Lyme Disease Vaccine for Lyme Disease

Recruiting at 28 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Must not be taking: Anticoagulants, Immuno-suppressive therapy

Disqualifiers: Chronic Lyme, Autoimmune, Malignancy, others

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

Compensation: Varies

Number of Visits: 6

625 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immuno-suppressive therapy, anticoagulants, or have received any other vaccines or investigational drugs recently, you may need to stop those before joining the trial.

What data supports the effectiveness of the Lyme Disease Vaccine treatment for Lyme Disease?

The Lyme disease vaccine, which targets the outer surface protein A (OspA) of the bacteria causing Lyme disease, showed an efficacy of 76% to 80% in preventing the disease in a large study with over 10,000 participants. Additionally, a booster dose of the vaccine maintained protective antibody levels in most adults. ^{1 2 3 4 5}

How is the VLA15 vaccine for Lyme disease different from other treatments?

The VLA15 vaccine is unique because it targets six different types of a protein found on the surface of the bacteria that cause Lyme disease, providing broad protection against various strains found in Europe and North America. Unlike other treatments, which may focus on treating the infection after it occurs, VLA15 aims to prevent the disease by inducing immunity before exposure. ^{1 3 5 6 7}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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.

Inclusion Criteria

If subject is of childbearing potential: Subject has a negative serum pregnancy test at screening (Visit 0) and agrees to employ adequate birth control measures according to following timelines:

I am in the booster phase, 5 months post-booster dose.

I can be reached by phone and can participate in the study for its entire duration.

Exclusion Criteria

I have a bleeding disorder or have taken blood thinners in the last 3 weeks.

I have an immune system issue or took immune-suppressing drugs recently.

I do not have any health issues that could affect my participation in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Main Study Phase (Part A)

Participants receive VLA15 or placebo vaccinations at Month 0, 2, and 6

6 months

3 visits (in-person)

Booster Phase (Part B)

Eligible participants receive booster injections with VLA15 or placebo at Month 18, 30, and 42

24 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

Treatment Details

Interventions

• Placebo
• VLA15

Trial Overview 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.

Participant Groups

Group I: Part A+B - Group 2 Experimental Treatment 2 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 1 Experimental Treatment 2 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 3 Placebo Group 1 Intervention

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

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+

References

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. 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]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

[Immunization in Lyme borreliosis--initial experience]. [2006]

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

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

6. 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]

7. 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]