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Safety, Reactogenicity, and Immunogenicity Study of a Self-Amplifying MRNA Influenza Vaccine in Healthy Adults

NCT ID: NCT06028347

Last Updated: 2024-11-27

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-05

Study Completion Date

2024-10-13

Brief Summary

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This is a Phase 1, first-in-human, randomized, placebo-controlled, observer blind study. The effect of two doses of an investigational vaccine on safety, reactogenicity, kinetics and magnitude of the post-vaccination antibody response will be evaluated at different timepoints as compared to placebo in healthy adults.

Approximately 96 evaluable subjects will be enrolled in this study; n=72 receiving investigational vaccine and n=24 receiving placebo.

The study has a screening period (Day -28 to Day -1), a treatment period (Day 1 to Day 43) and a follow-up period (Day 44 to Day 202).

Detailed Description

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Conditions

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Influenza, Human

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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sa-mRNA vaccine dose 1

Group Type EXPERIMENTAL

sa-mRNA vaccine Dose 1

Intervention Type BIOLOGICAL

self-amplifying mRNA vaccine

sa-mRNA vaccine dose 2

Group Type EXPERIMENTAL

sa-mRNA vaccine Dose 2

Intervention Type BIOLOGICAL

self-amplifying mRNA vaccine

sa-mRNA vaccine dose 3

Group Type EXPERIMENTAL

sa-mRNA vaccine Dose 3

Intervention Type BIOLOGICAL

self-amplifying mRNA vaccine

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Saline for injection

Interventions

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sa-mRNA vaccine Dose 1

self-amplifying mRNA vaccine

Intervention Type BIOLOGICAL

sa-mRNA vaccine Dose 2

self-amplifying mRNA vaccine

Intervention Type BIOLOGICAL

sa-mRNA vaccine Dose 3

self-amplifying mRNA vaccine

Intervention Type BIOLOGICAL

Placebo

Saline for injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Individuals 18 to 49 years of age OR 65 to 85 years of age, inclusive on the day of informed consent.
2. Individuals with body mass index (BMI) between 18 and 32 kg/m2, inclusive, at screening .
3. Individuals who can comply with study procedures including follow-up .

Exclusion Criteria

1. Female participants of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of highly effective contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so for the duration of the study.
2. Male participants who have not adhered to using barrier contraception such as a condom during at least 60 days after each vaccination, to prevent semen transfer to their sexual partners and prevent pregnancy of a female partner.
3. Progressive, unstable, or uncontrolled clinical conditions
4. Known hypersensitivity or allergy to any study vaccine component
5. Known history of Guillain-Barré syndrome or other demyelinating disease
6. Condition representing a contraindication to vaccination or blood draw
7. Abnormal function of immune system due to clinical condition, medications, or radiotherapy.
8. Receipt or planning to receive blood products, non-study vaccine, influenza vaccine, mRNA-platform vaccine within different timeframes; previous or from study vaccination.
9. Baseline abnormal clinically significant ECG, laboratory safety parameters or vital signs.
10. Plan to donate blood products (other than for this study), sperm, ova, tissues, or organs up to 60 days following the last vaccination.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seqirus

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Program Director

Role: STUDY_DIRECTOR

Seqirus

Locations

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Nucleus Network Brisbane Clinic

Brisbane, Queensland, Australia

Site Status

Nucleus network Melbourne Clinic

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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V202_01

Identifier Type: -

Identifier Source: org_study_id