Evaluation of Efficacy and Safety of Recombinant Sperm-Specific Contraceptive Vaccine in Albino Mice Shipra Goyal, Boomi Manivannan, Ganesh R. Kumraj, Abdul S. Ansari, Nirmal K. Lohiya Centre for Advanced Studies, Department of Zoology, University of Rajasthan, Jaipur, India Keywords Contraception, mice, SP-10, spermatozoa, vaccine Correspondence Nirmal K. Lohiya, Centre for Advanced Studies, Department of Zoology, University of Rajasthan, Jaipur – 302 004, India. E-mail: lohiyank@hotmail.com; lohiyank@gmail.com Submission January 3, 2013; accepted January 3, 2013. Citation Goyal S, Manivannan B, Kumraj GR, Ansari AS, Lohiya NK. Evaluation of efficacy and safety of recombinant sperm-specific contraceptive vaccine in albino mice. Am J Reprod Immunol 2013; 69: 495–508 doi:10.1111/aji.12085 Problem This study was undertaken to evaluate the efficacy and safety of recom- binant SP-10 protein for male contraception. Methods of study Adult male mice were divided into five groups. Group I was placebo- treated control while Groups II–V were immunized with recombinant SP-10 protein on day 0 and 21 with different doses (range 25–100 lg). From each Group, animals were put for mating fertility test. Histological and hematological parameters, sperm characteristics, serum clinical bio- chemistry and testosterone levels were investigated. Results Group I showed normal fertility. Group II–V showed dose dependent reduction in fertility. In contrast, at higher dose (75 and 100 lg), all animals were sterile for three months. Further, all parameters under investigation in experimental groups were comparable to those of con- trol animals. Conclusion Our study has put forth a proof of concept for male contraception for the first time, which may be considered suitable for contraceptive vac- cine development. Introduction Immunocontraception is the use of the body’s own immune defense mechanisms, which provide protec- tion against an unplanned pregnancy. This approach would require controlled, time-limited and non- pathogenic immune response to components of gametes. The prerequisite for designing such contra- ceptive vaccine should provide long-term but not permanent protection against unplanned pregnancy. In addition, such novel approach should also provide an additional option to current or potential users of family planning methods and services. The major advantages of developing immunocontraception are that it lacks endocrine and metabolic side effects. This approach would also not require any insertion of an implant or device. Hence, immunocontracep- tion vaccine development will be the most suitable for all developing countries that have population problem and also for developed nations for better option of contraception. Inducing an immune response against gamete-spe- cific antigens represents a promising approach in developing a contraceptive vaccine. The sperm cell has iso- and autoantigens, and potential to generate immunological response in both men and women against conception. 1–4 There have been number of gamete-specific antigens identified that are involved in sperm–egg interaction 4 , which have been shown to reduce the fertility in female animals. However, none of these antigens have been employed in female contraceptive trials in women. Moreover, till American Journal of Reproductive Immunology 69 (2013) 495–508 ª 2013 John Wiley & Sons A/S 495 ORIGINAL ARTICLE