NCT05035680

Proof of Concept Trial of Adjuvant Activity of SWE, a Squalene-based -Oil-in-water Emulsion

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Gates Medical Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to characterize safety and tolerability of the squalene-based adjuvant candidate SWE and its potential to enhance the immune response to seasonal influenza vaccine antigens in healthy older adults.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Unadjuvanted seasonal influenza vaccine	Single 0.5 mL IM injection
BIOLOGICAL	SWE adjuvant mixed with unadjuvanted seasonal influenza vaccine shortly before dosing (SWE + QIV)	Single 0.8 mL IM injection
BIOLOGICAL	MF59 adjuvanted seasonal influenza vaccine	Single 0.5 mL IM injection of MF59 adjuvanted seasonal influenza vaccine

Timeline

• Start date: 2022-07-14
• Primary completion: 2023-03-25
• Completion: 2023-11-25
• First posted: 2021-09-05
• Last updated: 2022-11-17