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Safety and Immunogenicity Study of SCB-1019T in Children

PHASE1NOT_YET_RECRUITING

This phase 1 study in Australia will evaluate the safety, reactogenicity and immunogenicity of the Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) in children 2-\<6 years of age.

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Study details:

This Phase 1 randomized, placebo-controlled, observer-blind study will evaluate the safety, reactogenicity and immunogenicity of 4 formulations of SCB-1019T vaccine at 2 escalating doses of 90 µg (low dose) and 180 µg (high dose) in children 2-\<6 years of age. Participants will receive the investigational vaccines outside of the RSV season if there is a clearly defined RSV season. A placebo is used as a control in the study because there is no licensed RSV comparator vaccine available for young children globally.

The sample size for this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1 study and decision-making to further pursue the clinical development of SCB-1019T.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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.

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Eligibility

Age eligible for study : 24 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2025-03-15

Primary completion: 2026-01-01

Study completion finish: 2026-06-01

Study type

PREVENTION

Phase

PHASE1

Trial ID

NCT06666179

Intervention or treatment

BIOLOGICAL: SCB-1019T 90 µg

BIOLOGICAL: SCB-1019T 90 µg + Alum

BIOLOGICAL: SCB-1019T 180 µg

BIOLOGICAL: SCB-1019T 180 µg + Alum

OTHER: Placebo

Conditions

• RSV Infection

Condition: RSV Infection
BIOLOGICAL: SCB-1019T 90 µg and other drugs
Perth, Western Australia, Australia
Sponsor: Clover Biopharmaceuticals AUS Pty Ltd

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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Find a site

Closest Location:

The Kids Research Institute

Research sites nearby

Select from list below to view details:

The Kids Research Institute
Perth, Western Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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	BIOLOGICAL: 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™.
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	BIOLOGICAL: 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™.
PLACEBO_COMPARATOR: Group 3 (Placebo) 8 children (2-\<6 years of age) will receive 0.9% NaCl saline placebo at Day 1	OTHER: Placebo 0.9% NaCl saline placebo
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	BIOLOGICAL: 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™.
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	BIOLOGICAL: 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™.
PLACEBO_COMPARATOR: Group 6 (Placebo) 8 children (2-\<6 years of age) will receive 0.9% NaCl saline placebo at Day 1	OTHER: Placebo 0.9% NaCl saline placebo

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Evaluate the reactogenicity of SCB-1019T vaccine	Porportion of participants with local and systemic solicied AEs	Within 7 days after vaccination
Evaluate the safety and tolerability of SCB-1019T vaccine	Porportions of participants with unsolicited AEs	Within 28 days after vaccination
Evaluate the safety and tolerability of SCB-1019T vaccine	Porportions of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study	Throughout the study period, from enrollment to 6 months follow up

Secondary outcome

Frequently Asked Questions

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References

Clinical Trials Gov: Safety and Immunogenicity Study of SCB-1019T in Children