A Study of APL-10456-Vaccine

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study to Evaluate the Safety, Tolerability, and Immunogenicity of APL-10456-Vaccine in Healthy Volunteers

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

Study Overview

• Status: Active, not recruiting
• Conditions: Rhinovirus
• Intervention / Treatment: Drug: APL-10456-Vaccine; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3124
      • Emeritus Research
    • Melbourne, Victoria, Australia, 3153
      • Veritus Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: in healthy volunteers age ≥18 years and ≤ 54 years Part B: in healthy volunteers ≥55 year; Part A: Three (3) APL-10456-Vaccine dose levels which will be a sequential cohort single dose-escalation are planned, Part B will be a parallel group randomized controlled study to evaluate a two dose, prime and boost regimen of APL-10456-Vaccine in 3 dose levels	Drug: APL-10456-Vaccine; 3 cohorts are planned for Part A and Part B
Placebo Comparator: Placebo; Placebo is a comparator to Study Vaccine	Other: Placebo; Placebo (a saline) is comparator to study vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety and reactogenicity of APL-10456-Vaccine in healthy volunteers (HVs)	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)	Through Study Completion (Approx 365 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	serotype-specific anti-APL-10456 antibody (IgG) titers and seroconversion rates in serum samples	Day 8 and Day 29 in Part A and approximately monthly visits up to Day 365 in Part B

Collaborators and Investigators

• Sponsor: Apollo Therapeutics Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): May 18, 2027
• Study Completion (Estimated): May 18, 2027

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: AP09CP01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No