Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children
Lyme Disease
About this trial
This is an interventional other trial for Lyme Disease focused on measuring Borreliosis, Borrelia burgdorferi, Spirochetes, Vector-Borne Disease, Lyme Disease Vaccine, VLA15, Outer Surface Protein A (OspA), Ticks
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.
Sites / Locations
- UAB Child Health Research Unit (CHRU)
- University of Alabama at Birmingham - School of Medicine
- Lakeview Clinical Research
- Coast Clinical Research, LLC
- Apex Research Group LLC
- New England Research Associates
- Stamford Therapeutics Consortium
- Children's National Medical Center
- Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
- Bio-Medical Research LLC
- Bio-Medical Research LLC
- GCP Research, Global Clinical professionals
- ForCare Clinical Research
- Tekton Research
- ASR, LLC
- Clinical Research Prime
- University of Chicago Medical Center
- Alliance for Multispecialty Research, LLC
- Johnson County Clinical Trials
- Alliance for Multispecialty Research, LLC
- Kentucky Pediatric/ Adult Research
- Bluegrass Clinical Research, Inc.
- MD Medical Research
- Virgo Carter Pediatrics
- Sisu BHR
- Michigan Center of Medical Research (MICHMER)
- Vida Clinical Studies, LLC
- Vida Clinical Studies, LLC
- Great Lakes Research Institute
- Clinical Research Institute
- Velocity Clinical Research, Omaha
- Hassman Research Institute
- Rutgers University
- IMA Clinical Research Warren
- Prime Global Research
- Advantage Clinical Trials
- Advantage Clinical Trials
- Buffalo Clinical and Translational Research Center
- Advanced Specialty Care
- Smith Allergy and Asthma Specialists
- Stony Brook Medicine Clinical Research Center
- Meridian Clinical Research, LLC
- Southampton Hospital
- Smith Allergy & Asthma Specialists
- NYU Langone Hospital - Long Island
- DiGiovanna Institute for Medical Education & Research
- Rochester Clinical Research, LLC
- Stony Brook University
- SUNY Upstate Medical University
- Meridian Clinical Research, LLC
- Centricity Research Columbus Ohio Multispecialty
- Allegheny Health and Wellness Pavilion
- Central Erie Primary Care
- Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
- Northeast Clinical Trials Group
- Coastal Carolina Research Center
- Benchmark Research
- Benchmark Research
- Texas Health Resources
- C & R Research Services USA
- DM Clinical Research - Cy Fair
- DM Clinical Research
- Research Your Health
- Sun Research Institute
- Velocity Clinical Research, Salt Lake City
- Pediatric Research of Charlottesville, LLC
- Clinical Research Partners, LLC
- Frontier Clinical research
- Preston Healthcare Services
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
VLA15
Normal Saline (Placebo)
Participants will receive 6-valent OspA-based Lyme disease vaccine (VLA15).
Participants will receive 0.9% sodium chloride solution for injection