Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults
- Conditions
- Pneumococcal Vaccines
- Interventions
- Biological: 24-Valent Pneumococcal Conjugate Vaccine
- Registration Number
- NCT05297578
- Lead Sponsor
- Vaxcyte, Inc.
- Brief Summary
The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 65 years of age and older.
- Detailed Description
The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels (Low: 1.1 mcg; Mid: 2.2 mcg; or Mixed: 2.2/4.4 mcg) compared to Prevnar 20™ (PCV20) in adults 65 years of age and older.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
- Male or female age 65 or older.
- 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.
- Previous pneumococcal disease (either confirmed or by self-reporting).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VAX-24 Low Dose 24-Valent Pneumococcal Conjugate Vaccine Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1. VAX-24 Mid Dose 24-Valent Pneumococcal Conjugate Vaccine Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1. VAX-24 Mixed Dose 24-Valent Pneumococcal Conjugate Vaccine Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1. PCV20 Pneumococcal 20-valent Conjugate Vaccine Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
- Primary Outcome Measures
Name Time Method Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCIs) 6 months after vaccination Percentage of participants with serious adverse events (SAEs) and new onset of chronic illness (NOCIs)
Percentage of Subjects Reporting Unsolicited Adverse Events Within 1 Month After Vaccination 1 month after vaccination Percentage of participants with at least one Treatment Emergent Adverse Event (unsolicited AEs and SAEs)
Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination 7 days after vaccination Solicited local reactions included redness/erythema, swelling/induration, and pain at injection site
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination 7 days after vaccination Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain within 7 days of vaccination
- Secondary Outcome Measures
Name Time Method 24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs) 1 month after vaccination The change from baseline to 1 month post-vaccination in the immune response directed against each of the 24 serotypes was evaluated by measuring IgG levels using an IgG multiplexed electrochemoluminescent assay (ECLA). Values below the lower limit of quantitation (LLOQ) were analyzed as 0.5\*LLOQ. Values above the upper limit of quantitation (ULOQ) were analyzed as 1\*ULOQ.
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs) 1 month after vaccination The change from baseline to 1 month post-vaccination in the immune response directed against each of the 24 serotypes was evaluated by measuring serotype-specific functional antibody responses with an opsonophagocytic (OPA) assay that assesses the functional capacity of pneumococcal antibodies.
Trial Locations
- Locations (18)
Accel Research Sites - DeLand Clinical Research Unit
🇺🇸DeLand, Florida, United States
Accellacare of Rocky Mount
🇺🇸Rocky Mount, North Carolina, United States
Healthcare Research Network
🇺🇸Hazelwood, Missouri, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Precision Clinical Research
🇺🇸Sunrise, Florida, United States
Pivotal Research Solutions
🇺🇸Stonecrest, Georgia, United States
Healthcare Research Network II, LLC
🇺🇸Flossmoor, Illinois, United States
AMR Wichita West
🇺🇸Wichita, Kansas, United States
Velocity Clinical Research, Salt Lake City
🇺🇸West Jordan, Utah, United States
CenExel RCA
🇺🇸Hollywood, Florida, United States
Meridian Clinical Research
🇺🇸Cincinnati, Ohio, 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
AMR Newton, formerly Heartland Research Associates
🇺🇸Newton, Kansas, United States
AMR New Orleans
🇺🇸New Orleans, Louisiana, United States
Accellacare of Charleston
🇺🇸Mount Pleasant, South Carolina, United States
Accel Research Sites-Birmingham Clinical Research Unit
🇺🇸Birmingham, Alabama, United States