The much delayed phase-2 trial of the controversial human papillomavirus (HPV) vaccine Gardasil, which was entangled in red-tapism, is likely to start soon. According to ICMR sources, the delay in beginning the trial was mainly due to the procedural delays which are being cleared.

A clinical trial proposal needs clearances from different committees. It has to go through several expert committees. There are a number of procedures involved in it and the proposal for the phase-2 clinical trial of HPV vaccine Gardasil is in the clearance stage. In fact, there is no delay for the proposal. If at all there is any, it is some procedural delay which is very much part of it, a senior ICMR official said.

The government proposal for the phase-2 trial of Gardasil is to study the tolerance level of this new three-stage vaccine among the Indian population. Though the ICMR has made all the preparations for launching the trial as early as March this year, it is still waiting clearances at various levels.
ICMR was to launch the trial of this cervical cancer vaccine, produced by US drug multinational Merck & Co, in April this year and had made all the necessary preparations. But it did not so far receive the necessary permission from the authorities.

Funded by ICMR, the study was to 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 human papillomaviruses which are known to cause most cases of cervical cancer.

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