The Indian scientists are in the process of developing a Human Papiloma Virus (HPV) vaccine to prevent cervical cancer, thanks to the initiative taken by the Department of Biotechnology to take up HPV vaccine development as an end-to-end mission project interlinking all related stakeholders in the country.
Soon a mega clinical trial will be initiated by the All India Institute of Medical Science (AIIMS) with the objective of creating a cohort of 500 HOV (the virus that causes cervical cancer) free women for trial purpose. The site for the trial is Govindpuri in Delhi where enumeration of about 4000 families has been done and about 800 married women counseled. The questionnaire, information sheet and informed consent forms have been prepared and recruitment would soon begin. The trial would simultaneously address several scientific issues such as role of nutrition, important markers, innate immunity, biology of clearance of HPV etc.
Sources said that prophylactic candidate vaccines using VLP and CLP of L1 and L2 capsid proteins and therapeutic candidate vaccines using E6/E7 proteins are being developed at NII, New Delhi; AIIMS New Delhi and ACTREC, Mumbai. Currently, ACTREC, Mumbai has expressed L1 and L2 proteins in S.cerevisa and shown VLPs in EM. NII group has also expressed the L1 protein and trying to improve the yield. NII have expressed L1 in baculovirus and E. coli expression system from cervical cancer sample. AIIMS is making efforts to construct a vector incorporating L1, E6 and E7 genes, which are known to elicit strong Cytotoxic T Lymphocyte (CTL) response, in order to address the problem of infected women.
Sources said the Department of Biotechnology has taken up the development of HPV vaccine as an end-to-end mission project, addressing all interlinked issues along with suitable partners. Important elements of the project include development and evaluation of suitable diagnostics i.e. paper smear collection method, PCR, reverse line blot by AIIMS, New Delhi; CMC, Vellore, NCBS, Bangalore and TMC, Mumbai. Molecular epidemiology of oncogenic strains covering different geographical regions of the country in hospital and population based studies are being done at RCC, Trivandrum, AIIMS, Kidwai Memorial Cancer Hospital, Bangalore, Cancer Foundation of India, Kolkata, CMC, Vellore and ACTREC, Mumbai.
All six centers have started collecting 100 samples each as per a standard protocol. Xcyton, Hyderabad is entrusted with the task of testing all these samples for various strains by PCR lineblot assay. The Centre for Genomic Application (TCGA), a collaborative venture of the Institute of Genomics and Integrative Biology (IGIB) and Institute of Molecular Medicine of the Chatterjee Group, will conduct sequence studies of all the 600 samples.
It may be noted that MSD India had tied up with the Indian Council of Medical Research (ICMR) a few months ago to try its HPV vaccine in the Indian population. GSK is also developing an HPV vaccine, which is undergoing Phase III clinical trials.
About 510,000 cases of cervical cancer are reported each year with nearly 80% occurring in developing countries. Cervical cancer is the most common form of cancer in India, with more than 130,000 new cases reported each year and 74,000 women dying annually from the disease, according to the World Health Organization (WHO). The disease accounts for an estimated 24 percent of India's cancer cases among women, compared with 20 percent for breast cancer.