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

Last updated: November 26, 2024
Sponsor: Seqirus
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

sa-mRNA vaccine Dose 3

sa-mRNA vaccine Dose 4

sa-mRNA vaccine Dose 1

Clinical Study ID

NCT06028347
V202_01
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Individuals 18 to 49 years of age OR 65 to 85 years of age, inclusive on the day ofinformed consent.

  2. Individuals with body mass index (BMI) between 18 and 32 kg/m2, inclusive, atscreening .

  3. Individuals who can comply with study procedures including follow-up .

Exclusion

Exclusion Criteria:

  1. Female participants of childbearing potential who are pregnant, lactating, or whohave not adhered to a specified set of highly effective contraceptive methods fromat least 30 days prior to informed consent and who do not plan to do so for theduration of the study.

  2. Male participants who have not adhered to using barrier contraception such as acondom during at least 60 days after each vaccination, to prevent semen transfer totheir 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, orradiotherapy.

  8. Receipt or planning to receive blood products, non-study vaccine, influenza vaccine,mRNA-platform vaccine within different timeframes; previous or from studyvaccination.

  9. Baseline abnormal clinically significant ECG, laboratory safety parameters or vitalsigns.

  10. Plan to donate blood products (other than for this study), sperm, ova, tissues, ororgans up to 60 days following the last vaccination.

Study Design

Total Participants: 96
Treatment Group(s): 5
Primary Treatment: sa-mRNA vaccine Dose 3
Phase: 1
Study Start date:
October 05, 2023
Estimated Completion Date:
October 13, 2024

Connect with a study center

  • Nucleus Network Brisbane Clinic

    Brisbane, Queensland 4006
    Australia

    Site Not Available

  • Nucleus network Melbourne Clinic

    Melbourne, Victoria 3004
    Australia

    Site Not Available

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