Lyme Disease Vaccine for Healthy Children

Recruiting at 74 trial locations

Overseen By Pfizer CT.gov Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Pregnancy, Immunodeficiency, 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: 7

Duration: 18 months

3235 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is to understand if the study vaccine (called VLA15) is safe in healthy children. We are looking for children who: * are healthy * are age 5 through 17 * have not been diagnosed with any form of Lyme disease in the past * have not received any vaccines for Lyme disease in the past Lyme disease happens most often in children of this age. The study vaccine may be used potentially to help prevent Lyme disease. The goal of this study is to get more information about the safety of the study vaccine in this age group. Participants will be in this study for about 2 years. During that time, they will receive VLA15 or placebo (sterile saltwater solution) by a "shot" in the arm. We will compare experience of children receiving VLA15 to those receiving the placebo. Participants will not know whether they get VLA15 or placebo. Everyone participating in this study will: * get the shots in a clinic or in a hospital office * receive a total of 4 shots * receive the first 3 shots within 6 months * receive the last shot about 1 year afterwards * need to come to the trial site for 6 planned visits; 4 of these are vaccination visits and 2 are follow-up visits. We will contact you by phone 1 time every year during the study to monitor your experience. You may have extra visits if you experience a severe reaction after a vaccine dose.

Do I need to stop my child's current medications for the Lyme disease vaccine trial?

The trial protocol does not specify if participants must stop taking their current medications. However, it mentions that children using certain immunosuppressant medications or systemic corticosteroids may not be eligible. It's best to discuss your child's specific medications with the trial team.

What data supports the effectiveness of the treatment VLA15 for Lyme disease?

The VLA15 vaccine has shown promising results in preclinical studies, providing protection in mice against several types of Borrelia bacteria, which cause Lyme disease. Additionally, a similar vaccine targeting the same protein (OspA) demonstrated effectiveness in preventing Lyme disease in adults, suggesting potential for VLA15's success in children. ^{1 2 3 4 5}

Is the Lyme disease vaccine safe for children?

The Lyme disease vaccine, including versions like VLA15, has been shown to be generally safe in humans. In clinical trials, most side effects were mild or moderate, such as pain at the injection site, and similar safety was observed in children aged 2 to 15 years. ^{2 3 6 7 8}

How is the VLA15 treatment for Lyme disease in children different from other treatments?

VLA15 is a novel vaccine targeting six common serotypes of the Lyme disease-causing bacteria, offering broad protection, unlike previous vaccines that targeted fewer serotypes. It is designed to be safe and effective for children, with a dosing schedule that provides protection for at least one tick season. ^{2 5 9 10 11}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Healthy children aged 5-17 who have never had Lyme disease or received a Lyme vaccine can join this study. They must be able to follow the study schedule and their parents/guardians agree to it. Kids with stable chronic conditions may participate, but those recently treated for Lyme, with known tick bites, on certain medications, or girls who are pregnant cannot.

Inclusion Criteria

I am willing and able to follow all study requirements.

I am healthy or have stable chronic conditions.

Exclusion Criteria

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

I am not pregnant, breastfeeding, and I am willing to use contraception as required.

I have been treated for Lyme disease within the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a total of 4 shots of either VLA15 or placebo, with the first 3 shots within 6 months and the last shot about 1 year afterwards

18 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (in-person), 1 phone call per year

Treatment Details

Interventions

• VLA15

Trial Overview The trial is testing VLA15, a new vaccine aimed at preventing Lyme disease in kids. Participants will get either VLA15 or a placebo (normal saline) shot without knowing which one they receive. The study involves four shots over about two years and six clinic visits plus phone check-ins.

Participant Groups

Group I: VLA15 Experimental Treatment 1 Intervention

Participants will receive 6-valent OspA-based Lyme disease vaccine (VLA15).

Group II: Normal Saline (Placebo) Placebo Group 1 Intervention

Participants will receive 0.9% sodium chloride solution for injection

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

Findings from Research

The adjuvanted recombinant vaccine LYMErix has been shown to be 76% effective in preventing Lyme disease in a clinical trial involving over 10,000 adults, following a three-dose schedule.

The vaccine is safe, with only mild to moderate transient side effects reported, and it induces protective antibody levels in nearly all children aged 2-14 years, making it a reliable option for Lyme disease prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevention of Lyme disease with vaccine. Poland, GA., Jacobson, RM.[2019]

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]

References

1. 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]

2. 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]

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

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

4. 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]

5. 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]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The prevention of Lyme disease with vaccine. [2019]

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

Lyme vaccine: issues and controversies. [2019]

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

Reactogenicity and immunogenicity of a Lyme disease vaccine in children 2-5 years old. [2006]

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

Immunogenicity of a recombinant Borrelia burgdorferi outer surface protein A vaccine against Lyme disease in children. [2019]

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

Safety and immunogenicity of a recombinant Borrelia burgdorferi outer surface protein A vaccine against lyme disease in healthy children and adolescents: a randomized controlled trial. [2019]