjuvanted SCB-1019T (90 µg) at Day 1

Placebo comparator: Group 3 (Placebo) - 8 children (2-\<6 years of age) will receive 0.9% NaCl saline placebo at Day 1

Experimental: Group 4 (SCB-1019T 180 µg) - 24 children (2-\<6 years of age) will receive high-dose unadjuvanted SCB-1019T (180 µg) at Day 1

Experimental: Group 5 (SCB-1019T 180 µg + Alum) - 24 children (2-\<6 years of age) will receive high-dose alum-adjuvanted SCB-1019T (180 µg) at Day 1

Placebo comparator: Group 6 (Placebo) - 8 children (2-\<6 years of age) will receive 0.9% NaCl saline placebo at Day 1


Treatment: Other: SCB-1019T 90 µg
l Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) designed to broadly neutralize the two dominant circulating strains of the virus. The SCB-1019T vaccine consists of the F glycoprotein subunits, stabilized in the prefusion conformation, from the two circulating strains, strain A and strain B, fused to Trimer-Tag™.

Treatment: Other: SCB-1019T 90 µg + Alum
l Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) designed to broadly neutralize the two dominant circulating strains of the virus. The SCB-1019T vaccine consists of the F glycoprotein subunits, stabilized in the prefusion conformation, from the two circulating strains, strain A and strain B, fused to Trimer-Tag™.

Treatment: Other: SCB-1019T 180 µg
l Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) designed to broadly neutralize the two dominant circulating strains of the virus. The SCB-1019T vaccine consists of the F glycoprotein subunits, stabilized in the prefusion conformation, from the two circulating strains, strain A and strain B, fused to Trimer-Tag™.

Treatment: Other: SCB-1019T 180 µg + Alum
l Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) designed to broadly neutralize the two dominant circulating strains of the virus. The SCB-1019T vaccine consists of the F glycoprotein subunits, stabilized in the prefusion conformation, from the two circulating strains, strain A and strain B, fused to Trimer-Tag™.

Other interventions: Placebo
0.9% NaCl saline placebo
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the reactogenicity of SCB-1019T vaccine
Timepoint [1] 0 0
Within 7 days after vaccination
Primary outcome [2] 0 0
Evaluate the safety and tolerability of SCB-1019T vaccine
Timepoint [2] 0 0
Within 28 days after vaccination
Primary outcome [3] 0 0
Evaluate the safety and tolerability of SCB-1019T vaccine
Timepoint [3] 0 0
Throughout the study period, from enrollment to 6 months follow up

Eligibility
Key inclusion criteria
* Male and female participants 2 to <6 years of age at Visit 1.
* Parents/guardians of participants willing and able to provide written informed consent and comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
* 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).
* Growing normally for age and has a current height and weight above the 3 rd percentile for age as demonstrated on a WHO growth chart.
* Has received routine immunizations appropriate for age as per local recommendation.
Minimum age
24 Months
Maximum age
71 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Acute disease or fever (=38°C) at time of vaccination. For participants with minor illness and/or fever at the time of vaccination, Visit 1 may be rescheduled.
* Evidence of chronic diseases including hepatitis, bleeding disorders, metabolic diseases, autoimmune diseases, neurological conditions that impair respiratory functions, genetic disorders that increase the risk of severe respiratory diseases, major congenital malformations, cardiac and lung diseases or reactive airway diseases.
* Wheezing episode or received bronchodilator therapy within the past 12 months. • Prior hospitalization for RSV disease in the last two years.
* Any history of febrile seizures.
* History of epilepsy.
* Suspected or documented developmental disorders or delay and other developmental issues.
* 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 investigational RSV vaccine at any time before vaccination (Day 1), or planned receipt during the study.
* 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 investigational or approved monoclonal antibodies against RSV within 12 months before vaccination (Day 1), or planned receipt throughout the study.
* 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.
* Immunocompromised with known or suspected immunodeficiency, as determined by medical history and/or laboratory/physical examination (no laboratory testing required).
* Administration of immune-modifying therapy within 6 months before the study vaccination, or planned administration during the conduct of this study.
* Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.

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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
112
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
The Kids Research Institute - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Xuesong Pei
Address 0 0
Country 0 0
Phone 0 0
+86 185-1544-5890
Fax 0 0
Email 0 0
xuesong.pei@cloverbiopharma.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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/NCT06666179