Each year, approximately 2 million children worldwide die from diarrhoea. A quarter of these are caused by rotavirus infections. Indian scientists have developed a live, oral Rotavirus Vaccine (ORV116E), which is being evaluated in a phase III trial partly funded by the Research Council of Norway (RCN). Live, oral vaccines often induce lower responses in children from low and middle-income countries. It has been suggested that this could be caused by several factors such as maternal antibodies in breast milk or with other intestinal infections.
In a randomised controlled trial we will therefore assess whether or not breast milk given with the vaccine reduces its immune response. We will also collect stool samples from all enrolled children and test these samples for other enteric viruses. Anti-rotavirus antibodies will be measured in maternal and child serum, saliva from the child and in breast milk. The proportion who seroconvert (defined by a four-fold increase in serum anti VP-6 antibodies from baseline to one month after the third vaccine dose) will be compared between children where breast milk is withheld and those who are encouraged to breast feed, as well as between those with and without other enteric virus infections at enrolment.
This project will be carried out in collaboration with the partners of the phase III project and we will use the Indian ORV 116E vaccine strain. The collaborative activities will further include a course in vaccinology to be held in India as well as joint supervision of postgraduate students from Norway and India. The Centre for Health Research and Development, Society for Applied Studies in New Delhi, India will lead the field work while the immunoassays and microbiological analyses will be undertaken at Christian Medical College in Vellore, India and the Norwegian Institute of Public Health in Oslo, Norway.
The clinical trial is expected to start in November 2011.