Interim results from a clinical trial suggest that a new Lyme disease vaccine is both safe and effective, offering hope of the first human vaccine for the disease since Lymerix was removed from the market in 2001. Publishing the findings in The Lancet, Lyme disease researchers detail the new multivalent recombinant OspA Lyme Borreliosis (mv rOspA LB) Vaccine and its use in adults.
The primary purpose of the study was to assess the safety and immunogenicity of different doses of the vaccine with and without adjuvant in those without evidence of infection with Lyme disease. Secondary aims included working out an optimal dose for the new formulation in a larger population of both seronegative and seropositive adults.
Large Clinical Trial for Lyme Disease Vaccine in Europe
The vaccine was developed by scientists at Stony Brook University, Brookhaven National Laboratory, and at Baxter International Inc. and this phase I and II clinical trial in Europe involved some 300 people from Austria and Germany, countries where Lyme disease is arguably more well recognized, better diagnosed and more easily treated than in the US.
Three Shots and a Booster for Lyme Disease Prevention
Those taking part in the new Lyme disease vaccine study had three primary immunizations and a single booster shot, either with or without an adjuvant to stimulate an immune response to the vaccine. All of the doses and formulations were seen to trigger the production of antibodies to all of the Borrelia species included in the vaccine. The inclusion of a wide range of species is important in making the vaccine commercially viable in both Europe and North America.
Vaccine with Adjuvant Performs Best for Lyme Disease Prevention
Importantly, there were no serious adverse effects attributed to the vaccine and only mild side-effects reported in a few cases. Interestingly, those who did have an undesirable reaction to the vaccine tended to be in the group receiving the non-adjuvanted formula. The adjuvanted formula at a 30 microgram dose was the best tolerated of all of the vaccine protocols, with 10% of patients experiencing a headache, 32% having pain at the injection site and 34% having tenderness in the area. No other side-effects occurred in more than 6% of those receiving this dose and formula.
Lowest Dose Best for New Lyme Disease Vaccine from Baxter
Three different doses of the vaccine were used in both adjuvanted and non-adjuvanted form (ranging from the 30 microgram formula to 90 micrograms with around 50 people included in each group). All of the groups had substantial mean IgG antibody titers against OspA serotypes 1-6 after the three vaccinations and booster. As well as having the lowest rate of adverse effects, the 30 microgram dose also induced the highest response to the vaccination after the booster shot.
New Lyme Disease Vaccine for the US and Europe
The antigens included in the vaccine cover the whole range of Borrelia known to be responsible for Lyme disease in the entire Northern Hemisphere. Phase III trials are planned after tests have been carried out on those who were seropositive for Lyme disease, so as to observe the potential benefits of this vaccine in a larger number of people. This novel multivalent OspA vaccine could be the long hoped for Lyme disease prevention strategy for both Europe and the US. Those who remember the LYMErix affair will likely be watching closely to see how manufacturer of this new Lyme disease vaccine, Baxter, handle the publicity and promotion of their product.
Nina Wressnigg, Eva-Maria Pöllabauer, Gerald Aichinger, Daniel Portsmouth, Alexandra Löw-Baselli, Sandor Fritsch, Ian Livey, Brian A Crowe, Michael Schwendinger, Peter Brühl, Andreas Pilz, Thomas Dvorak, Julia Singer, Clair Firth, Benjamin Luft, Bernhard Schmitt, Markus Zeitlinger, Markus Müller, Herwig Kollaritsch, Maria Paulke-Korinek, Meral Esen, Peter G Kremsner, Hartmut J Ehrlich, P Noel Barrett, Safety and immunogenicity of a novel multivalent OspA vaccine against Lyme borreliosis in healthy adults: a double-blind, randomised, dose-escalation phase 1/2 trial, The Lancet Infectious Diseases, Early Online Publication, 10 May 2013, doi:10.1016/S1473-3099(13)70110-5.