Clinical trial NCT05297578: Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumococcal Vaccines
Lead sponsor: Vaxcyte, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-28
Enrollment: 207
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 65 years of age and older.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination
timeFrame: 7 days after vaccination
measure: Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination
timeFrame: 7 days after vaccination
measure: Percentage of Subjects Reporting Unsolicited Adverse Events Within 1 Month After Vaccination
timeFrame: 1 month after vaccination
measure: Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCIs)
timeFrame: 6 months after vaccination
Secondary outcomes:
measure: VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
timeFrame: 1 month after vaccination
measure: 24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
timeFrame: 1 month after vaccination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Accel Research Sites-Birmingham Clinical Research Unit
state: Alabama
city: DeLand
country: United States
facility: Accel Research Sites - DeLand Clinical Research Unit
state: Florida
city: Hollywood
country: United States
facility: CenExel RCA
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Stonecrest
country: United States
facility: Pivotal Research Solutions
state: Georgia
city: Flossmoor
country: United States
facility: Healthcare Research Network II, LLC
state: Illinois
city: Newton
country: United States
facility: AMR Newton, formerly Heartland Research Associates
state: Kansas
city: Wichita
country: United States
facility: AMR Wichita West
state: Kansas
city: New Orleans
country: United States
facility: AMR New Orleans
state: Louisiana
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Rocky Mount
country: United States
facility: Accellacare of Rocky Mount
state: North Carolina
city: Cincinnati
country: United States
facility: Meridian Clinical Research
state: Ohio
city: Mount Pleasant
country: United States
facility: Accellacare of Charleston
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research
state: South Carolina
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
city: Salt Lake City
country: United States
facility: CenExel JBR Clinical Research
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
Study officials:
affiliation: Vaxcyte, Inc.
name: Clinical Development
role: STUDY_DIRECTOR
References:
citation: Wassil J, Sisti M, Fairman J, Rankin B, Clark J, Bennett S, Johnson D, Migone TS, Nguyen K, Paschenko A, Sauer P, Iki S, Hanson ME, Simon JK. A phase 2, randomized, blinded, dose-finding, controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults 65 years and older. Vaccine. 2024 Nov 14;42(25):126124. doi: 10.1016/j.vaccine.2024.07.025. Epub 2024 Jul 17.