The National Institute of Allergy and Infectious Diseases (NIAID) has awarded Arlene Seña, MD, MPH, a member of the Institute for Global Health & Infectious Diseases and professor of infectious diseases, $1.9 million to initiate a longitudinal clinical study over 16 months that will advance diagnostic product development for syphilis, with the potential for additional funding over another 3 years.
The number of syphilis cases, especially congenital syphilis, has significantly increased nationally in the last five years, and there are no signs of slowing. Syphilis is an STI caused by the bacterial pathogen Treponema pallidum currently diagnosed by using a screening algorithm that involves multiple serum antibody tests, which have been used since the 1900s. However, these tests have well-known limitations, including the inability to reliably distinguish between current and past infections, and difficulty in determining cure after antibiotic administration. In the past few decades, modern molecular techniques such as nucleic acid amplification systems and platforms, transcriptomics, proteomics and metabolomics have been developed and successfully applied to diagnosis of infectious diseases. Yet, developers of potential syphilis diagnostics have little to no access to high-quality syphilis patient specimens for advancing product development.
“It is vital for clinicians to have better methods for diagnosing syphilis and determining response to treatment than our current tests,” said Seña, who is also co-project director of a cooperative research grant for a Treponema pallidum vaccine development initiative and a global clinical research consortium. “In this longitudinal study we will be obtaining specimens from syphilis patients from US and international sites, as well as abstracted clinical data, to fill a gap and facilitate efforts towards improving syphilis diagnostics.”
The multisite clinical study will enroll untreated patients who are suspected of having primary, secondary, or early latent syphilis, as well as a subset of patients with a serofast status, a persistent non-treponemal serological response. The subjects will be followed over time and are anticipated to have a range of treatment outcomes, including recovery, serofast, and failure.
After a primary infection, appearing as painless genital ulcers, syphilis can spread to a rash, swollen lymph nodes, hair loss, or even hepatitis. Most symptoms can be nonspecific, and may not be recognized as syphilis by patients and healthcare providers.After these initial stages, there is a period of latency with no symptoms. Eventually, the infection will present as neurosyphilis, affecting the cerebrospinal nervous system (CNS). At its most severe, syphilis at these stages can affect the cardiovascular system.