Leishmanin Skin Test Reactivity a Long-Lasting Surrogate Marker of Exposure and Protection: Implications for Anti-Leishmania Vaccines’ Efficiency: Case Report

Khalil EAG; Younis BM; Saeed WSE; Elhassan AM; Musa AM

doi:10.58372/2835-6276.1414

Authors

Khalil EAG
Younis BM
Saeed WSE
Elhassan AM
Musa AM

DOI:

https://doi.org/10.58372/2835-6276.1414

Keywords:

Leishmanin Skin Test, surrogate markers of immunogenicity/protection, anti-leishmania vaccines

Abstract

The leishmaniases are major causes of morbidity and mortality worldwide. Few killed-Leishmania+adjuvant vaccines reached Phase III with variable immunogenicity/efficacy with considerable cost and procrastination. Efficient surrogate markers of immunogenicity/efficacy are lacking. The Leishmanin skin test (LST) is an in vivo test that indicates previous exposure and probable immunity. This study aims to introduce LST as a simple and long-lasting surrogate marker of exposure/protection against leishmania. This was a prospective longitudinal study that was conducted in two phases: Phase I (December 1997- December 2012), following informed consent, total population census for study villages, collection of demographic/clinical data and LST/DAT were conducted. A study cohort of 659 consenting, sequential and LST-reactive volunteers were enrolled. Fifteen years later, the majority (91.0%, 600/659) were re-recruited, interviewed examined and LST re-tested. In Phase II (Dec 2012- Dec 2022), volunteers were asked to continue reporting febrile illnesses till study conclusion. At the end of Phase I, the majority of the cohort volunteers (91.0%, 600/659) were alive and had a mean LST induration of 9.7±2.9 mm compared to 7.6 ±1.1 mm seen in 1997 (p>0.5). LST reactivity persisted and was consistent with some individuals showing scars from previous LST induration. Phase II, the majority of cohort volunteers (541/600, 90.2%) could be traced, interviewed and examined. No visceral leishmaniasis (VL) cases were reported, with 7.5% (50/659) of volunteers had febrile episodes during the study duration, investigations ruled-out VL. Currently, anti-leishmania vaccines seem the only promise to control leishmaniasis. "Current vaccines‘ immunogenicity/efficacy surrogate markers like leishmanization and Th¹ cytokines production tests" are expensive and are not field-friendly. LST on the other hand is simple, cheap, long-lasting and field-friendly that can be used as an immunogenicity/efficacy surrogate marker. LST reactivity persistence, probably due to continuous natural challenge or presence of memory cells. In this study visceral leishmaniasis cases were not reported among the study cohort during more than two decades of follow up. In conclusion, LST is a simple, cheap, long-lasting and consistent surrogate marker of exposure/immunity that can be used to circumvent vaccines’ efficacy studies.

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