1. Investigation of syphilis immunology and Treponema pallidum subsp. pallidum biology to improve clinical management and design a broadly protective vaccine: study protocol
- Author
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Osias, Ethan, Hung, Phoebe, Giacani, Lorenzo, Stafylis, Chrysovalantis, Konda, Kelika A, Vargas, Silver K, Reyes-Díaz, E Michael, Comulada, W Scott, Haake, David A, Haynes, Austin M, Caceres, Carlos F, and Klausner, Jeffrey D
- Subjects
Sexually Transmitted Infections ,Vaccine Related ,Pediatric ,HIV/AIDS ,Clinical Research ,Infectious Diseases ,Infant Mortality ,Immunization ,Rare Diseases ,Perinatal Period - Conditions Originating in Perinatal Period ,Aetiology ,2.1 Biological and endogenous factors ,Infection ,Good Health and Well Being ,Antigens ,Bacterial ,Bacterial Vaccines ,Base Sequence ,Cohort Studies ,Cytokines ,DNA ,Bacterial ,Follow-Up Studies ,Humans ,Molecular Typing ,Peru ,Syphilis ,Treponema pallidum ,Vaccination ,Cytokine profiling ,Molecular typing ,Vaccine development ,Microbiology ,Clinical Sciences ,Medical Microbiology - Abstract
BackgroundThe syphilis epidemic continues to cause substantial morbidity and mortality worldwide, particularly in low- and middle-income countries, despite several recent disease control initiatives. Though our understanding of the pathogenesis of this disease and the biology of the syphilis agent, Treponema pallidum subsp. pallidum has improved over the last two decades, further research is necessary to improve clinical diagnosis and disease management protocols. Additionally, such research efforts could contribute to the identification of possible targets for the development of an effective vaccine to stem syphilis spread.MethodsThis study will recruit two cohorts of participants with active syphilis infection, one with de novo infection, one with repeat infection. Whole blood specimens will be collected from each study participant at baseline, 4, 12, 24, 36, and 48 weeks, to track specific markers of their immunological response, as well as to compare humoral reactivity to Treponema pallidum antigens between the two groups. Additionally, we will use serum specimens to look for unique cytokine patterns in participants with early syphilis. Oral and blood samples, as well as samples from any syphilitic lesions present, will also be collected to sequence any Treponema pallidum DNA found.DiscussionBy furthering our understanding of syphilis pathogenesis and human host immune response to Treponema pallidum, we will provide important data that will help in development of new point-of-care tests that could better identify active infection, leading to improved syphilis diagnosis and management. Findings could also contribute to vaccine development efforts.
- Published
- 2020