Clinical trial NCT06984094: First-in-human Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
Official title: A Phase 1, Randomized, Observer-blind, First-in-human Study to Describe the Safety, Reactogenicity and Immunogenicity of SCB-1022 and SCB-1033 in Healthy Older Adults Aged 60-85 Years
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Vaccination
Human Metapneumovirus Vaccination
Parainfluenza Vaccination
Keywords: Respiratory Syncytial Virus vaccination
Human Matapneumovirus vaccination
Parainfluenza vaccination
healthy volunteers
Lead sponsor: Clover Biopharmaceuticals, Ltd
Sponsor class: INDUSTRY
First posted: 2025-05-22
Enrollment: 192
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.
timeFrame: Within 7 days after vaccination
measure: To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.
timeFrame: Within 28 days after vaccination
measure: To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.
timeFrame: Throughout the study period, from enrollment to 6 months follow up
measure: To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.
timeFrame: Screening and day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Fusion Clinical Research
state: Southern Australia
Study officials:
affiliation: Fusion Clinical Research
name: Christopher D Rook, MD
role: PRINCIPAL_INVESTIGATOR
References: