A Study of APL-10456-Vaccine

Apollo Therapeutics

Status and phase: Enrolling; Early Phase 1

Conditions: Rhinovirus

Treatments: Drug: APL-10456-Vaccine; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07399132

AP09CP01

Details and patient eligibility

About

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

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: APL-10456-Vaccine

Placebo

Placebo Comparator group

Description:

Placebo is a comparator to Study Vaccine

Treatment:

Other: Placebo