NCT07291635

Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine

A Randomized, Observer-Blind, Adaptive, Active Comparator-Controlled, Dose-Ranging, Multicenter, Safety, Tolerability, and Immunogenicity Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine in Adults 18 Years of Age and Older

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 728 (estimated)
• Sponsor: Aramis Biotechnologies Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This Phase 1/2 study is intended to assess the safety, tolerability, and immunogenicity of recombinant TVLP in adults 18-64 and 65 years of age and above and to confirm the dose(s) to be developed further in these two age cohorts.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Influenza vaccine candidate	Plant-Based Seasonal Recombinant Trivalent TVLP Influenza Vaccine
BIOLOGICAL	Commercial Influenza vaccine	Influenza vaccine commercially available on the Canadian market

Timeline

• Start date: 2026-02-25
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2025-12-18
• Last updated: 2026-03-13

Locations

7 sites across 1 country: Canada