A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine

Sponsor

Affinivax, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03803202

Collaborator

(none)

630

Enrollment

Locations

Arms

20.1

Actual Duration (Months)

24.2

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13) in adults 18 to 64 years of age in Stage 1. Stage 2 will evaluate the safety, tolerability, and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active comparator PCV13 in elderly 65 to 85 years of age. In addition, Stage 2 will evaluate the immunogenicity of 3 different dose levels of ASP3772 relative to the response seen following administration of Pneumovax® 23 (PPSV23) for the serotypes not included in PCV13.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers Pneumococcal Disease	Biological: ASP3772 Biological: PCV13 Biological: PPSV23	Phase 1/Phase 2

Detailed Description

The study population will consist of 3 different groups: Group 1 - Stage 1 PCV13 naïve participants randomized within 3 sequential cohorts to ASP3772 or PCV13; Group 2 - Stage 2 PCV13 naïve participants randomized within 3 sequential cohorts to ASP3772 or PCV13; and Group 3 - Stage 2 participants previously vaccinated with PCV13 that will receive PPSV23.

Study Design

Study Type:

Interventional

Actual Enrollment :

630 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

A Phase 1/2, Randomized, Single Ascending Dose Study in Adults (Stage 1) and Randomized, Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, a Pneumococcal Vaccine

Actual Study Start Date :

Jan 24, 2019

Actual Primary Completion Date :

Sep 28, 2020

Actual Study Completion Date :

Sep 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stage 1, Group 1 ASP3772 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 Injection
Active Comparator: Stage 1, Group 1 PCV13 in Adults Participants will receive a single intramuscular injection of the standard dose of PCV13 on Day 1.	Biological: PCV13 Intramuscular Injection Other Names: Prevnar 13
Experimental: Stage 2, Group 2 ASP3772 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 Injection
Active Comparator: Stage 2, Group 2 PCV13 in Elderly Participants will receive a single intramuscular injection of the standard dose of PCV13 on Day 1.	Biological: PCV13 Intramuscular Injection Other Names: Prevnar 13
Active Comparator: Stage 2, Group 3 PPSV23 in Elderly Participants will receive a single intramuscular injection of the standard dose of PPSV23 on Day 1.	Biological: PPSV23 Intramuscular Injection Other Names: Pneumovax 23

Outcome Measures

Primary Outcome Measures

Percentage of participants reporting 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) [Up to Day 180]
Percentage of participants with adverse events (AEs), SAEs, MAAEs including NOCDs, and PIMMCs.
Percentage of participants experiencing abnormal vital signs [Up to Day 30]
Percentage of participants with potentially clinically significant vital sign values.
Percentage of participants reporting solicited systemic adverse reactions for up to 7 days after vaccination [Up to Day 7]
Systemic reactions include nausea/vomiting, diarrhea, headache, fever, fatigue, joint pain/arthralgia and muscle discomfort or pain/myalgia.
Percentage of participants reporting solicited local adverse reactions for up to 7 days after vaccination [Up to Day 7]
Local reactions include pain, tenderness, redness/erythema, and swelling/induration.
Percentage of participants with laboratory value abnormalities and/or adverse events (AEs) [Up to Day 30]
Percentage of participants with potentially clinically significant laboratory values.
Percentage of participants with physical examination abnormalities and/or adverse events (AEs) [Up to Day 30]
Percentage of participants with potentially clinically significant physical examination values.
Safety assessed by 12-lead electrocardiogram (ECG) [Up to Day 30]
A 12-lead, resting is to be recorded.

Secondary Outcome Measures

Immunological response of PCV13 at Day 30 [Day 30]
Immunological response of PCV13 will be determined at Day 30 (Stage 1, Group 1 and Stage 2, Group 2).
Immunological response of ASP3772 at Day 30 [Day 30]
Immunological response of ASP3772 will be determined at Day 30 (Stage 1, Group 1 and Stage 2, Group 2).
Immunological response of PPSV23 at Day 30 [Day 30]
Immunological response of PPSV23 will be determined at Day 30 (Stage 2, Group 3).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Stage 1: Subject is healthy male or female between 18 and 64 year of age inclusive, at screening.
Stage 2: Subject is a male or female between 65 and 85 years of age, inclusive, at screening who is healthy or has chronic controlled, stable disease with no change in disease severity, medical therapy and no hospitalization records in last 12 weeks as determined by medical history, physical examination and laboratory data.
A female subject is eligible to participate if not pregnant and at least 1 of the following conditions applies:
Not a woman of childbearing potential (WOCBP) OR
WOCBP who agrees to follow the contraceptive guidance at screening and for at least 28 days after the study vaccine administration.
Female subject must agree not to breastfeed starting at screening and for 28 days after the study vaccine administration.
Female subject must not donate ova starting at screening and for 28 days after the study vaccine administration.
A male subject with female partner(s) of childbearing potential must agree to use contraception at screening and for at least 28 days after the study vaccine administration.
Male subject must not donate sperm starting at screening and for 90 days after the study vaccine administration.
Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding at screening and for 28 after the study vaccine administration.
Subject agrees not to participate in another interventional study while participating in the present study.

Exclusion Criteria:

Subject has a known or suspected hypersensitivity to ASP3772, its comparators or any components of the formulations used.
Subject has had previous exposure with ASP3772.
Subject has had known previous exposure with PPSV23.
Subject has received PCV13 or any other licensed or investigational pneumococcal vaccine at any time. (Note: This exclusion criterion is not applicable to Group 3; those subjects 65 to 85 years of age who previously received immunization with PCV13. Prior PCV13 immunization should have taken place no less than 10 months and no more than 2 years prior to study vaccine administration. These subjects are eligible to be enrolled in the nonrandomized arm of Stage 2, Group 3.
Subject has a history of microbiologically-proven invasive disease caused by S. pneumoniae.
Subject has an immune disorder(s) (including autoimmune disease) and/or clinical conditions requiring immunosuppressive drugs.
Subject has any evidence of any unstable or active clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, e.g., uncontrolled hypertension, uncontrolled diabetes, heart failure, uncontrolled chronic obstructive pulmonary disease, end-stage renal disease.
Subject has history of illicit drug(s) or alcohol abuse that will interfere with the protocol requirements and/or a positive urine drug test (for Stage 1 subjects only) at screening.
Subject has any clinically significant history of allergic conditions including drug allergies, asthma or anaphylactic reactions, but excluding untreated asymptomatic seasonal allergies prior to study vaccine administration.
Subject has a coagulation disorder contraindicating intramuscular immunization.
Subject has a positive serology test for hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies (anti-HCV) confirmed by reflex testing (HCV-RNA) or antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at screening.
Subject has/had febrile illness (> 100.4°F oral equivalent) or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day 1.
Subject has any clinically significant abnormality from the physical examination, ECG and clinical laboratory tests during screening.
Subject is unlikely to adhere to study procedures, keep appointments, is planning to relocate during the study or cannot be adequately followed for safety according to the protocol.
Subject has any other condition, which precludes the subject's participation in the study.
Subject has received any vaccines within 30 days prior of receipt of the study vaccine (exception: Influenza virus vaccine given according to recommended guidelines must be given at least 7 days prior to receiving study vaccine).
Subject has had significant blood loss, donated 1 unit (450 mL or more) or received transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to day 1.
Subject has received any systemically absorbed antibiotics during the 7-day period prior to day 1.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Clinical Research-Rancho Paseo	Banning	California	United States	92220
2	Artemis Institute	San Diego	California	United States	92103
3	Artemis Institute	San Marcos	California	United States	92078
4	Research Centers of America	Hollywood	Florida	United States	33024
5	Meridian Clinical Research	Savannah	Georgia	United States	31406
6	Sundance Clinical Research	Saint Louis	Missouri	United States	63141
7	Meridian Clinical Research	Norfolk	Nebraska	United States	68701
8	United Medical Associates	Binghamton	New York	United States	13901
9	PMG Research of Raleigh	Raleigh	North Carolina	United States	27604
10	PMG Research of Hickory, LLC	Rocky Mount	North Carolina	United States	27804
11	Piedmont HealthCare, PA	Statesville	North Carolina	United States	28625
12	Wilmington Health	Wilmington	North Carolina	United States	28401
13	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina	United States	27103
14	Tekton Research - George Town	Yukon	Oklahoma	United States	73099
15	PMG Research	Knoxville	Tennessee	United States	37912
16	PMG Research	Knoxville	Tennessee	United States	37938
17	Advanced Clinical Research Institute	Cedar Park	Texas	United States	78613
18	Texas Healthcare, PLLC	Fort Worth	Texas	United States	76104
19	Benchmark Research	Fort Worth	Texas	United States	76135
20	Texas Center for Drug Development	Houston	Texas	United States	77081
21	Healthcare Associatiates of Texas	McKinney	Texas	United States	75070
22	DM Clinical Research	Pearland	Texas	United States	77584
23	Benchmark Research	San Angelo	Texas	United States	76904
24	Clinical Trials of Texas	San Antonio	Texas	United States	78229
25	Martin Diagnostic Clinic	Tomball	Texas	United States	77375
26	CRA of Tidewater Inc	Norfolk	Virginia	United States	23507