Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Prior Pneumococcal Vaccination
Purpose
The study will evaluate the safety, tolerability, and immunogenicity of VAX-31 in adults ≥50 years of age.
Condition
- Pneumococcal Vaccines
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Male or female ≥50 years of age (inclusive) at the time of randomization into the study. - Previous receipt of a licensed pneumococcal vaccine or combination of licensed vaccines, with most recent vaccination ≥1 year prior to randomization; the exception is PCV21, which may have been received ≥6 months prior to randomization (confirmed). - Able and willing to complete the informed consent process. - Available for clinical follow-up through the last study visit. - In good general health or with stable underlying chronic condition(s), as determined by medical history, oral temperature, physical examination, and clinical judgment of the Investigator (ongoing chronic conditions must be documented as stable per Investigator). - Willing to have blood samples collected and used for research purposes. - Able to provide proof of identity to the satisfaction of the site personnel completing the enrollment process. - Female participants of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test immediately prior to randomization and agree to use acceptable contraception. Male subjects with partners of childbearing potential must agree to practice an acceptable contraception method. - Able to access and use a device connected to Wi-Fi or cellular network for completion of an electronic diary (eDiary).
Exclusion Criteria
- Previous invasive pneumococcal disease (IPD) or pneumococcal pneumonia (either confirmed or self-reported) at any age. - Previous receipt of an investigational pneumococcal vaccine at any age. - Receipt of any investigational product within 30 days prior to Day 1, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study. - Receipt of any live vaccine within 30 days prior to Day 1, or receipt of any non-live (including inactivated) vaccine within 14 days prior to Day 1. - Body temperature >38.0°C (>100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescreened). - Current diagnosis of human immunodeficiency virus, Hepatitis B, or Hepatitis C. - History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any previous vaccination. - Individual who is pregnant, breastfeeding, or planning to become pregnant during study participation. - Has a known or suspected immunocompromising condition, including, but not limited to, leukemia, lymphoma, chronic renal failure, or congenital or acquired immunodeficiency. - Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically significant bruising or bleeding difficulties with IM injections or blood draws. - Receipt of blood or blood product (including polyclonal intravenous immunoglobulin) within 60 days prior to enrollment into the study. - Is currently receiving immunosuppressive or immune-modifying therapy, including systemic corticosteroids (this includes ≥3 months of prednisone equivalent from 5 to ≤10 mg/day and ≥2 weeks of prednisone equivalent >10 mg/day). - Received any part of a ≥14-day course of systemic corticosteroids (prednisone equivalent >10 mg/day) within 14 days of study vaccination • History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. - Any medical, psychiatric, or social condition that in the judgment of the Investigator is a contraindication to protocol participation or impairs a subject's ability to give informed consent. - Employee of, or first-degree relative of, any person employed by the Sponsor, the contract research organization (CRO), the Investigator, site personnel, or site
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort 1 (VAX-31): Prior PPSV23 |
Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
|
|
Active Comparator Cohort 1 (PCV20): Prior PPSV23 |
Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
|
|
Experimental Cohort 2 (VAX-31): Prior PCV20 |
Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
|
|
Active Comparator Cohort 2 (PCV20): Prior PCV20 |
Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
|
|
Experimental Cohort 3 (VAX-31): Other prior licensed pneumococcal vaccine or combination |
Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
|
|
Active Comparator Cohort 3 (PCV20): Other prior licensed pneumococcal vaccine or combination |
Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
|
Recruiting Locations
Avacare (CCT Research)
Phoenix 5308655, Arizona 5551752 85044
Phoenix 5308655, Arizona 5551752 85044
Chase Medical Research
Waterbury 4845193, Connecticut 4831725 06708
Waterbury 4845193, Connecticut 4831725 06708
CenExel (RCA)
Hollywood 4158928, Florida 4155751 33024
Hollywood 4158928, Florida 4155751 33024
Eximia (Health Awareness)
Jupiter 4160610, Florida 4155751 33458
Jupiter 4160610, Florida 4155751 33458
Eximia (Health Awareness)
Port Saint Lucie 4169171, Florida 4155751 34952
Port Saint Lucie 4169171, Florida 4155751 34952
Precision Clinical Research
Sunrise 4174402, Florida 4155751 33351
Sunrise 4174402, Florida 4155751 33351
The Villages
The Villages 4175179, Florida 4155751 32162
The Villages 4175179, Florida 4155751 32162
DelRicht Clinical Research
Stockbridge 4224681, Georgia 4197000 30281
Stockbridge 4224681, Georgia 4197000 30281
Velocity Clinical Valparaiso
Valparaiso 4927537, Indiana 4921868 46383
Valparaiso 4927537, Indiana 4921868 46383
Johnson County Clin-Trials, LLC
Lenexa 4274356, Kansas 4273857 66219
Lenexa 4274356, Kansas 4273857 66219
DelRicht Clinical Research
New Orleans 4335045, Louisiana 4331987 70115
New Orleans 4335045, Louisiana 4331987 70115
Velocity (Meridian Clinical Research)
Rockville 4367175, Maryland 4361885 20854
Rockville 4367175, Maryland 4361885 20854
DM Clinical Research-Detroit
Southfield 5010636, Michigan 5001836 48076
Southfield 5010636, Michigan 5001836 48076
AMR
Kansas City 4393217, Missouri 4398678 64114
Kansas City 4393217, Missouri 4398678 64114
DelRicht Research (Command Family Medicine)
Springfield 4409896, Missouri 4398678 65807
Springfield 4409896, Missouri 4398678 65807
Quality Clinical Research
Omaha 5074472, Nebraska 5073708 68114
Omaha 5074472, Nebraska 5073708 68114
Rochester Clinical Research, Inc.
Rochester 5134086, New York 5128638 14609
Rochester 5134086, New York 5128638 14609
Headlands (Trial Management Associates)
Wilmington 4499379, North Carolina 4482348 28403
Wilmington 4499379, North Carolina 4482348 28403
Contact:
Shakira Aguilar-Oseguera
Retrieving data. Wait a few se
shakira.aguilar-oseguera@headlandsresearch.com
Shakira Aguilar-Oseguera
Retrieving data. Wait a few se
shakira.aguilar-oseguera@headlandsresearch.com
Tekton Research
Edmond 4535740, Oklahoma 4544379 73013
Edmond 4535740, Oklahoma 4544379 73013
DelRicht Research
Hendersonville 4628735, Tennessee 4662168 37075
Hendersonville 4628735, Tennessee 4662168 37075
Tekton Research
Austin 4671654, Texas 4736286 78745
Austin 4671654, Texas 4736286 78745
REX Clinical Trials
Beaumont 4672989, Texas 4736286 77701
Beaumont 4672989, Texas 4736286 77701
Flourish Research
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
DM Clinical Research
Sugar Land 4734825, Texas 4736286 77478
Sugar Land 4734825, Texas 4736286 77478
Alcanza (Charlottesville Medical Research)
Charlottesville 4752031, Virginia 6254928 22911
Charlottesville 4752031, Virginia 6254928 22911
Health Research of Hampton Roads, Inc.
Newport News 4776024, Virginia 6254928 23606
Newport News 4776024, Virginia 6254928 23606
More Details
- Status
- Recruiting
- Sponsor
- Vaxcyte, Inc.