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Clinical trial finds VLA15 vaccination safe and effective against Lyme disease: Lancet

Written By : Jacinthlyn Sylvia |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-06-08T08:45:24+05:30  |  Updated On 8 Jun 2024 8:45 AM IST
Clinical trial finds VLA15 vaccination safe and effective against Lyme disease: Lancet
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The incidence of Lyme borreliosis has been rising steadily which leads to severe health outcomes and highlights the urgent need for effective preventive measures. Despite this growing need, no vaccine is currently available for human use to combat Lyme disease. Thereby, the outcomes of two recent clinical studies published in The Lancet Infectious Diseases journal finds VLA15, an investigational vaccine targeting outer surface protein A (OspA) serotypes 1–6 safe and effective against the most common Borrelia species causing Lyme disease in Europe and North America.

The randomised, multicentre phase 2 trials were conducted in adult population who were of 18 to 65 years without a recent history of Lyme borreliosis or tick bites. Study one included a total of 573 participants at nine sites in the USA, Germany and Belgium, while study two included a total of 248 participants at five of the original US sites. The participants were assigned to receive either 90 μg (study one only), 135 μg or 180 μg of VLA15, or a placebo via intramuscular injection across various schedules.

Initial safety phases in study one led to the discontinuation of the 90 μg dose following recommendations from the Data Safety Monitoring Board, proceeding with the 135 μg and 180 μg doses. Stratified randomisation by study site, age group and baseline B burgdorferi serostatus ensured balanced participant allocation across the groups.

The primary endpoint measured OspA-specific IgG geometric mean titres (GMTs) one month after the third vaccination showed robust antibody responses. In study one, the highest GMTs for the 180 μg dose were observed at 308.6 units per mL for serotype 3. Study two, extended the vaccination schedule to months 0, 2 and 6, this in turn demonstrated even stronger immune responses with GMTs reaching up to 596.8 units per mL for serotype 3 in the 180 μg group.

Safety evaluations revealed that the vaccine was well tolerated. The participants who received VLA15 reported higher frequencies of solicited local and systemic adverse events when compared to the placebo group, though these were mostly mild or moderate. Unsolicited adverse events were comparable between vaccine and placebo groups and serious adverse events were rare and unrelated to the vaccine. These findings pave the way for further clinical development for a preventive vaccine for Lyme borreliosis to combat its rising incidence.

Source:

Bézay, N., Wagner, L., Kadlecek, V., Obersriebnig, M., Wressnigg, N., Hochreiter, R., Schneider, M., Dubischar, K., Derhaschnig, U., Klingler, A., Larcher-Senn, J., Eder-Lingelbach, S., & Bender, W. (2024). Optimisation of dose level and vaccination schedule for the VLA15 Lyme borreliosis vaccine candidate among healthy adults: two randomised, observer-blind, placebo-controlled, multicentre, phase 2 studies. In The Lancet Infectious Diseases. Elsevier BV. https://doi.org/10.1016/s1473-3099(24)00175-0

The Lancet Infectious Diseases JournalLyme borreliosisVLA15 vaccine
Source : The Lancet Infectious Diseases
Jacinthlyn Sylvia
Jacinthlyn Sylvia

    Neuroscience Masters graduate

    Jacinthlyn Sylvia, a Neuroscience Master's graduate from Chennai has worked extensively in deciphering the neurobiology of cognition and motor control in aging. She also has spread-out exposure to Neurosurgery from her Bachelor’s. She is currently involved in active Neuro-Oncology research. She is an upcoming neuroscientist with a fiery passion for writing. Her news cover at Medical Dialogues feature recent discoveries and updates from the healthcare and biomedical research fields. She can be reached at editorial@medicaldialogues.in

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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