A Study of APL-10456-Vaccine

NCT07399132 | Recruiting Early Phase 1

• 1 other identifier: AP09CP01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

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

Conditions

Rhinovirus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Part A: in healthy volunteers age ≥18 years and ≤ 54 years Part B: in healthy volunteers ≥55 year

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo is a comparator to Study Vaccine

Other: Placebo

Interventions

APL-10456-Vaccine DRUG

3 cohorts are planned for Part A and Part B

Part A: in healthy volunteers age ≥18 years and ≤ 54 years Part B: in healthy volunteers ≥55 year

Placebo OTHER

Placebo (a saline) is comparator to study vaccine

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age Part A: Age ≥18 years and ≤54 years Part B: Age ≥55 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Apollo Therapeutics Ltd: lead

Study Sites (2)

Emeritus Research

Melbourne, Victoria, 3124, Australia

RECRUITING

Veritus Research

Melbourne, Victoria, 3153, Australia

RECRUITING

Central Study Contacts

Sanjay Aggarwal, MD

CONTACT

07814792267; sanjay.aggarwal@apollotx.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 10, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): August 2, 2026
• Study Completion (Estimated): October 21, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)