NIAID Webpage on Lyme Vaccines

The National Institute of Allergy & Infectious Diseases (NIAID), National Institutes of Health (NIH), has a page on Lyme vaccines including its information on what occurred with the first Lyme vaccine, LYMErix, and what is happening with some current vaccines and vaccine research.

https://www.niaid.nih.gov/diseases-conditions/lyme-disease-vaccines




Pfizer Gets Priority Review for Tick-Borne Encephalitis Vaccine

Pfizer has received priority review for their vaccine, TicoVac, which protects against tick-borne encephalitis. This tick-borne virus can cause meningitis and trigger long-term neurological symptoms in humans. If approved, the vaccine would potentially protect travelers and members of the United States military that are deployed to regions where the virus is common, such as Europe and parts of Asia.

TicoVac is an inactivated virus vaccine that has been highly effective at preventing tick-borne encephalitis throughout Europe for four decades. With this FDA fast-pass, it is hoped that a US approval would occur by August and would simplify the process for US military members to get the vaccine. 

Pfizer is also developing a vaccine for another tick-borne illness: Lyme disease.

Read full article here.

Read more LDA posts on vaccines here




Phase 2 Study for Lyme Disease Vaccine Candidate Begins

Valneva and Pfizer announced that they have initiated a Phase 2 study for their Lyme disease vaccine candidate. This is currently the only active Lyme disease vaccine in clinical development. 

This new study builds on previous studies, including new dose regimens as well as being the first clinical study to include children between the ages 5-17 years. Advancement to Phase 3 studies will depend on the outcome of this study.

Six serotypes prevalent in both North America and Europe will be covered by this vaccine and the vaccine targets one of the most dominant surface proteins expressed by Borrelia the pathogen when present in a tick, the outer surface protein A (OspA). 

Note: The Lyme Disease Association Inc. has not taken a position on this vaccine but presents current information so consumers take actions relating to any information presented or can make informed decisions on issues presented. 

Read the full article here.
Read articles on vaccines from LDA here.




COVID Pre-Exposure Prophylaxis for Pregnant Women

COVID pre-exposure prophylaxis for pregnant women is a critical issue as pregnant women are at higher risk for developing severe complications of COVID infections including preterm delivery, fetal demise, respiratory failure and maternal death. As pregnant women initially may not be eligible to receive COVID-19 vaccines due to the unknown effects on mother and fetus, these women urgently need an option for protection from COVID when vaccine candidates are not available to them. 

A peer-reviewed report, co-authored by Melissa C. Fesler and Raphael B. Stricker, has been published in the International Journal of General Medicine which evaluates pre-exposure prophylaxis (PrEP) with medications approved for use in pregnant women to prevent gestational problems and severe illness in this high-risk population. 

This report evaluates pre-exposure prophylaxis medications with findings that hydroxychloroquine (HCQ) may provide the safest most effective means to reduce effects of or prevent SARS-CoV-2 infection in pregnancy. 

Read 24/7 press release here.

Read published study: Fesler MC, Stricker RB. Pre-Exposure Prophylaxis for COVID-19 in Pregnant Women. Int J Gen Med. 2021;14:279-284  https://doi.org/10.2147/IJGM.S295627   

Read other COVID related LDA posts here.




NY Supreme Court Judge Orders Hospital: Give Patient Ivermectin for COVID-19

According to “TrialSite News” on January 21, “Apparently, a judge just ordered the Millard Fillmore Suburban Hospital to allow an 80-year old woman to be treated with Ivermectin.  A New York Supreme Court judge ordered hospital to allow her to be treated with Ivermectin for COVID-19.  Ivermectin, which had been administered in the ICU with noticeable symptom improvement was discontinued when the patient was moved to another unit in the hospital. Family members took legal action after the doctor in the new unit disallowed the use of the drug, and the woman’s health condition again declined. Family members immediately involved lawyers and legal action to resume treatment. Judge, Henry J. Nowak aligned with the family.

Ivermectin is approved for fighting parasites and lice. NIH states that in general, the drug is well tolerated and is currently being evaluated as a potential treatment for COVID-19. However, is not yet approved for use by the US Food and Drug Administration (FDA).

The National Institute of Health (NIH) COVID-19 Treatment Guidelines Panel recently issued a change in position on Ivermectin

NIH COVID-19 Recommendation:

  • The COVID-19 Treatment Guidelines Panel (the Panel) has determined that currently there are insufficient data to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin for the treatment of COVID-19.

Read full article here

 




Disulfiram for Lyme and Babesiosis Treatment: Retrospective 3 yr Review

Dr. Kenneth Liegner, MD
Dr. Kenneth Liegner, Co-author

In a retrospective review on the use of Disulfiram as a repurposed drug in the treatment of Lyme and Babesiosis, most patients experienced benefits with regard to their symptoms. It was found that although patients on high dose experienced higher risk for adverse reactions than the low dose patients, they were also more likely to show “enduring remission” which is defined as remaining clinically well for ≥6 months without further anti-infective treatment. Adverse reactions from disulfiram treatment observed in the high-dose group were fatigue (66.7%), psychiatric symptoms (48.5%), peripheral neuropathy (27.3%), and mild to moderate elevation of liver enzymes (15.2%).  It was also found that patients with co-infection of babesiosis and bartonellosis tended to require higher doses of disulfiram to achieve clinical improvement of their symptoms.

The authors concluded that disulfiram monotherapy is useful in the treatment of Lyme disease through individualized and flexible approach with shared decision-making with patients. They also suggest that further study and treatment trials seems warranted. This article was co-authored by Dr. Kenneth Liegner, LLMD, who serves on the LDA Scientific and Professional Advisory Board.

Read review here: Gao, J.; Gong, Z.; Montesano, D.; Glazer, E.; Liegner, K. “Repurposing” Disulfiram in the Treatment of Lyme Disease and Babesiosis: Retrospective Review of First 3 Years’ Experience in One Medical Practice. Antibiotics 20209, 868.

Dr. Kenneth Liegner Interview with ‘Disulfiram for Lyme Support Group’

 

 




New Direct Detection Test for Lyme

A new direct test for Lyme disease was announced by Galaxy Diagnostics Inc., the Nanotrap® Urine Test for Lyme Borreliosis.  This is a urine-based Lyme antigen test, that Galaxy states “provides the most sensitive direct detection of Borrelia burgdorferi infection at all stages of the disease.” The test is easily administered through collection of urine; and identifies positive cases missed by CDC-recommended two-tiered testing, reducing concern for false positive results via direct detection of OspA proteins. 

Published data shows that the Nanotrap® Urine Test is very effective for confirmation of early stage Lyme borreliosis in patients with EM rashes. Galaxy states that their unpublished validation data shows that the Nanotrap® Urine Test often confirms active infection in patients with negative CDC recommended Two-Tiered Testing results.

Clinical utility of this test for other presentations of Lyme, including Lyme arthritis, Lyme carditis, and neuroborreliosis, needs further research.

This information is provided by LDA for informational purposes only. The LDA does not recommend or endorse this test but provides it for informational purposes only.  Contact your health care provider for medical advice. 

Galaxy Diagnostics News Release: November 10, 2020

Application of Nanotrap technology for high sensitivity measurement of urinary outer surface protein A carboxyl-terminus domain in early stage Lyme borreliosis

 




Dr. Horowitz In Vivo Dapsone Combination Therapy Study Published

Richard Horwitz, MD, et al., have published a new case study and retrospective chart review of 40 patients on double dose dapsone combination therapy (DDD CT) in the journal Antibiotics

Dapsone Combination Therapy
Dr. Richard Horowitz

The study found that of the 40 patients analyzed, an 8-week course of dapsone combined with doxycycline and rifampin effectively improved symptoms in 98% of patients, as well as led to long-term remission in 45% of the total patients studied, even though most of the individuals were ill for a decade or longer. The research included a segment of 12 patients with the presence of EM rashes. Of these, 100% showed improvement with 58% remaining in remission. The study abstract states, “In conclusion, double-dose dapsone therapy could represent a novel and effective anti-infective strategy in chronic Lyme disease/post-treatment Lyme disease syndrome (PTLDS), especially in those individuals who have failed regular dose dapsone combination therapy (DDS CT) or standard antibiotic protocols.”

The above-mentioned dapsone combination therapy study is a follow-up in vivo clinical study to the initial groundbreaking in vitro culture study published in September 2020, which definitively showed that Borrelia burgdorferi (Bb) forms biofilms to shield the organism and that combining antibiotics with the leprosy drug dapsone effectively kills the bacteria by disrupting the biofilm.

Both studies by Horowitz, examining biofilm, and ‘persister’ forms of Bb, are critical in revealing the underlying cause of resistant chronic Lyme disease symptoms. The most recent follow-up study also demonstrates the importance of accompanying tick-borne infections (TBD), such as Babesia and Bartonella, and the role these co-infections can play in causing resistant, long-term illness.

What comes next for dapsone combination therapy?
The next step is for Dr. Horowitz and his team to perform a randomized, placebo-controlled trial using DDD CT, done in parallel with studies aimed at finding answers for resistant tick-borne co-infections. Horowitz is hopeful that this will positively demonstrate that the elusive “cure” for Lyme disease, which has evaded researchers and clinicians for decades, may finally be within reach and offer the potential to end a medical debate that has caused suffering in millions of patients worldwide.

Read the most recent in vivo clinical study, “Efficacy of Double-Dose Dapsone Combination Therapy in the Treatment of Chronic Lyme Disease/Post-Treatment Lyme Disease Syndrome (PTLDS) and Associated Co-infections: A Report of Three Cases and Retrospective Chart Review” in the journal, Antibiotics.

Read the initial in vitro study, “Effect of Dapsone Alone and in Combination with Intracellular Antibiotics Against the Biofilm form of B. Burgdorferi in BMC Research Notes.




New Dapsone Study: Breaking Biofilm

Dr. Richard Horrowitz co-author of the published case study on Lyme disease and COVID-19
Dr. Richard Horowitz, lead-author: Effect of dapsone alone and in combination with intracellular antibiotics against the biofilm form of B. burgdorferi

New in vitro study on dapsone (diaminodiphenyl sulfone), and dapsone combination therapy (DDS CT) was just published by Dr. Richard Horowitz et al. and provides hope of effective treatment for patients with persistent Lyme disease.

The study is suggestive that dapsone combination therapy may well characterize both a novel and successful option to treat Borrelia burgdorferi persister cells in the form of biofilm.  There are several hypotheses causing great controversy regarding the persistent symptoms that greater than 10-20% of patients are experiencing after infection with B. burgdorferi. The study evaluated the effectiveness of dapsone against B. burdorferi biofilm forms of the bacteria by testing in individual as well as in combination therapy with several drugs including cefuroxime, doxycycline, rifampin, and azithromycin in vitro.

The results were robust, showing that using dapsone alone or in various combinations with the above stated drugs significantly reduced the mass and protective glycosaminoglycan layer affecting the capability of the biofilm form of B. burdorferi. DDS CT efficacy on the B. burgdorferi biofilms was also determined by ascertaining the biofilm polysaccharide matrix content, glycosaminoglycans (GAG).

Study results showed the most efficient single use antibiotic at reducing biofilm was dapsone at both 10 µM and 50 µM concentrations,  showing 69% and 58% residual viability respectively. Used individually, other antibiotic treatments (doxycycline, cefuroxime, and azithromycin) proved to be less efficient and, in some cases, even caused an increase biofilm mass. In contrast, triple and quadruple combination antibiotic therapies showed greater efficacy. The most significant finding was that dapsone used individually or in combination therapy with rifampin, and a tetracycline and/or a macrolide and/or a cephalosporin showed great promise in the treatment of persistent Lyme patients, with prior clinical studies demonstrating improvement in many of the debilitating symptoms that patients suffer including fatigue, pain, neuropathy, sleep disturbances, cognitive dysfunction, sweats and flushing. It is urgent that randomized trials are launched to evaluate the clinical effectiveness of DDS CT as the spread of Lyme disease continues to increase on a global scale.

Read the full journal article: Effect of dapsone alone and in combination with intracellular antibiotics against the biofilm form of B. burgdorferi

Read the 2016 article: The Use of Dapsone as a Novel “Persister” Drug in the Treatment of ChronicLyme Disease/Post Treatment Lyme Disease Syndrome




NIH Grants 1.9 Million for Vaccine to Prevent Lyme

Ticks with blades of grass in a jarWest Virginia University researchers received a $1.9 million grant from the National Institute of Allergy and Infectious Diseases, an institution of the National Institute of Health (NIH), for a vaccine to prevent humans from contracting Lyme disease.

Mariette Barbier, assistant professor in the School of Medicine’s Department of Microbiology, Immunology and Cell Biology, is leading the five-year project, along with Timothy Driscoll, assistant professor of biology in the Eberly College of Arts and Sciences, and Heath Damron, assistant professor and director of the WVU Vaccine Development Center.

Barbier and her team will try to develop a vaccine effective against the various species of Borrelia (the Lyme disease bacteria). They will be using RNA sequencing to examine how pathogens respond in both infected ticks and mice, and identify relevant antigens during infection.

Driscoll will be studying the proteins made by Borrelia during the black-legged ticks life cycle. “In vaccine development, what we try to do is identify those proteins and target them in hopes of clearing the pathogen out, killing it, essentially. If a protein is essential for survival, it makes it harder for the pathogen to change it and evade the immune system,” says Driscoll.

Barbier has studied bacterial pathogens, including Pseudomonas aeruginosa, which requires iron to grow and infect their host. “We figured out which antigens could be used to formulate a vaccine, and found the Achilles heel to the bacteria to use against it,” Barbier said. “We focused on one system, which is the iron acquisition system of Pseudomonas.”  Since Borrelia does not require iron, she is driven to find what would be required of Borrelia.

Barbier said. “If it doesn’t use iron, what else can we use against it? By bringing in the expertise of others, we’re going to crack the problem.”

Read more about the project here (eurekalert.org)

Click here for Project Info on NIH site

Read about another recent NIH-funded Lyme Vaccine study here