Hilleman Labs (HL) has been working on the development of vaccine technologies against some of the key causes of bacterial meningitis. Akanki Sharma speaks to Dr Manoj Kumar, Senior Director – R&D, Hilleman Laboratories to find out more details about the vaccine, the technology and science behind its development and how it would help tackle the significant disease burden posed by meningitis in India
How huge is the disease burden of meningitis in India?
Although meningococcal disease surveillance in India is not routine and data on endemic disease are lacking, the country is known to experience occasional outbreaks. The small amount of data suggests multiple meningococcal outbreaks in the 1980s in Delhi, Gujarat, Andhra Pradesh, Madhya Pradesh, and Orissa and more recently 2000’s outbreaks have occurred in Delhi and North Eastern states. The outbreaks showed a high fatality rate and with a high prevalence of meningococcal serogroup A. On an average between 3000-4000 annual cases with around 250-300 deaths have been reported due to meningococcal meningitis in India in recent years. Due to the lack of enough meningococcal epidemiological data in India, these numbers might be underestimates of the actual meningococcal disease burden.
Share a brief about the ongoing vaccine research at Hilleman Laboratories to combat meningitis
Meningitis is a disease of the central nervous system, more specifically inflammation of meninges, the coverings of the brain and spinal cord, which can affect people of any age group. There are several causes of meningitis which include viral and bacterial infections. Hilleman Labs (HL) has been working on the development of vaccine technologies against some of the key causes of bacterial meningitis, which include Neisseria meningitidis (Meningococcus), Haemophilus influenzae type B (Hib) and Group B streptococcus (GBS). We have completed pre-clinical studies of improved Hib conjugate vaccines and are working on the development of novel meningococcal conjugate vaccines. Besides this, we have also initiated work on the development of a GBS conjugate vaccine candidate. Our vaccine R&D portfolio covers bacterial meningitis to a great extent including causes of maternal and infant mortality.
What is the form and dosage of the vaccine you are working on? How will it enable better outcomes than the existing vaccines for meningitis?
Hilleman Labs is targeting the development of a liquid form of the meningococcal vaccine in a single container closure which will enable a reduction in cost and help easy administration of the vaccine as compared to most other meningococcal vaccines which are developed fully or partially based on lyophilization technology and require two container closures to be handled.
What are the challenges in developing a vaccine for meningitis?
Meningococcal conjugate vaccine development as with any other conjugate vaccine is quite complex which involves the production of different antigens (polysaccharides) and carrier proteins by multiple fermentations or organic synthesis in the synthetic approach, followed by their purification, conjugation and vaccine formulation. At each stage, the intent is to reduce the process losses and shorten the processing time. Finally, each batch of a multi-valent vaccine requires several analytical tests to confirm the quality of the vaccine. Finally, to develop a vaccine to be stable in liquid formulation requires significant experiments and defining the formulation combinations. The optimised formulation becomes further important when a component of the vaccine is known to be prone to degradation due to its chemical structure e.g. meningococcal serogroup A polysaccharide in this case.
What’s the cost incurred on this development? In addition, are you getting any financial aid for this vaccine?
Hilleman Labs is developing the technologies for manufacturing readiness which takes years of scientific research. Normally, vaccine development until the establishment of proof of concept ranges from $2-20 million or even more, based on the type of innovation/technology, ...
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