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
NCT ID: NCT03803202
Last Updated: 2023-12-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
630 participants
INTERVENTIONAL
2019-01-24
2020-09-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stage 1, Group 1 Adults, ASP3772 Low dose
Healthy adults aged 18 to 64 years received a low dose \[1 microgram (μg)\] of ASP3772 intramuscularly on Day 1.
ASP3772
Participants received a single dose of ASP3772 (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose) intramuscularly
Stage 1, Group 1 Adults, ASP3772 Medium dose
Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
ASP3772
Participants received a single dose of ASP3772 (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose) intramuscularly
Stage 1, Group 1 Adults, ASP3772 High dose
Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
ASP3772
Participants received a single dose of ASP3772 (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose) intramuscularly
Stage 1, Group 1, PCV13 Pooled Comparator
Healthy adults aged 18 to 64 years received a single dose of PCV13 0.5 milliliter (mL) intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
PCV13
Participants received a single dose of PCV13 intramuscularly.
Stage 2, Group 2 Older Adults, ASP3772 Low dose
Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1.
ASP3772
Participants received a single dose of ASP3772 (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose) intramuscularly
Stage 2, Group 2 Older Adults, ASP3772 Medium dose
Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1.
ASP3772
Participants received a single dose of ASP3772 (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose) intramuscularly
Stage 2, Group 2 Older Adults, ASP3772 High dose
Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1.
ASP3772
Participants received a single dose of ASP3772 (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose) intramuscularly
Stage 2, Group 2, PCV13 Pooled Comparator
Older adults aged 65 to 85 years received a single dose of PCV13 0.5 mL intramuscularly on Day 1. Data from participants in each group given PCV13 were pooled for comparison with each ASP3772 dose group (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose).
PCV13
Participants received a single dose of PCV13 intramuscularly.
Stage 2, Group 3, PPSV23 Comparator
Older adults aged 65 to 85 years who had been previously vaccinated with PCV13, were enrolled and received a single of dose PPSV23 on Day 1.
PPSV23
Participants received a single dose of PPSV23 intramuscularly.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ASP3772
Participants received a single dose of ASP3772 (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose) intramuscularly
PCV13
Participants received a single dose of PCV13 intramuscularly.
PPSV23
Participants received a single dose of PPSV23 intramuscularly.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
85 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Affinivax, Inc.
INDUSTRY
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Advanced Clinical Research-Rancho Paseo
Banning, California, United States
Artemis Institute
San Diego, California, United States
Artemis Institute
San Marcos, California, United States
Research Centers of America
Hollywood, Florida, United States
Meridian Clinical Research
Savannah, Georgia, United States
Sundance Clinical Research
St Louis, Missouri, United States
Meridian Clinical Research
Norfolk, Nebraska, United States
United Medical Associates
Binghamton, New York, United States
PMG Research of Raleigh
Raleigh, North Carolina, United States
PMG Research of Hickory, LLC
Rocky Mount, North Carolina, United States
Piedmont HealthCare, PA
Statesville, North Carolina, United States
Wilmington Health
Wilmington, North Carolina, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States
Tekton Research - George Town
Yukon, Oklahoma, United States
PMG Research
Knoxville, Tennessee, United States
PMG Research
Knoxville, Tennessee, United States
Advanced Clinical Research Institute
Cedar Park, Texas, United States
Texas Healthcare, PLLC
Fort Worth, Texas, United States
Benchmark Research
Fort Worth, Texas, United States
Texas Center for Drug Development
Houston, Texas, United States
Healthcare Associatiates of Texas
McKinney, Texas, United States
DM Clinical Research
Pearland, Texas, United States
Benchmark Research
San Angelo, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
CRA of Tidewater Inc
Norfolk, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Borys D, Rupp R, Smulders R, Chichili GR, Kovanda LL, Santos V, Malinoski F, Siber G, Malley R, Sebastian S. Safety, tolerability and immunogenicity of a novel 24-valent pneumococcal vaccine in toddlers: A phase 1 randomized controlled trial. Vaccine. 2024 Apr 11;42(10):2560-2571. doi: 10.1016/j.vaccine.2024.02.001. Epub 2024 Feb 14.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3772-CL-1001
Identifier Type: OTHER
Identifier Source: secondary_id
219659
Identifier Type: -
Identifier Source: org_study_id