Lyme Disease Vaccine for Healthy Children

No longer recruiting at 91 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, VLA15, to determine its safety for healthy children aged 5-17 who have not had Lyme disease or a Lyme vaccine. Lyme disease is common in children, and this vaccine could help prevent it. Participants will receive either the VLA15 vaccine or a placebo (a harmless saltwater shot) over two years, with six clinic visits. The study seeks children who are generally healthy and have not been treated for Lyme disease. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking Lyme disease prevention method.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that VLA15, the Lyme disease vaccine being tested, has been safe in earlier studies. In past research, VLA15 was safe and well tolerated in both adults and children. Most side effects were mild or moderate, such as soreness at the injection site or mild flu-like symptoms, which are common with many vaccines.

One study found that while some participants experienced these mild side effects, they were not serious and didn't last long. Overall, the vaccine was considered well tolerated up to 19 months after vaccination.

This study aims to confirm these findings in children aged 5 to 17, a group often affected by Lyme disease. The goal is to ensure the vaccine is safe for this age group. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for Lyme disease, which typically involves antibiotics, the VLA15 vaccine is designed to prevent the disease altogether. Researchers are excited about VLA15 because it targets the outer surface protein A (OspA) of the bacteria that cause Lyme disease, potentially stopping the infection before it starts. This vaccine could offer a proactive approach to Lyme disease, providing protection for children in areas where the disease is prevalent, which is a significant advancement over current reactive treatments.

What evidence suggests that this vaccine might be an effective treatment for Lyme disease?

Research has shown that the VLA15 vaccine, which participants in this trial may receive, works well in children and teenagers. In earlier studies, children who received the VLA15 vaccine developed strong protection after an additional dose. Their immune responses were at least as strong as those in adults. The vaccine proved safe and well-tolerated. These results suggest that VLA15 could effectively prevent Lyme disease in children. ^{2 4 6 7 8}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. pfizer.com pfizer.com/news/announcements/valneva-and-pfizer-report-positive-pediatric-and-adolescent-phase-2-booster

Valneva and Pfizer Report Positive Pediatric ... Strong immune response shown in both children and adolescents one month after booster dose (month 19) in VLA15-221 study · Previously observed ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40294611/

a randomised, observer-blind, placebo-controlled, phase 2 ... We aimed to investigate the safety and immunogenicity of two-dose and three-dose schedules of VLA15 within a broader population, including children and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1473309925000921

Immunogenicity and safety of different immunisation ... Immune responses in children and adolescents after the second dose of VLA15 when administered with a 0–2–6-month schedule were at least as high as those in ...

4. academic.oup.com academic.oup.com/ofid/article/12/Supplement_1/ofae631.797/7987854

P-599. 6-Valent, OspA-Based VLA15 Lyme Disease Vaccine ... The Month 18 VLA15-221 booster dose was safe and immunogenic in both adults and children. The Month 30 booster data is under analysis. The ...

5. valneva.com valneva.com/research-development/lyme-disease/

Lyme Disease - VLA15 - Valneva Data from the Phase 2 studies continue to demonstrate strong immunogenicity in adults as well as in children, with acceptable safety and tolerability profiles ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2870557/

The Lyme vaccine: a cautionary tale - PMC - PubMed Central After review of available data, the FDA found insufficient evidence to support a causal relationship between the reported adverse effects and the vaccine and ...

7. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099(25)00092-1/abstract

a randomised, observer-blind, placebo-controlled, phase 2 ... Solicited local adverse events after any vaccination occurred more frequently among VLA15 recipients (M0-2-6, 178 [94%; 95% CI 89–96] of 190; M ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1473309923002104

Safety and immunogenicity of a novel multivalent OspA- ... VLA15 was safe and well tolerated and the majority of adverse events were mild or moderate. Overall, adverse events were more frequent in the 48 μg and 90 μg ...