APL-10456 Rhinovirus Vaccine in Healthy Adults

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

This study will test whether the APL-10456 rhinovirus vaccine is safe, what side effects it causes, and whether it triggers an immune response in younger and older healthy adults compared with a placebo.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Apollo Therapeutics Ltd (Industry-sponsored)
• Drugs / interventions: infliximab
• Locations: 2 sites (Melbourne, Victoria and 1 other locations)
• Trial ID: NCT07399132 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 1, two-part trial conducted at research centers in Melbourne, Australia, enrolling healthy adult volunteers. The study compares APL-10456 vaccine to placebo to characterize safety, local and systemic side effects, and immune responses. Part A enrolls adults 18–54 years and Part B enrolls adults aged 55 and older, with dose and safety monitoring appropriate for an early-phase vaccine trial. As a Phase 1 trial, the primary focus is on tolerability and immunogenicity rather than proof of clinical effectiveness against rhinovirus illness.

Who should consider this trial

Good fit: Ideal candidates are healthy adults who are 18–54 years (Part A) or 55 years and older (Part B) with no significant medical conditions and who can attend study visits in Melbourne.

Not a fit: People with a history of severe allergic/anaphylactic reactions, known immunodeficiency, recent acute illness, or clinically significant chronic disease are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, the vaccine could reduce the risk or severity of rhinovirus infections by producing protective immune responses.

How similar studies have performed: Rhinovirus vaccine development has been challenging and there are few if any licensed rhinovirus vaccines, so this approach is relatively early-stage compared with well-established viral vaccines.

Eligibility criteria

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

Where this trial is running

Melbourne, Victoria and 1 other locations

• Emeritus Research — Melbourne, Victoria, Australia (Recruiting)
• Veritus Research — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Sanjay Aggarwal, MD

Conditions Rhinovirus