Lyme Disease Vaccine for Lyme Disease
(VALOR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new vaccine called VLA15 to prevent Lyme disease. It targets healthy people aged 5 and older who live in areas where Lyme disease is common. The vaccine helps the immune system recognize and fight the bacteria that cause Lyme disease.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude people who are using certain antibiotics like doxycycline or minocycline for acne or other conditions. If you're on these medications, you might not be eligible to participate.
Is the Lyme disease vaccine VLA15 safe for humans?
The Lyme disease vaccine, including VLA15, has generally been well tolerated in clinical trials, with most side effects being mild or moderate, such as pain at the injection site. However, there have been rare reports of arthritis following vaccination with a similar vaccine, which suggests a potential risk that needs further investigation.12345
How is the Lyme disease vaccine VLA15 different from other treatments?
VLA15 is unique because it targets six different types of a protein called OspA found on the bacteria that cause Lyme disease, providing broad protection against various strains in Europe and North America. Unlike antibiotics that treat Lyme disease after infection, VLA15 is a preventive vaccine designed to stop the infection before it starts.23678
What data supports the effectiveness of the treatment VLA15 for Lyme disease?
Research shows that a similar Lyme disease vaccine targeting outer surface protein A (OspA) was effective, with 80% efficacy in preventing Lyme disease. VLA15, which targets multiple OspA serotypes, has shown promising safety and immune response results in early studies, suggesting it could be effective in preventing Lyme disease.12389
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for healthy individuals aged 5 and older who are often in Lyme disease-endemic areas due to outdoor activities or living conditions. It's not for those with recent Lyme disease, known tick bites within the last month, chronic use of certain antibiotics, pregnant or breastfeeding women, or people with unstable health conditions that could confuse Lyme disease assessment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Primary Vaccination Series
Participants receive a 3-dose primary vaccination series at 0, 2, and 5 to 9 months
Booster Dose
Participants receive a booster dose about 12 months after the end of the primary vaccination series
Follow-up
Participants are monitored for safety and effectiveness after the booster dose
Extended Follow-up
A subset of participants is followed for a third Lyme disease season
What Are the Treatments Tested in This Trial?
Interventions
- VLA15
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Valneva Austria GmbH
Industry Sponsor