A Study of APL-10456-Vaccine

Exclusion Criteria15

• History of severe allergic or anaphylactic reactions of any type
• Acutely ill or febrile (temperature ≥38.0°C/100.4°F) 72 hours prior to or at the Day 1 visit
• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric or neurological disease/disorder within the past 3 months, or any acute minor illness (e.g. common cold, influenza, minor infection) within the past 1 month, determined by the PI (or delegate) to be clinically relevant
• Reported history of congenital or acquired immunodeficiency
• Dermatologic conditions that could affect local solicited AR assessments
• Coagulopathy or a bleeding disorder that is considered a contraindication to IM injection or phlebotomy
• Diagnosis of a malignancy within previous 5 years
• Has received systemic immunosuppressants for >14 days in total within 180 days prior to the Randomization Visit
• Has received or plans to receive any licensed or authorized vaccine, including COVID-19 vaccines, ≤28 days prior to the study injection (Day 1) or plans to receive a licensed or authorized vaccine within 28 days after the final study injection
• Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (eg, infliximab), or blood products within 90 days prior to the Randomization Visit or plans to receive them during the study
• Female participant with positive pregnancy test or Lactating females
• Has positive serology tests result (HIV, HCV and HBsAg) at screening visit
• Has positive drugs of abuse test results at screening visit
• Has participated in an interventional clinical study within 3 months prior to the Randomization Visit or plans to do so while participating in this study
• Has donated ≥450 mL of blood products within 28 days prior to the Randomization Visit or plans to donate blood products during the study