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

Phase 2Active Not RecruitingNCT06984094

Clover Biopharmaceuticals AUS Pty612 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

612

Conditions

RSV Infection Human Metapneumovirus Infection Parainfluenza Infection

Interventions

SCB-1019TBIOLOGICAL

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-1022BIOLOGICAL

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-1033BIOLOGICAL

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).

Eligibility

Sex: ALLMin age: 60 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Fusion Clinical Research

Adelaide, Southern Australia, Australia

Paratus Clinical Research

Melbourne, Victoria, Australia

Linear Clinical Research

Perth, Western Australia, Australia

Outcomes

Primary Outcomes

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).

Proportion of participants with local and systemic solicited AEs

Time frame: 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).

Proportion of participants with unsolicited AEs

Time frame: 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).

Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study

Time frame: 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).

Mean change and shift from baseline in hematology, biochemistry and coagulation parameters; by safety set.

Time frame: Screening and day 8

Data from ClinicalTrials.gov

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