VLA15 for Borrelia Infections

Phase-Based Estimates
1
Effectiveness
2
Safety
Rochester Clinical Research, Inc., Rochester, NY
Borrelia Infections+2 More
VLA15 - Biological
Eligibility
Any Age
All Sexes
Eligible conditions
Borrelia Infections

Study Summary

This study is evaluating whether a vaccine may help prevent Lyme disease.

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Eligible Conditions

  • Borrelia Infections
  • Lyme Disease
  • Lyme Polyradiculitis
  • Lyme Neuroborreliosis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether VLA15 will improve 1 primary outcome and 17 secondary outcomes in patients with Borrelia Infections. Measurement will happen over the course of 7 Days.

28 Days
Frequency of unsolicited AEs (Adverse Events) after each vaccination
7 Days
Frequency of solicited local and solicited systemic AEs (Adverse Events)
Day 208/Month 7
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype
Month 19
GMFRs (Geometric Mean of the Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (Part B)
until Day 208
GMFRs (Geometric Mean of the Fold Rises) for IgG against each OspA (Outer Surface Protein A) serotype (Part A)
until Month 18
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (Part A)
SCRs (Seroconversion Rates) for each OspA (Outer Surface Protein A) serotype specific IgG (Immunoglobulin G) (Part A)
until Month 19
GMFRs (Geometric Mean Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part A)
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part A)
SCRs (Seroconversion Rates) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part A)
until Month 54
Frequency of AESIs (Adverse Events of Special Interest)
Frequency of SAEs (Serious Adverse Events)
Frequency of SAEs (Serious Adverse Events), AESIs(Adverse Events of Special Interest), unsolicited and solicited AEs stratified by age cohort
GMFRs (Geometric Mean Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part B)
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (Part B)
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part B)
SCRs (Seroconversion Rates) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part B)
SCRs (Seroconversion Rates) for each OspA (Outer Surface Protein A) serotype specific IgG (Immunoglobulin G) (Part B)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

3 Treatment Groups

Part A+B - Group 3
Part A+B - Group 2
Placebo group

This trial requires 625 total participants across 3 different treatment groups

This trial involves 3 different treatments. VLA15 is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Part A+B - Group 2Part A: VLA15 at Month 0 and 6, placebo at Month 2 - Part B: VLA15 or placebo depending on schedule selection
Part A+B - Group 1Part A: VLA15 at Month 0, 2 and 6 - Part B: VLA15 or placebo depending on schedule selection
Part A+B - Group 3
Biological
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VLA15
2018
Completed Phase 2
~580
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: until month 54
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly until month 54 for reporting.

Closest Location

Rochester Clinical Research, Inc. - Rochester, NY

Eligibility Criteria

This trial is for patients born any sex of any age. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
For subjects aged 5-17 years, written informed consent by the subject's legal representative(s) is required according to local requirements, and written informed assent of the subject is also required, if applicable, prior to any study related procedures. show original
, and consent to the subject's participation The parents/legal representatives understand the study and its procedures and agree to its provisions show original
, 9 years The main study phase of the study is nine years long. show original
A booster dose of 18F-FDG PET/CT was administered to all patients at Month 23. show original
The subject is between the ages of 5 and 65 at the time of the screening. show original
Subject is in good physical health. show original
The subject is willing and able to comply with the study's scheduled visits, treatment plan, and other specified procedures. show original
The subject is available for the entire study and can be contacted by telephone during the study. show original
If you are over the age of 18, we will need your written consent before any study-related procedures can take place. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of borrelia infections?

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Signs of Lyme disease typically include malaise or fever, or skin rash, sore lymph nodes or a nonocclusive vascular pattern. Other symptoms may include muscle pain, heart palpitations or headaches. A nonocclusive vascular pattern is present in about a quarter of reported cases of Lyme disease, but often does not correlate with the severity or duration of illness. Therefore, the diagnosis of Lyme disease may be difficult in some patients.

Unverified Answer

Can borrelia infections be cured?

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Only a complete eradication of the infection and the development of a sustained and sustained immune responses are capable of providing sustained and sustained infection cure. The lack of a cure for Lyme disease may not be interpreted by an inability of physicians to make the diagnosis, but rather by the difficulty of proving a cure for an infectious disease, since the absence of a sustained and sustained immune response does not definitively prove that an infectious agent does not have a cure for it.

Unverified Answer

What are common treatments for borrelia infections?

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Treatment is typically provided orally after careful patient assessment, and can be effective, especially if the patient remains well and free of major or severe autoimmune symptoms. The common treatments of BQ fever include antibiotic (usually doxycycline) and immunoglobulins. A single-dose rifabutin is effective in the treatment of Lyme borreliosis, but it should be avoided in the treatment of Lyme arthritis. Antibiotics may also be useful in the treatment of relapsing Lyme borreliosis.

Unverified Answer

How many people get borrelia infections a year in the United States?

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The American Lyme Disease Foundation believes more than half the United States population is currently in the disease, with the number of people with borrelia infections growing every year. The incidence of borrelia infection is estimated to be as high as 10 percent of the total population.

Unverified Answer

What causes borrelia infections?

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Besides immunocompromised hosts, in general borrelia infection is spread by ticks. In temperate areas, borrelia can be spread by infected insects. It is important to exclude tick exposure or infection. Other forms of spread include contact with fluids from infected subjects. Finally it is important to check if borrelia infections occur in rodents.

Unverified Answer

What is borrelia infections?

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Borrelia is a group of small spirochetes found among ticks and rodents that cause a spirochetal illness of fever and a spectrum of neurological and cardiotoxic presentations when introduced in a nonhuman organism. Spirochetes do not have flagella and must be viewed in light of their potential as a new infectious agent. Our current knowledge has been growing exponentially but, despite this, the microbiologic investigation of borreliosis remains controversial due to methodological and technical difficulties.

Unverified Answer

Does vla15 improve quality of life for those with borrelia infections?

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The Vla15 immunoprophylaxis is effective at reduction in PSSQoL regardless of borrelia serostatus, although additional studies are warranted to confirm the efficacy of Vla15 in reducing PSSQoL in patients with other diseases and to evaluate its long-term efficacy.

Unverified Answer

Is vla15 typically used in combination with any other treatments?

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This is the first report on the efficacy of combinations of Vla15 and antibiotics against borrelia infection. These combination therapies may have the potential of preventing progression of disease and providing a new treatment strategy for individuals with severe infections.

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How does vla15 work?

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This is an important step forward, both conceptually and in terms of our understanding of an infectious agent which, until recently, had a limited repertoire of identifiable virulence factors and required the help of host factors.

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Have there been any new discoveries for treating borrelia infections?

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There has been no new treatments that would make borrelia infection a treatable disease. There are still no vaccines available. The current management strategy is to treat patients appropriately based on their presenting symptomatology and laboratory and radiological evidence of the disease.

Unverified Answer

What are the common side effects of vla15?

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The majority of vla15 positive subjects reported side effects. Although it is generally not fatal, some of the reported symptoms did have a negative impact on the quality of life. However, most vla15 positive patients did not experience a significant decrease in their general quality of life.

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Has vla15 proven to be more effective than a placebo?

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Among those not receiving the oral or topical antibacterial treatment, the majority (60%) had an unfavorable prognosis after a month of follow-up compared with 20% in the treatment group. However, this difference was not statistically significant, although this may give a false impression. Further studies are needed to confirm the clinical value of V150 treatment.

Unverified Answer
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