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

Influenza, Human Clinical Trial

Official title:
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

Clinical Trial Summary

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

Clinical Trial Description

Phase 1, first-in-human, randomized, controlled, observer blind, 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 three 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. Investigational Vaccine: ARCT-2138 Control Vaccines: licensed influenza vaccines (inactivated) - For younger adults: Flucelvax® Quad, Seqirus Pty Ltd. - For older adults: Fluad® Quad, Seqirus Pty Ltd. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06125691
Study type Interventional
Source Arcturus Therapeutics, Inc.
Contact Clinical Trial Disclosure Manager
Phone (858) 900-2660
Email clinicaltrials@arcturusrx.com
Status Recruiting
Phase Phase 1
Start date January 22, 2024
Completion date October 2024
View Details
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