Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population
NCT ID: NCT04801420
Last Updated: 2025-11-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
625 participants
INTERVENTIONAL
2021-03-08
2025-07-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Part A+B - Group 1
Part A: VLA15 at Month 0, 2 and 6 Part B: VLA15 at Month 18, 30 and 42
VLA15
a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate
Part A+B - Group 2
Part A: VLA15 at Month 0 and 6, placebo at Month 2 Part B: VLA15 at Month 18, 30 and 42
VLA15
a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate
Placebo
PBS (Phosphate Buffered Saline)
Part A+B - Group 3
Part A: Placebo at Month 0, 2 and 6 Part B: Placebo at Month 18, 30 and 42
Placebo
PBS (Phosphate Buffered Saline)
Interventions
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VLA15
a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate
Placebo
PBS (Phosphate Buffered Saline)
Eligibility Criteria
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Inclusion Criteria
* Subject is of good general health
* Parent(s)/legal representative(s) and subject understand the study and its procedures, agree to its provisions
* for subjects aged 18-65 years: written informed consent prior to any study related procedures
* for subjects aged 5-17 years: written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable, prior to any study related procedures.
* If subject is of childbearing potential: Subject has a negative serum pregnancy test at screening (Visit 0) and agrees to employ adequate birth control measures according to following timelines:
* Main Study Phase: duration of entire study
* Booster Phase: until 5 months after each booster vaccination (Booster 1 until Month 23, Booster 2 until Month 35 and Booster 3 until Month 47)
* Subject is willing and able to comply with scheduled visits, treatment plan, and other study procedures
* Subject is available for the duration of the study and can be contacted by telephone during study participation
Exclusion Criteria
* Subject received previous vaccination against LB;
* Subject had a tick bite within 4 weeks prior to Day 1;
* Subject has a medical history of or currently has a clinically relevant disease;
* Subject has a medical history of or currently has a neuro- inflammatory or autoimmune disease;
* Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the 3 weeks prior to Day 1;
* Subject has received an active or passive immunization within 4 weeks prior to Day 1;
* Subject has received any other registered or non-registered medicinal product in another clinical trial within 4 weeks prior to vaccination at Day 1;
* Subject has a known or suspected defect of the immune system or received immuno-suppressive therapy within 4 weeks prior to Day 1;
* Subject has a history of anaphylaxis of unknown cause or severe allergic reactions of unknown cause or has a known hypersensitivity or allergic reactions to one of the components of the vaccine;
* Subject had any malignancy in the past 5 years;
* Subject is pregnant, has plans to become pregnant during the course of the study or is lactating at the time of enrollment;
* Subject has donated or plans to donate blood or blood-derived products 4 weeks prior to Day 1;
* Subject has any condition that may compromise its well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;
* Subject is in a dependent relationship with the sponsor/investigator
5 Years
65 Years
ALL
Yes
Sponsors
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Valneva Austria GmbH
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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New England Research Associates
Bridgeport, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Pediatric Associates of Conn. PC
Waterbury, Connecticut, United States
Quest Diagnostics
Marlborough, Massachusetts, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States
Foundation Pediatrics
East Orange, New Jersey, United States
Med Clinical Research Partners, LLC
Irvington, New Jersey, United States
Meridian Clinical Research LLC
Binghamton, New York, United States
Pfizer Vaccine Research and Development
Pearl River, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Advantage Clinical Trials
The Bronx, New York, United States
Velocity Clinical Research, Inc.
Cleveland, Ohio, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States
Liberty Family Practice
Erie, Pennsylvania, United States
Lockman & Lubell Pediatric Associates
Fort Washington, Pennsylvania, United States
Hasbro Children's Hospital
Providence, Rhode Island, United States
Rhode Island Hospital
Providence, Rhode Island, United States
The Miriam Hospital
Providence, Rhode Island, United States
Velocity Clinical Research Providence
Warwick, Rhode Island, United States
Synevo Studien Service Labor GmbH c/o Institut für Medizinische Diagnostik
Berlin, , Germany
Countries
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References
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Wagner L, Obersriebnig M, Hochreiter R, Kadlecek V, Larcher-Senn J, Hegele L, Maguire JD, Murphy T, Derhaschnig U, Bezay N, Jaramillo JC, Eder-Lingelbach S, Messier M. Immunogenicity and safety of an 18-month booster dose of the VLA15 Lyme borreliosis vaccine candidate after primary immunisation in children, adolescents, and adults in the USA: a randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2025 Nov 7:S1473-3099(25)00541-9. doi: 10.1016/S1473-3099(25)00541-9. Online ahead of print.
Wagner L, Obersriebnig M, Kadlecek V, Hochreiter R, Ghadge SK, Larcher-Senn J, Hegele L, Maguire JD, Derhaschnig U, Jaramillo JC, Eder-Lingelbach S, Bezay N. Immunogenicity and safety of different immunisation schedules of the VLA15 Lyme borreliosis vaccine candidate in adults, adolescents, and children: a randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2025 Sep;25(9):986-999. doi: 10.1016/S1473-3099(25)00092-1. Epub 2025 Apr 25.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4601008
Identifier Type: OTHER
Identifier Source: secondary_id
VLA15-221
Identifier Type: -
Identifier Source: org_study_id