Pneumonia, BacterialPhase 1/2NCT03803202
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
A Phase 1/2 study testing ASP3772, PCV13 and PPSV23 in people with Pneumonia, Bacterial and Healthy Volunteers, run by GlaxoSmithKline at 26 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Bacterial, Healthy Volunteers, Pneumococcal Disease
- What is being tested?
- ASP3772, PCV13 and PPSV23
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 26 sitesUnited States
- Study dates
- 24 Jan 2019to 28 Sep 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Advanced Clinical Research-Rancho Paseo
Banning, California, 92220
United Medical Associates
Binghamton, New York, 13901
Advanced Clinical Research Institute
Cedar Park, Texas, 78613
Texas Healthcare, PLLC
Fort Worth, Texas, 76104
Benchmark Research
Fort Worth, Texas, 76135
Research Centers of America
Hollywood, Florida, 33024
Texas Center for Drug Development
Houston, Texas, 77081
PMG Research
Knoxville, Tennessee, 37912
PMG Research
Knoxville, Tennessee, 37938
Healthcare Associatiates of Texas
McKinney, Texas, 75070
Meridian Clinical Research
Norfolk, Nebraska, 68701
CRA of Tidewater Inc
Norfolk, Virginia, 23507
DM Clinical Research
Pearland, Texas, 77584
PMG Research of Raleigh
Raleigh, North Carolina, 27604
PMG Research of Hickory, LLC
Rocky Mount, North Carolina, 27804
Benchmark Research
San Angelo, Texas, 76904
Clinical Trials of Texas
San Antonio, Texas, 78229
Artemis Institute
San Diego, California, 92103
Artemis Institute
San Marcos, California, 92078
Meridian Clinical Research
Savannah, Georgia, 31406
Sundance Clinical Research
St Louis, Missouri, 63141
Piedmont HealthCare, PA
Statesville, North Carolina, 28625
Martin Diagnostic Clinic
Tomball, Texas, 77375
Wilmington Health
Wilmington, North Carolina, 28401
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103
Tekton Research - George Town
Yukon, Oklahoma, 73099
About this study
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
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.
Read the 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.
- Being tested
- ASP3772, PCV13, PPSV23
- Keywords
- Pneumococcal vaccine, Vaccine, Pneumococccal Disease, ASP3772
- Medical subject headings
- Pneumonia, Bacterial, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP3772Biological
Participants received a single dose of ASP3772 (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose) intramuscularly
PCV13Biological
Also called Prevnar 13
Participants received a single dose of PCV13 intramuscularly.
PPSV23Biological
Also called Pneumovax 23
Participants received a single dose of PPSV23 intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low dose | Experimental | Healthy adults aged 18 to 64 years received a low dose [1 microgram (μg)] of ASP3772 intramuscularly on Day 1. Receives: Biological: ASP3772 |
| Stage 1, Group 1 Adults, ASP3772 Medium dose | Experimental | Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1. Receives: Biological: ASP3772 |
| Stage 1, Group 1 Adults, ASP3772 High dose | Experimental | Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. Receives: Biological: ASP3772 |
| Stage 1, Group 1, PCV13 Pooled Comparator | Active 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). Receives: Biological: PCV13 |
| Stage 2, Group 2 Older Adults, ASP3772 Low dose | Experimental | Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1. Receives: Biological: ASP3772 |
| Stage 2, Group 2 Older Adults, ASP3772 Medium dose | Experimental | Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1. Receives: Biological: ASP3772 |
| Stage 2, Group 2 Older Adults, ASP3772 High dose | Experimental | Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. Receives: Biological: ASP3772 |
| Stage 2, Group 2, PCV13 Pooled Comparator | Active 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). Receives: Biological: PCV13 |
| Stage 2, Group 3, PPSV23 Comparator | Active 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. Receives: Biological: PPSV23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1]
An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization.
A new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature.
Measured: From Day 1, Up to Day 180
Number of Participants With TEAEs, [Stage 2, Group 2]
An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization.
A new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature. As specified in protocol, data was planned to be analyzed for PCV13 pooled comparator from each group given PCV13 to compare with each ASP3772 dose.
Measured: From Day 1, Up to Day 180
Number of Participants With TEAEs, [Stage 2, Group 3]
An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization.
A new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature.
Measured: From Day 1, Up to Day 30
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Vital signs parameters included blood pressure (hypotension and hypertension), pulse rate (tachycardia and bradycardia), body temperature and respiratory rate. Any change in vital sign abnormalities that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition.
Measured: During first hour post vaccination (vaccine administered at Day 1)
Number of Participants With Potentially Clinically Significant Laboratory Values
Clinical laboratory testing included hematology, clinical chemistry, or urinalysis. Any abnormal laboratory test result (e.g., in hematology, clinical chemistry, or urinalysis) that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Laboratory tests of clinical interest included total bilirubin ≥ 2x ULN and Alkaline phosphatase > 1.5 × upper limit of normal. Study Investigator's interest was to assess only potentially clinically significant values.
Measured: Up to Day 30
Number of Participants With Potentially Clinically Significant Physical Examination Values
A physical examination consists of an examination of general appearance, eyes, nose throat, neck (including thyroid), lymph nodes, chest, lungs, cardiovascular, abdomen, skin, extremities, musculoskeletal and neurological system including mental status. Any abnormal test result that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Study Investigator's interest was to assess only potentially clinically significant values.
Measured: Up to Day 30
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2]
The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management.
Any clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE.
Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition.
Measured: 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]
The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management.
Any clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE.
Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition.
Measured: At Day 7
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 2, Group 3]
The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management.
Any clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE.
Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition.
Measured: 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]
Local reactions include pain, tenderness, redness/erythema, swelling and induration.
Measured: 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]
Assessed solicited local reactions were pain, tenderness, redness/erythema, swelling, induration, itching at injection site and pruritus at injection site.
Measured: Up to 7 Day post Vaccination (vaccine administered at Day 1)
Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1]
Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia.
Measured: 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]
Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia.
Measured: Up to 7 Day post Vaccination (vaccine administered at Day 1)
Secondary outcomes (13)
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
OPA titers were determined for serotypes: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. OPA titer was expressed as the reciprocal of the serum dilution that causes a 50% reduction in the colony-forming units.
Measured: At Day 1 and Day 30
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Immunological responses were assessed in terms of IgG GMCs and expressed as titers. The assessed serotypes were: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.
Measured: At Day 1 and Day 30
Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]
Immunological responses were assessed in terms of IgG GMFRs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, and 33F.
Measured: At Day 30
Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1]
Immunological responses were assessed in terms of percentage of participants with serotype-specific IgG concentration >=4-fold increase. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.
Measured: At Day 30
GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1]
Immunological responses were assessed in terms of OPA GMTs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.
Measured: At Day 30
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Immunological responses were assessed in terms of OPA GMTs and expressed as titers. The assessed serotypes were: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.
Measured: At Day 1 and Day 30
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Immunological responses were assessed in terms of IgG GMCs and expressed as titers. The assessed serotypes were: 1, 3,4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.
Measured: At Day 1 and Day 30
GMFR for Unique Serotypes IgG, [Stage 2, Group 2]
Immunological responses were assessed in terms of IgG GMFRs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, and 33F.
Measured: 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]
Immunological responses were assessed in terms of percentage of participants with unique serotypes IgG concentration >=4-fold increase. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.
Measured: At Day 30
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
An analysis of covariance (ANCOVA) model was conducted with age categories (65 to 74 years and 75 to 85 years) serving as covariates, and treatment groups (ASP3772 1 µg, 2 µg, and 5 µg) as the factor of interest. The natural logarithm (log) of pneumococcal OPA titers for each serotype were examined to assess the dose-response relationship. The assessed serotypes were: 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F,20B, 22F, 23F, and 33F. he assessed serotypes were: 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F,20B, 22F, 23F, and 33F.
Measured: At Day 30
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
An analysis of covariance (ANCOVA) model was conducted with age categories (65 to 74 years and 75 to 85 years) serving as covariates, and treatment groups (ASP3772 1 µg, 2 µg, and 5 µg) as the factor of interest. The natural logarithm (log) of IgG concentrations for each serotype were examined to assess the dose-response relationship.
Measured: At Day 30
GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3]
Immunological responses were assessed in terms of OPA GMTs. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.
Measured: At Day 30
GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3]
Immunogenicity was measured in terms of IgG GMCs and expressed as titers. The assessed serotypes were: 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, 33F.
Measured: At Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start24 Jan 2019
- Primary completion28 Sep 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, BacterialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Affinivax, Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803202
- Sponsor's protocol ID
- 219659
- Other IDs
- 3772-CL-1001
- Status last verified
- Nov 2023
- First submitted
- 11 Jan 2019
- Last updated
- 21 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38360475Chichili 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.
PubMed 35690500
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03803202
- Acronym / sponsor ID
- 219659
- Keywords
- Pneumococcal vaccine, Vaccine, Pneumococccal Disease, ASP3772
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Affinivax, Inc.
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Posted 21 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Stage 1, Group 1 Adults, ASP3772 Low dose | Experimental | Biological: ASP3772Healthy adults aged 18 to 64 years received a low dose [1 microgram (μg)] of ASP3772 intramuscularly on Day 1. |
| Stage 1, Group 1 Adults, ASP3772 Medium dose | Experimental | Biological: ASP3772Healthy adults aged 18 to 64 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1. |
| Stage 1, Group 1 Adults, ASP3772 High dose | Experimental | Biological: ASP3772Healthy adults aged 18 to 64 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| Stage 1, Group 1, PCV13 Pooled Comparator | Active comparator | Biological: PCV13Healthy 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). |
| Stage 2, Group 2 Older Adults, ASP3772 Low dose | Experimental | Biological: ASP3772Healthy older adults aged 65 to 85 years received a low dose (1 μg) of ASP3772 intramuscularly on Day 1. |
| Stage 2, Group 2 Older Adults, ASP3772 Medium dose | Experimental | Biological: ASP3772Healthy older adults aged 65 to 85 years received a medium dose (2 μg) of ASP3772 intramuscularly on Day 1. |
| Stage 2, Group 2 Older Adults, ASP3772 High dose | Experimental | Biological: ASP3772Healthy older adults aged 65 to 85 years received a high dose (5 μg) of ASP3772 intramuscularly on Day 1. |
| Stage 2, Group 2, PCV13 Pooled Comparator | Active comparator | Biological: PCV13Older 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). |
| Stage 2, Group 3, PPSV23 Comparator | Active comparator | Biological: PPSV23Older 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP3772Participants received a single dose of ASP3772 (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose) intramuscularly | Biological | Stage 1, Group 1 Adults, ASP3772 High dose, Stage 1, Group 1 Adults, ASP3772 Low dose, Stage 1, Group 1 Adults, ASP3772 Medium dose, Stage 2, Group 2 Older Adults, ASP3772 High dose, Stage 2, Group 2 Older Adults, ASP3772 Low dose, Stage 2, Group 2 Older Adults, ASP3772 Medium dose |
| PCV13Also: Prevnar 13Participants received a single dose of PCV13 intramuscularly. | Biological | Stage 1, Group 1, PCV13 Pooled Comparator, Stage 2, Group 2, PCV13 Pooled Comparator |
| PPSV23Also: Pneumovax 23Participants received a single dose of PPSV23 intramuscularly. | Biological | Stage 2, Group 3, PPSV23 Comparator |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1]
Time frame: From Day 1, Up to Day 180
An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization. A new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature.
Number of Participants With TEAEs, [Stage 2, Group 2]
Time frame: From Day 1, Up to Day 180
An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization. A new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature. As specified in protocol, data was planned to be analyzed for PCV13 pooled comparator from each group given PCV13 to compare with each ASP3772 dose.
Number of Participants With TEAEs, [Stage 2, Group 3]
Time frame: From Day 1, Up to Day 30
An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization. A new-onset chronic disease TEAEs (NOCD) is defined as a MAAE which a) was absent at baseline; b) has not resolved at the follow-up telephone call; c) requires continuous medical care or attention. Potentially Immune Mediated medical condition TEAEs (PIMMCs) are defined as any AEs of autoimmune or auto inflammatory nature.
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Time frame: During first hour post vaccination (vaccine administered at Day 1)
Vital signs parameters included blood pressure (hypotension and hypertension), pulse rate (tachycardia and bradycardia), body temperature and respiratory rate. Any change in vital sign abnormalities that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition.
Number of Participants With Potentially Clinically Significant Laboratory Values
Time frame: Up to Day 30
Clinical laboratory testing included hematology, clinical chemistry, or urinalysis. Any abnormal laboratory test result (e.g., in hematology, clinical chemistry, or urinalysis) that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Laboratory tests of clinical interest included total bilirubin ≥ 2x ULN and Alkaline phosphatase > 1.5 × upper limit of normal. Study Investigator's interest was to assess only potentially clinically significant values.
Number of Participants With Potentially Clinically Significant Physical Examination Values
Time frame: Up to Day 30
A physical examination consists of an examination of general appearance, eyes, nose throat, neck (including thyroid), lymph nodes, chest, lungs, cardiovascular, abdomen, skin, extremities, musculoskeletal and neurological system including mental status. Any abnormal test result that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Study Investigator's interest was to assess only potentially clinically significant values.
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2]
Time frame: Day - 28 to Day -1 (28 days prior to study vaccination)
The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management. Any clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE. Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition.
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 1, Group 1] and [Stage 2, Group 2]
Time frame: At Day 7
The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management. Any clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE. Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition.
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG), [Stage 2, Group 3]
Time frame: Day - 28 to Day -1 (28 days prior to study vaccination)
The Investigator assessed standard 12-lead ECG recordings for the purposes of safety assessment and participant management. Any clinically significant abnormality, as determined by the investigator's medical and scientific judgment and unrelated to underlying disease, should be reported as an unsolicited (S)AE. Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition.
Reactogenicity Assessed by Number of Participants With Solicited Local Reactions, [Stage 1, Group 1]
Time frame: Up to 7 Day post Vaccination (vaccine administered at Day 1)
Local reactions include pain, tenderness, redness/erythema, swelling and induration.
Reactogenicity Assessed by Number of Solicited Local Reactions, [Stage 2, Group 2 and Group 3]
Time frame: Up to 7 Day post Vaccination (vaccine administered at Day 1)
Assessed solicited local reactions were pain, tenderness, redness/erythema, swelling, induration, itching at injection site and pruritus at injection site.
Reactogenicity Assessed by Number of Solicited Systemic Reactions, [Stage 1, Group 1]
Time frame: Up to 7 Day post Vaccination (vaccine administered at Day 1)
Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia.
Reactogenicity Assessed by Number of Solicited Systemic Reactions [Stage 2, Group 2 and Group 3]
Time frame: Up to 7 Day post Vaccination (vaccine administered at Day 1)
Assessed systemic reactions were nausea/vomiting, diarrhea, headache, fever, fatigue and muscle discomfort or pain/myalgia.
13 secondary outcomes
Geometric Mean Titers (GMTs) for Serotype-specific Opsonophagocytic Activity (OPA) Titer, [Stage 1, Group 1]
Time frame: At Day 1 and Day 30
Geometric Mean Concentration (GMCs) for Serotype-specific Immunoglobulin G (IgG), [Stage 1, Group 1]
Time frame: At Day 1 and Day 30
Geometric Mean Fold Rise (GMFR) for Unique Serotypes IgG [Stage 1, Group 1]
Time frame: At Day 30
Percentage of Participants With Unique Serotypes IgG of Greater Than or Equal to (>=) 4-fold Increase, [Stage 1, Group 1]
Time frame: At Day 30
GMTs for Unique Serotype OPA Titer, [Stage 1, Group 1]
Time frame: At Day 30
GMTs for Serotype-specific OPA Titer, [Stage 2, Group 2]
Time frame: At Day 1 and Day 30
GMCs for Serotype-specific IgG, [Stage 2, Group 2]
Time frame: At Day 1 and Day 30
GMFR for Unique Serotypes IgG, [Stage 2, Group 2]
Time frame: 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]
Time frame: At Day 30
Dose Response in OPA Titer for ASP3772 (Stage 2, Group 2)
Time frame: At Day 30
Dose Response in the IgG Concentrations for ASP3772 [Stage 2, Group 2]
Time frame: At Day 30
GMTs for Unique Serotype OPA Titer [Stage 2, Group 2 and Group 3]
Time frame: At Day 30
GMCs for Unique Serotypes IgG, [Stage 2, Group 2 and Group 3]
Time frame: At Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38360475Borys 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.
- Derived from this study: PubMed 35690500Chichili 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Global Development, Inc.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ASP3772, PCV13 and PPSV23 in people with Pneumonia, Bacterial and Healthy Volunteers, run by GlaxoSmithKline at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs), [Stage 1, Group 1] (time frame: From Day 1, Up to Day 180). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03803202, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023; AzTrials last refreshed its copy on 30 Oct 2026.