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

Pneumococcal Vaccines Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05297578
• Other study ID #: VAX24-102
• Status: Completed
• Phase: Phase 2
• Start date: June 15, 2022
• Est. completion date: February 15, 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 65 years of age and older.

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 information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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 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.

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
• Pneumococcal 20-valent Conjugate Vaccine
0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1

Locations

Country	Name	City	State
United States	Accel Research Sites-Birmingham Clinical Research Unit	Birmingham	Alabama
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Meridian Clinical Research	Cincinnati	Ohio
United States	Accel Research Sites - DeLand Clinical Research Unit	DeLand	Florida
United States	Healthcare Research Network II, LLC	Flossmoor	Illinois
United States	Healthcare Research Network	Hazelwood	Missouri
United States	CenExel RCA	Hollywood	Florida
United States	Accellacare of Charleston	Mount Pleasant	South Carolina
United States	AMR New Orleans	New Orleans	Louisiana
United States	AMR Newton, formerly Heartland Research Associates	Newton	Kansas
United States	Coastal Carolina Research	North Charleston	South Carolina
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Accellacare of Rocky Mount	Rocky Mount	North Carolina
United States	CenExel JBR Clinical Research	Salt Lake City	Utah
United States	Clinical Trials of Texas, LLC	San Antonio	Texas
United States	Meridian Clinical Research	Savannah	Georgia
United States	Pivotal Research Solutions	Stonecrest	Georgia
United States	Precision Clinical Research	Sunrise	Florida
United States	Velocity Clinical Research, Salt Lake City	West Jordan	Utah
United States	AMR Wichita West	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Vaxcyte, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination	Solicited local reactions included redness/erythema, swelling/induration, and pain at injection site	7 days after vaccination
Primary	Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination	Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain within 7 days of vaccination	7 days after vaccination
Primary	Percentage of Subjects Reporting Unsolicited Adverse Events Within 1 Month After Vaccination	Percentage of participants with at least one Treatment Emergent Adverse Event (unsolicited AEs and SAEs)	1 month after vaccination
Primary	Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCIs)	Percentage of participants with serious adverse events (SAEs) and new onset of chronic illness (NOCIs)	6 months after vaccination
Secondary	VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)	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.	1 month after vaccination
Secondary	24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)	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.	1 month after vaccination