Photo By Tommy Lamkin | BETHESDA, Md. (Nov. 21, 2024) Naval Medical Research Command (NMRC)’s Clinical...... read more read more
BETHESDA, Md. – Naval Medical Research Command (NMRC)’s Clinical Trials Center (CTC) is seeking volunteers to participate in a phase 1 clinical trial for a vaccine aimed at reducing frequency and severity of infections caused by Staphylococcus aureus bacteria, a leading cause of skin and soft tissue infections.
The study, beginning in December and funded by LimmaTech Biologics, is seeking 129 participants to help evaluate the safety of the vaccine, called LTB-SA7. Participants will receive two injections, four weeks apart.
According to the Center for Disease Control, Staphylococcus aureus (staph) is a type of germ that about 30% of people carry on their skin or in their noses. In some cases, staph can cause infections, which can lead to serious or fatal outcomes. Staph can cause serious infections with significant morbidity that includes pain, scarring and time lost from school and work.
Staph is a leading cause of skin and soft tissue infections in U.S. military populations, and a leading pathogen of concern, due to the antimicrobial resistance of Methicillin-resistant Staphylococcus aureus.
“Between January 2016 and September 2020, over 200,000 cases of skin and soft tissue infections affected 174,893 service members,” said Lt. Cmdr. Jaqueline Clerk, deputy director of the CTC. “Our junior service members are the ones most likely to be affected and are at highest risk of infection during training and deployments. A safe and effect vaccine to reduce the burden of Staph infections would significantly improve the lives of service members and reduce the amount of antibiotics used.”
The LTB-SA7 vaccine consists of five components, including seven toxoids. The use of inactive toxins, or toxoids, allows for the controlled introduction of products that will trigger an immune response without causing the toxin-induced disease. The toxoids in the LTB-SA7 are from three families of staphylococcal toxins.
“First-in-human clinical trials provide the first look at how a product will act in people,” said the CTC's Dr. Chad Porter. “They also represent the first step in a long clinical development process. It is exciting to be a part of the earliest clinical evaluation for a product that could have such significant benefit for the military and other populations.”
The CTC study is open to the public for all healthy people between the ages of 18 and 50 years. Participants must have a body mass index (BMI) between 19-35 and be able to complete at least seven in-person visits over one year. Active-duty personnel must complete a supervisor’s approval form as part of the study. Participants may be eligible for compensation.
NMRC CTC is located at Naval Support Activity Bethesda, Building 17B (2nd floor). If you would like to participate or have any questions, please contact the center at 301-295-4735 (call) or 301-233-9640 (text), or via e-mail at usn.nmrc.ctc@health.mil to schedule an appointment.
The NMRC CTC evaluates vaccines, therapeutics, prophylactics in human subjects to advance products from the laboratory to the front line and maximize the medical readiness of the warfighter. NMRC is engaged in a broad spectrum of activities, from basic science in the laboratory to field studies in austere and remote areas of the world to investigations in operational environments. In support of the Navy, Marine Corps and joint U.S. warfighters, researchers study infectious diseases, biological warfare detection and defense, combat casualty care, environmental health concerns, aerospace and undersea medicine, medical modeling, simulation, operational mission support, epidemiology and behavioral sciences.
| Date Taken: | 12.17.2024 |
| Date Posted: | 12.17.2024 15:25 |
| Story ID: | 487730 |
| Location: | BETHESDA, MARYLAND, US |
| Web Views: | 94 |
| Downloads: | 0 |
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