ICMR and Pune’s National Institute of Virology will jointly conduct the trial, expected to start next month.

Cervavac is a new vaccine, and the World Health Organization (WHO) has recommended observing its effects for two years, one of the two officials cited above said on condition of anonymity. This will provide clarity on the vaccine’s efficiency, check whether antibodies remain intact, and figure out its side effects. Before introducing in India, Cervavac was put on a trial to match the efficacy of Gardasil, which is made by Merck and Co.

“When it is just a trial, the focus is on a limited audience. But when it goes into the market, it is necessary to know if there is anything else coming in a pragmatic situation, because it has been licensed for everyone and there is no more inclusion and exclusion criteria for implementation of vaccine. So, there can be something new, and hence, there is need for post-marketing surveillance,” the official noted.

An email was sent to Serum Institute seeking response remained unanswered. The trial also aims to find out if a single dose of the Indian vaccine is sufficient to protect against the human papillomavirus (HPV), which causes cervical cancer. According to WHO, a single dose provides protection if administered before the age of 20; however, for Cervavac, it is still two doses for all ages. The trial will also try to find out if a single dose is good enough, the official added. As per officials, the government wants to ensure there are enough vaccine stocks before starting the programme, given the large number of recipients to cover.

Separately, Delhi’s All India Institute of Medical Sciences plans to study the impact of HPV vaccine on HIV-positive patients, a senior doctor at the institute said. AIIMS may screen these patients for cervical cancer at the anti-retroviral therapy (ART) centres, given that they are at high risk. The question is whether they will get good immunity since there are many types of HPV, the doctor added.