H1N1 vaccine: Phases II, III human trials begin today
The Serum Institute of India will begin phase II and III human clinical trials of the nasal spray vaccine against the H1N1 virus at two sites in Pune and three other centres on Monday. The virus has claimed 201 lives in Pune itself.
Dr Prasad Kulkarni, director of clinical trials at the institute, told Newsline on Sunday that they had received the required approval from the Drug Controller General of India (DCGI). A total of 330 people in three age groups — paediatric, adult and elderly — will be enrolled for the trial. “Initially, the trial will begin at four centres; We will include two more later.”
The trial sites have been identified at Pune, Ahmedabad, Kolkata, Indore, Bangalore and Chennai. A private hospital and a medical college are taking part in the trial in Pune.
Dr Prasad Kulkarni, director of clinical trials at the institute, told Newsline on Sunday that they had received the required approval from the Drug Controller General of India (DCGI). A total of 330 people in three age groups — paediatric, adult and elderly — will be enrolled for the trial. “Initially, the trial will begin at four centres; We will include two more later.”
The trial sites have been identified at Pune, Ahmedabad, Kolkata, Indore, Bangalore and Chennai. A private hospital and a medical college are taking part in the trial in Pune.
The Serum Institute will enroll 300 people for the trial.Explaining the procedure, an institute official said the vaccine, in the form of an inhalation mix, would be administered in each nostril in doses of 2.5 ml. “Here, the virus is live but weakened (attenuated). It produces immunity but does not cause disease. As it is given intra nasal, it mimics the natural route of infection. It grows in the nasopharynx and produces local immunity followed by systemic immunity.”
Once the intra nasal spray vaccine has been administered, the results will be tested in laboratories at the Serum Institute and National Institute of Virology.
The officials hope to submit the trial data to the DCGI by the second or third week of April.
Kulkarni said the results of the Phase I clinical trial of the injectable vaccine against the HINI virus would be submitted to the DCGI soon.
The Ahmedabad-based Zydus Cadila has also embarked upon the multi-centric Phase II and III clinical trials of the vaccine.
Once the intra nasal spray vaccine has been administered, the results will be tested in laboratories at the Serum Institute and National Institute of Virology.
The officials hope to submit the trial data to the DCGI by the second or third week of April.
Kulkarni said the results of the Phase I clinical trial of the injectable vaccine against the HINI virus would be submitted to the DCGI soon.
The Ahmedabad-based Zydus Cadila has also embarked upon the multi-centric Phase II and III clinical trials of the vaccine.
Source: http://www.indianexpress.com/news/h1n1-vaccine-phases-ii-iii-human-trials-begin-today/587951/2