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Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults

Sponsor
Vaxcyte, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05297578
Collaborator
(none)
200
Enrollment
21
Locations
4
Arms
11.5
Anticipated Duration (Months)
9.5
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: 24-Valent Pneumococcal Conjugate Vaccine
  • Biological: Pneumococcal 20-valent Conjugate Vaccine
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase 2, Randomized, Observer-Blind, Dose-Finding, Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Adults 65 Years and Older
Actual Study Start Date :
Jun 15, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels.

Biological: 24-Valent Pneumococcal Conjugate Vaccine
0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
Experimental: Group 2

Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels.

Biological: 24-Valent Pneumococcal Conjugate Vaccine
0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
Experimental: Group 3

Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels.

Biological: 24-Valent Pneumococcal Conjugate Vaccine
0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
Active Comparator: Group 4

Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.

Biological: Pneumococcal 20-valent Conjugate Vaccine
0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
Other Names:
  • Prevnar 20, PCV20

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. Percentage of subjects reporting unsolicited adverse events within 1 month after vaccination [1 month after vaccination]

      Percentage of participants with adverse events and serious adverse events (SAEs)

    4. Percentage of participants reporting SAEs and new onset of chronic illnesses (NOCIs) [6 months after vaccination]

      Percentage of participants with SAEs and NOCIs

    Secondary Outcome Measures

    1. 24 VAX-24 Pneumococcal serotype-specific opsonophagocytic assay (OPA) geometric mean titer (GMTs) [1 month after vaccination]

      Antibody geometric mean titers as measured by OPA for the 24 pneumococcal serotypes in VAX-24

    2. 24 VAX-24 Pneumococcal serotype-specific IgG geometric mean concentration (GMCs) [1 month after vaccination]

      Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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 IM 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Accel Research Sites-Birmingham Clinical Research Unit Birmingham Alabama United States 35216
    2 Accel Research Sites - DeLand Clinical Research Unit DeLand Florida United States 32720
    3 CenExel RCA Hollywood Florida United States 33024
    4 Precision Clinical Research Sunrise Florida United States 33351
    5 Meridian Clinical Research Savannah Georgia United States 31406
    6 Pivotal Research Solutions Stonecrest Georgia United States 30038
    7 Healthcare Research Network II, LLC Flossmoor Illinois United States 60422
    8 AMR Newton, formerly Heartland Research Associates Newton Kansas United States 67114
    9 AMR Wichita West Wichita Kansas United States 67205
    10 AMR New Orleans New Orleans Louisiana United States 70119
    11 Healthcare Research Network Hazelwood Missouri United States 63042
    12 Meridian Clinical Research Omaha Nebraska United States 68134
    13 Accellacare of Rocky Mount Rocky Mount North Carolina United States 27804
    14 Acellacare of Wilmington Wilmington North Carolina United States 28401
    15 Meridian Clinical Research Cincinnati Ohio United States 45219
    16 Accellacare of Charleston Mount Pleasant South Carolina United States 29464
    17 Coastal Carolina Research North Charleston South Carolina United States 29405
    18 Clinical Trials of Texas, LLC San Antonio Texas United States 78229
    19 CenExel JBR Clinical Research Salt Lake City Utah United States 84107
    20 Velocity Clinical Research, Salt Lake City West Jordan Utah United States 84088
    21 Charlottesville Medical Research Charlottesville Virginia United States 22911

    Sponsors and Collaborators

    • Vaxcyte, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vaxcyte, Inc.
    ClinicalTrials.gov Identifier:
    NCT05297578
    Other Study ID Numbers:
    • VAX24-102
    First Posted:
    Mar 28, 2022
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vaccines
    Heptavalent Pneumococcal Conjugate Vaccine

    Study Results

    No Results Posted as of Jul 28, 2022