Efforts are being made toward a new and effective Lyme disease vaccine. Baxter Healthcare Corporation has recently reported the results of its Phase 1/2 Lyme Vaccine Study that began on March 1, 2011 and ended on May 8, 2012. Study participants received three primary immunizations and one booster immunization. The study involved measuring the antibody response to the vaccine at 28 days after the third vaccination (which would be day 85) and determining the frequency and severity of injection site and systemic reactions within 7 days after each vaccination (which would be on day 8, day 36, and day 64).
The stated purpose of the study was “to obtain safety and immunogenicity data of different dose levels of a multivalent recombinant OspA Lyme Borreliosis (mv rOspA LB) Vaccine with and without adjuvant in seronegative healthy adults aged 18 to 70 years. The outcome shall provide the basis for dose/formulation selection for Section 2 of the study” and [Section 2] “An additional purpose of the study is to evaluate the safety and immunogenicity of the optimal dose(s)/formulation of the mv rOspA LB Vaccine in a larger portion of seronegative and seropositive healthy subjects aged 18 to 70 years.” (An adjuvant is a pharmacological agent added to a drug to increase or aid its effect, or an immunological agent that increases the antigenic response.) The study’s participants were from Austria and Germany.
What Is A Phase 1/2 Study?
A Phase 1 clinical trial is the first step in testing a new investigational medication (or new use of a marketed drug) in humans. Phase 1 studies are mainly concerned with evaluating a drug’s safety profile, including the safe dosage range. The studies also determine how the drug is absorbed and broken down by the body, what is the best way to give the drug to a patient (for example by mouth, or by injection), what side effects may be likely, and how the drug is absorbed, distributed, metabolized, and excreted as well as its duration of action. Except for drugs used to treat cancer, Phase 1 clinical trials are usually conducted in healthy individuals and are not intended to treat disease or illness. Because cancer can be such a life-threatening condition, Phase 1 trials with anti-cancer drugs are usually carried out in patients who already have the disease.
A Phase 2 clinical trial involves volunteers who have the disease or condition to be treated. These trials help physicians and researchers begin to learn more about the safety of the new drug treatment and how well the drug treats the targeted disease or condition. Several different doses of the drug may be looked at to see which dose has the desired effects. Patients are monitored for side effects and for any improvement in their illness, symptoms, or both.
Phase 1/2 trials combine a Phase 1 and a Phase 2 trial of the same treatment into a single protocol. First the Phase 1 part of the trial is done to determine the Maximum Tolerable Dose (MTD). Then, more patients are treated at the MTD in the Phase 2 portion of the study, to further evaluate safety and/or efficacy.
In the May 10, 2013 online version of The Lancet Infectious Diseases journal, it was reported that the Baxter Healthcare Corporation’s study involved 300 participants who were randomly assigned to adjuvanted vaccines (151 of the participants) or to non-adjuvanted vaccines (149 of the participants) at four sites in Austria and Germany. Study participants received three primary immunizations and one booster immunization. It was reported that adverse reactions were predominantly mild and that there were no vaccine-related serious adverse events reported. It was further reported that the risk of systemic reactions and of moderate or severe systemic reactions was significantly lower for adjuvanted formulations than for non-adjuvanted formulations of the vaccine. The report stated that all doses and formulations induced substantial mean IgG antibody titres against OspA serotypes 1 – 6 after the first three vaccinations and booster immunizations, with the 30ug adjuvanted formulation inducing the highest antibody titres after the booster.
The Lancet Infectious Diseases article concluded, “The novel multivalent OspA vaccine could be an effective intervention for prevention of Lyme borreliosis in Europe and the USA, and possibly worldwide. Larger confirmatory formulation studies will need to be done that include individuals seropositive for Borrelia burgdorferi sensu lato before placebo-controlled phase 3 efficacy studies can begin.” (A Phase 3 clinical trial: after a drug has been shown to have positive results in small groups of patients, it may be studied in a larger Phase 3 trial to confirm efficacy and identify adverse events from long-term use. A Phase 3 trial usually compares how well the study drug works compared with an inactive placebo and/or another approved medication. One group of patients may receive the new drug being tested, while another group of patients may receive the comparator drug (already-approved drug for the disease being studied), or placebo. Source)
In discussing the results of the Phase 1/2 study, Baxter’s vice president of research and development in its vaccines business stated, “Our candidate Lyme disease vaccine is a great example of innovation in exploring new ways to prevent disease through our vaccine technology. Based on the results of this study, we are fully committed to further investigating the candidate vaccine in larger populations.”
With an ever-increasing population in the United States being exposed to the risk of Lyme disease, and the increasing number of Lyme disease cases in the United States being reported to the CDC every year, the availability of an effective Lyme disease vaccine would be most welcomed.
If you or a family member were misdiagnosed or late diagnosed with Lyme disease, you should promptly contact a local Lyme-literate lawyer who may investigate your Lyme disease claim for you and represent you in a misdiagnosis of Lyme disease or delayed diagnosis of Lyme disease claim.
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