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

Sponsor
Aramis Biotechnologies Inc.
Study ID
NCT07291635
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Recombinant Influenza vaccine candidate — BIOLOGICAL
    Plant-Based Seasonal Recombinant Trivalent TVLP Influenza Vaccine
  • Commercial Influenza vaccine — BIOLOGICAL
    Influenza vaccine commercially available on the Canadian market

Study Details

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.

Key Dates

First listed
Dec 18, 2025
Start date
Feb 25, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
728 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group 1 (18-64): 15 μg
  • Experimental: Group 2 (18-64): 30 μg
  • Experimental: Group 3 (18-64): 60 μg
  • Active Comparator: Group 4 (18-64): STD TIV
  • Experimental: Group 5 (65+): 30 μg
  • Experimental: Group 6 (65+): 60 μg
  • Active Comparator: Group 7 (65+): HD TIV

Primary Outcome Measure

Immediate AEs [ Time Frame: 30 minutes ]

Central Contacts

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