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Active, Not Recruiting

NCT Number: NCT06984094

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

RSV Infection Human Metapneumovirus Infection Infections Mononegavirales Infections Parainfluenza Infection Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fusion Clinical Research, Adelaide, Southern Australia, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SCB-1019T

Biological

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)).

SCB-1022

Biological

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).

SCB-1033

Biological

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).

Placebo (Saline)

Biological

0.9% saline

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Clover Biopharmaceuticals AUS Pty

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 22, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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