Shantha’s investigational rotavirus vaccine enters phase III clinical trials in India

The live, oral, ready-to-use tetravalent rotavirus vaccine candidate is designed to protect young children from severe diarrhoea

Sanofi Pasteur, the vaccines division of Sanofi, announced the start of a phase III clinical trial in India for its investigational rotavirus vaccine, developed and manufactured by its affiliate Shantha Biotechnics in Hyderabad. The trial is designed to show non-inferiority against a currently licensed vaccine with the use of three, ready-to-use liquid doses administered orally, starting from six-to-eight weeks of age, with the subsequent doses administered at four weeks intervals. Close to 1,200 volunteers are being sought at 12 clinical trial sites in India. Shantha’s investigational rotavirus vaccine includes antigens against serotypes G1, G2, G3 and G4.

A phase I/ II study was carried out with the long-term aim to produce a locally licensed vaccine that is safe and able to protect children against rotavirus gastroenteritis. Overall, the results showed that all three doses of the vaccine evaluated in the study were safe, well tolerated and displayed good immunogenicity (dose–response) in healthy Indian infants.1

Olivier Charmeil, President and Chief Executive Officer, Sanofi Pasteur, said, “We aim to provide an affordable vaccine to meet the still significant medical need in emerging markets.”

The World Health Organization (WHO) recommends that vaccination with rotavirus vaccines should be included in all national immunisation programmes.2 Gavi, has established an accelerated vaccine introduction initiative with the objective of driving the sustainable introduction of rotavirus vaccine in 30 Gavi-eligible countries by 2015.3 In addition, PATH, an international, non-profit organisation to improve public health, is working to accelerate access to rotavirus vaccines and sustain their implementation and use in countries where children need them most urgently.4

Rotavirus infections, caused mostly by Group A viruses, are prevalent in human populations worldwide. Although the virus can and does infect older individuals, illness caused by rotavirus can be quite severe in infants and young children. In low income countries, the median age at the primary rotavirus infection ranges from six to nine months (80 per cent occur among infants less than one year old) whereas in high income countries the first episode may occasionally be delayed until the age of two to five years, though the majority still occur in infancy (65 per cent occur among infants less than 1 year old).1

The WHO estimates that in 2008 approximately 453,000 (420,000–494,000) rotavirus gastroenteritis (RVGE)-associated child deaths occurred worldwide. These fatalities accounted for about five per cent of all child deaths and a cause-specific mortality rate of 86 deaths per 100,000 population aged less than five years. About 90 per cent of all rotavirus-associated fatalities occur in low income countries in Africa and Asia and are related to poor healthcare.

It is estimated that one of every 260 children born each year will die from diarrhoea caused by rotavirus infection by their fifth birthday.2 Recent studies indicate that rotavirus causes approximately 40 per cent of childhood diarrhoeal hospitalisations worldwide,3 40.7 per cent in Sub Saharan African countries, 4 33 per cent in Nepal, 5 34 per cent in Pakistan6 ,40–50 per cent in Japan,7 and around 39 per cent in India in children less than five years of age.8 India, with more than one billion people, 11 per cent of whom are less than five years of age, has an especially large population at risk of clinically significant RVGE.9

There is no specific drug approved to cure or ameliorate rotavirus gastroenteritis. Since virtually all infants and young children will suffer at least one rotavirus infection and many will become infected two or more times, even in settings where good hygiene is practiced, universal immunisation of infants with a vaccine is clearly the way to reduce rotavirus related morbidity, mortality, and associated medical costs.1


1. M.S. Dhingra et al. Evaluation of safety and immunogenicity of a live attenuated tetravalent (G1–G4) Bovine-Human Reassortant Rotavirus vaccine (BRV-TV) in healthy Indian adults and infants. Vaccine 32S (2014) A117–A123
2. Accessed 15 Sept 2014
3. Accessed 15 Sept 2014
4. Accessed 15 Sept 2014
5. WHO. Rotavirus vaccines. WHO position paper – January 2013. Wkly Epidemiol Rec 2013; 88:49–64.
6. Tate JE, Burton AH, Pinto CB, Steele AD, Duque J, Parashar UD, et al. 2008 estimate of worldwide rotavirus-associated mortality in children younger than 5years before the introduction of universal rotavirus vaccination programmes: a systematic review and meta-analysis. Lancet Infect Dis 2012; 12:136–41.
7. World Health Organization. Global networks for surveillance of rotavirus gastroenteritis, 2001-2008. Wkly Epidemiol Rec 2008; 83:421–5.
8. Mwenda JM, Tate JE, Parashar UD, Mihigo R, Agócs M, Serhan F, et al. African rotavirus surveillance network. A brief overview. Pediatr Infect Dis J2014; 33:S6–8.
9. Sherchand JB, Nakagomi O, Dove W, Nakagomi T, Yokoo M, Pandey BD, et al. Molecular epidemiology of rotavirus diarrhea among children aged less than 5 years in Nepal: predominance of emergent G12 strains during 2 years. JID2009; 2000(Suppl. 1):S182–7.
10. Alam MM, Khurshid A, Shaukat S, Naeema A, Sharifa S, Angeza M, et al. Epidemiology and genetic diversity of rotavirus strains in children with acute gastroenteritis in Lahore, Pakistan. PLoS ONE 2013; 8(6):e67998.
11. Kamiya H, Nakano T, Kamiya Hi, Yui A, Taniguchi K, Parashar U. Rotavirus associated acute gastroenteritis hospitalizations among Japanese children aged less than 5 years: active rotavirus surveillance in Mie Prefecture, Japan. Jpn J Infect Dis2011; 64:482–7.
12. Kang G, Arora R, Chitamber SD, Deshpande J, Gupte MD, Kulkarni M. Multicenter, hospital based surveillance of rotavirus disease and strains among Indian children aged less than 5 years. J Infect Dis 2009; 200 (Suppl. 1):S147–53.
13. Census of India. Govt. of India – Ministry of Home Affairs, Official web-site. Table C-10: population attending educational institution by age, sex, and type of educational institution (Census of India 2001); 2001.Available at: Published/C-Series/C-Series link/c10 india.pdf. Accessed 15 Sept 2014.

EP News BureauMumbai

Comments (0)
Add Comment