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  • Title: Options for immunocontraception and issues to be addressed in the development of birth control vaccines.
    Author: Griffin PD.
    Journal: Scand J Immunol Suppl; 1992; 11():111-7. PubMed ID: 1514024.
    Abstract:
    Although the number of family planning methods currently available to couples has never been greater, the range and type of options are still not adequate to meet the widely varying personal needs and demands of individuals worldwide. Birth control vaccines offer a number of theoretical attractions although the development, preclinical and clinical testing of such vaccines pose a number of unique problems requiring novel solutions. If the on-going studies in this area are successful, a valuable new family planning method may be available by the end of the current decade. Research on immunization against self-antigens as a means of controlling normal physiological processes, such as those involved in reproduction, has not been extensive. Candidates for antifertility vaccines include molecules that are tissue-specific proteins expressed on the mature gametes (sperm and/or ovum) and the trophectoderm of the preimplantation embryo and, to a lesser extent, the pituitary gonadotropin, follicle stimulating hormone. The most advanced work in this area involves the development of vaccines based on human chorionic gonadotropin (hCG), the hormone that is produced in, and secreted by, the trophectoderm of the preimplantation embryo. The WHO Task Force on Vaccines for Fertility Regulation has conducted studies in connection with its anti-hCG vaccine development program since the early 1970s. The various stages of clinical testing of a novel antifertility vaccine begin with Phase I to determine the safety of the preparation in humans. Phase I studies usually involve about 50 subjects allocated sequentially to increasing dose groups, and take 1-2 years to complete. The principal purpose of a Phase II clinical trial of an antifertility vaccine is to determine the efficacy of a selected dose of vaccine in healthy, fertile volunteers. Phase II studies typically involve 100-200 subjects and take 2-3 years to complete. A Phase III clinical trial determines efficacy and safety in the general population by recruiting more than 1000 subjects, and it may take 4-6 years to complete. The development process from prototype to final product may require modifications for scientific or medical reasons, such as large differences in individual immune responses or the appearance of unacceptable side effects of low incidence, or for practical reasons, such as quality assurance and formulation needs when scaling up production from experimental quantities to large-scale manufacture.
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