GlaxoSmithKline (GSK) has selected St John’s National Academy of Health Sciences as one of the five locations to conduct the trial for the H1N1 vaccine ‘Pandemrix’ in the country. The trial is expected to commence by the month-end.
The hospital’s department of Chest Diseases will carry out the trial on healthy volunteers who will form its staff in the non-medical departments. These people have not been potentially exposed to the flu virus. The Ethics Committee headed by Father Saji has cleared the study where a total of 50 volunteers will be part of the assessment. Under the World Health Organization guidelines, the government of India is keen to administer the vaccine on healthcare workers who are the most susceptible to the flu. The WHO had pointed out that developing countries could be the most hit by the H1N1 pandemic.
We received a communication from GSK that our hospital is being audited for conduct of the H1N1 trials. The facility has been approved as an ethical site for conduct of the human study based on its early efforts to efficiently coordinate for the clinical programme. The hospital has now submitted the necessary ethical approval data and is gearing up to conduct the human study, Dr George D’Souza, additional vice dean, professor and head of the department of chest diseases, St John’s National Academy of Health Sciences and chief coordinator of the H1N1 trial, told Pharmabiz.
The key objective of this study is to vaccinate the personnel who are not exposed to the H1N1 virus. After the inoculation, the blood samples will be drawn to study if the vaccine is effective in terms of immune response, he added.
The duration of the trial is two weeks, and within six weeks St John’s will extrapolate the blood data of the volunteers and make the submission to GSK.
Other than St John’s, four locations identified are CMC, Vellore and Ludhiana, BG Medical College, Pune, and an institute in Kolkata. A total of 200 volunteers are required for the study.
After the six weeks assessment, the volunteers will be under observation for a period anywhere between three and six months.
During the peak of the epidemic H1N1 in Karnataka St John’s had set up a dedicated flu clinic to diagnose and treat patients. The clinic had over 300 cases accessing the facility in a day. During that phase, the hospital recorded 7 fatal cases. Now with the patient numbers coming down to 30, the clinic has been discontinued and the patients can access the department of chest diseases for diagnosis and treatment, said Dr D’Souza.
Wit the onset of winter, World Health Organization (WHO) report has already indicated a spurt in influenza cases in the temperate zone regions. India has also been identified as one of the countries expected to see a surge in the H1N1 cases. The vaccine is of utmost importance and we are looking to fast track the trial at St John’s so that the vaccine can hit the market early as patients suffering from respiratory diseases, cold cough and fever are on the rise, he said.