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Vaccine

Lyme Disease Vaccine for Lyme Disease (VALOR Trial)

Phase 3
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Key
Individuals who participate in activities in areas with tall grass, smaller wooded areas beside forests, open fields, lakesides, and riversides.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to approximately 30 months.
Awards & highlights
Pivotal Trial

VALOR Trial Summary

This trial is being conducted to test the safety and effectiveness of a Lyme disease vaccine.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests a new vaccine called VLA15 against saline (a saltwater placebo) to prevent Lyme disease. Participants will be randomly assigned to receive either the vaccine or placebo in a series of three initial doses followed by a booster dose before peak Lyme seasons over approximately two and a half years.See study design
What are the potential side effects?
Potential side effects were not provided in the information given. However, like other vaccines, common side effects may include pain at injection site, fatigue, headache, muscle pain, chills, fever and nausea.

VALOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I'm sorry, but "Key" is not a criterion or sufficient information to provide a summary. Please provide more context or information.
Select...
I often spend time in areas with tall grass, woods, open fields, or near water.
Select...
I often spend time in areas with tall grass, woods, open fields, or near water.

VALOR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to approximately 30 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to approximately 30 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6)
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 2
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 3
+7 more
Secondary outcome measures
Vaccine efficacy among participants after primary series
Vaccines

Side effects data

From 2020 Phase 2 trial • 572 Patients • NCT03769194
90%
Injection site pain
52%
Myalgia
34%
Headache
28%
Fatigue
28%
Injection site erythema
17%
Nausea
14%
Injection site swelling
10%
Injection site induration
10%
Influenza like illness
7%
Pyrexia
7%
Arthralgia
3%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
VLA15 Low Dose
Placebo
VLA15 Medium Dose
VLA15 High Dose

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

VALOR Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: VLA15 Lot 3 (3-dose primary vaccination series and booster dose)Experimental Treatment1 Intervention
Shot in the deltoid muscle (preferable in the nondominant arm)
Group II: VLA15 Lot 2 (3-dose primary vaccination series and booster dose)Experimental Treatment1 Intervention
Shot in the deltoid muscle (preferable in the nondominant arm)
Group III: VLA15 Lot 1 (3-dose primary vaccination series and booster dose)Experimental Treatment1 Intervention
Shot in the deltoid muscle (preferable in the nondominant arm)
Group IV: Placebo (3-dose primary vaccination series and booster dose)Placebo Group1 Intervention
Shot in the deltoid muscle (preferable in the nondominant arm)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VLA15
2018
Completed Phase 2
~820

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,547 Previous Clinical Trials
11,413,796 Total Patients Enrolled
5 Trials studying Lyme Disease
4,958 Patients Enrolled for Lyme Disease
Valneva Austria GmbHIndustry Sponsor
44 Previous Clinical Trials
46,451 Total Patients Enrolled
4 Trials studying Lyme Disease
1,622 Patients Enrolled for Lyme Disease
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,459 Previous Clinical Trials
8,595,266 Total Patients Enrolled
5 Trials studying Lyme Disease
4,958 Patients Enrolled for Lyme Disease

Media Library

VLA15 (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05477524 — Phase 3
Lyme Disease Research Study Groups: VLA15 Lot 1 (3-dose primary vaccination series and booster dose), VLA15 Lot 2 (3-dose primary vaccination series and booster dose), VLA15 Lot 3 (3-dose primary vaccination series and booster dose), Placebo (3-dose primary vaccination series and booster dose)
Lyme Disease Clinical Trial 2023: VLA15 Highlights & Side Effects. Trial Name: NCT05477524 — Phase 3
VLA15 (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05477524 — Phase 3
Lyme Disease Patient Testimony for trial: Trial Name: NCT05477524 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
Pennsylvania
New York
Other
How old are they?
65+
18 - 65
What site did they apply to?
Amherst Family Practice, P.C.
Care Access Mobile Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0

Why did patients apply to this trial?

i waslooking to see if i qualified for any studies. Lyme disease must be controlled. I’ll do anything to help.
PatientReceived no prior treatments
I have seen what lyme has done to Appalachian Trail thruhikers. I consider Lyme Disease to be a growing and serious health issue.
PatientReceived 1 prior treatment
Im in the woods and fields a lot so lyme disease is a constant concern.
PatientReceived no prior treatments
~4725 spots leftby Dec 2025