Clinical trial NCT05266456: Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pneumococcal Vaccines
Lead sponsor: Vaxcyte, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-04
Enrollment: 835
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: 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 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.

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.

Primary outcomes:
measure: Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group
timeFrame: 7 days after vaccination
measure: Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group
timeFrame: 7 days after vaccination
measure: Percentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group
timeFrame: 1 month after vaccination
measure: Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)
timeFrame: 6 months after vaccination
Secondary outcomes:
measure: Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values
timeFrame: 1 month after vaccination
measure: VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
timeFrame: 1 month after vaccination
measure: VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
timeFrame: 1 month after vaccination
Other outcomes:
Locations:
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: Valparaiso
country: United States
facility: Velocity Clinical Research
state: Indiana
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research
state: Missouri
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Wilmington
country: United States
facility: Acellacare of Wilmington
state: North Carolina
city: Warwick
country: United States
facility: Velocity Clinical Research
state: Rhode Island
city: North Charleston
country: United States
facility: Coastal Carolina Research
state: South Carolina
city: San Angelo
country: United States
facility: Benchmark Research
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
affiliation: Vaxcyte, Inc.
name: Clinical Development
role: STUDY_DIRECTOR
References:
citation: 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.