Preclinical evaluation of performance, safety and usability of VAX-ID®, a novel intradermal injection device.

The recent SARS-Cov2 pandemic and mpox health emergency have led to renewed interest in intradermal vaccination due to its dose sparing potential. Indeed, intradermal vaccination is particularly of interest for use in mass vaccination campaigns, pandemic preparedness programs, and/or for vaccines that are expensive or in short supply. Moreover, the rich immune network in the skin makes it an attractive target not only for prophylactic vaccination, but also for therapeutic vaccination, like immunotherapy and (dendritic) cell-based therapies. The aim of the current paper was to provide an overview of preclinical data generated with VAX-ID®, a novel intradermal drug delivery device, to allow assessing it performance, safety and usability. The device can overcome challenges seen with the Mantoux technique whereby the needle needs to be inserted under a shallow angle. Various parameters of VAX-ID® were evaluated, including dead-space volume, dose accuracy, penetration depth & liquid deposit in piglets, as well as usability by healthcare professionals. The device has shown to have a low dead volume and a high dose accuracy. Importantly, the device performed successful injections at a predefined depth into the dermis with a high safety profile as confirmed by visual and histological evaluation in piglets. Moreover, the device was rated as easy to use by healthcare professionals. The combined preclinical performance and usability findings indicate that VAX-ID® can provide reliable, standardized and accurate drug delivery in the dermal layer of the skin with a high ease of use. The device offers a solution for injection of various prophylactic as well as therapeutic vaccines.

Vitamin B12 Deficiency Among the Healthy Jordanian Adult Population: Diagnostic Levels, Symptomology and Risk Factors.

BACKGROUND: Compared to the data available for developed countries, there is a marked scarcity of information on the levels and symptomology of vitamin B12 deficiency in developing countries, particularly in the Middle Eastern region. OBJECTIVE: To explore (a) the risk factors associated with a deficiency of vitamin B12, and (b) the baseline (cut-off) serum level of vitamin B12 for a clinically-symptomatic deficiency in the Jordanian adult population. METHODS: A total of 485 subjects were included in this study. Blood samples were drawn for biochemical analysis and data regarding socio-demographics, general health, anthropometric measures, and past medical, surgical, and medication history were collected. To explore the cut-off point, we compared all parameters included in a standard complete blood count as well as the main symptoms reported to be associated with B12 deficiency between groups of different B12 cut-off values, consisting of those above and below 200, 175, 150 and 125 pg/ml. RESULTS: Low dairy intake habits, age, recurrent headaches, heartburn, and peptic ulcer disease were found to be significantly associated with lower vitamin B12 levels. Surprisingly, daily smoking was associated with significantly higher B12 levels. The results revealed that none of the included potential indicators of B12 deficiency could be considered an indicative feature of deficiency. There were no significant differences neither in the symptoms nor in the CBC parameters between any of the tested study groups. CONCLUSION: Low dairy intake, older ages, recurrent headaches, heartburn, and peptic ulcer disease all could be considered as risk factors of having low vitamin B12 levels within the Jordanians. Also, they tend to have lower levels of vitamin B12 levels, in comparison to countries in the West, without necessarily having deficiency symptoms. The cut-off value to diagnose functional B12 deficiency could be less than 125 pg/ml for the Jordanians. More local studies are needed to establish an accurate vitamin B12 cut-off value for the population in Jordan.