With our heat-stable rotavirus vaccine, we aim to support the govt’s efforts to reduce child mortality

Hilleman Laboratories has recently initiated phase I/ II clinical trials for both rotavirus and cholera vaccines in Bangladesh. Dr Davinder Gill, Chief Executive Officer, Hilleman Laboratories in an interaction with Usha Sharma, provides details on the progress of the trials and what it has in store for the Indian market

Recently, Hilleman Laboratories formed a JV with MSD and Wellcome Trust to initiate two vaccines into the clinical trial stage. Tell us more about these leads and their relevance to the Indian market.

Hilleman Laboratories is a global vaccine research and development organisation focused on making affordable vaccines using innovation to address gaps that exist in low resource settings. Hilleman Labs received approvals to conduct phase I/ II clinical trials for both rotavirus and cholera vaccines from all relevant approval authorities in Bangladesh. The trials were conducted in collaboration with Bangladesh-based International Centre for Diarrhoeal Diseases (ICDDR, B) and will establish the safety and immunogenicity of the vaccines in infants and adults to decrease the child mortality both in Indian and regional markets. For our cholera vaccine, we have partnered with Gotovax AB of Sweden and with Incepta Vaccines, Bangladesh. Our rotavirus vaccine is a collaboration with MSD.

The company has already obtained regulatory clearances for the pre-clinical stage, what’s the progress on both the studies

After conducting pre-clinical studies, we have now initiated clinical studies in Bangladesh. Both the studies will complete enrolment and follow-up of study participants by Q4 2016. Final study report will be submitted to regulators and ethical bodies by Q1 2017.

How many healthy volunteers have you enrolled for individual studies and how soon do you intend to enter into phase II clinical trials?

Since both the vaccine formulations of Hilleman laboratories are being tested for the first time in human subjects, the studies have staggered enrolment of adult participants, followed by adolescents and infants. Rotavirus study will enrol 100 healthy subjects whereas cholera vaccine will have 840 subjects. After successful completion of the above pilot studies, we will initiate phase IIb pivotal studies by Q2 2017, for both vaccines.

Tell us about the objective behind conducting a clinical study on a rotavirus vaccine candidate in India?

Our rotavirus vaccine is a heat stable vaccine. We are presently conducting our clinical trials in Bangladesh. If proven safe and immunogenic, the vaccine could be brought to India as early as 2020 to help bridging the gap in vaccine delivery caused by high dependence on cold chain systems for preservation in India. This vaccine can withstand extreme climates.

How will the new vaccine help the government reduce child mortality?

Hilleman Labs is focussed on the diarrhoeal diseases which are major cause of hospitalisations and child deaths globally. Together, they account for approximately one in six deaths among children younger than five years. Of India’s more than 2.3 million annual deaths among children, about 334000 are attributable to diarrhoeal diseases. Rotavirus is the leading cause of severe diarrhoea in children in developed and developing countries. Introduction of these vaccines is expected to reduce child mortality by decreasing the incidence of severe diarrhoea and the frequency of death from diarrhoeal disease. The Indian Government’s efforts to reduce child mortality by including rotavirus vaccines under the UIP is highly appreciated. However, success of the vaccine is highly dependent on cold chain process and delivery system. With our heat-stable rotavirus vaccine, we aim to further support the government’s efforts of expanding coverage and reducing child mortality.

India lags in supply chain maintenance and vaccines need high end supply chain systems, how are you going to ensure it? Are you working with the government on this front?

At Hilleman Labs, we have developed rotavirus vaccine heat/ thermostable which can sustain higher temperature for longer duration of time. With this technology of heat stability, we can overcome the problem of cold chain. We will be delighted to work with and support the efforts of the government.

How much do you plan to invest in different phases of clinical trials? When do you plan to launch the vaccines in the Indian market?

We have just entered into the clinical phase of trials and it’s too early to comment on the investment in different phases. Hilleman could seek licensure based on the non-inferiority date for its rotavirus vaccine within the four year timelines as it is a heat stable formulation of an exciting vaccine. While on one hand, our heat-stable technology will offer longer stability to the rotavirus vaccine in extreme climates, the next-generation oral cholera vaccine will be affordable and easy to administer.

How do you plan to overcome regulatory hurdles in India?

We are working along with the government and will be focussing on meeting all regulatory requirements in India.

Which are your other research molecules, and in which stages of development? When are they likely to hit the market?

We are presently working on Meningococcal and ETEC vaccine. We have initiated the processes and it’s too early to comment on its availability in the market.

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