The development of a cost-effective and stable single-administration vaccine (SAV) formulation to achieve vaccination regimen reduction

Vaccination has greatly reduced the burden of infectious diseases worldwide. However, many vaccines e.g. for DTP and Polio require repeated administration over months to achieve effective immunity. Consequently, children especially in developing countries and in rural areas often do not receive their booster immunisations. This issue can be addressed through single-administration vaccine (SAV) formulations which provide the repeated administrations automatically. An injectable vaccine formulation can be designed to release pulses of vaccine antigen to the immune system 1-6 months post injection. Such formulation will mimic antigen multiple dosing without requirement of patient return for booster immunisations. This can lead to better patient compliance due to less injections, potentially improved immunogenicity, and significant cost-savings to immunisation programmes through dispensing smaller number of doses and reduced logistical burden.

A smart particle delivery system capable of pulsatile vaccine release i.e. single dose with multiple pulses over 1-6 months (rather than weeks) will be developed at Aston University in partnership with ENESI Pharma. Particle fabrication methods such as spray drying will be used during the project to develop vaccine formulations with superior shelf-stability and controlled release kinetics. It is anticipated that the new formulation will tackle the key challenges of SAVs e.g. poor stability, low antigen loading, complex manufacturing process and poor in vivo performance. It will also be developed on a cost-effective and scalable manufacturing platform. The formulated vaccine particles will then be incorporated into ENESI’s solid dose delivery platform ImplaVax® which is an innovative needle-free technology.

The PhD studentship is funded through the Midlands Integrative Biosciences Training Partnership (MIBTP). This is a BBSRC-funded CASE (Industrial Collaboration PhD) studentship which is designed to provide students with a first-rate challenging research training experience within the context of a mutually-beneficial research collaboration between academic and non-academic partner organisations. The collaboration between Aston University and ENESI Pharma will provide numerous multidisciplinary training opportunities for the PhD candidate. This includes training on processing of biologics and vaccines using spray drying, particle engineering to produce controlled-release systems, on novel delivery devices and bioscience analytical methods for vaccines such as ELISA, on thermal techniques and stability assessment protocols. Furthermore, the successful candidate is expected to spend several months spread out throughout the studentship at ENESI’s ISO-accredited labs, thus exposes them to real-life experience of working in an industrial environment under a specific regulatory framework. The PhD candidate needs to be open to frequent travel between Aston University and ENESI when required. The student will be provided with accommodation and travel/food expenses during placements at ENESI.

The project provides a unique opportunity for a graduate with drug delivery or related biosciences background to work on a multidisciplinary project spanning research areas such as vaccine delivery, nano-microparticle fabrication, and immunology-bioanalytical method development. The successful candidate will also experience the commercial development of vaccines through placements at ENESI.