A Study of APL-10456-Vaccine (NCT07399132) | Clinical Trial Compass
RecruitingEarly Phase 1
A Study of APL-10456-Vaccine
Australia144 participantsStarted 2026-02-16
Plain-language summary
AP09CP01 is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study which is conducted in Australia. The main purpose of this research study is to evaluate the safety, side effects, and immune response of APL-10456-Vaccine, a Rhinovirus (RV) Vaccine, when compared with a placebo in Younger and Older Healthy Volunteers
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age Part A: Age ≥18 years and ≤54 years Part B: Age ≥55 years
* Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Exclusion Criteria:
* 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 receiv…
What they're measuring
1
To evaluate the safety and reactogenicity of APL-10456-Vaccine in healthy volunteers (HVs)
Timeframe: Through Study Completion (Approx 365 days)