Last updated: 11/30/2023 16:50:16
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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of Participants with Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1]
Timeframe: From Day 1, Up to Day 180
Number of Participants with TEAEs, [Stage 2, Group 2]
Timeframe: From Day 1, Up to Day 180
Number of Participants with TEAEs, [Stage 2, Group 3]
Timeframe: From Day 1, Up to Day 30
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Timeframe: During first hour post vaccination (vaccine administered at Day 1)
Number of Participants with Potentially Clinically Significant Laboratory Values
Timeframe: Up to Day 30
Number of Participants with Potentially Clinically Significant Physical Examination Values
Timeframe: Up to Day 30
Number of Participants with Clinically significant Abnormal electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2]
Timeframe: Day - 28 to Day -1 (28 days prior to study vaccination)
Number of Participants with Clinically significant Abnormal electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2]
Timeframe: At Day 7
Number of Participants with Clinically significant Abnormal electrocardiogram (ECG), [Stage 2, Group 3]
Timeframe: Day - 28 to Day -1 (28 days prior to study vaccination)
Reactogenicity Assessed by Number of participants with Solicited Local Reactions, [Stage 1, Group 1]
Timeframe: Up to 7 Day post Vaccination (vaccine administered at Day 1)
Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3]
Timeframe: Up to 7 Day post Vaccination (vaccine administered at Day 1)
Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1]
Timeframe: Up to 7 Day post Vaccination (vaccine administered at Day 1)
Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3]
Timeframe: Up to 7 Day post Vaccination (vaccine administered at Day 1)
Secondary outcomes:
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Timeframe: At Day 1 and Day 30
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Timeframe: At Day 1 and Day 30
Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]
Timeframe: At Day 30
Percentage of Participants with Unique Serotypes IgG of greater than or equal to (>=) 4-fold increase, [Stage 1, Group 1]
Timeframe: At Day 30
GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1]
Timeframe: At Day 30
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Timeframe: At Day 1 and Day 30
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Timeframe: At Day 1 and Day 30
GMFR for Unique Serotypes IgG, [Stage 2, Group 2]
Timeframe: At Day 30
Percentage of Participants with Unique Serotype-specific IgG Concentration of greater than or equal to (>=) 4-fold increase, [Stage 2, Group 2]
Timeframe: At Day 30
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Timeframe: At Day 30
Dose response in the IgG concentrations for ASP3772 [Stage 2, Group 2]
Timeframe: At Day 30
GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3]
Timeframe: At Day 30
GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3]
Timeframe: At Day 30
Interventions:
Biological/vaccine: ASP3772
Biological/vaccine: PCV13
Biological/vaccine: PPSV23
Enrollment:
630
Observational study model:
Not applicable
Primary completion date:
2020-28-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pneumonia, Bacterial, healthy volunteers, Pneumococcal disease
Product
Not applicable
Collaborators
Affinivax Inc.
Study date(s)
January 2019 to September 2020
Type
Interventional
Phase
1/2
Participation criteria
Sex
Female & Male
Age
18 - 85 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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: o Not a woman of childbearing potential (WOCBP) OR o 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.
Trial location(s)
Location
PMG Research of Winston-Salem, LLC
Winston-Salem, NC, Unmapped, 27103
Status
Study Complete
Location
Advanced Clinical Research-Rancho Paseo
Banning, CA, Unmapped, 92220
Status
Study Complete
Location
Advanced Clinical Research Institute
Cedar Park, TX, Unmapped, 78613
Status
Study Complete
Location
Healthcare Associatiates of Texas
McKinney, TX, Unmapped, 75070
Status
Study Complete
Location
Clinical Research of Atlanta
Griffin, GA, Unmapped, 30224
Status
Terminated/Withdrawn
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2020-28-09
Actual study completion date
2020-28-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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