Single Ascending Dose of ASP3772 Study in Japanese Healthy Male and Female Adults, and Single Ascending Dose Study of ASP3772 in Comparison With PPSV23 in Japanese Elderly Male and Female Subjects
ASP3772 Phase 1 Study: Single Ascending Dose Study in Japanese Healthy Male and Female Adults, and PPSV23-controlled, Randomized, Single Ascending Dose Study in Japanese Elderly Male and Female Subjects
1 other identifier
interventional
126
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of 3 different dose levels of ASP3772 administered subcutaneously or intramuscularly to Japanese healthy adults 20 to 49 years of age. This study will also evaluate the safety and tolerability of 3 different dose levels of ASP3772 administered subcutaneously or intramuscularly, in comparison to the active comparator 23-valent pneumococcal polysaccharide vaccine (PPSV23) in Japanese elderly subjects 65 to 85 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Feb 2020
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2020
CompletedFirst Posted
Study publicly available on registry
February 12, 2020
CompletedStudy Start
First participant enrolled
February 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2020
CompletedMay 2, 2022
April 1, 2022
9 months
February 9, 2020
April 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Percentage of participants with treatment emergent adverse events (TEAEs) including serious AEs (SAEs), medically attended adverse events (MAAEs), potentially immune mediated medical conditions (PIMMCs) and new onset chronic diseases (NOCDs)
An adverse event (AE) is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. TEAE is defined as an AE occurring after study immunization to the last visit (up to 30 days post-vaccination if the study is discontinued for an individual subject). An IP-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator or subinvestigator.
Up to Day 30
Percentage of participants with vital sign abnormalities and/or adverse events (AEs)
Percentage of participants with potentially clinically significant vital sign values.
Up to Day 30
Percentage of participants reporting solicited local adverse reactions
Local reactions include pain, tenderness, erythema/redness, swelling, and induration. The reaction will be graded with 4-range grade: 1 (mild) to 4 (potentially life-threatening).
Up to Day 7
Percentage of participants reporting solicited systemic adverse reactions
Systemic reactions include nausea, vomiting, diarrhea, headache, fever, fatigue and myalgia and arthralgia. Vital signs up to 7 days postvaccination are collected as systemic reactions. The reaction will be graded with 4-range grade: 1 (mild) to 4 (potentially life-threatening).
Up to Day 7
Percentage of participants with laboratory value abnormalities and/or adverse events (AEs)
Percentage of participants with potentially clinically significant laboratory values.
Up to Day 30
Percentage of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Percentage of participants with potentially clinically significant ECG values.
Up to Day 30
Percentage of participants with physical exam abnormalities and/or adverse events (AEs)
Percentage of participants with potentially clinically significant physical exam values.
Up to Day 30
Secondary Outcomes (14)
Geometric mean titer (GMT) for opsonophagocytic activity (OPA) for each serotype contained in ASP3772
On Day 30
GMT for OPA for each serotype contained in PPSV23
On Day 30
Ratio of the OPA GMT (each ASP3772 dose level/PPSV23)
On Day 30
Geometric mean concentration (GMC) for pneumococcal serotype-specific anticapsular polysaccharide immunoglobulin G (PS IgG) for each serotype contained in ASP3772
On Day 30
GMC for pneumococcal serotype-specific anticapsular PS IgG for each serotype contained in PPSV23
On Day 30
- +9 more secondary outcomes
Study Arms (6)
ASP3772 (subcutaneous) in Adults
EXPERIMENTALParticipants will receive a single dose of ASP3772 administered as an subcutaneous injection on Day 1 at one of three dose levels.
ASP3772 ((intramuscular) in Adults
EXPERIMENTALParticipants will receive a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels.
ASP3772 (subcutaneous) in Elderly
EXPERIMENTALParticipants will receive a single dose of ASP3772 administered as an subcutaneous injection on Day 1 at one of three dose levels.
ASP3772 (intramuscular) in Elderly
EXPERIMENTALParticipants will receive a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels
PPSV23 (subcutaneous) in Elderly
ACTIVE COMPARATORParticipants will receive a single subcutaneous injection of the standard dose of PPSV23 on Day 1.
PPSV23 (intramuscular) in Elderly
ACTIVE COMPARATORParticipants will receive a single intramuscular injection of the standard dose of PPSV23 on Day 1.
Interventions
Subcutaneous injection
Intramuscular injection
Subcutaneous injection
Intramuscular injection
Eligibility Criteria
You may qualify if:
- Group 1: Subject is a healthy male or female between 20 and 49 years of age inclusive, at informed consent.
- Group 2: Subject is a male or female between 65 and 85 years of age inclusive, at informed consent who is healthy or has chronic controlled, stable disease with no change in disease severity, medical therapy and no hospitalization history in last 12 weeks from informed consent as determined by medical history, physical examination, and laboratory data.
- Female subject of non-childbearing potential; male subject not able to father children or who is able to father children and willing to use a highly effective method of contraception.
- Subject agrees not to participate in another interventional study while participating in the present study.
- Subject has a body mass index (BMI) range of 17.6 to 26.4 kg/m\^2 inclusive in Group 1 and 15.4 to 28.6 kg/m\^2 inclusive in Group 2, and body weight at least 50 kg for male and 40 kg for female at screening.
You may not qualify if:
- Subject has had previous vaccination with any licensed or investigational pneumococcal vaccine at any time.
- Subject has a history of microbiologically-proven invasive disease caused by Streptococcus pneumoniae.
- Subject has an immune disorder(s) (including autoimmune disease), clinical conditions requiring immunosuppressive drugs and/or a close relative who has congenital immunodeficiency.
- Group 1: Subject has any illness that requires medication or treatment.
- Group 2: Subject has any evidence of unstable or active clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease, e.g., uncontrolled hypertension, uncontrolled diabetes, heart failure, uncontrolled chronic obstructive pulmonary disease, end-stage renal disease, malignancy which is active and requires treatment.
- Subject has any clinically significant history of allergic conditions including drug allergies, asthma or anaphylactic reactions, but excluding untreated asymptomatic seasonal allergies just before study vaccine administration.
- Subject has a positive serology test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies (anti-HCV) or antigens/antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at screening.
- Subject has/had febrile illness or symptomatic of viral, bacterial (including upper respiratory infection) or fungal (excluding skin infection) infection within 7 days prior to day 1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Affinivax, Inc.lead
Study Sites (1)
JP81001
Fukuoka, Japan
Related Publications (1)
Borys D, Smulders R, Haranaka M, Nakano T, Chichili GR, Ebara M, Hashimoto A, Iwahana M, Oizumi Y, Nanra J, Malley R, Sebastian S. Safety, reactogenicity, and immunogenicity of a novel 24-valent pneumococcal vaccine candidate in healthy, pneumococcal vaccine-naive Japanese adults: A phase 1 randomized dose-escalation trial. Vaccine. 2025 Jan 12;44:126545. doi: 10.1016/j.vaccine.2024.126545. Epub 2024 Nov 29.
PMID: 39612802DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- 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
February 9, 2020
First Posted
February 12, 2020
Study Start
February 19, 2020
Primary Completion
November 7, 2020
Study Completion
November 7, 2020
Last Updated
May 2, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."