Status of immunodiagnosis and immunocontraceptive vaccines in India.

Abstract

The article focuses on the Indian initiative of making kits for diagnosis of various infectious and non-infectious diseases as well as reproductive hormones and hormones in various other endocrine disorders. Indigenous diagnostic kits for the detection of various infections such as filariasis, typhoid, amebiasis, Japanese encephalitis, hepatitis, HIV, dengue, leishmaniasis, malaria, rabies, toxoplasmosis, rotavirus, and group A streptococci have been developed. Agreements to transfer the know-how of some of these leads to industries have been signed. The know-how of enzyme-linked immunosorbent assay (ELISA) for detection of hepatitis C has been successfully transferred to industry and is being commercially produced. For detection of HIV-1 and HIV-2, indigenous diagnostic kits based on three different formats, namely ELISA, Western blot and rapid test have been developed and are being commercially produced by Indian industries. The factors influencing the successful transfer of laboratory-scale diagnostic assays from academia to industry and their commercial exploitation have been discussed. Indian scientists have made seminal contributions in exploring the possibility to develop an effective and safe contraceptive vaccine to control the increasing human population of India. Achieving contraception by means of vaccine is a novel approach, which entails generation of a specific antibody response against antigens critically involved in the process of mammalian reproduction. In India, three major programs on contraceptive vaccines based on the beta-subunit of human chorionic gonadotrophin ((beta)hCG) for women, ovine follicle stimulating hormone (oFSH) for men, and riboflavin carrier protein for both males and females have been initiated. The work at the National Institute of Immunology, New Delhi on contraceptive vaccine for women, based on (beta)hCG, has demonstrated, for the first time, that it is feasible to regulate fertility by such an approach. Basic research being carried out to achieve immunocontraception by interfering at sperm-oocyte interaction level has been briefly discussed. These developments are still at the research stage. In addition to advances in the area of contraceptive vaccines, a non-steroidal contraceptive oral pill has been developed by Central Drug Research Institute, Lucknow, commercially produced by two Indian pharmaceutical companies and has been incorporated in the National Family Welfare Program. Another interesting approach for fertility regulation in male has been developed in India, which involves vas occlusion with styrene maleic anhydride (SMA) and is currently undergoing clinical trials in human subjects.