Hilleman Labs completes phase I/II clinical trials of its cholera & rotavirus vaccines

New Delhi: The Hilleman Laboratories, a joint-venture between Merck Sharp & Dohme (MSD) and the Wellcome Trust, has announced the successful completion of Phase I/II clinical trial of its oral vaccine against the deadly rotavirus disease. At the same time, the company has also successfully completed the Phase I/II clinical trials of its novel Oral Cholera Vaccine, Hillchol.

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

An easy to use and heat stable rotavirus vaccine

Sharing results of the study, Dr K  Zaman, Senior Scientist and Epidemiologist at ICDDR, Bangaldesh said, “Safety data have demonstrated that administration of easy-to-use Heat Stable Rotavirus Vaccine (HSRV) when 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. Based on the encouraging results obtained in this study, HSRV will be further evaluated in immunogenicity and safety studies in infants.

Talking about the accomplishment, Dr Davinder Gill, CEO Hilleman Laboratories said, “Rotavirus is the leading cause of severe diarrhoea and related deaths in children less than 5 years worldwide. 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 vaccine.”

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.

Cholera vaccine shows good results, holds promise to fulfil the gap

According to the WHO, Cholera is endemic in over 50 countries with 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 Hilleman Laboratories partnered with Gotovax AB of Sweden and Incepta Vaccines of Bangladesh for the development of an affordable Cholera vaccine. Clinical trial design and development was supported by the ICDDR, Bangaldesh.

Sharing results of the latest clinical study, Dr Ajit Pal Singh – Vice President Clinical R&D at Hilleman Labs stated, “Hillchol was tested in 840 subjects that included adults, adolescents as well as small children.  We were able to demonstrate safety and tolerability of Hillchol in our Phase I/II trials.  Our vaccine consists of a novel Hikojima strain that expresses both the Ogawa and Inaba serotypes.  When compared against Shanchol, the Cholera vaccine pre-qualified by WHO, we could achieve non-inferiority in terms of seroconversion as well as Geometric Mean Titre for both the Ogawa and Inaba serotypes.  These results are very encouraging and warrant further development of our Cholera vaccine.”

Dr Tarun Sharma, Director R&D at Hilleman Labs stated, “The Hillchol Phase I/II clinical trial results support our Hikojima vaccine design and mirror the impressive results we have been able to achieve in Preclinical studies.  This encourages us to conduct further clinical studies as well as undertake further research in our labs for additional innovations in next-generation Oral Cholera Vaccines”

Talking about the accomplishment, Dr Davinder Gill, CEO Hilleman Laboratories said, “There is an urgent need for effective and affordable Cholera vaccines for use in both 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 percent by the year 2030”.