Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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

PHASE1PHASE2ACTIVE_NOT_RECRUITING

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).

Study details:

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.

Eligibility criteria

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

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.

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.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

PREVENTION

Phase

PHASE1PHASE2

Study ID

NCT06984094

Intervention or treatment

BIOLOGICAL: SCB-1019T

BIOLOGICAL: SCB-1022

BIOLOGICAL: SCB-1033

Conditions

RSV Infection
Human Metapneumovirus Infection
Parainfluenza Infection

Condition: RSV Infection, Human Metapneumovirus Infection and more
BIOLOGICAL: SCB-1019T and other drugs
Adelaide, Southern Australia, Australia
Sponsor: Clover Biopharmaceuticals AUS Pty

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If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Fusion Clinical Research

Select from list below to view details:

Fusion Clinical Research
Adelaide, Southern Australia, Australia

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Who is running the clinical trial?

CBAP

Clover Biopharmaceuticals AUS Pty

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-1022 dose level 1) 24 adults to receive dose level 1 of SCB-1022 at Day 1	Biological: SCB-1022
EXPERIMENTAL: Group 2 (SCB-1022 dose level 2) 24 adults to receive dose level 2 of SCB-1022 at Day 1	Biological: SCB-1022
EXPERIMENTAL: Group 3 (SCB-1033 dose level 1) 24 adults to receive dose level 1 of SCB-1033 at Day 1	Biological: SCB-1033
ACTIVE_COMPARATOR: Group 4 (SCB-1019T) 24 adults to receive SCB-1019T at Day 1	Biological: SCB-1019T
EXPERIMENTAL: Group 5 (SCB-1022 dose level 3) 24 adults to receive dose level 3 of SCB-1022 at Day 1	Biological: SCB-1022
EXPERIMENTAL: Group 6 (SCB-1033 dose level 2) 24 adults to receive dose level 2 of SCB-1033 at Day 1	Biological: SCB-1033
EXPERIMENTAL: Group 7 (SCB-1033 dose level 3) 24 adults to receive dose level 3 of SCB-1033 at Day 1	Biological: SCB-1033
ACTIVE_COMPARATOR: Group 8 (SCB-1019T) 24 adults to receive SCB-1019T at Day 1	Biological: SCB-1019T
EXPERIMENTAL: Group 9 (SCB-1022 Formulation 1) 105 adults to receive formulation 1 of SCB-1022 at Day 1	Biological: SCB-1022
EXPERIMENTAL: Group 10 (SCB-1022 Formulation 2) 105 adults to receive formulation 2 of SCB-1022 at Day 1	Biological: SCB-1022
EXPERIMENTAL: Group 11 (SCB-1033) 105 adults to receive SCB-1033 at Day 1	Biological: SCB-1033
EXPERIMENTAL: Group 12 Placebo (saline) 105 adults to receive placebo at Day 1	Biological: Placebo (saline)

What is the study measuring?

Primary Outcome

Measure	Description	Time Frame
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.	Proportion of participants with local and systemic solicited AEs	Within 7 days after vaccination
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.	Proportion of participants with unsolicited AEs	Within 28 days after vaccination
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.	Proportion 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
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.	Mean change and shift from baseline in hematology, biochemistry and coagulation parameters; by safety set.	Screening and day 8

Secondary Outcome

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References

Clinical Trials Gov: First-in-human Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults

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