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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803202
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : April 29, 2022
Sponsor:
Information provided by (Responsible Party):
Affinivax, Inc.

Tracking Information
First Submitted Date  ICMJE January 11, 2019
First Posted Date  ICMJE January 14, 2019
Last Update Posted Date April 29, 2022
Actual Study Start Date  ICMJE January 24, 2019
Actual Primary Completion Date September 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • 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.
  • Percentage of participants experiencing abnormal vital signs [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Up to Day 30 ]
    Percentage of participants with potentially clinically significant physical examination values.
  • Safety assessed by 12-lead electrocardiogram (ECG) [ Time Frame: Up to Day 30 ]
    A 12-lead, resting is to be recorded.
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
  • 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.
  • Percentage of participants experiencing abnormal vital signs [ Time Frame: 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 [ Time Frame: Up to Day 7 ]
    Systemic reactions include nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia.
  • 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.
  • 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.
  • 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.
  • Safety assessed by 12-lead electrocardiogram (ECG) [ Time Frame: Up to Day 30 ]
    A 12-lead, resting is to be recorded.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
  • 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).
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Healthy Volunteers
  • Pneumococcal Disease
Intervention  ICMJE
  • Biological: ASP3772
    Intramuscular Injection
  • Biological: PCV13
    Intramuscular Injection
    Other Name: Prevnar 13
  • Biological: PPSV23
    Intramuscular Injection
    Other Name: Pneumovax 23
Study Arms  ICMJE
  • 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.
    Intervention: Biological: ASP3772
  • 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.
    Intervention: Biological: PCV13
  • 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
    Intervention: Biological: ASP3772
  • 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.
    Intervention: Biological: PCV13
  • 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.
    Intervention: Biological: PPSV23
Publications * Chichili GR, Smulders R, Santos V, Cywin B, Kovanda L, Van Sant C, Malinoski F, Sebastian S, Siber G, Malley R. Phase 1/2 study of a novel 24-valent pneumococcal vaccine in healthy adults aged 18 to 64 years and in older adults aged 65 to 85 years. Vaccine. 2022 Jul 29;40(31):4190-4198. doi: 10.1016/j.vaccine.2022.05.079. Epub 2022 Jun 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2020)
630
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2019)
618
Actual Study Completion Date  ICMJE September 28, 2020
Actual Primary Completion Date September 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03803202
Other Study ID Numbers  ICMJE 3772-CL-1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL: https://www.clinicalstudydatarequest.com/
Current Responsible Party Affinivax, Inc.
Original Responsible Party Astellas Pharma Global Development, Inc.
Current Study Sponsor  ICMJE Affinivax, Inc.
Original Study Sponsor  ICMJE Astellas Pharma Global Development, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Astellas Pharma Global Development, Inc.
PRS Account Affinivax, Inc.
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP