This is a safety and Immunogenicity first-in-human dose-ranging study of self-amplifying RNA Seasonal Influenza Vaccine (ARCT-2138) in adults.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
139
Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle.
Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle.
Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle.
Nucleus Network Brisbane Clinic
Brisbane, Queensland, Australia
Emeritus Research Camberwell
Melbourne, Victoria, Australia
Percentage of participants reporting local Adverse Events
Solicited local AEs include injection-site pain, erythema and swelling
Time frame: 14 Days following study vaccination
Percentage of participants reporting systemic Adverse Events
Solicited systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills, and fever.
Time frame: 14 Days following study vaccination
Percentage of participants reporting unsolicited Adverse Events
Spontaneously reported adverse events and as elicited by investigational site staff
Time frame: 29 Days following study vaccination
Percentage of participants reporting laboratory or vital signs abnormalities
Abnormal clinically significant values
Time frame: 29 Days following study vaccination
Percentage of participants reporting serious adverse events, medically attended adverse events adverse events of special interest and adverse events leading early termination
Spontaneously reported adverse events and as elicited by investigational site staff
Time frame: 29 Days following study vaccination
Serum hemagglutination inhibition (HAI) antibody levels against the HA glycoprotein.
HAI antibody levels expressed as GMT, GMFI, SCRs and HAI titers.
Time frame: 29 days following study vaccination
Serum neuraminidase enzyme-linked lectin (ELLA) assay antibody levels against the NA glycoproteins.
ELLA antibody levels expressed as GMT, GMFI, SCRs and HAI titers.
Time frame: 29 days following study vaccination
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Percentage of participants reporting serious adverse events, medically attended adverse events adverse events of special interest and adverse events leading early termination
Spontaneously reported adverse events and as elicited by investigational site staff
Time frame: 181 days following study vaccination
Serum hemagglutination inhibition (HAI) antibody levels against the HA glycoprotein.
HAI antibody levels expressed as GMT, GMFI, SCRs and HAI titers.
Time frame: 181 days following study vaccination
Serum neuraminidase enzyme-linked lectin (ELLA) assay antibody levels against the NA glycoproteins.
ELLA antibody levels expressed as GMT, GMFI, SCRs and HAI titers.
Time frame: 181 days following study vaccination