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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.