In an exploration of the natural history of post-kala-azar dermal leishmaniasis (PKDL), 134 residents of Sudan who had recently been diagnosed as cases of the disease were investigated. In each case, diagnosis had been based on clinical criteria, the temporal relationship between the rash and the treatment of visceral leishmaniasis (VL), positive results in direct agglutination tests (DAT) and/or leishmanin skin tests (LST), and the exclusion of other skin conditions. The mean (S.D.) age of the subjects was 6.4 (3.0) years. Although PKDL appeared commonest among those aged 4-8 years (P < 0.05), it was most severe in children aged

Post-kala-azar dermal leishmaniasis (PKDL) is a chronic, stigmatizing skin condition occurring frequently after apparent clinical cure from visceral leishmaniasis. Given an urgent need for new treatments, we conducted a phase IIa safety and immunogenicity trial of ChAd63-KH vaccine in Sudanese patients with persistent PKDL. LEISH2a (ClinicalTrials.gov: NCT02894008) was an open-label three-phase clinical trial involving sixteen adult and eight adolescent patients with persistent PKDL (median duration, 30 months; range, 6-180 months). Patients received a single intramuscular vaccination of 1 Â 10 10 viral particles (v.p.; adults only) or 7.5 Â 10 10 v.p. (adults and adolescents), with primary (safety) and secondary (clinical response and immunogenicity) endpoints evaluated over 42-120 days follow-up. AmBisome was provided to patients with significant remaining disease at their last visit. ChAd63-KH vaccine showed minimal adverse reactions in PKDL patients and induced potent innate and cell-mediated immune responses measured by whole-blood transcriptomics and ELISpot. 7/23 patients (30.4%) monitored to study completion showed >90% clinical improvement, and 5/23 (21.7%) showed partial improvement. A logistic regression model applied to blood transcriptomic data identified immune modules predictive of patients with >90% clinical improvement. A randomized controlled trial to determine whether these clinical responses were vaccine-related and whether ChAd63-KH vaccine has clinical utility is underway.

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Diabetic peripheral neuropathy (DPN) involves sensory and motor nerves, resulting in demyelination as well as axonal degeneration. This study was conducted to describe the pattern of lower limb nerve involvement in children with type 1 diabetes mellitus (DM) based on the parameters of nerve conduction study (NCS). This cross-sectional study recruited 50 children with type 1 DM having mean disease duration of 4.92±3.84 years who attended the referred clinic in Sudan Childhood Diabetes Center. Their mean age was 15.00±2.19 years, 42% were males, and 58% were females. Twenty six matched healthy control subjects were involved; their mean age was 13.88±2.46 years, 38.46% were males, and 61.54% were females. Bilateral NCS of the sensory and motor lower limb nerves was performed using Medelec Synergy machine. Interpretation of the patients’ results was based on our own control reference values. Data was analysed using IBM SPSS statistics. Out of the 50 diabetic patients, 44 (88%) had electrophysiological evidence of peripheral neuropathy (abnormalities in at least two of the electrophysiological parameters). The majority (68.2%) had motor involvement and 31.8% had sensorimotor, while none of them (0%) had pure sensory involvement. Regarding abnormal NCS parameters (conduction velocity vs. amplitude of the compound action potential), conduction slowing feature predominated in 61.4% and only few (6.8%) showed amplitude reduction, while 31.8% showed mixed features. The most frequently affected nerve was the common peroneal, followed by posterior tibial, and the least was the sural nerve. The most sensitive parameter was the common peroneal conduction velocity. Motor precedes sensory nerve involvement. The most frequent neurophysiological abnormality was the conduction slowing, and the common peroneal was the most vulnerable nerve. These findings signify generation of a protocol for early screening of neuropathy in children with type 1 diabetes.