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
Chinle Center for Indigenous Health
Chinle, Arizona 86503
Chinle, Arizona 86503
Avacare (CCT Research)
Phoenix, Arizona 85044
Phoenix, Arizona 85044
Whiteriver Center for Indigenous Health
Whiteriver, Arizona 85941
Whiteriver, Arizona 85941
Chase Medical Research
Waterbury, Connecticut 06708
Waterbury, Connecticut 06708
CenExel (RCA)
Hollywood, Florida 33024
Hollywood, Florida 33024
Eximia (Health Awareness)
Jupiter, Florida 33458
Jupiter, Florida 33458
Eximia (Health Awareness)
Port Saint Lucie, Florida 34952
Port Saint Lucie, Florida 34952
Precision Clinical Research
Sunrise, Florida 33351
Sunrise, Florida 33351
The Villages
The Villages, Florida 32162
The Villages, Florida 32162
DelRicht Clinical Research
Stockbridge, Georgia 30281
Stockbridge, Georgia 30281
Velocity Clinical Valparaiso
Valparaiso, Indiana 46383
Valparaiso, Indiana 46383
Johnson County Clin-Trials, LLC
Lenexa, Kansas 66219
Lenexa, Kansas 66219
DelRicht Clinical Research
New Orleans, Louisiana 70115
New Orleans, Louisiana 70115
Velocity (Meridian Clinical Research)
Rockville, Maryland 20854
Rockville, Maryland 20854
DM Clinical Research-Detroit
Southfield, Michigan 48076
Southfield, Michigan 48076
DelRicht Research (Command Family Medicine)
Springfield, Missouri 65807
Springfield, Missouri 65807
Quality Clinical Research
Omaha, Nebraska 68114
Omaha, Nebraska 68114
Center of American Indian Health
Gallup, New Mexico 87301
Gallup, New Mexico 87301
Shiprock Center for Indigenous Health
Shiprock, New Mexico 87420
Shiprock, New Mexico 87420
Rochester Clinical Research, Inc.
Rochester, New York 14609
Rochester, New York 14609
Headlands (Trial Management Associates)
Wilmington, North Carolina 28403
Wilmington, North Carolina 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, Oklahoma 73013
Edmond, Oklahoma 73013
DelRicht Research
Hendersonville, Tennessee 37075
Hendersonville, Tennessee 37075
Tekton Research
Austin, Texas 78745
Austin, Texas 78745
Flourish Research
San Antonio, Texas 78229
San Antonio, Texas 78229
DM Clinical Research
Sugar Land, Texas 77478
Sugar Land, Texas 77478
Alcanza (Charlottesville Medical Research)
Charlottesville, Virginia 22911
Charlottesville, Virginia 22911
Health Research of Hampton Roads, Inc.
Newport News, Virginia 23606
Newport News, Virginia 23606
More Details
- NCT ID
- NCT07425392
- Status
- Recruiting
- Sponsor
- Vaxcyte, Inc.