Promising results have come out of the only active clinical trial for a vaccine against Lyme disease. Valneva, a French biotech company, recently announced its first Phase 2 clinical trial has shown that its vaccine against Lyme disease is both safe and effective. The vaccine works by triggering the body’s immune system to produce antibodies for the six common serotypes of the disease that are found in North America and Europe. It does this by introducing an isolated protein of the pathogen to the body, allowing the immune system to recognize and respond to the surface proteins found on the bacteria responsible for Lyme disease, Borrelia burgdorferi. Over 570 healthy adults in the US and Europe were given one of two dose levels of the vaccine in three injections, while others were given a placebo as a control. Both groups that received the active dose were found to have produced a significant amount of antibodies against each of the six most prevalent Outer Surface Protein A serotypes of B. burgdorferi. Lyme disease is caused by the bacteria B. burgdorferi transmitted by infected ticks that live in forested areas of Asia, Europe, and the US. It’s especially common in visitors to rural areas, such as campers and hikers, and affects some 300,000 people in the US and 65,000 people in Europe each year. Although it can be easily treated with antibiotics if caught early, it can go on to cause an extremely unpleasantly illness if left untreated, involving symptoms such as muscle pain, nerve pain, chronic tiredness, inflammation of the brain and spinal cord, and severe headaches. One of the main reasons the disease is left untreated is because patients are often incorrectly diagnosed with other diseases, such as chronic fatigue syndrome, lupus, or mental health problems This new potential vaccine, known as VLA15, is currently the only active Lyme disease vaccine in clinical development. Back in 1998, the US Food and Drug Administration (FDA) approved a Lyme disease vaccine known as LYMErix. It was withdrawn from the market just three years later following doubts over its effectiveness and other contentions. Much of the controversy, however, was often said to have been kicked up by the anti-vaccination movement, which was growing in momentum at the time. The Lyme disease vaccine development project by Valneva received a multi-million dollar cash injection from the big pharma giant Pfizer. Of course, there’s more work to be done. Even if the next phases of development go as expected, it will still be some years before this vaccination is available on the market. After all, vaccine development is a long and arduous process. Nevertheless, the results are looking promising so far. “Further data from the ongoing Phase 2 trials in the coming months will support further dose and schedule decisions. We are closely working with Pfizer to advance the development of VLA15 expeditiously,” Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva, commented in a press release. Source
