This is a Phase I, first-in-human, randomized, modified double-blind, active-controlled, dose-escalation study to assess the safety and immunogenicity of up to 3 dose levels of mRNA NA vaccines, administered as a single IM injection in healthy adults aged 18 years and older. Two age groups, 18 to 64 years and ≥65 years, will be included in this study.
This study will include a screening visit, 6 study visits occurring on Days 1, 3, 9, 29, 91, and 181, and a safety follow-up telephone call on Day 366.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
233
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
AES - DRS - Optimal Research_Site 8400007
Huntsville, Alabama, United States
Central Phoenix Medical Clinic, LLC_Site: 8400010
Phoenix, Arizona, United States
Optimal Research San Diego, LLC_Site: 8400009
San Diego, California, United States
AES - DRS - Optimal Research_Site 8400002
Melbourne, Florida, United States
Number of participants with immediate adverse events
Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination
Time frame: Within 30 minutes after vaccination
Number of participants with solicited injection site or systemic reaction
Time frame: From Day 1 to Day 8
Number of participants with unsolicited adverse events
Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited reactions
Time frame: From Day 1 to Day 29
Number of participants with serious adverse events
Serious adverse events are collected throughout the study
Time frame: From Day 1 to Day 366
Number of participants with adverse events of special interest
Adverse events of special interest are collected throughout the study
Time frame: From Day 1 to Day 366
Number of patients with clinically significant changes in clinical laboratory tests
Laboratory tests include hematology: complete blood count (CBC) with differential, platelet count, coagulation panel (prothrombin time and PTT) and serum chemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total and fractionated bilirubin, C-reactive protein, serum creatinine, and blood urea nitrogen
Time frame: From Day 1 to Day 8
Neuraminidase inhibition (NAI) Antibodies at Day 1 and 29
Antibody are expressed as GMTs at baseline and post-baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AES - DRS - Optimal Research_Site 8400001
Peoria, Illinois, United States
Synexus Clinical Research_Site 8400003
Cincinnati, Ohio, United States
Time frame: Day 1 and 29
Individual Neuraminidase inhibition (NAI) titer
Antibody titers are expressed as GMTs at baseline and post-baseline
Time frame: Day 1 and Day 29
2-fold and 4-fold rise in NAI antibody titers
Expressed as percentage post-baseline
Time frame: From Day 1 to Day 29
Percentage of participants with detectable antibody titers greater than or equal to (≥) 10 [1/dil]
Expressed as percentage at baseline and post-baseline
Time frame: Day 1 and Day 29