What is the mechanism of action of this treatment?

The most common treatments for Lyme Neuroborreliosis involve antibiotics such as doxycycline, ceftriaxone, or amoxicillin, which work by targeting and killing the Borrelia bacteria responsible for the infection. This reduces bacterial load and inflammation, alleviating symptoms and preventing further neurological damage. The VLA15 vaccine, currently in trials, aims to induce an immune response against Borrelia bacteria, preventing infection from occurring in the first place. This preventive strategy is significant for patients as it can reduce the incidence of Lyme Neuroborreliosis and its associated complications, offering a proactive approach to managing Lyme disease.

What side effects are associated with this type of intervention?

The VLA15 vaccine, which targets Borrelia bacteria to prevent Lyme disease, is currently under study. Similar vaccines, such as the OspA vaccine, have shown efficacy but also reported side effects. Common side effects of Lyme disease vaccines include mild and transient reactions such as fever, pain at the injection site, fatigue, body aches, and headaches. Severe adverse events are rare but can include more serious conditions like arthritis, although no significant association has been found between the vaccine and the development of arthritis. Overall, the side effects are generally mild and short-lasting.

What prior FDA approvals exist?

Currently, the primary FDA-approved treatments for Lyme Neuroborreliosis involve antibiotics such as doxycycline, amoxicillin, and cefuroxime axetil, which target the Borrelia bacteria causing the infection. The VLA15 vaccine, which is under investigation, aims to prevent Lyme disease by inducing an immune response against Borrelia bacteria, representing a preventive approach rather than a treatment for active infection. This vaccine could potentially reduce the incidence of Lyme Neuroborreliosis by preventing the initial infection.

What other types of research exist?

Promising novel alternatives to the VLA15 vaccine for Lyme Neuroborreliosis patients include vaccines that utilize omics approaches to identify new tick-protective antigens and pathogen-derived antigens. These vaccines aim to target both the tick vector and the Borrelia bacteria. Additionally, combining multiple antigens with different protective mechanisms is a promising strategy. Research is also exploring the use of new adjuvants and advanced screening platforms to enhance vaccine efficacy.

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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)

For subjects aged 5-17 years: written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable, prior to any study related procedures

Must not have

Subject has donated or plans to donate blood or blood-derived products 4 weeks prior to Day 1

Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB, or received treatment for LB within the last 3 months prior to Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to month 54

Summary

This trial tests the VLA15 vaccine, which aims to protect against Lyme disease. It includes healthy people aged 5-65 years, both with and without a history of Lyme disease. The vaccine helps the immune system recognize and fight the bacteria that cause Lyme disease. The VLA15 vaccine builds on previous vaccines for Lyme disease.

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.

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.

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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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 5 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not donated blood or plan to donate within 4 weeks before starting the trial.

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I have Lyme disease or was treated for it in the last 3 months.

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I have or had a neuro-inflammatory or autoimmune disease.

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I have been vaccinated against Lyme disease.

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I have had cancer within the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 54

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Baseline, Day 85, Day 180, Day 194 and Day 208 During the Main Study Phase

GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Day 85, Day 180 and Day 194 During the Main Study Phase

Geometric Mean of the Fold Rise (GMFR) for IgG Against Each OspA Serotype (ST1 to ST6) at Day 85 and Day 208 During the Main Study Phase

+10 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

Pyrexia

Arthralgia

Upper respiratory tract infection

100%

80%

60%

40%

20%

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 at Month 18, 30 and 42

Group II: Part A+B - Group 1Experimental Treatment2 Interventions

Part A: VLA15 at Month 0, 2 and 6 Part B: VLA15 at Month 18, 30 and 42

Group III: Part A+B - Group 3Placebo Group1 Intervention

Part A: Placebo at Month 0, 2 and 6 Part B: Placebo at Month 18, 30 and 42

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Lyme Neuroborreliosis involve antibiotics such as doxycycline, ceftriaxone, or amoxicillin, which work by targeting and killing the Borrelia bacteria responsible for the infection. This reduces bacterial load and inflammation, alleviating symptoms and preventing further neurological damage. The VLA15 vaccine, currently in trials, aims to induce an immune response against Borrelia bacteria, preventing infection from occurring in the first place. This preventive strategy is significant for patients as it can reduce the incidence of Lyme Neuroborreliosis and its associated complications, offering a proactive approach to managing Lyme disease.

From Bench to Field: A Guide to Formulating and Evaluating Anti-Tick Vaccines Delving beyond Efficacy to Effectiveness.The tick and I: Parasite-host interactions between ticks and humans.Translational biotechnology for the control of ticks and tick-borne diseases.