11 May 2010
By Anuradha Mascarenhas
Two Thousand children have been involved in a WHO project at KEM Hospital to develop an intra–nasal vaccine that can be administered through a nebulizer.
After the success of the Phase 1 clinical trial, Serum Institute of India Limited and National Institute of Virology (NIV) are working on the trial that hopes to fetch results ahead of the dry measles powder vaccine. “This is a liquid vaccine which is administered via the intra–nasal route,” said Dr A C Mishra, Director of NIV. “We had good results in Phase 1 of the clinical trials at Pune, Kolkata and Chennai,” he said.
Dr Ashish Bawdekar, principal investigator of the trial, said 20 adults, 20 adolescents and 20 children were involved in Phase 1. “After the success, we decided on a larger group and 2,000 children were recruited and administered the liquid vaccine via an inhaler device spray. The follow–up will be done for a year and results will be available by next year. The regular measles vaccine is dissolved and aerosolized. The trial is under way to find out if it can lead to immunisation.” What has given Serum Institute of India Limited hope is that the immunogenicity results are good within three months of the vaccination. “Data on how good the antibodies are among the children after the vaccine was administered are being analysed and will be submitted to the Drug Controller and General of India (DCGI),” said Dr S V Kapre, executive director of Serum Institute.
“The aim is to do away with injectible vaccines,” Bawdekar said. Five hundred children die of measles every day. Vaccine coverage against measles in the country is as low as 66 per cent, even below 50 per cent in some states. Hence the hunt for a painless, non–injectible vaccine, Mishra said.
Within a month, the Serum Institute will also launch human clinical trials of the dry powder vaccine, delivered straight into the child’s lungs by inhalation. The inhalable vaccine has been created by Robert Sievers of University of Colorado.