NCT06460064

First-in-human Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine fH1/DSP-0546LP

A Single Center, Randomized, Double-blind, Placebo-controlled, First-in-human Phase 1 Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine "fH1/DSP-0546LP" After Intramuscular (IM) Administrations in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Sumitomo Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study is a single center, randomized, double-blind, placebo-controlled, dose-finding, FIH, Phase 1 study to assess the safety, tolerability, and immunogenicity of the adjuvanted Universal Influenza Vaccine (fH1/DSP-0546LP) after IM administrations in healthy adults.

Detailed description

This will be a single center, randomized, placebo-controlled, double-blind study. In this study, safety, tolerability, and immunogenicity of fH1 formulated with DSP-0546LP will be assessed after IM administration in healthy adults aged 18 to 40 years. This study includes 6 cohorts, with a combination of 2 dose levels of fH1 (2 and 8 μg), 3 dose levels of DSP-0546LP (2.5, 5, and 10 μg), and placebo. Each dose level of fH1 will be combined with the low, medium, and high dose level of DSP-0546LP. Subjects will receive 2 administrations at 3-week intervals. Randomized subjects will undergo 11 visits including screening, 2 administration visits (Day 1 and Day 22 \[± 2\]), and follow-up visits on Day 4 (+1) (telephone contact), Day 8 (± 1), Day 25 (+1) (telephone contact), Day 29 (± 1), Day 36 (± 2), Day 50 (± 4), Day 204 (± 7), and Day 386 (± 10).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	fH1 2 ug	2 administrations at 3-week intervals.
BIOLOGICAL	fH1 8 ug	2 administrations at 3-week intervals.
BIOLOGICAL	DSP-0546LP 2.5 ug	2 administrations at 3-week intervals.
BIOLOGICAL	DSP-0546LP 5 ug	2 administrations at 3-week intervals.
BIOLOGICAL	DSP-0546LP 10 ug	2 administrations at 3-week intervals.
BIOLOGICAL	Placebo	2 administrations at 3-week intervals.

Timeline

• Start date: 2024-06-26
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-06-14
• Last updated: 2026-04-17

Locations

1 site across 1 country: Belgium