NCT05581407

Safety, Tolerability, and Immunogenicity of TETRALITE, a Novel Adjuvanted, Low-dose Influenza Vaccin

A Randomized First-in-human, Observer-blind, 3-arm Study to Evaluate Safety, Tolerability, and Immunogenicity of a Single Administration of TETRALITE, a Novel Adjuvanted, Low-dose Influenza Vaccine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: LiteVax BV · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

There is an obvious need for an affordable and more effective seasonal influenza vaccine. TETRALITE is a novel, inactivated, adjuvanted influenza vaccine combining a low dose of a licensed vaccine with the novel, potent LiteVax Adjuvant. A licensed vaccine (Cohort 1) with a normal dose \[15 ug per strain\] and no adjuvant will be compared with two TETRALITE study vaccines with 1/5th of the licensed vaccine added with a low (Cohort 2) or high (Cohort 3) dose of LiteVax Adjuvant.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	TETRALITE	LiteVax Adjuvanted Seasonal Influenza Vaccine

Timeline

• Start date: 2022-10-03
• Primary completion: 2023-08-03
• Completion: 2023-10-23
• First posted: 2022-10-14
• Last updated: 2024-01-25

Locations

1 site across 1 country: Belgium