Rhinovirus
Conditions
Brief 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
Interventions
DRUGAPL-10456-Vaccine
3 cohorts are planned for Part A and Part B
OTHERPlacebo
Placebo (a saline) is comparator to study vaccine
Sponsors
Apollo Therapeutics Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and reactogenicity of APL-10456-Vaccine in healthy volunteers (HVs) | Through Study Completion (Approx 365 days) | Collecting AEs in Part A: HVs from 18 to 54 years of age, inclusive and Part B: HVs ≥ 55 years of age. Incidence, severity, relationship and outcome of Adverse Events (AE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the immunogenicity of a single dose of APL-10456-Vaccine in Part A and B, and a prime/boost administration of APL-10456-Vaccine in Part B | Day 8 and Day 29 in Part A and approximately monthly visits up to Day 365 in Part B | serotype-specific anti-APL-10456 antibody (IgG) titers and seroconversion rates in serum samples |
Countries
Australia
Outcome results
None listed