The Hilleman Laboratories, which is a joint-venture between Merck Sharp & Dohme (MSD) and the Wellcome Trust. The Hilleman Laboratories has been named after renowned scientist and father of modern vaccines - Dr. Maurice Hilleman. His dedication to making a difference through the practical application of vaccine research and delivering vaccines to people in need, forms the core mission of Hilleman Laboratories.

On October 12, 2017, the Laboratories has announced the successful completion of Phase I/II clinical trial of its two vaccines: Heat Stable Rotavirus Vaccine (HSRV) oral vaccine against the deadly Rotavirus disease and its novel Oral Cholera Vaccine HillcholTM.

The clinical trials were conducted in partnership with the International Centre for Diarrhoeal Disease Research (ICDDR), Bangladesh. The results of these clinical trials were presented at the Vaccines for Enteric Disease Conference 2017, held in Albufeira, Portugal.

Oral Cholera Vaccine Hillchol:

HillcholTM was tested on 840 subjects that included adults, adolescents as well as small children to assess safety and tolerability. The HillcholTM vaccine consists of a novel Hikojima strain that expresses both the Ogawa and Inaba serotypes, and also replaces three virulent O1 strains inactivated by two different processes used in currently licensed vaccines.

According to the WHO, Cholera is endemic in over 50 countries with an estimated mortality of 100,000 - 120,000 deaths annually, and a morbidity of 3.8 - 4.4 million annual cases attributed to this disease. Cholera vaccine production is low, with demands currently exceeding supply. In 2014, the Hilleman Laboratories partnered with Gotovax AB of Sweden and Incepta Vaccines of Bangladesh for the development of an affordable Cholera vaccine9. Speaking on the results Dr. Tarun Sharma, Director R&D at Hilleman Labs said,"The Hillchol" Phase I/II clinical trial results support the Hikojima vaccine design and mirrors the impressive results achieved in preclinical studies. This encourages conducting further clinical studies as well as undertaking further research in for additional innovations in next-generation Oral Cholera Vaccines"

Dr Davinder Gill, CEO Hilleman Laboratories said, "There is an urgent need for effective and affordable Cholera vaccines for use both during Cholera outbreaks and in mass vaccination campaigns. Currently, WHO recommends Oral Cholera Vaccines for humanitarian crises and in outbreaks. With the advancement of Hillchol", we hope to make available to the global health community, an affordable vaccine for mass vaccination in hotspots against Cholera-endemic countries. This will greatly assist in the global initiative recently announced by WHO to reduce Cholera deaths by 90% by the year 2030".

Heat Stable Rotavirus Vaccine (HSRV):

HSRV study has demonstrated safety profile when administered and compared with placebo, did not result in an increased reporting of solicited AEs in the adult cohort. In infants, when administered as 3-dose primary series, HSRV had a safety profile similar to RotaTeq in terms of frequency, severity, and causality of solicited adverse effect. Immunogenicity assessment was found to be comparable between the HSRV and RotaTeq in infants.

The percentage of infants exhibiting a 3-fold rise in serum anti-rotavirus IgA at 1 month post-dose 3 administration from baseline in HSRV group was 88%. The percentage of infants who had a similar increase in the RotaTeq group was 84%. In addition, HSRV elicited comparable Geometric Mean Titre relative to RotaTeq, 1 month after completion of 3-dose vaccination schedule.

After successful completion of the preclinical animal studies and obtaining regulatory clearance for human studies, Hilleman Laboratories had initiated a clinical study in April 2016, to establish proof-of-concept for its heat stable Rotavirus vaccine. The vaccine is aimed at allowing greater temperature stability and less reliance on exact storage timing and refrigeration.

Dr Davinder Gill, CEO Hilleman Laboratories said, "Worldwide, Rotavirus is the leading cause of severe diarrhoea and related deaths in children less than 5 years of age. First-generation Rotavirus vaccines possess thermostability profiles that may not meet storage requirements in developing countries, highlighting the need for heat stable vaccines. Considering the urgent need for effective and affordable Rotavirus vaccines, we would like to accelerate development of our simplified, easy-to-use, heat stable vaccine10."

Footnote

9 http://www.hillemanlabs.org/news-details.aspx?mpgid=31&pgid=32&nid=51

10 http://www.hillemanlabs.org/news-details.aspx?mpgid=31&pgid=32&nid=52

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