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Published On: Mon, May 13th, 2013

Lyme disease vaccine produces substantial immune response in clinical trials

An investigational Lyme disease vaccine co-developed by researchers at Stony Brook University, Brookhaven National Laboratory, and at Baxter International Inc. has shown promising safety and efficacy in phase 1/2 clinical trial in Europe where some 300 people from Austria and Germany participated.

This 2007 photograph depicts the pathognomonic erythematous rash in the pattern of a “bull’s-eye”, which manifested at the site of a tick bite on this Maryland woman’s posterior right upper arm, who’d subsequently contracted Lyme disease. Image/CDC/ James Gathany

This 2007 photograph depicts the pathognomonic erythematous rash in the pattern of a “bull’s-eye”, which manifested at the site of a tick bite on this Maryland woman’s posterior right upper arm, who’d subsequently contracted Lyme disease.
Image/CDC/ James Gathany

The article that shows the results from the trials, “Safety and immunogenicity of a novel multivariant OspA vaccine against Lyme borreliosis in healthy adults: a double-blind, randomized, dose-escalation phase 1/2 trial,” was recently published in The Lancet Infectious Diseases.

In the study,  participants received three primary immunizations and one booster immunization. All doses and formulations, some of which included an adjuvant, an additive to stimulate immune response to the vaccine, induced substantial antibody titers against all species of Borrelia. The vaccine demonstrated predominantly mild adverse reactions and no-vaccine related serious events occurred in the sample population.

Specifically, the finding were as described in paper:

300 participants were randomly assigned: 151 to adjuvanted vaccines (50 to 30 μg, 51 to 60 μg, and 50 to 90 μg doses), and 149 to non-adjuvanted vaccines (50 to 30 μg, 49 to 60 μg, and 50 to 90 μg doses). Adverse reactions were predominantly mild, and no vaccine-related serious adverse events were reported. The risk of systemic reactions (risk ratio 0·54 [95% CI 0·41—0·70]; p<0·0001) and of moderate or severe systemic reactions (0·35 [0·13—0·92]; p=0·034) was significantly lower for adjuvanted than non-adjuvanted formulations. The 30 μg adjuvanted formulation had the best tolerability profile; only headache (five [10%, 95% CI 4—20] of 50), injection-site pain (16 [32%, 21—45]), and tenderness (17 [34%, 23—47]) affected more than 6% of patients. All doses and formulations induced substantial mean IgG antibody titres against OspA serotypes 1—6 after the first three vaccinations (range 6944—17 321) and booster (19 056—32 824) immunizations  The 30 μg adjuvanted formulation induced the highest antibody titres after the booster: range 26 143 (95% CI 18 906—36 151) to 42 381 (31 288—57 407).

“The results of the clinical trial conducted by Baxter are promising because the vaccine generated a potent human immune reaction, covered the complete range of Borrelia active in the entire Northern hemisphere, and produced no major side effects,” said Benjamin Luft, MD, a co-author on the paper. “We hope that a larger-scale, Phase 3 trial will demonstrate not only a strong immune response but true efficacy in a large population that illustrates protection against Lyme disease.”

The researchers interpretation of the results of the trials say 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.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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