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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Biological: ASP3772 (subcutaneous); Biological: ASP3772 (intramuscular); Biological: PPSV23 (subcutaneous); Biological: PPSV23 (intramuscular)

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
    • JP81001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ASP3772 (subcutaneous) in Adults; Participants will receive a single dose of ASP3772 administered as an subcutaneous injection on Day 1 at one of three dose levels.	Biological: ASP3772 (subcutaneous); Subcutaneous injection
EXPERIMENTAL: ASP3772 ((intramuscular) in Adults; Participants will receive a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels.	Biological: ASP3772 (intramuscular); Intramuscular injection
EXPERIMENTAL: ASP3772 (subcutaneous) in Elderly; Participants will receive a single dose of ASP3772 administered as an subcutaneous injection on Day 1 at one of three dose levels.	Biological: ASP3772 (subcutaneous); Subcutaneous injection
EXPERIMENTAL: ASP3772 (intramuscular) in Elderly; Participants will receive a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels	Biological: ASP3772 (intramuscular); Intramuscular injection
ACTIVE_COMPARATOR: PPSV23 (subcutaneous) in Elderly; Participants will receive a single subcutaneous injection of the standard dose of PPSV23 on Day 1.	Biological: PPSV23 (subcutaneous); Subcutaneous injection; Other Names: Pneumovax NP
ACTIVE_COMPARATOR: PPSV23 (intramuscular) in Elderly; Participants will receive a single intramuscular injection of the standard dose of PPSV23 on Day 1.	Biological: PPSV23 (intramuscular); Intramuscular injection; Other Names: Pneumovax NP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean titer (GMT) for opsonophagocytic activity (OPA) for each serotype contained in ASP3772	OPA measure will be used to characterize the immunological response on Day 30 after administration of ASP3772.	On Day 30
GMT for OPA for each serotype contained in PPSV23	OPA measure will be used to characterize the immunological response on Day 30 after administration of PPSV23	On Day 30
Ratio of the OPA GMT (each ASP3772 dose level/PPSV23)	OPA measure will be used to characterize the immunological response on Day 30 after administration of ASP3772 and PPSV23	On Day 30
Geometric mean concentration (GMC) for pneumococcal serotype-specific anticapsular polysaccharide immunoglobulin G (PS IgG) for each serotype contained in ASP3772	PS IgG measure will be used to characterize the immunological response on Day 30 after administration of ASP3772.	On Day 30
GMC for pneumococcal serotype-specific anticapsular PS IgG for each serotype contained in PPSV23	PS IgG measure measure will be used to characterize the immunological response on Day 30 after administration of PPSV23	On Day 30
Ratio of GMC for pneumococcal serotype-specific anticapsular PS IgG (each ASP3772 dose level/PPSV23)	PS IgG measure will be used to characterize the immunological response on Day 30 after administration of ASP3772 and PPSV23.	On Day 30
Geometric mean fold rise (GMFR) in anticapsular PS IgG concentration on day 30 relative to pre-immunization contained in ASP3772	PS IgG measure will be used to characterize the immunological response on Day 30 after administration of ASP3772.	On Day 30
GMFR in anticapsular PS IgG concentration on day 30 relative to pre-immunization contained in PPSV23	PS IgG measure will be used to characterize the immunological response on Day 30 after administration of PPSV23	On Day 30
GMFR in OPA titer on day 30 relative to pre-immunization contained in ASP3772	OPA titer will be used to characterize the immunological response on Day 30 after administration of ASP3772.	On Day 30
GMFR in OPA titer on day 30 relative to pre-immunization contained in PPSV23	OPA titer will be used to characterize the immunological response on Day 30 after administration of PPSV23	On Day 30
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	PS IgG measure will be used to characterize the immunological response on Day 30 after administration of ASP3772.	On Day 30
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	PS IgG measure will be used to characterize the immunological response on Day 30 after administration of PPSV23	On Day 30
Proportion of subjects with a ≥ 4-fold increase relative to baseline in OPA titer for each serotype contained in ASP3772	OPA titer will be used to characterize the immunological response on Day 30 after administration of ASP3772.	On Day 30
Proportion of subjects with a ≥ 4-fold increase relative to baseline in OPA titer for each serotype contained in PPSV23	OPA titer will be used to characterize the immunological response on Day 30 after administration of PPSV23	On Day 30

Collaborators and Investigators

• Sponsor: Affinivax, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 19, 2020
• Primary Completion (ACTUAL): November 7, 2020
• Study Completion (ACTUAL): November 7, 2020

Study Registration Dates

• First Submitted: February 9, 2020
• First Submitted That Met QC Criteria: February 9, 2020
• First Posted (ACTUAL): February 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Pneumococcal vaccine; ASP3772
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 3772-CL-1011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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."

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes