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Study Summary
This trial is testing the safety and effectiveness of two different schedules of vaccinations for Lyme disease. The study will last a maximum of 19 months for participants, who will be given either 3 or 2 vaccinations. 600 people aged 5-65 years will be enrolled.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 572 Patients • NCT03769194Trial Design
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Who is running the clinical trial?
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- I have a bleeding disorder or have taken blood thinners in the last 3 weeks.I am in the booster phase, 5 months post-booster dose.I can be reached by phone and can participate in the study for its entire duration.I am between 5 and 65 years old.You are generally healthy.I have an immune system issue or took immune-suppressing drugs recently.I do not have any health issues that could affect my participation in the study.You have a history of severe allergic reactions or sensitivity to any ingredients in the vaccine.I have not donated blood or plan to donate within 4 weeks before starting the trial.You are in overall good health.You were bitten by a tick within the past 4 weeks before the study starts.I have Lyme disease or was treated for it in the last 3 months.I can be reached by phone and can participate in the study for its entire duration.I have or had a neuro-inflammatory or autoimmune disease.I haven't taken part in another clinical trial within the last 4 weeks.I have not had any vaccinations in the last 4 weeks.My legal guardian has given written consent, and I have agreed to participate if I'm between 5-17 years old.I am between 18 and 65 years old and have given my written consent.You are in good overall health.I, and if applicable, my legal guardian, understand and agree to the study's procedures.The subject is willing and able to comply with the study's scheduled visits, treatment plan, and other specified procedures.A booster dose of 18F-FDG PET/CT was administered to all patients at Month 23.I have been vaccinated against Lyme disease.I have had cancer within the last 5 years.I am between 5 and 65 years old.I have a significant ongoing or past health condition.
- Group 1: Part A+B - Group 3
- Group 2: Part A+B - Group 1
- Group 3: Part A+B - Group 2
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many research centers are conducting this trial?
"The primary clinical trial site is Stamford Therapeutics Consortium in Stamford, Connecticut. Other locations where this study is running include Square-1 Clinical Research, Inc. - AHN Health and Wellness Pavilion in Erie, Rhode island; Velocity Clinical Research - Providence in Warwick, New jersey; as well as 14 other centres."
What is the known safety profile of VLA15?
"The safety of VLA15 has been tentatively established in Phase 2 clinical trials. However, more data is needed to confirm its efficacy."
If I meet the qualifications, may I join this experiment?
"This clinical trial is enrolling 625 participants with lyme polyradiculitis aged 5 and 65. Most notable, candidates must meet the following criteria: Parent(s)/legal representative(s) and subject understand the study and its procedures, agree to its provisions, Booster Phase: until Month 23 (i.e. 5 months after booster dose), Subject is aged 5 to 65 years at the day of screening (Visit 0), Subject is of good general health, 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"
Can patients sign up for this trial right now?
"According to the latest update on clinicaltrials.gov, this particular trial is not looking for new patients at this time. The study was originally posted on March 15th 2021 but has not been updated since July 26th of the same year. Although this may be the case, there are 8 other trials that are currently recruiting patients."
Can elderly patients participate in this scientific experiment?
"According to the rules that determine who can participate in this research, the youngest age an individual can be is 5 and the oldest is 65."
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