Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children

Lyme Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05634811
• Other study ID #: C4601012
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 12, 2022
• Est. completion date: June 6, 2025

Study information

• Verified date: March 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3242
• Est. completion date: June 6, 2025
• Est. primary completion date: June 6, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lyme Disease

Intervention

Biological:
• VLA15
6-valent OspA-based Lyme disease vaccine

Other:
• Normal Saline
0.9% sodium chloride solution for injection

Locations

Country	Name	City	State
United States	Tekton Research, LLC.	Atlanta	Georgia
United States	Benchmark Research	Austin	Texas
United States	Kentucky Pediatric/ Adult Research	Bardstown	Kentucky
United States	Coast Clinical Research, LLC	Bellflower	California
United States	Hassman Research Institute	Berlin	New Jersey
United States	Michigan Center of Medical Research (MICHMER)	Bingham Farms	Michigan
United States	UAB Child Health Research Unit (CHRU)	Birmingham	Alabama
United States	University of Alabama at Birmingham - School of Medicine	Birmingham	Alabama
United States	ASR, LLC	Boise	Idaho
United States	Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research	Brandon	Florida
United States	New England Research Associates	Bridgeport	Connecticut
United States	Advantage Clinical Trials	Bronx	New York
United States	Advantage Clinical Trials	Bronx	New York
United States	Prime Global Research	Bronx	New York
United States	Buffalo Clinical and Translational Research Center	Buffalo	New York
United States	Pediatric Research of Charlottesville, LLC	Charlottesville	Virginia
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Centricity Research Columbus Ohio Multispecialty	Columbus	Ohio
United States	Advanced Specialty Care	Commack	New York
United States	Smith Allergy and Asthma Specialists	Cortland	New York
United States	Vida Clinical Studies, LLC	Dearborn Heights	Michigan
United States	Vida Clinical Studies, LLC	Dearborn Heights	Michigan
United States	Stony Brook Medicine Clinical Research Center	East Setauket	New York
United States	Upstate Global Health Institute	East Syracuse	New York
United States	Alliance for Multispecialty Research, LLC	El Dorado	Kansas
United States	Meridian Clinical Research, LLC	Endwell	New York
United States	Allegheny Health and Wellness Pavilion	Erie	Pennsylvania
United States	Central Erie Primary Care	Erie	Pennsylvania
United States	Apex Research Group LLC	Fair Oaks	California
United States	Benchmark Research	Fort Worth	Texas
United States	Texas Health Resources	Fort Worth	Texas
United States	Lakeview Clinical Research	Guntersville	Alabama
United States	Southampton Hospital	Hampton Bays	New York
United States	Smith Allergy & Asthma Specialists	Horseheads	New York
United States	C & R Research Services USA	Houston	Texas
United States	DM Clinical Research	Houston	Texas
United States	DM Clinical Research - Cy Fair	Houston	Texas
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	Frontier Clinical research	Kingwood	West Virginia
United States	Preston Healthcare Services	Kingwood	West Virginia
United States	Johnson County Clinical Trials	Lenexa	Kansas
United States	Bluegrass Clinical Research, Inc.	Louisville	Kentucky
United States	Bio-Medical Research LLC	Miami	Florida
United States	Bio-Medical Research LLC	Miami	Florida
United States	NYU Langone Hospital - Long Island	Mineola	New York
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Rutgers University	New Brunswick	New Jersey
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	DiGiovanna Institute for Medical Education & Research	North Massapequa	New York
United States	Velocity Clinical Research, Omaha	Omaha	Nebraska
United States	MD Medical Research	Oxon Hill	Maryland
United States	Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)	Pittsburgh	Pennsylvania
United States	Research Your Health	Plano	Texas
United States	Clinical Research Partners, LLC	Richmond	Virginia
United States	Rochester Clinical Research, LLC	Rochester	New York
United States	GCP Research, Global Clinical professionals	Saint Petersburg	Florida
United States	Sun Research Institute	San Antonio	Texas
United States	Northeast Clinical Trials Group	Scranton	Pennsylvania
United States	Virgo Carter Pediatrics	Silver Spring	Maryland
United States	Great Lakes Research Institute	Southfield	Michigan
United States	Sisu BHR	Springfield	Massachusetts
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	Stony Brook University	Stony Brook	New York
United States	SUNY Upstate Medical University	Syracuse	New York
United States	SUNY Upstate Medical University	Syracuse	New York
United States	ForCare Clinical Research	Tampa	Florida
United States	Meridian Clinical Research, LLC	Vestal	New York
United States	IMA Clinical Research Warren	Warren	New Jersey
United States	Children's National Medical Center	Washington	District of Columbia
United States	Velocity Clinical Research, Salt Lake City	West Jordan	Utah
United States	Alliance for Multispecialty Research, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of participants reporting prompted local reactions		Within 7 days following each study intervention administration
Primary	The percentage of participants reporting prompted systemic events		Within 7 days following each study intervention administration
Primary	The percentage of participants reporting adverse events (AEs)		Through 1 month following each study intervention administration
Primary	The percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)		Through study completion, up to 24 months
Primary	The percentage of participants reporting serious adverse events (SAEs)		Through study completion, up to 24 months

External Links

•   To obtain contact information for a study center near you, click here.