NCT06125691

Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults

A Phase 1, First-in-Human, Randomized, Observer-blind, Controlled, Dose-ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of a Self-Amplifying mRNA Seasonal Influenza Vaccine (ARCT-2138), When Administered to Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Arcturus Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is a safety and Immunogenicity first-in-human dose-ranging study of self-amplifying RNA Seasonal Influenza Vaccine (ARCT-2138) in adults.

Detailed description

Phase 1, first-in-human, randomized, controlled, observer blind (open label Part 4 only), dose-escalation study, to assess the safety, tolerability, and immunogenicity of different dose levels of the ARCT-2138 vaccine, administered as a single dose to healthy young and older adults, in comparison with an inactivated influenza vaccine. Study drug (ARCT-2138 or control) will be administered as an intramuscular (IM) injection. The study comprises of four parts. In Part 1, escalating dose levels of ARCT-2138 given as a single injection to younger adults will be evaluated sequentially. Low, medium, and high dose levels of ARCT-2138 (as recommended by DSMB) will be further evaluated in younger adults in Part 2. Part 3 will evaluate low, medium, and high dose levels of ARCT-2138 (as recommended by DSMB) in older adults. Part 4 (dose expansion phase) will administer a lower dose of ARCT-2138 in young adults. Investigational Vaccine: ARCT-2138 (Part 1-3 only, no control vaccine for Part 4) Control Vaccines: licensed influenza vaccines (inactivated) * For younger adults: Flucelvax® Quad, Seqirus Pty Ltd. * For older adults: Fluad® Quad, Seqirus Pty Ltd.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	ARCT-2138	Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle.
BIOLOGICAL	Licensed Quadrivalent Vaccine for younger adults	Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle.
BIOLOGICAL	Licensed Quadrivalent Vaccine for older adults	Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle.

Timeline

• Start date: 2024-01-22
• Primary completion: 2024-08-10
• Completion: 2025-01-07
• First posted: 2023-11-09
• Last updated: 2025-10-03

Locations

2 sites across 1 country: Australia