On Friday (May 31), Viennese biotech company Valneva announced that a key expert panel had recommended the EU’s approval of the chikungunya vaccine. Good news came the same day. Results of clinical trials for a Lyme disease vaccine developed by Valneva with Pfizer are published in “The Lancet Infectious Diseases.” Three-part vaccines can protect against the disease.
“VLA15 (candidate vaccine; reference) was safe, well tolerated and elicited a strong antibody response against all six OspA serotypes (Lyme disease variants; reference). These results support further clinical development of VLA15 at doses of 180 micrograms (dose). Reference to the antigen in the vaccine ) and the vaccination schedule 0-2-6 months (one day, two months and half a year later; note), which brings about a better immune response,” said Nicole Besse and her co-authors of “Lancet Infectious Diseases”.
The Austrian-French biotech company has specialized in developing vaccines since its inception. The first vaccine was against Japanese encephalitis, followed by a cholera vaccine, and the world’s first chikungunya vaccine from Valneva was approved in the US in the fall of 2023. The latter will now also take place in the EU following the recommendation of the European Medicines Agency (EMA).
VLA15 from Valneva in partnership with Pfizer is the world’s only Lyme disease vaccine currently in clinical development. It is a subunit vaccine with alum adjuvant (adjuvant for vaccine boosting; note). The vaccine is intended to cover six common variants of the OspA surface protein of Borrelia burgdorferi sensu lato (the tick; reference) found in North America and Europe. OspA is one of the key proteins produced by Borrelia burgdorferi during tick infection.
More than 800 test subjects between the ages of 18 and 65 participated in two studies, with test subjects randomly assigned to individual dose groups or placebo. In the first study, participants received a dose of vaccine on day one, one and two months later, and the vaccination schedule was an intramuscular injection on day one, two and six months later. The antigen dose was 90, 135 or 180 micrograms depending on the group.
Good immunity
The vaccine induced a good immune response. He did well with the three part vaccinations with the second vaccination schedule. Endurance was also good. Pfizer VLA15 is now undergoing a phase III approval study (efficacy and tolerability) in six countries with approximately 6,000 test subjects (including a placebo group). Now there is evidence that the vaccine – aside from the phase II immunological results – actually protects people from the disease. These results will take some time to arrive. Pfizer announced this in August 2022.
The market for effective Lyme disease vaccines is large: About 476,000 people in the United States contract the disease each year. There are an estimated 130,000 patients in Europe each year. There are two extremes of the disease – depending on the amount of time people spend outdoors: children and the elderly. The Lyme disease vaccine was already available in the United States. However, it was taken off the market again in 2002.
Generations of scientists have literally cut their teeth on the development of well-tolerated and effective Lyme disease vaccines. Austrian virology doyen Christian Kunz was able to develop a nearly 100% effective TBE vaccine against tick-borne viral infections, making Lyme disease much more difficult to treat as a bacterial disease. Former Vienna Immuno AG failed after initial promising results in further development after Phase I clinical studies.
The new vaccine actually immunizes against ticks. The vaccine-induced antibody response against OspA is via antibodies to vaccinate ticks. If OspA is inhibited, Borrelia cannot leave the tick during the bite, thereby infecting the victim.
