Phase
III trial of anti-diarrhoea drug was carried out in six sites in India
A rotavirus vaccine tested on children during a Phase III trial
has been found to be safe and efficacious.
The vaccine (ROTASIL) manufactured by the Pune-based Serum
Institute of India has nearly 39% efficacy in children with severe rotavirus
cases and nearly 55% against the very severe form of rotavirus diarrhoea.
The vaccine targets all the five rotavirus serotypes.
In 2013, an estimated 47,000 rotavirus deaths occurred in India.
India accounted for 22% of all rotavirus deaths in the world.
The Phase III trial was carried out at six sites in India.
Three doses of the vaccine were given at 6, 10, and 14 weeks of
age to 3,749 infants, while another group of 3,751 children was given a dummy.
Children were randomly assigned to receive either the vaccine or
the dummy and neither the children and their parents nor those involved in
vaccinating the children were aware who was receiving the vaccine and who was
receiving the dummy.
The trial followed the vaccinated children till they turned two
to study the safety of the vaccine. The results were published in the journal Vaccine .
Three doses
The three doses of the vaccine were given at 6, 10, and 14 weeks
to coincide with the routine vaccination under India’s universal immunisation
programme.
The vaccine used is a mixture (reassortment) of bovine and human
rotavirus.
“We took five numbers of the single bovine rotavirus serotype
and added one gene from each of the five human rotavirus serotypes to the
bovine serotype. The bovine serotype acted as a backbone while the gene from
the human rotavirus conferred protection.
“The bovine serotype does not cause diarrhoea in children. But
as the bovine serotype carried the human antigen (gene) it helps the human body
to develop antibodies against all the five human rotavirus serotypes,” says Dr.
Prasad S. Kulkarni, Medical Director at Serum Institute, Pune.
Bharat Biotech launched a human rotavirus vaccine in 2015.
Unlike the Serum Institue vaccine, the one introduced by Bharat
Biotech contains only one serotype. Even the rotavirus from GSK is a monovalent
vaccine, while Merck’s vaccine contains all the five human rotavirus serotypes.
The international NGO PATH partnered with Serum Institute on
evaluating the vaccine in the Phase III trial.
It helps the body to develop antibodies against all 5
human rotavirus serotypes
Source: THE HINDU-28th September,2017
