Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults
NCT ID: NCT05297578
Last Updated: 2024-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
207 participants
INTERVENTIONAL
2022-06-15
2023-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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VAX-24 Low Dose
Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine
0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mid Dose
Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine
0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
VAX-24 Mixed Dose
Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.
24-Valent Pneumococcal Conjugate Vaccine
0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
PCV20
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
Pneumococcal 20-valent Conjugate Vaccine
0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
Interventions
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24-Valent Pneumococcal Conjugate Vaccine
0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
Pneumococcal 20-valent Conjugate Vaccine
0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able and willing to complete the informed consent process.
* Available for clinical follow-up through the last study visit at 6 months after the study vaccination.
* In good general health as determined by medical history, vital signs, physical examination, and clinical judgment of the investigator. Preexisting medical conditions must be stable as defined by no change in treatment at least 6 weeks prior to study participation.
* Willing to have blood samples collected, stored indefinitely, and used for research purposes.
* Able to provide proof of identity to the satisfaction of the study staff completing the enrollment process.
Exclusion Criteria
* Previous receipt of a licensed or investigational pneumococcal vaccine.
* Receipt of any investigational study product within 30 days prior to enrollment into the study, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
* Planned or actual administration of any licensed vaccine during the period starting 30 days before enrollment into the study through Day 29.
* Physical examination indicating any clinically significant medical condition.
* Body Temperature \> 38.0°C (\> 100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescheduled).
* Previous or existing diagnosis of HIV, Hepatitis B or Hepatitis C.
* History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
* Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular injections or blood draws.
* Any other chronic or clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety or rights of the subject or confound evaluation of the study vaccine.
* 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.
* Received blood or blood product (including Immune Globulin IV) within 90 days prior to enrollment into the study.
* Received systemic corticosteroids for ≥ 14 consecutive days and has not completed treatment ≤30 days prior to enrollment into the study.
* Receiving immunosuppressive therapy.
* History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
65 Years
ALL
Yes
Sponsors
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Vaxcyte, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development
Role: STUDY_DIRECTOR
Vaxcyte, Inc.
Locations
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Accel Research Sites-Birmingham Clinical Research Unit
Birmingham, Alabama, United States
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, United States
CenExel RCA
Hollywood, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Meridian Clinical Research
Savannah, Georgia, United States
Pivotal Research Solutions
Stonecrest, Georgia, United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, United States
AMR Newton, formerly Heartland Research Associates
Newton, Kansas, United States
AMR Wichita West
Wichita, Kansas, United States
AMR New Orleans
New Orleans, Louisiana, United States
Healthcare Research Network
Hazelwood, Missouri, United States
Meridian Clinical Research
Omaha, Nebraska, United States
Accellacare of Rocky Mount
Rocky Mount, North Carolina, United States
Meridian Clinical Research
Cincinnati, Ohio, United States
Accellacare of Charleston
Mt. Pleasant, South Carolina, United States
Coastal Carolina Research
North Charleston, South Carolina, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
CenExel JBR Clinical Research
Salt Lake City, Utah, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Countries
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References
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Wassil J, Sisti M, Fairman J, Rankin B, Clark J, Bennett S, Johnson D, Migone TS, Nguyen K, Paschenko A, Sauer P, Iki S, Hanson ME, Simon JK. A phase 2, randomized, blinded, dose-finding, controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults 65 years and older. Vaccine. 2024 Nov 14;42(25):126124. doi: 10.1016/j.vaccine.2024.07.025. Epub 2024 Jul 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VAX24-102
Identifier Type: -
Identifier Source: org_study_id
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