Lyme Disease Vaccine for Lyme Disease

(VALOR Trial)

Recruiting at 145 trial locations

Overseen By Pfizer CT.gov Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must not be taking: Tetracyclines, Chronic antibiotics

Disqualifiers: Pregnancy, Recent Lyme disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

12557 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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. ^{1 2 3 8 9}

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

I work in an area or job (like landscaping or forestry) that has a high risk of tick exposure.

Participants who reside in areas with endemic Lyme disease and who lead lifestyles that put them at increased risk for Lyme disease

Individuals who pursue recreational activities such as hiking, camping, fishing, hunting, jogging, or gardening in such areas

Exclusion Criteria

I was diagnosed with Lyme disease in the last 3 months.

I have had Lyme disease affecting my heart, nervous system, joints, or it has spread throughout my body.

I am taking long-term antibiotics like doxycycline for acne or other conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Primary Vaccination Series

Participants receive a 3-dose primary vaccination series at 0, 2, and 5 to 9 months

5 to 9 months

3 visits (in-person)

Booster Dose

Participants receive a booster dose about 12 months after the end of the primary vaccination series

1 month

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the booster dose

Up to 2 and a half years

At least 7 visits (in-person), 5 telephone contacts

Extended Follow-up

A subset of participants is followed for a third Lyme disease season

Up to 3 and a half years

What Are the Treatments Tested in This Trial?

Interventions

• VLA15

Trial Overview 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.

How Is the Trial Designed?

Group I: VLA15 Lot 3 (3-dose primary vaccination series and booster dose) Experimental Treatment 1 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 Treatment 1 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 Treatment 1 Intervention

Shot in the deltoid muscle (preferable in the nondominant arm)

Group IV: Placebo (3-dose primary vaccination series and booster dose) Placebo Group 1 Intervention

Shot in the deltoid muscle (preferable in the nondominant arm)

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

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

Trials

46

Recruited

59,100+

Published Research Related to This Trial

The only FDA-approved Lyme disease vaccine, based on the OspA protein, was effective in generating immunity against the disease but was withdrawn from the market in 2002 due to the need for booster doses and issues with false positive test results.

New clinical trials are currently underway for a multivalent OspA vaccine aimed at providing better protection against Lyme disease in both the United States and Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief history of OspA vaccines including their impact on diagnostic testing for Lyme disease. Wormser, GP.[2022]

Citations

1. New Zealand pubmed.ncbi.nlm.nih.gov

Adjuvanted Lyme disease vaccine: a review of its use in the management of Lyme disease. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

An open-label, nonrandomized, single-center, prospective extension, clinical trial of booster dose schedules to assess the safety profile and immunogenicity of recombinant outer-surface protein A (OspA) Lyme disease vaccine. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a novel multivalent OspA-based vaccine candidate against Lyme borreliosis: a randomised, phase 1 study in healthy adults. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Prospective incidence epidemiology study protocol: conducting active surveillance to assess the burden of Lyme disease (BOLD) in primary care practices in endemic areas of six European countries. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Development of an mRNA-lipid nanoparticle vaccine against Lyme disease. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Arthritis following recombinant outer surface protein A vaccination for Lyme disease. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

A brief history of OspA vaccines including their impact on diagnostic testing for Lyme disease. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The novel Lyme borreliosis vaccine VLA15 shows broad protection against Borrelia species expressing six different OspA serotypes. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Protective immunity in lyme borreliosis. [2019]