Lyme Disease Vaccine Candidate Clinical Trials, Dosage, Side Effects
Lyme disease vaccine research includes early-stage discovery and novel vaccine formulations, including tick saliva-based approaches. In addition, the U.S. National Institutes of Health (NIH) published a Strategic Plan for Tickborne Disease Research that prioritizes vaccines needed to prevent diseases. As of October 2024, the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the United Kingdom have not approved a preventive Lyme disease vaccine. The only human Lyme disease vaccine marketed in the U.S. was LYMERix®, which was discontinued in 2002.
According to IMARC, the Lyme disease market reached a value of $594 million in 2023. Over the next decade, this market is expected to exceed $1 billion by 2034, exhibiting a growth rate of 6.45%.
Lyme Disease Vaccine Candidates 2024
VLA15, a multivalent Lyme Disease vaccine candidate produced by Pfizer Inc. and Valneva SE, targets Borrelia's outer surface protein A and conducts late-stage clinical trials.
Moderna Inc. is advancing a seven-valent approach with two Lyme disease vaccine candidates that will be developed in parallel. mRNA-1982 is designed to elicit antibodies specific for Borrelia burgdorferi, which causes almost all Lyme disease in the U.S. mRNA-1975 is designed to elicit antibodies specific for the four major Borrelia species causing disease in the U.S. and Europe.
TP-05 is a novel investigative oral therapeutic TP-05 for potentially preventing Lyme disease. TP-05 is an oral systemic formulation of lotilaner, a well-characterized anti-parasitic agent that selectively inhibits parasite-specific GABA-CI channels.
The National School of Tropical Medicine at Baylor College of Medicine and Texas Children's Hospital's Center for Vaccine Development received an $860,000 grant from the U.S. Department of Defense to develop a recombinant protein vaccine for Lyme disease. Under Award No, the Congressionally Director of Medical Research Programs supports this work through the DoD Tickborne Disease Research Program. W81XWH-20-1-0913.
Penn Medicine's Lyme disease vaccine candidate uses mRNA-LNP platform technology pioneered at Penn. After a single immunization, the OspA mRNA-LNP vaccine induced superior humoral and cell-mediated immune responses in mice. These potent immune responses resulted in protection against bacterial infection.
CyanVac's intranasal parainfluenza virus 5 (PIV5)-based vaccine for Lyme Disease was found in a study to induce protection against a multi-strain Borrelia burgdorferi tick challenge in mice. The Lyme disease project was a collaboration between CyanVac and Immuno Technologies, Inc. and was supported by the National Institute of Allergy and Infectious Disease.
Lyme Disease Diagnostics
Most tickborne infections are misdiagnosed because these nonspecific symptoms mirror other illnesses. In addition, there are several Borrelia sub-species and strains, and researchers continue to discover new species.
Lyme Disease Overview
According to the U.S. NIH, Borreliosis is an infectious disease caused by spiral-shaped bacteria known as Borreliae, often carried by ticks. The species of Borreliae known to cause disease in humans are split into the following two groups: B. burgdorferi sensu lato, which causes Lyme disease, and Relapsing Fever Borrelia, which causes Tickborne Relapsing Fever.
Lyme Disease Vaccine News
September 19, 2023 - The Tufts Lyme Disease Initiative recently received more than $7 million in grants.
May 31, 2023 - Rutgers University is one of 50 clinical trial sites for a Lyme disease vaccine candidate being tested on children in New Jersey and other parts of the U.S.
April 11, 2023 - Moderna Inc. confirmed mRNA-1982 and mRNA-1975, representing the Company's first application of its mRNA technology to bacterial pathogens.
December 15, 2022 - Tarsus Pharmaceuticals, Inc. announced positive topline results from the completed Phase 1b study and enrollments in the Phase 2a clinical trial.
December 23, 2021 - MassBiologic's Lyme PrEP (2217LS) has begun a phase 1 clinical trial to test for the safety of Lyme PrEP and to determine how long it lasts in the human bloodstream. Lyme PrEP uses a monoclonal antibody.
December 2, 2021 - Yale researchers are developing an mRNA vaccine against Lyme disease.
November 19, 2020 - The National School of Tropical Medicine at Baylor College of Medicine, along with Texas Children's Hospital's Center for Vaccine Development, has received an $860,000 grant from the Department of Defense to develop a recombinant protein vaccine for Lyme disease, the most common vector-borne disease in the general U.S. population and the U.S. military. In addition, Baylor researchers will partner with Lyme disease experts from the Wadsworth Center, New York State Department of Health.
