What is the mechanism of action of this treatment?

The VLA15 vaccine for Lyme Disease targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacterium responsible for the disease. By generating an immune response against OspA, the vaccine aims to prevent the bacterium from being transmitted to humans, offering a preventive approach. This is crucial for reducing the incidence of Lyme Disease. In contrast, common treatments like antibiotics (doxycycline, amoxicillin, cefuroxime) work by killing the bacteria or inhibiting their growth once an infection has occurred, which is essential for managing and curing the disease, especially in its early stages.

What side effects are associated with this type of intervention?

The most common treatments for Lyme disease include antibiotics such as doxycycline and vaccines like the OspA-based vaccines. The OspA-based vaccines, including the VLA15, have been associated with mild to moderate side effects such as local injection site reactions (e.g., erythema, pain, or bruising). In some cases, more severe reactions like hypersensitivity, including rash and urticaria, have been reported. Antibiotics like doxycycline can cause gastrointestinal symptoms, photosensitivity, and, rarely, severe allergic reactions. Overall, these treatments are generally well-tolerated with manageable side effects.

What prior FDA approvals exist?

There are currently no FDA-approved vaccines for Lyme disease. The VLA15 vaccine, which is a 6-valent OspA-based vaccine, is under clinical investigation to prevent Lyme disease. Historically, the only Lyme disease vaccine approved by the FDA was LYMErix, which was withdrawn from the market in 2002 due to low demand and concerns about side effects. Treatment for Lyme disease typically involves antibiotics such as doxycycline, amoxicillin, or cefuroxime axetil.

What other types of research exist?

As of now, VLA15 (6-valent OspA-based Lyme disease vaccine) is the primary novel vaccine under investigation for Lyme disease. No other specific alternatives are mentioned in the provided context.

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Vaccine

Lyme Disease Vaccine for Lyme Disease (VALOR Trial)

Phase 3

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through the end of the lyme disease season beginning 1 month after completing the primary series (28 days after completion of the primary series until end of october)

Awards & highlights

Pivotal Trial

Summary

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ beginning 1 month after receiving the booster dose (28 days after receiving the booster dose through the end of the lyme disease season following the booster dose (end of october)).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~beginning 1 month after receiving the booster dose (28 days after receiving the booster dose through the end of the lyme disease season following the booster dose (end of october)).

This trial's timeline: 3 weeks for screening, Varies for treatment, and beginning 1 month after receiving the booster dose (28 days after receiving the booster dose through the end of the lyme disease season following the booster dose (end of october)). 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 ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6)

Relative incidence rate reduction of confirmed Lyme disease cases in the VLA15 group compared to the placebo group

Secondary study objectives

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

Pyrexia

Arthralgia

Upper respiratory tract infection

100%

80%

60%

40%

20%

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.

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

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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 VLA15 vaccine for Lyme Disease targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacterium responsible for the disease. By generating an immune response against OspA, the vaccine aims to prevent the bacterium from being transmitted to humans, offering a preventive approach. This is crucial for reducing the incidence of Lyme Disease. In contrast, common treatments like antibiotics (doxycycline, amoxicillin, cefuroxime) work by killing the bacteria or inhibiting their growth once an infection has occurred, which is essential for managing and curing the disease, especially in its early stages.

Safety and outcomes of eculizumab for acetylcholine receptor-positive generalized myasthenia gravis in clinical practice.Expert consensus on the use of omalizumab in chronic urticaria in China.'Minimal symptom expression' in patients with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis treated with eculizumab.