The Indian Council of Medical Research (ICMR) will soon launch the phase 2 clinical study of the controversial human papillomavirus (HPV) vaccine Gardasil, produced by US drug multinational, Merck & Co. Funded by the ICMR, the study will focus on the tolerance level of this new three-stage vaccine among the Indian population.

The study will be conducted at multi locations in the country including at the Institute of Cytology & Preventive Oncology (ICPO), an arm of ICMR, at Noida near New Delhi. The HPV vaccine is expected to protect against a variety of HPV known to cause most cases of cervical cancer. The study will begin in the first week of April this year.

Last year, Union health ministry had singed a memorandum of understanding (MoU) with the US company covering the entire gamut of the trial and its launch in the country. As per the MoU, this pre-introductory trial will be done at several centres in the country including ICPO and it will be done for a duration of 6 months as the three doses will be given at three stages of 0,2,6 months. The success or otherwise of this 'bridge study' will be known in a year's time as there will be a 6-month waiting period to observe the subjects, sources said.

Meanwhile, the health ministry is yet to finalise on the cost of the three-dose vaccine. As per the MoU, Merck is bound to provide the medicine at 'affordable prices'. Merck is calculating the price at which it can provide the vaccine to India. As the currently quoted price of around Rs 30,000 for a 3-dose regime is quite high, Merck is learnt to be working out a different price for India. But what exactly will be the affordable price is yet to be worked out. "Once the vaccine is found effective in the tolerance study, the price issue will be settled between the government and the company", sources said.

Interestingly, while the Indian government is showing its keenness to introduce the drug in the country, the drug is creating controversies in the US. The compulsory vaccination of this product for prevention of treating human papillomavirus (HPV) among all school going girls, proposed in the state of Texas in the US by its governor Rick Perry, had attracted strong opposition from parents and public health bodies. The governor's order directs the Texas health and human services commission to require that by September 2008, all girls entering sixth grade receive Gardasil.

A leading medical expert said that in the backdrop of the experience in the US, the initiative of ICMR raises several questions about its marketing in India: Will the government make it mandatory to vaccinate girls against HPV at the behest of its producers? As the Indian market is a huge one, such a scenario in future cannot be ruled out, the expert said. Another important question is on the efficacy of the vaccine. In the US itself the opinion is vertically divided over HPV vaccine as the only prevention for cervical cancer.

Terming the vaccine as medical madness, a section of medical experts in the US are of the view that cervical cancer is prevented in a hundred other ways, including adequate sunlight exposure and vitamin D consumption, supplementation with probiotics, adequate intake of selenium and zinc, increased consumption of trace minerals and iodine, regular physical exercise and many other safe, natural, non-patented strategies.

"As of now we cannot say the exact efficacy of the vaccine. It will take at least another 25 years when we come to know about the efficacy of the vaccine. When all the vaccinated girls become free from cervical cancer even in their low-immunity age, then only we get the exact picture", the scientist said.