A Study of APL-10456-Vaccine | NCT07399132

NCT07399132

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Emeritus Research		Melbourne	Victoria	3124	Australia
Veritus Research