NovaDigm Therapeutics said today it has been awarded $6 million by the U.S. Department of Defense (DoD) to study its lead candidate, the vaccine NDV-3A, in military personnel at high risk for skin and soft tissue infections (SSTIs) due to Staphylococcus aureus, including methicillin-resistant S. aureus (MRSA).
NovaDigm said it will collaborate with the Uniformed Services University of the Health Sciences (USU) on a Phase IIa study assessing NDV-3A among U.S. Army Infantry trainees at Fort Benning, GA. The study will enroll 420 trainees in an individually randomized, double-blind, placebo-controlled clinical trial to assess the vaccine’s safety, immunogenicity, and efficacy in reducing nasal/oral acquisition of S. aureus.
“We have had a long and fruitful collaboration with the DoD for the development of NDV-3A to prevent S. aureus infections. This Phase IIa study is the culmination of these efforts and represents a new approach to preventing community infections in high-risk populations,” NovaDigm CEO Timothy Cooke, Ph.D., said in a statement.
According to the company, earlier studies have shown that about one-third of trainees are nasally colonized with S. aureus at entry, while approximately two-thirds are colonized by the completion of their 14-week training period.
Research has linked military training environments to several factors that may enhance transmission and colonization of S. aureus, including crowding and limited access to hygiene during field training.
A 2002 study of 22 of 206 (10.7%) of U.S. military trainees in San Diego who became infected with MRSA associated several other variables with infection—such as antibiotic use within the 12 months prior to training, dietary supplement use prior to training, having a roommate in training with a prior skin infection, having a family member or friend who worked in a healthcare setting, and having a parent or member of the household who smoked during the trainee's childhood.
“The unique requirements of military training make this population especially susceptible to SSTIs. SSTIs cause discomfort and can result in hospitalization impairing the recruits' successful completion of training,” added Army Col. Michael Kozar, director of the Military Infectious Diseases Research Program at the U.S. Army Medical Research and Materiel Command, Fort Detrick, MD. “This study is an important first step to determine if a vaccine can prevent or reduce infections caused by S. aureus and MRSA.”
NDV-3A is being developed as an immunotherapy and as a preventative vaccine for infections caused by several species of the fungus Candida, including Candida albicans, and the bacterium S. aureus, including MRSA.
According to NovaDigm, NDV-3A is the first vaccine to have shown preclinical efficacy in reducing the severity of disease caused by both fungal and bacterial pathogens—including effectiveness in reducing the impact of bloodstream and skin infections caused by S. aureus.
The NDV-3A development program has been based on research in the laboratories of NovaDigm’s scientific founders at the Los Angeles BioMedical Research Institute at Harbor–UCLA Medical Center. The work was supported in part by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) (grant numbers AI19990, AI063382, and AI071554) and by the Department of the Army (award numbers JW81XWH-10-2-0035, W81XWH-11-1-0686, and W81XWH-16-C-0125).