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

May 18, 2026 updated by: Clover Biopharmaceuticals AUS Pty

A Phase 1/2, Randomized, Observer-blind, First-in-human Study to Describe the Safety, Reactogenicity and Immunogenicity of SCB-1022, a Combination Recombinant RSV-hMPV Protein Subunit Vaccine Candidate, and SCB-1033, a Combination Recombinant RSV-hMPV-PIV3 Protein Subunit Vaccine Candidate in Healthy Older Adults Aged 60-85 Years

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

612

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Southern Australia
      • Adelaide, Southern Australia, Australia, 5067
        • Fusion Clinical Research
    • Victoria
      • Melbourne, Victoria, Australia, 3070
        • Paratus Clinical Research
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Linear Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

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?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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
SCB-1022 (combination recombinant RSV-hMPV vaccine candidate) consists of three recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), and hMPV (SCB-1021).
Experimental: Group 2 (SCB-1022 dose level 2)
24 adults to receive dose level 2 of SCB-1022 at Day 1
Biological: SCB-1022
SCB-1022 (combination recombinant RSV-hMPV vaccine candidate) consists of three recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), and hMPV (SCB-1021).
Experimental: Group 3 (SCB-1033 dose level 1)
24 adults to receive dose level 1 of SCB-1033 at Day 1
Biological: SCB-1033
SCB-1033 (combination recombinant RSV-hMPV-PIV3 vaccine candidate) consists of four recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), hMPV (SCB-1021) and PIV3 (SCB-1020).
Active Comparator: Group 4 (SCB-1019T)
24 adults to receive SCB-1019T at Day 1
Biological: SCB-1019T
SCB-1019T (bivalent recombinant RSV vaccine candidate) consists of two recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)) and RSV B strain (SCB-1019T(B)).
Experimental: Group 5 (SCB-1022 dose level 3)
24 adults to receive dose level 3 of SCB-1022 at Day 1
Biological: SCB-1022
SCB-1022 (combination recombinant RSV-hMPV vaccine candidate) consists of three recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), and hMPV (SCB-1021).
Experimental: Group 6 (SCB-1033 dose level 2)
24 adults to receive dose level 2 of SCB-1033 at Day 1
Biological: SCB-1033
SCB-1033 (combination recombinant RSV-hMPV-PIV3 vaccine candidate) consists of four recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), hMPV (SCB-1021) and PIV3 (SCB-1020).
Experimental: Group 7 (SCB-1033 dose level 3)
24 adults to receive dose level 3 of SCB-1033 at Day 1
Biological: SCB-1033
SCB-1033 (combination recombinant RSV-hMPV-PIV3 vaccine candidate) consists of four recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), hMPV (SCB-1021) and PIV3 (SCB-1020).
Active Comparator: Group 8 (SCB-1019T)
24 adults to receive SCB-1019T at Day 1
Biological: SCB-1019T
SCB-1019T (bivalent recombinant RSV vaccine candidate) consists of two recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)) and RSV B strain (SCB-1019T(B)).
Experimental: Group 9 (SCB-1022 Formulation 1)
105 adults to receive formulation 1 of SCB-1022 at Day 1
Biological: SCB-1022
SCB-1022 (combination recombinant RSV-hMPV vaccine candidate) consists of three recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), and hMPV (SCB-1021).
Experimental: Group 10 (SCB-1022 Formulation 2)
105 adults to receive formulation 2 of SCB-1022 at Day 1
Biological: SCB-1022
SCB-1022 (combination recombinant RSV-hMPV vaccine candidate) consists of three recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), and hMPV (SCB-1021).
Experimental: Group 11 (SCB-1033)
105 adults to receive SCB-1033 at Day 1
Biological: SCB-1033
SCB-1033 (combination recombinant RSV-hMPV-PIV3 vaccine candidate) consists of four recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), hMPV (SCB-1021) and PIV3 (SCB-1020).
Experimental: Group 12 Placebo (saline)
105 adults to receive placebo at Day 1
Biological: Placebo (saline)
0.9% saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T (Part 1 and Part 2) or Placebo (Part 3).
Time Frame: Within 7 days after vaccination
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 (Part 1 and Part 2) or Placebo (Part 3).
Time Frame: Within 28 days after vaccination
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 (Part 1 and Part 2) or placebo (Part 3).
Time Frame: Throughout the study period, from enrollment up to 2 years follow-up
Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
Throughout the study period, from enrollment up to 2 years follow-up
To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2).
Time Frame: Screening and day 8
Mean change and shift from baseline in hematology, biochemistry and coagulation parameters; by safety set.
Screening and day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clover Biopharmaceuticals AUS Pty

Investigators

  • Principal Investigator: Christopher D Rook, MD, Fusion Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

May 14, 2025

First Submitted That Met QC Criteria

May 14, 2025

First Posted (Actual)

May 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLO-SCB-1033-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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