Phase II and III human clinical trials of the nasal spray vaccine against the H1N1 virus will be started by the Serum Institute of India on Monday. These trials would be taking place at two sites in Pune and three other centres.
Director of clinical trials at the institute Dr Prasad Kulkarni, said approval was received from the Drug Controller General of India (DCGI). Reports state that about 330 people in three groups called, paediatric, adult and elderly, will be put under the trial.
He added, “The trial will begin at four centres initially but two more will be included later.”
Sites where the trials will take place are Pune, Kolkata, Indore, Ahmedabad, Bangalore and Chennai.
According to the information provided by an official, the inhalation mix, would be administered in doses of 2.5 ml in each nostril.
The virus here is week. No disease is caused here though it produces immunity. The natural route of infection is mimicked as it is given intra nasal. It grows in the nasopharynx and local immunity followed by systemic immunity is produced.
Post the nasal spray vaccine administration, the results will go for further testing at laboratories at the Serum Institute and National Institute of Virology.
It is hoped that the data would arrive by third week of April. There are reports that in Pune alone 201 lives have been claimed by the virus.
Related News
- Trials on to Check Efficacy of HIV Vaccine
- US flu season marked by Back-to-school signals
- A universal flu vaccine nasal spray on course to become a reality!
- Hendra May Spread to Humans from Bats
- Good News for AIDS Patients
- Malaria Vaccine Could Be Rolled Out by 2015
- Swine Flu Claims another Venezuelan
