New Vaccine Against Lyme Disease Reportedly Safe and Effective

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In a recent study published in lancet infectionresearchers determined the safety and immunogenicity of a novel vaccine candidate against Lyme borreliosis.

study: Safety and immunogenicity of a novel multivalent OspA-based vaccine candidate against Lyme borreliosis: a randomized phase 1 study in healthy adults. Image credit: Evgeniyqw / Shutterstock.com

What is Lyme disease?

Lyme borreliosis is a tick-borne disease that occurs commonly in North America and Europe. Lyme borreliosis affects more than 200,000 and her 500,000 people in Europe and the United States each year.

Lyme disease is caused by a pathogenic spirochete belonging to Lyme disease. Borrelia burgdorferi sensrat complex. This species includes B. Burgdorferi sensu stricto, which causes serotype 1; B. Galinicausing serotypes 3, 5 and 6, as well as B. Afzeri and B. babalyensiscausing serotypes 2 and 4, respectively.

Lyme borreliosis presents as erythema migrans, an erythematous skin lesion with a serotype-specific incidence, accompanied by fever, malaise, headache, muscle or joint pain, and mild neck stiffness.

Although the disease is easily treated with antibiotics if detected in its early stages, untreated Lyme borreliosis can affect the joints and heart, causing oligoarthritis and carditis, respectively. Neurologic consequences of untreated Lyme borreliosis include facial paralysis, meningitis, and radiculopathy.

Previous monovalent Lyme borreliosis vaccines were withdrawn from distribution in the United States due to concerns over possible post-vaccination induction of autoimmune arthritis and poor acceptance. However, no evidence was found to support this safety concern.

About research

In this study, investigators evaluated the immunogenicity and safety of the hexavalent candidate vaccine VLA15 in humans after the vaccine was shown to induce long-lasting immunity in mouse models.

The targets of most Lyme borreliosis vaccines are predominantly expressed on outer surface protein A (OspA). Borrelia Midgut spirochete that carries ticks. Antibodies induced by vaccines Borrelia OspA is expected to target and neutralize spirochetes in the tick midgut before causing infection in humans.

The hexavalent VLA15 vaccine contains three lipidated fusion proteins, each of which joins the OspA C-terminal domains of two serotypes to ultimately target six serotypes.

All study participants were healthy adults between the ages of 18 and 40 who were confirmed to be seronegative for Lyme borreliosis by enzyme-linked immunosorbent assay (ELISA). Participants were randomly assigned to groups that received 12, 48, or 90 microgram (μg) doses of vaccine with or without adjuvant.

The primary objective of this study is to assess safety, including the severity and frequency of unsolicited systemic and local side effects, and unsolicited mild to severe side effects, for up to 1 month after completion of primary vaccination. It was to observe the endpoint.

Reported local side effects included injection site pain, erythema, swelling, tenderness, itching, and induration. Systemic reactions during the first week after vaccination include fever, nausea, headache, malaise, rash, arthralgia, flu-like symptoms, and myalgia.

Secondary endpoints included assessment of adverse events at various times up to 1 year after completion of the primary vaccination regimen, with additional observations at 1 and 6 months after booster vaccination. was broken. Vaccine immunogenicity was assessed based on geometric mean immunoglobulin G (IgG) titers against one of six serotypes and was measured by seroconversion and ELISA.

A safe and effective vaccine against Lyme disease

Primary vaccination with three doses of the hexavalent VLA15 vaccine against Lyme borreliosis was safe and well tolerated in the healthy adult population participating in the study. VLA15 also induced significant immune responses against all six OspA-based serotypes.

Mild systemic and local side effects such as injection site tenderness and pain, myalgia, malaise, and headache were observed. However, no side effects resembling symptoms of Lyme borreliosis or signs of systemic inflammation, including changes in biomarkers such as C-reactive protein, leukocytes and erythrocyte sedimentation rate, were observed.

A booster vaccination 13 months after the first dose was similarly safe and induced a substantial anamnestic immune response. The observed reactions to the VLA15 vaccine were typical side effects to other lipid-combined recombinant vaccines.

Conclusion

The hexavalent VLA15 vaccine against Lyme borreliosis was found to be safe and did not induce serious systemic or local side effects. The vaccine also elicited significant antibody responses against all six serotypes against which the vaccine is intended. In addition, a booster vaccination approximately 1 year after the primary vaccination induced a substantial anamnestic immune response.

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