Lyme vaccine advances to phase two

After positive results from phase one
Thu, 03/14/2019 - 4:30pm

Testing on a new, groundbreaking Lyme disease vaccine is advancing through phase two of a three-phase clinical trial testing process. 

Valneva SE, a France-based biotechnology company, began mid-stage testing of its vaccine VLA15 in December 2018. The vaccine operates by stimulating the human immune system to produce antibodies that attack the bacteria inside of a tick after it has bitten a host.

The U.S. Food and Drug Administration put the company’s vaccine on a fast-track  in July of 2017.

A press release emailed to The Times from the company stated: “We initiated a Phase two clinical trial for VLA15 in late 2018 at trial sites in the U.S and Europe. The overall objective is to determine the optimal dosage level and schedule for use in Phase three pivotal field efficacy studies, based on immunogenicity and safety data. Around 800 subjects will be included in the Phase two study. As we are still in Phase two testing, we have not yet discussed potential pricing. Our ultimate goal is to bring a safe and effective Lyme vaccine to all people in need as soon as is possible.”

“The overall phase two objective for VLA15 is to determine the optimal dosage level and schedule for use in the phase three pivotal field efficacy studies, based on immunogenicity and safety data,” the press release continued. “The phase two development for the Lyme disease vaccine candidate will include the evaluation of the highest dose of VLA15 tested in phase one in addition to two higher doses. Furthermore, the company plans to include the evaluation of an additional, alternative three-dose schedule.”

Phase two “is a randomized, observer-blind, placebo controlled clinical trial conducted at trial sites in the U.S. and Europe. Initially, 120 subjects will receive one of three dosage levels of VLA15, or placebo, followed by a Data Safety Monitoring Board review of safety data. Thereafter, 450 subjects will receive one of two dose levels of VLA15 (180 subjects each), or placebo (90 subjects), in the main study phase. VLA15 will be tested as alum adjuvanted formulation and will be administered intramuscularly in three injections, given at days one, 29 and 57. Subjects will be followed for one year.”

Adjuvanted means a substance which enhances the body's immune response to an antigen. In this case, the VLA15 vaccine would serve as the adjuvanted formulation to induce an immune response.

Of the company’s clinical trials, Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva, said, “Lyme disease cases in the U.S. have increased dramatically over the last 30 years or so, substantially increasing the costs for healthcare systems. The fear of contracting Lyme disease diminishes the quality of life of people of all ages. As the disease footprint widens, the need for a vaccine to prevent this significant unmet medical need increases. Valneva is doing everything possible, in consultation with the FDA and the European Medicines Agency, to develop a safe and effective vaccine under the fast-track designation.”

Results from Valneva’s phase one clinical study indicate that the vaccine was safe and tolerable at different dose levels and formulations by its human trial participants. During the trial, the vaccine produced an immune system response in its human participants, enabling antibodies that destroy antigens. “VLA15 was more immunogenic in adjuvanted treatment groups compared to non-adjuvanted treatment using the same dose level.”

“This study was a first-in-human observer-blind, partially randomized, dose escalation phase one study that aims to evaluate the safety, tolerability and immunogenicity of Valneva´s vaccine candidate VLA15.”

“The study enrolled 179 healthy adults under 40 years of age in Europe and the U.S. who were not previously infected with Borrelia burgdorferi. Subjects were randomized into six treatment groups to receive one of three dose levels either in an alum adjuvanted formulation or without adjuvant. Study subjects were vaccinated on three occasions one month apart.”

Bender said that Valneva was “extremely pleased to report a successful first human trial for our vaccine candidate (VLA15) against Lyme disease, a severe infection which affects an increasing number of people each year. We look forward to providing access to an effective prevention against a disease that is too often underdiagnosed, leaving many infected people with no or inadequate treatment and resulting in a heavy public health and economic burden.”