Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults

Clover Biopharmaceuticals AUS Pty

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: RSV Infection; Human Metapneumovirus Infection; Parainfluenza Infection

Treatments: Biological: SCB-1033; Biological: Placebo (saline); Biological: SCB-1019T; Biological: SCB-1022

Study type: Interventional

Funder types: Industry

Identifiers

NCT06984094

CLO-SCB-1033-001

Details and patient eligibility

About

This phase 1/2 study will evaluate the safety, reactogenicity and immunogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Parts 1 and 2) or Placebo (Part 3).

Full description

In Part 1 and Part 2, the study will descriptively evaluate three dose levels of SCB-1022 and SCB-1033. Part 3 will descriptively compare SCB-1022 and SCB-1033 against placebo.

The sample size of this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1/2 study. The study will be overseen by a safety monitoring committee.

Enrollment: 612 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female participants 60 to 85 years of age 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.

Please refer to Protocol for full list of Inclusion and Exclusion criteria.

Exclusion criteria

• Pregnancy or potential to become pregnant during the study.
• Acute disease or fever (≥38°C) at time of vaccination.
• History of Guillain-Barré Syndrome (GBS).
• Recurrent or un-controlled neurological disorders or seizures.
• Serious or unstable chronic illnesses. Please refer to Protocol for full list of Inclusion and Exclusion criteria.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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612 participants in 12 patient groups

Group 1 (SCB-1022 dose level 1)

Experimental group

Description:

24 adults to receive dose level 1 of SCB-1022 at Day 1

Treatment:

Biological: SCB-1022

Group 2 (SCB-1022 dose level 2)

Experimental group

Description:

24 adults to receive dose level 2 of SCB-1022 at Day 1

Treatment:

Biological: SCB-1022

Group 3 (SCB-1033 dose level 1)

Experimental group

Description:

24 adults to receive dose level 1 of SCB-1033 at Day 1

Treatment:

Biological: SCB-1033

Group 4 (SCB-1019T)

Active Comparator group

Description:

24 adults to receive SCB-1019T at Day 1

Treatment:

Biological: SCB-1019T

Group 5 (SCB-1022 dose level 3)

Experimental group

Description:

24 adults to receive dose level 3 of SCB-1022 at Day 1

Treatment:

Biological: SCB-1022

Group 6 (SCB-1033 dose level 2)

Experimental group

Description:

24 adults to receive dose level 2 of SCB-1033 at Day 1

Treatment:

Biological: SCB-1033

Group 7 (SCB-1033 dose level 3)

Experimental group

Description:

24 adults to receive dose level 3 of SCB-1033 at Day 1

Treatment:

Biological: SCB-1033

Group 8 (SCB-1019T)

Active Comparator group

Description:

24 adults to receive SCB-1019T at Day 1

Treatment:

Biological: SCB-1019T

Group 9 (SCB-1022 Formulation 1)

Experimental group

Description:

105 adults to receive formulation 1 of SCB-1022 at Day 1

Treatment:

Biological: SCB-1022

Group 10 (SCB-1022 Formulation 2)

Experimental group

Description:

105 adults to receive formulation 2 of SCB-1022 at Day 1

Treatment:

Biological: SCB-1022

Group 11 (SCB-1033)

Experimental group

Description:

105 adults to receive SCB-1033 at Day 1

Treatment:

Biological: SCB-1033

Group 12 Placebo (saline)

Experimental group

Description:

105 adults to receive placebo at Day 1

Treatment:

Biological: Placebo (saline)