Clinical trial NCT05634811: Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children
Official title: A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY OF A 6-VALENT OspA-BASED LYME DISEASE VACCINE (VLA15) IN HEALTHY CHILDREN 5 THROUGH 17 YEARS OF AGE
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Lyme Disease
Keywords: Borreliosis
Borrelia burgdorferi
Spirochetes
Vector-Borne Disease
Lyme Disease Vaccine
VLA15
Outer Surface Protein A (OspA)
Ticks
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-12-02
Enrollment: 3235
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is to understand if the study vaccine (called VLA15) is safe in healthy children.

We are looking for children who:

* are healthy
* are age 5 through 17
* have not been diagnosed with any form of Lyme disease in the past
* have not received any vaccines for Lyme disease in the past

Lyme disease happens most often in children of this age. The study vaccine may be used potentially to help prevent Lyme disease. The goal of this study is to get more information about the safety of the study vaccine in this age group.

Participants will be in this study for about 2 years. During that time, they will receive VLA15 or placebo (sterile saltwater solution) by a "shot" in the arm. We will compare experience of children receiving VLA15 to those receiving the placebo. Participants will not know whether they get VLA15 or placebo.

Everyone participating in this study will:

* get the shots in a clinic or in a hospital office
* receive a total of 4 shots
* receive the first 3 shots within 6 months
* receive the last shot about 1 year afterwards
* need to come to the trial site for 6 planned visits; 4 of these are vaccination visits and 2 are follow-up visits. We will contact you by phone 1 time every year during the study to monitor your experience. You may have extra visits if you experience a severe reaction after a vaccine dose.


Eligibility criteria: Inclusion Criteria:

* Healthy participants at enrollment who are determined to be eligible for inclusion in the study. Participants with preexisting chronic medical conditions determined to be stable may be included.
* Participants and/or participants' parent(s)/guardian who are willing and able to comply with all scheduled visits, study procedures and lifestyle considerations for the duration of the study.

Exclusion Criteria:

* Female participants that are pregnant, breastfeeding, or have a positive urine pregnancy test at Visit 1. Sexually active females and fertile males unwilling to use contraception as per protocol.
* Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
* Any diagnosis of Lyme disease within the past 3 months.
* Any history of Lyme arthritis, carditis, neuroborreliosis, or other disseminated Lyme Disease (LD), regardless of when diagnosed.
* Known tick bite within the past 4 weeks.
* Congenital or acquired immunodeficiency or other conditions or treatments associated with immunosuppression that would inhibit the ability to mount an immune response to a vaccine.
* Other medical, psychiatric condition, active suicidal ideation/behavior or lab abnormality which increases risk of study participation or, in investigator's judgment is inappropriate for the study.
* Receipt of a previous vaccination for LD.
* Treatment for LD in the 3 months prior to study intervention administration.
* Receipt of blood/plasma products or immunoglobulins within 6 months before study intervention administration through conclusion of the study.
* Receipt of systemic corticosteroids for ≥14 days within 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical corticosteroids are permitted.
* Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months before study intervention administration.
* Current use of any prohibited concomitant medication(s) or participants unwilling/unable to use a permitted concomitant medication(s).
* Participation in other studies involving investigational drugs/vaccines/devices within 28 days prior to study entry and/or during study participation (observational studies are acceptable).
* Investigator site staff, sponsor/sponsor delegates directly involved in the conduct of the study and their family members; site staff supervised by the investigator and their family members.

Primary outcomes:
measure: The percentage of participants reporting prompted local reactions
timeFrame: Within 7 days following each study intervention administration
measure: The percentage of participants reporting prompted systemic events
timeFrame: Within 7 days following each study intervention administration
measure: The percentage of participants reporting adverse events (AEs)
timeFrame: Through 1 month following each study intervention administration
measure: The percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)
timeFrame: Through study completion, up to 24 months
measure: The percentage of participants reporting serious adverse events (SAEs)
timeFrame: Through study completion, up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Child Health Research Unit (CHRU)
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - School of Medicine
state: Alabama
city: Guntersville
country: United States
facility: Lakeview Clinical Research
state: Alabama
city: Bellflower
country: United States
facility: Coast Clinical Research, LLC
state: California
city: Fair Oaks
country: United States
facility: Apex Research Group LLC
state: California
city: Bridgeport
country: United States
facility: New England Research Associates
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Brandon
country: United States
facility: Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
state: Florida
city: Miami
country: United States
facility: Bio-Medical Research LLC
state: Florida
city: Miami
country: United States
facility: Bio-Medical Research LLC
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Research, Global Clinical professionals
state: Florida
city: Tampa
country: United States
facility: Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Tekton Research, LLC.
state: Georgia
city: Boise
country: United States
facility: ASR, LLC
state: Idaho
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: El Dorado
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Lenexa
country: United States
facility: Johnson County Clinical Trials
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/ Adult Research
state: Kentucky
city: Louisville
country: United States
facility: Bluegrass Clinical Research, Inc.
state: Kentucky
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Silver Spring
country: United States
facility: Virgo Carter Pediatrics
state: Maryland
city: Springfield
country: United States
facility: Sisu BHR
state: Massachusetts
city: Bingham Farms
country: United States
facility: Michigan Center of Medical Research (MICHMER)
state: Michigan
city: Dearborn Heights
country: United States
facility: Vida Clinical Studies, LLC
state: Michigan
city: Dearborn Heights
country: United States
facility: Vida Clinical Studies, LLC
state: Michigan
city: Southfield
country: United States
facility: Great Lakes Research Institute
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Omaha
country: United States
facility: Velocity Clinical Research, Omaha
state: Nebraska
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
city: Warren
country: United States
facility: IMA Clinical Research Warren
state: New Jersey
city: Bronx
country: United States
facility: Prime Global Research
state: New York
city: Bronx
country: United States
facility: Advantage Clinical Trials
state: New York
city: Bronx
country: United States
facility: Advantage Clinical Trials
state: New York
city: Buffalo
country: United States
facility: Buffalo Clinical and Translational Research Center
state: New York
city: Commack
country: United States
facility: Advanced Specialty Care
state: New York
city: Cortland
country: United States
facility: Smith Allergy and Asthma Specialists
state: New York
city: East Setauket
country: United States
facility: Stony Brook Medicine Clinical Research Center
state: New York
city: East Syracuse
country: United States
facility: Upstate Global Health Institute
state: New York
city: Endwell
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Hampton Bays
country: United States
facility: Southampton Hospital
state: New York
city: Horseheads
country: United States
facility: Smith Allergy & Asthma Specialists
state: New York
city: Mineola
country: United States
facility: NYU Langone Hospital - Long Island
state: New York
city: North Massapequa
country: United States
facility: DiGiovanna Institute for Medical Education & Research
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Vestal
country: United States
facility: Velocity Clinical Research, Vestal
state: New York
city: Columbus
country: United States
facility: Centricity Research Columbus Ohio Multispecialty
state: Ohio
city: Erie
country: United States
facility: Allegheny Health and Wellness Pavilion
state: Pennsylvania
city: Erie
country: United States
facility: Central Erie Primary Care
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
state: Pennsylvania
city: Scranton
country: United States
facility: Northeast Clinical Trials Group
state: Pennsylvania
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Fort Worth
country: United States
facility: Texas Health Resources
state: Texas
city: Houston
country: United States
facility: C & R Research Services USA
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Cy Fair
state: Texas
city: Houston
country: United States
facility: DM Clinical Research
state: Texas
city: Plano
country: United States
facility: Research Your Health
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Kingwood
country: United States
facility: Frontier Clinical research
state: West Virginia
city: Kingwood
country: United States
facility: Preston Healthcare Services
state: West Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: