Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:18 AM
Study NCT ID:
NCT07399132
Status:
RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of APL-10456-Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-10-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-02-03', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and reactogenicity of APL-10456-Vaccine in healthy volunteers (HVs)', 'timeFrame': 'Through Study Completion (Approx 365 days)', 'description': '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)'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': 'Day 8 and Day 29 in Part A and approximately monthly visits up to Day 365 in Part B', 'description': 'serotype-specific anti-APL-10456 antibody (IgG) titers and seroconversion rates in serum samples'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rhinovirus']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age Part A: Age ≥18 years and ≤54 years Part B: Age ≥55 years\n* Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.\n\nExclusion Criteria:\n\n* History of severe allergic or anaphylactic reactions of any type\n* Acutely ill or febrile (temperature ≥38.0°C/100.4°F) 72 hours prior to or at the Day 1 visit\n* 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\n* Reported history of congenital or acquired immunodeficiency\n* Dermatologic conditions that could affect local solicited AR assessments\n* Coagulopathy or a bleeding disorder that is considered a contraindication to IM injection or phlebotomy\n* Diagnosis of a malignancy within previous 5 years\n* Has received systemic immunosuppressants for \\>14 days in total within 180 days prior to the Randomization Visit\n* 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\n* 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\n* Female participant with positive pregnancy test or Lactating females\n* Has positive serology tests result (HIV, HCV and HBsAg) at screening visit\n* Has positive drugs of abuse test results at screening visit\n* 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\n* Has donated ≥450 mL of blood products within 28 days prior to the Randomization Visit or plans to donate blood products during the study'}, 'identificationModule': {'nctId': 'NCT07399132', 'briefTitle': 'A Study of APL-10456-Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apollo Therapeutics Ltd'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AP09CP01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: in healthy volunteers age ≥18 years and ≤ 54 years Part B: in healthy volunteers ≥55 year', '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', 'interventionNames': ['Drug: APL-10456-Vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo is a comparator to Study Vaccine', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'APL-10456-Vaccine', 'type': 'DRUG', 'description': '3 cohorts are planned for Part A and Part B', 'armGroupLabels': ['Part A: in healthy volunteers age ≥18 years and ≤ 54 years Part B: in healthy volunteers ≥55 year']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo (a saline) is comparator to study vaccine', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Melbourne', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Emeritus Research', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Sanjay Aggarwal, MD', 'role': 'CONTACT', 'email': 'sanjay.aggarwal@apollotx.com', 'phone': '07814792267'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apollo Therapeutics Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}