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

Pneumococcal Vaccines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05266456
• Other study ID #: VAX24-101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 22, 2022
• Est. completion date: January 10, 2023

Study information

• Verified date: March 2024
• Source: Vaxcyte, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 835
• Est. completion date: January 10, 2023
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumococcal Vaccines

Intervention

Biological:
• 24 valent pneumococcal conjugate vaccine
0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
• 20 valent pneumococcal conjugate vaccine
0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1

Locations

Country	Name	City	State
United States	CenExel RCA	Hollywood	Florida
United States	Alliance for Multispecialty Research	Kansas City	Missouri
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Benchmark Research	Metairie	Louisiana
United States	Coastal Carolina Research	North Charleston	South Carolina
United States	Rochester Clinical Research	Rochester	New York
United States	JBR Clinical Research	Salt Lake City	Utah
United States	Benchmark Research	San Angelo	Texas
United States	Meridian Clinical Research	Savannah	Georgia
United States	Precision Clinical Research	Sunrise	Florida
United States	Velocity Clinical Research	Valparaiso	Indiana
United States	Velocity Clinical Research	Warwick	Rhode Island
United States	Acellacare of Wilmington	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Vaxcyte, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 adult — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)	Percentage of participants with SAEs and NOCIs	6 months after vaccination
Secondary	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
Secondary	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
Secondary	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