Pune: 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.
After a clearance from 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 totally safe," Prasad Kulkarni, in charge of the Human clinical trials of the vaccine, told a news agency here.
Apart from its potential wide sphere of application, the development assumes significance for about 40 lakh population of the city which of late has emerged as epicentre of the pandemic in India, registering first fatality of the H1N1 virus on August 3 last year.
Since then the swine flu toll here has galloped to 160 as of today.
Explaining the procedure of human clinical trials
starting next week, Kulkarni said the healthy volunteer would
be kept under observation for a minimum 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 safety
of the vaccine, Dr Kulkarni said while it could be varying in
different individuals, the minimum that is required is one
week.
After the spray is successfully tested on the healthy
individuals, the trial would be expanded in its scope covering
common population including children and aged people.
The follow-up could take a few weeks.
He said the SII was confident of the safety aspect as
the nasal spray has been successfully used in America and
Russia.
Asked how the vaccine acts against the deadly H1N1,
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 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
administration which, at present remains the only successful
line of treatment, if started at an early stage of the
infection.
PTI