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

A Phase 1/2, Randomized, Observer-Blind, Dose-Finding, Controlled, Parallel-Group, Two-Stage Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Adults Aged 18 to 64 Years

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 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-24 at 3 dose levels compared to PCV20 in adults aged 50 to 64 years of age in Phase 2.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Vaccines
• Intervention / Treatment: Biological: 24 valent pneumococcal conjugate vaccine; Biological: 20 valent pneumococcal conjugate vaccine

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 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity 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 PCV20 in adults aged 50 to 64 years of age.

• Study Type: Interventional
• Enrollment (Actual): 835
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hollywood, Florida, United States, 33024
      • CenExel RCA
    • Sunrise, Florida, United States, 33351
      • Precision Clinical Research
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Velocity Clinical Research
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Johnson County Clin-Trials
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Benchmark Research
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Alliance for Multispecialty Research
  • New York
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Acellacare of Wilmington
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Velocity Clinical Research
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research
  • Texas
    • San Angelo, Texas, United States, 76904
      • Benchmark Research
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • JBR Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female age 18 to 49 years (inclusive) for the Phase 1 group, or 50 to 64 years (inclusive) for the Phase 2 group at the time of enrollment into the study.
• 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.
• Screening laboratory values must be within the central laboratory normal limits prior to study enrollment. Minor abnormalities are considered acceptable if not clinically significant.
• 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.
• Negative pregnancy test (urine and serum) for women of childbearing potential.

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).
• Seropositive to HIV, HCV, or HBsAg.
• History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
• Female who is breast-feeding or planning to become pregnant during study participation.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VAX-24 Low Dose; Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.	Biological: 24 valent pneumococcal conjugate vaccine; 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
Experimental: VAX-24 Mid Dose; Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1.	Biological: 24 valent pneumococcal conjugate vaccine; 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
Experimental: 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.	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: PCV20; Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.	Biological: 20 valent pneumococcal conjugate vaccine; 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group	Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group	7 days after vaccination
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group	Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain	7 days after vaccination
Percentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group	Percentage of participants in each age group with adverse events (AEs) whose date of onset occurs after the study vaccine and within the 28 days after vaccination.	1 month after vaccination
Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)	Percentage of participants with SAEs and NOCIs	6 months after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values	Shifts from Normal at Baseline to Abnormal on Day 29 in Clinical Chemistry Parameters Occurring in >5% of Subjects Aged 50 to 64 Years	1 month after vaccination
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)	Antibody geometric mean titers as measured by OPA for the 24 pneumococcal serotypes in VAX-24	1 month after vaccination
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)	Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24	1 month after vaccination

Collaborators and Investigators

• Sponsor: Vaxcyte, Inc.
• Investigators: Study Director: Clinical Development, Vaxcyte, Inc.

Publications and helpful links

General Publications

• Wassil J, Sisti M, Fairman J, Davis M, Fierro C, Bennett S, Johnson D, Migone TS, Nguyen K, Sauer P, Currie M, Iki S, Simon JK. Evaluating the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults aged 18 to 64 years: a phase 1/2, double-masked, dose-finding, active-controlled, randomised clinical trial. Lancet Infect Dis. 2024 Mar;24(3):308-318. doi: 10.1016/S1473-3099(23)00572-8. Epub 2023 Dec 4.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Actual): January 10, 2023
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: VAX24-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Vaxcyte is committed to providing access to anonymized data from the company's clinical trials for the purpose of legitimate scientific research. Requests for data may be addressed to datasharing@vaxcyte.com. Requests must be accompanied by a detailed analysis plan and will be reviewed for scientific validity. Data will be made available after initial product approval. Sharing of data may require execution of a data-sharing agreement.
• IPD Sharing Time Frame: Individual participant data will be shared after deidentification and made available starting 6 months after initial product approval.
• IPD Sharing Access Criteria: Criteria will depend on the specific proposal received and may include qualification of the scientific researchers, potential contribution to the research field, scientific rigor of statistical and analytical methods, and other criteria appropriate for the proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No