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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

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ClinicalTrials.gov Identifier: NCT03803202
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
Affinivax
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 618 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 : January 24, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Pneumovax 23




Primary Outcome Measures :
  1. 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) [ Time Frame: Up to Day 180 ]
    Percentage of participants with adverse events (AEs), SAEs, MAAEs including NOCDs, and PIMMCs.

  2. Percentage of participants experiencing abnormal vital signs [ Time Frame: Up to Day 30 ]
    Percentage of participants with potentially clinically significant vital sign values.

  3. Percentage of participants reporting solicited systemic adverse reactions for up to 7 days after vaccination [ Time Frame: Up to Day 7 ]
    Systemic reactions include nausea/vomiting, diarrhea, headache, fever, fatigue, joint pain/arthralgia and muscle discomfort or pain/myalgia.

  4. Percentage of participants reporting solicited local adverse reactions for up to 7 days after vaccination [ Time Frame: Up to Day 7 ]
    Local reactions include pain, tenderness, redness/erythema, and swelling/induration.

  5. Percentage of participants with laboratory value abnormalities and/or adverse events (AEs) [ Time Frame: Up to Day 30 ]
    Percentage of participants with potentially clinically significant laboratory values.

  6. Percentage of participants with physical examination abnormalities and/or adverse events (AEs) [ Time Frame: Up to Day 30 ]
    Percentage of participants with potentially clinically significant physical examination values.

  7. Safety assessed by 12-lead electrocardiogram (ECG) [ Time Frame: Up to Day 30 ]
    A 12-lead, resting is to be recorded.


Secondary Outcome Measures :
  1. Immunological response of PCV13 at Day 30 [ Time Frame: Day 30 ]
    Immunological response of PCV13 will be determined at Day 30 (Stage 1, Group 1 and Stage 2, Group 2).

  2. Immunological response of ASP3772 at Day 30 [ Time Frame: Day 30 ]
    Immunological response of ASP3772 will be determined at Day 30 (Stage 1, Group 1 and Stage 2, Group 2).

  3. Immunological response of PPSV23 at Day 30 [ Time Frame: Day 30 ]
    Immunological response of PPSV23 will be determined at Day 30 (Stage 2, Group 3).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 B core antibody (anti-HBc), 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803202


Contacts
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Contact: Astellas Pharma Global Development 800-888-7704 Astellas.registration@astellas.com

Locations
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United States, California
Advanced Clinical Research-Rancho Paseo Recruiting
Banning, California, United States, 92220
Artemis Institute Recruiting
San Diego, California, United States, 92103
United States, Florida
Research Centers of America Recruiting
Hollywood, Florida, United States, 33024
United States, Georgia
Meridian Clinical Research Recruiting
Savannah, Georgia, United States, 31406
United States, Missouri
Sundance Clinical Research Recruiting
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Meridian Clinical Research Recruiting
Norfolk, Nebraska, United States, 68701
United States, New York
United Medical Associates Suspended
Binghamton, New York, United States, 13901
United States, North Carolina
PMG Research of Raleigh Recruiting
Raleigh, North Carolina, United States, 27604
Wilmington Health Recruiting
Wilmington, North Carolina, United States, 28401
PMG Research of Winston-Salem, LLC Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Texas
Advanced Clinical Research Institute Recruiting
Cedar Park, Texas, United States, 78613
Texas Healthcare, PLLC Recruiting
Fort Worth, Texas, United States, 76104
Benchmark Research Recruiting
Fort Worth, Texas, United States, 76135
Benchmark Research Recruiting
San Angelo, Texas, United States, 76904
Clinical Trials of Texas Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Affinivax
Investigators
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Study Director: Medical Director Astellas Pharma Global Development, Inc.

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Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT03803202     History of Changes
Other Study ID Numbers: 3772-CL-1001
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Studies conducted with product indications or formulations that remain in development are assessed after study completion to determine if Individual Participant Data can be shared. The plan to share Individual Participant Data is based on the status of product approval or termination of the compound, in addition to other study-specific criteria described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
Pneumococcal vaccine
Vaccine
Pneumococccal Disease
ASP3772
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs