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This is a safety and Immunogenicity first-in-human dose-ranging study of self-amplifying RNA Seasonal Influenza Vaccine (ARCT-2138) in adults.
Full 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.
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132 participants in 9 patient groups
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Clinical Trial Disclosure Manager
Data sourced from clinicaltrials.gov
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