First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults

Clover Biopharmaceuticals AUS Pty

Status and phase: Completed; Phase 1

Conditions: Respiratory Syncytial Virus Vaccination

Treatments: Biological: candidate vaccine, SCB-1019T; Biological: AREXVY; Biological: placebo; Biological: Candidate vaccine, SCB-1019

Study type: Interventional

Funder types: Industry

Identifiers

NCT06194318

CLO-SCB-1019-001

Details and patient eligibility

About

First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults

Full description

A Phase 1, placebo-controlled, randomized, observer-blind, First-in-human Study to describe the Safety, reactogenicity and immunogenicity of a bivalent recombinant RSV vaccines (SCB-1019 and SCB-1019T) in healthy adults

Enrollment: 160 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male and female participants 60 to 85 years of age at the screening visit.
2. Individuals willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
3. 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.

Exclusion criteria

1. Acute disease or fever (≥38°C) at time of vaccination.
2. History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.
3. Any progressive unstable or uncontrolled clinical conditions.
4. Any progressive or severe neurologic disorder, seizure disorder, or history of Guillain-Barré syndrome.

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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160 participants in 14 patient groups, including a placebo group

group 1 (SCB-1019 low dose with Alum; young adults)

Experimental group

Description:

4 young adults (18-59 years old) will receive SCB-1019 (Low Dose with Alum) at Day 1

Treatment:

Biological: Candidate vaccine, SCB-1019

group 2 (Placebo; young adults)

Placebo Comparator group

Description:

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

Treatment:

Biological: placebo

group 3 (SCB-1019 high dose with Alum; Young Adults)

Experimental group

Description:

4 young adults (18-59 years old) will receive SCB-1019 (high dose with Alum) at Day 1

Treatment:

Biological: Candidate vaccine, SCB-1019

group 4 (Placebo; young adults)

Placebo Comparator group

Description:

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

Treatment:

Biological: placebo

group 5 (SCB-1019 low dose without Alum; older adults)

Experimental group

Description:

10 older adults (60-85 years old) will receive SCB-1019 (low dose without Alum) at Day 1

Treatment:

Biological: Candidate vaccine, SCB-1019

group 6 (SCB-1019 low dose with Alum; older adults)

Experimental group

Description:

10 older adults (60-85 years old) will receive SCB-1019 (low dose with Alum) at Day 1

Treatment:

Biological: Candidate vaccine, SCB-1019

group 7 (Placebo; older adults)

Placebo Comparator group

Description:

4 older adults (60-85 years old) will receive Placebo at Day 1

Treatment:

Biological: placebo

group 8 (SCB-1019 high dose without Alum; older adults)

Experimental group

Description:

10 older adults (60-85 years old) will receive SCB-1019 (high dose without Alum) at Day 1

Treatment:

Biological: Candidate vaccine, SCB-1019

group 9 (SCB-1019 high dose with Alum; older adults)

Experimental group

Description:

10 older adults (60-85 years old) will receive SCB-1019 (high dose with Alum) at Day 1

Treatment:

Biological: Candidate vaccine, SCB-1019

group 10 (Placebo; older adults)

Placebo Comparator group

Description:

4 older adults (60-85 years old) will receive Placebo at Day 1

Treatment:

Biological: placebo

Group 11 (SCB-1019T high dose without Alum; older adults)

Experimental group

Description:

30 older adults (60-85 years old) will receive SCB-1019T (high dose without Alum) at Day

Treatment:

Biological: candidate vaccine, SCB-1019T

Group 12 (AREXVY; older adults)

Active Comparator group

Description:

30 older adults (60-85 years old) will receive AREXVY at Day 1

Treatment:

Biological: AREXVY

Group 13 (Placebo; older adults)

Placebo Comparator group

Description:

10 older adults (60-85 years old) will receive Placebo at Day 1

Treatment:

Biological: placebo

Group 14 (SCB-1019T mid dose with Alum; older adults)

Experimental group

Description:

30 older adults (60-85 years old) will receive SCB-1019T (mid dose with Alum) at Day 1

Treatment:

Biological: candidate vaccine, SCB-1019T