Nasal H1N1 vaccine human trials to start next week
January 9, 2010
The long wait for an effective vaccine to fight Swine flu in the country could be over in a few months, if the intra-nasal spray made by Serum Institute of India (SII) here is tested successfully on humans next week, reports PTI.
After a clearance from the Drug Controller General of India (DCGI), the institute, which has already submitted a report on toxicity and tolerance of the vaccine in animal trials, is now in the process of identifying 50 'completely healthy' adults to undertake Phase- I human clinical trials in Pune, Delhi and Ahmedabad, according to Dr Rajiv Dhere, director, SII.
"We are on the right track, as the animal trials have been found to be totally safe," Dr Prasad Kulkarni, in charge of the human clinical trials of the vaccine, told PTI in Pune.
Apart from its potential wide sphere of application, the development assumes significance for about 40 lakh people in Pune, which has emerged as the epicentre of the pandemic in India after registering first fatality from the H1N1 virus on 3 August 2009.
Since then, the Swine flu toll in Pune has risen to 160, in a relentless spread of the infection during the past five months.
Explaining the procedure of human clinical trials starting next week, Dr Kulkarni said the healthy volunteers would be kept under observation for a minimum of three hours after being given the intra-nasal spray to note any possible reactions.
"After completion of this observation, he would be sent home and asked to register—either write down or communicate with us—his own observations in the next eight days," he added.
Asked to define the period needed to determine the safety of the vaccine, Dr Kulkarni said while it could vary for different individuals, the minimum period is one week.
After the spray is successfully tested on healthy individuals, the trial would be expanded to cover the general population, including children and aged people. The follow-up could take a few weeks.
Dr Kulkarni said the SII was confident of the safety aspect, as the nasal spray has been successfully used in America and Russia.
How does it act against the deadly H1N1 virus? Dr Kulkarni said when the vaccine is spread in the nose, it creates antibodies in the nasal cavity within a week's time. "Later, the antibodies are developed in the blood within two weeks," giving immunity from the virus.
The SII is also simultaneously working on the injective variety of the H1N1 vaccine.
Meanwhile, health officials and National Institute of Virology (NIV) sources said that the Swine flu virus has not mutated significantly to offer resistance to Tamiflu medication which, at present, remains the only successful line of treatment, if started at an early stage of the infection.