NCT06028347

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

Phase 1, Randomized, Placebo-Controlled, Observer Blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an Investigational Self-Amplifying MRNA Influenza Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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).

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	sa-mRNA vaccine Dose 1	self-amplifying mRNA vaccine
BIOLOGICAL	sa-mRNA vaccine Dose 2	self-amplifying mRNA vaccine
BIOLOGICAL	sa-mRNA vaccine Dose 3	self-amplifying mRNA vaccine
BIOLOGICAL	Placebo	Saline for injection

Timeline

• Start date: 2023-10-05
• Primary completion: 2024-10-13
• Completion: 2024-10-13
• First posted: 2023-09-08
• Last updated: 2024-11-27

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study