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Lyme Disease Vaccine for Lyme Disease

Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 54
Awards & highlights

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.

Who is the study for?
Healthy individuals aged 5-65, with or without a past Lyme disease infection, can join this trial. They must understand and agree to the study's procedures, attend all visits, and be reachable by phone. Women of childbearing age need a negative pregnancy test and must use birth control during the study.Check my eligibility
What is being tested?
The VLA15-221 trial is testing VLA15, a vaccine candidate for Lyme disease. Participants will receive either three shots (at months 0, 2, and 6) or two shots (months 0 and 6), compared to placebo. The main phase lasts up to 19 months with an optional booster phase extending it.See study design
What are the potential side effects?
Potential side effects of VLA15 are not detailed in the provided information but may include typical vaccine reactions such as pain at injection site, fever, fatigue or allergic responses among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am in the booster phase, 5 months post-booster dose.
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I am between 5 and 65 years old.
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I can be reached by phone and can participate in the study for its entire duration.
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I can be reached by phone and can participate in the study for its entire duration.
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My legal guardian has given written consent, and I have agreed to participate if I'm between 5-17 years old.
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I am between 18 and 65 years old and have given my written consent.
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I, and if applicable, my legal guardian, understand and agree to the study's procedures.
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I am between 5 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 54
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 54 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 Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
+2 more
Secondary outcome measures
GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase
GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Month 19 During the Booster Phase
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase
+14 more

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

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Part A+B - Group 2Experimental Treatment2 Interventions
Part A: VLA15 at Month 0 and 6, placebo at Month 2 Part B: VLA15
Group II: Part A+B - Group 1Experimental Treatment2 Interventions
Part A: VLA15 at Month 0, 2 and 6 Part B: VLA15
Group III: Part A+B - Group 3Placebo Group1 Intervention
Part A: Placebo at Month 0, 2 and 6 Part B: Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VLA15
2018
Completed Phase 2
~820
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,556 Previous Clinical Trials
10,907,057 Total Patients Enrolled
3 Trials studying Lyme Neuroborreliosis
997 Patients Enrolled for Lyme Neuroborreliosis
Valneva Austria GmbHIndustry Sponsor
44 Previous Clinical Trials
54,826 Total Patients Enrolled
3 Trials studying Lyme Neuroborreliosis
997 Patients Enrolled for Lyme Neuroborreliosis
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,467 Previous Clinical Trials
8,088,494 Total Patients Enrolled
3 Trials studying Lyme Neuroborreliosis
997 Patients Enrolled for Lyme Neuroborreliosis

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04801420 — Phase 2
Lyme Neuroborreliosis Research Study Groups: Part A+B - Group 3, Part A+B - Group 1, Part A+B - Group 2
Lyme Neuroborreliosis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04801420 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04801420 — Phase 2
Lyme Neuroborreliosis Patient Testimony for trial: Trial Name: NCT04801420 — Phase 2

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
New York
Maryland
Other
How old are they?
18 - 65
What site did they apply to?
Rochester Clinical Research, Inc.
Richmond Behavioral Associates
Velocity Clinical Research - Cleveland
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I trued all sort of treatments, all failed. I live in a high-risk area for ticks carrying Lyme Disease and am interested in a vaccine for this purpose.
PatientReceived 2+ prior treatments
I'm actively outdoors most of the year and have been diagnosed with Lyme disease three years ago. Although I take many precautions, I was bitten by ticks twice in the past year.
PatientReceived 1 prior treatment
Interested I visit family that have been diagnosed with Lyme disease also interested in Spinal degenerative disease trials Hiw much are they paying it doesn’t say on either trial ty Deb Keenan 917470 4530 tel new address 3800 Amboy rd Si ny 10308 # 2.
PatientReceived no prior treatments
~156 spots leftby Mar 2025