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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-18

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Respiratory Syncytial Virus Vaccination Human Metapneumovirus Vaccination Parainfluenza Vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1 (SCB-1022 dose level 1)

24 adults to receive dose level 1 of SCB-1022 at Day 1

Group Type EXPERIMENTAL

SCB-1022

Intervention Type 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).

Group 2 (SCB-1022 dose level 2)

24 adults to receive dose level 2 of SCB-1022 at Day 1

Group Type EXPERIMENTAL

SCB-1022

Intervention Type 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).

Group 3 (SCB-1033 dose level 1)

24 adults to receive dose level 1 of SCB-1033 at Day 1

Group Type EXPERIMENTAL

SCB-1033

Intervention Type 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).

Group 4 (SCB-1019T)

24 adults to receive SCB-1019T at Day 1

Group Type ACTIVE_COMPARATOR

SCB-1019T

Intervention Type 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)).

Group 5 (SCB-1022 dose level 3)

24 adults to receive dose level 3 of SCB-1022 at Day 1

Group Type EXPERIMENTAL

SCB-1022

Intervention Type 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).

Group 6 (SCB-1033 dose level 2)

24 adults to receive dose level 2 of SCB-1033 at Day 1

Group Type EXPERIMENTAL

SCB-1033

Intervention Type 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).

Group 7 (SCB-1033 dose level 3)

24 adults to receive dose level 3 of SCB-1033 at Day 1

Group Type EXPERIMENTAL

SCB-1033

Intervention Type 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).

Group 8 (SCB-1019T)

24 adults to receive SCB-1019T at Day 1

Group Type ACTIVE_COMPARATOR

SCB-1019T

Intervention Type 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)).

Interventions

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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)).

Intervention Type 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).

Intervention Type 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).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes