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

Affinivax

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: PPSV23 (subcutaneous); Biological: ASP3772 (intramuscular); Biological: PPSV23 (intramuscular); Biological: ASP3772 (subcutaneous)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04265911

3772-CL-1011

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

---

126 participants in 6 patient groups

ASP3772 (subcutaneous) in Adults

Experimental group

Description:

Participants will receive a single dose of ASP3772 administered as an subcutaneous injection on Day 1 at one of three dose levels.

Treatment:

Biological: ASP3772 (subcutaneous)

ASP3772 ((intramuscular) in Adults

Experimental group

Description:

Participants will receive a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels.

Treatment:

Biological: ASP3772 (intramuscular)

ASP3772 (subcutaneous) in Elderly

Experimental group

Description:

Participants will receive a single dose of ASP3772 administered as an subcutaneous injection on Day 1 at one of three dose levels.

Treatment:

Biological: ASP3772 (subcutaneous)

ASP3772 (intramuscular) in Elderly

Experimental group

Description:

Participants will receive a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels

Treatment:

Biological: ASP3772 (intramuscular)

PPSV23 (subcutaneous) in Elderly

Active Comparator group

Description:

Participants will receive a single subcutaneous injection of the standard dose of PPSV23 on Day 1.

Treatment:

Biological: PPSV23 (subcutaneous)

PPSV23 (intramuscular) in Elderly

Active Comparator group

Description:

Participants will receive a single intramuscular injection of the standard dose of PPSV23 on Day 1.

Treatment:

Biological: PPSV23 (intramuscular)