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

Clover Biopharmaceuticals AUS Pty

Status and phase: Enrolling; Phase 1

Conditions: Human Metapneumovirus Vaccination; Parainfluenza Vaccination; Respiratory Syncytial Virus Vaccination

Treatments: Biological: SCB-1022; Biological: SCB-1019T; Biological: SCB-1033

Study type: Interventional

Funder types: Industry

Identifiers

NCT06984094

CLO-SCB-1033-001

Details and patient eligibility

About

This phase 1 study will evaluate the safety, reactogenicity, and immunogenicity of 3 different dose levels of SCB-1022 and SCB-1033 in healthy adults aged 60-85 years.

Full description

The study will descriptively evaluate three dose levels of SCB-1022 and SCB-1033. 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. The study will be overseen by a safety monitoring committee.

Enrollment: 192 estimated patients

Sex: All

Ages: 65 to 80 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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192 participants in 8 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