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

NCT ID: NCT05266456

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 835 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-22
• Study Completion Date: 2023-01-10

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 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.

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.

Conditions

Pneumococcal Vaccines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

VAX-24 Low Dose

Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.

Group Type: EXPERIMENTAL

24 valent pneumococcal conjugate vaccine

Intervention Type: BIOLOGICAL

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.

Group Type: EXPERIMENTAL

24 valent pneumococcal conjugate vaccine

Intervention Type: BIOLOGICAL

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.

Group Type: EXPERIMENTAL

24 valent pneumococcal conjugate vaccine

Intervention Type: BIOLOGICAL

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.

Group Type: ACTIVE_COMPARATOR

20 valent pneumococcal conjugate vaccine

Intervention Type: BIOLOGICAL

0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1

Interventions

24 valent pneumococcal conjugate vaccine

0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1

Intervention Type: BIOLOGICAL

20 valent pneumococcal conjugate vaccine

0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vaxcyte, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development

Role: STUDY_DIRECTOR

Vaxcyte, Inc.

Locations

CenExel RCA

Hollywood, Florida, United States

Precision Clinical Research

Sunrise, Florida, United States

Meridian Clinical Research

Savannah, Georgia, United States

Velocity Clinical Research

Valparaiso, Indiana, United States

Johnson County Clin-Trials

Lenexa, Kansas, United States

Benchmark Research

Metairie, Louisiana, United States

Alliance for Multispecialty Research

Kansas City, Missouri, United States

Rochester Clinical Research

Rochester, New York, United States

Acellacare of Wilmington

Wilmington, North Carolina, United States

Velocity Clinical Research

Warwick, Rhode Island, United States

Coastal Carolina Research

North Charleston, South Carolina, United States

Benchmark Research

San Angelo, Texas, United States

JBR Clinical Research

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 38061367 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VAX24-101

Identifier Type: -

Identifier Source: org_study_id