Clinical trial NCT04265911: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pneumococcal vaccine
ASP3772
Lead sponsor: Affinivax, Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-12
Enrollment: 126
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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)
timeFrame: Up to Day 30
measure: Percentage of participants with vital sign abnormalities and/or adverse events (AEs)
timeFrame: Up to Day 30
measure: Percentage of participants reporting solicited local adverse reactions
timeFrame: Up to Day 7
measure: Percentage of participants reporting solicited systemic adverse reactions
timeFrame: Up to Day 7
measure: Percentage of participants with laboratory value abnormalities and/or adverse events (AEs)
timeFrame: Up to Day 30
measure: Percentage of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
timeFrame: Up to Day 30
measure: Percentage of participants with physical exam abnormalities and/or adverse events (AEs)
timeFrame: Up to Day 30
Secondary outcomes:
measure: Geometric mean titer (GMT) for opsonophagocytic activity (OPA) for each serotype contained in ASP3772
timeFrame: On Day 30
measure: GMT for OPA for each serotype contained in PPSV23
timeFrame: On Day 30
measure: Ratio of the OPA GMT (each ASP3772 dose level/PPSV23)
timeFrame: On Day 30
measure: Geometric mean concentration (GMC) for pneumococcal serotype-specific anticapsular polysaccharide immunoglobulin G (PS IgG) for each serotype contained in ASP3772
timeFrame: On Day 30
measure: GMC for pneumococcal serotype-specific anticapsular PS IgG for each serotype contained in PPSV23
timeFrame: On Day 30
measure: Ratio of GMC for pneumococcal serotype-specific anticapsular PS IgG (each ASP3772 dose level/PPSV23)
timeFrame: On Day 30
measure: Geometric mean fold rise (GMFR) in anticapsular PS IgG concentration on day 30 relative to pre-immunization contained in ASP3772
timeFrame: On Day 30
measure: GMFR in anticapsular PS IgG concentration on day 30 relative to pre-immunization contained in PPSV23
timeFrame: On Day 30
measure: GMFR in OPA titer on day 30 relative to pre-immunization contained in ASP3772
timeFrame: On Day 30
measure: GMFR in OPA titer on day 30 relative to pre-immunization contained in PPSV23
timeFrame: On Day 30
measure: Proportion of subjects with a ≥ 4-fold increase relative to baseline in pneumococcal serotype-specific anticapsular PS IgG concentration for each serotype contained in ASP3772
timeFrame: On Day 30
measure: Proportion of subjects with a ≥ 4-fold increase relative to baseline in pneumococcal serotype-specific anticapsular PS IgG concentration for each serotype contained in PPSV23
timeFrame: On Day 30
measure: Proportion of subjects with a ≥ 4-fold increase relative to baseline in OPA titer for each serotype contained in ASP3772
timeFrame: On Day 30
measure: Proportion of subjects with a ≥ 4-fold increase relative to baseline in OPA titer for each serotype contained in PPSV23
timeFrame: On Day 30
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: JP81001
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_DIRECTOR
References: