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Lyme Disease Vaccine for Lyme Disease (VALOR Trial)
VALOR Trial Summary
This trial is being conducted to test the safety and effectiveness of a Lyme disease vaccine.
VALOR Trial Timeline
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 • NCT03769194VALOR Trial Design
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Who is running the clinical trial?
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- I work in an area or job (like landscaping or forestry) that has a high risk of tick exposure.I was diagnosed with Lyme disease in the last 3 months.I have had Lyme disease affecting my heart, nervous system, joints, or it has spread throughout my body.You live in an area where Lyme disease is common and engage in activities that increase your chances of getting Lyme disease.You live near trees and have frequent contact with them.You live in an area with lots of trees and have frequent contact with them.You have a dog that spends a lot of time outside and often comes back with ticks attached to them.I am taking long-term antibiotics like doxycycline for acne or other conditions.You engage in outdoor activities like hiking, camping, fishing, hunting, jogging, or gardening in certain areas.I do not have new or worsening health issues that could confuse Lyme disease assessment.I am not pregnant or breastfeeding.I was bitten by a tick in the last 4 weeks.I often spend time in areas with tall grass, woods, open fields, or near water.I live near trees and have regular contact with them.I have an autoimmune condition that could affect Lyme disease assessment.You have recently been in areas with tall grass, small wooded areas beside forests, open fields, lakesides, and riversides.You regularly participate in outdoor activities like hiking, camping, fishing, hunting, jogging, or gardening in these areas.Individuals who work in B burgdorferi-infected/tick-infested areas, especially those with occupations that may be associated with higher risk of exposure, such as landscaping, forestry, and wildlife and parks management.You have a dog that spends a lot of time outside and often comes back with ticks on them.You have a dog who often plays outside and comes back with ticks on them.You engage in outdoor activities like hiking, camping, fishing, hunting, jogging, or gardening in the study area.I often spend time in areas with tall grass, woods, open fields, or near water.You live near trees and frequently come into contact with them.I'm sorry, but "Key" is not a criterion or sufficient information to provide a summary. Please provide more context or information.I often spend time in areas with tall grass, woods, open fields, or near water.
- Group 1: VLA15 Lot 1 (3-dose primary vaccination series and booster dose)
- Group 2: VLA15 Lot 2 (3-dose primary vaccination series and booster dose)
- Group 3: VLA15 Lot 3 (3-dose primary vaccination series and booster dose)
- Group 4: Placebo (3-dose primary vaccination series and booster dose)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 different medical facilities are coordinating this trial today?
"Presently, this clinical trial is taking place in 58 hospitals, with locations in Punxsutawney, Rockland, Colchester, and 55 other towns. If you enroll in the trial, you will be asked to choose the hospital closest to you in order to minimize travel."
How many people are included as participants in this clinical trial?
"In order to gain the desired data, this study requires 18,000 participants that meet the pre-specified medical criteria. These potential patients can visit one of the many authorised sites, such as Care Access Mobile Site in Punxsutawney, Pennsylvania and Care Access - Hingham in Rockland, Massachusetts."
How does VLA15's safety profile compare to similar drugs?
"VLA15's safety is based on the fact that it is a Phase 3 trial, so our team gives it a 3."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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