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    783221
    Peer Reviewed

    Evaluating the safety and efficacy of placental antigen vaccines for fertility regulation.

    World Health Organization [WHO]. Special Programme of Research, Development and Research Training in Human Reproduction. Task Force on Immunological Methods for Fertility Regulation

    Clinical and Experimental Immunology. 1978 Aug; 33(2):360-375.

    Since guidelines for safety evaluation of antifertility vaccines do not exist, this WHO report attempts to define the parameters to be examined and the methodology which might be used for such a safety assessment. In principle, antifertility vaccines may: 1) prevent sperm transport and/or fertilization; 2) prevent or disrupt implantation; and 3) prevent blastocyst development. Potential advantages of this immunological approach to fertility regulation include: 1) possibility of infrequent administration, possibly by paramedicals; 2) use of antigens or antigen frangments that are not pharmacologically active; and 3) the possibility of large-scale synthesis and manufacture of vaccine at relatively low cost in the case of antigens of known chemical structure. To evaluate the efficacy and safety of placental antigen vaccines, placental antigens used should not possess significant immunological similarity with tissue other than placenta. Carriers or haptens may require structural remodifications of placental molecules to overcome natural immunological tolerance. Adjuvants may be needed to enhance the immune response required. Quality-control procedures for vaccine component production include tests for: 1) purity; 2) toxicity; 3) sterility; and 4) shelf-life. Acute, subacute, and chronic toxicity testing in animals is described for it must be performed separately for the haptenated antigen or conjugate and adjuvant. Such tests would include hematological parameters, blood chemistry, urinanaylsis, gross pathological and organ weight analysis, and ophthalmological tests. Animal models are suggested. Means of monitoring the immune reponse and potential hazards of immunization (e.g., allergy or autoimmune disease) are discussed. The rationale and protocol for safety and efficacy studies of human chorionic gonadotropin-peptide vaccine receive similar attention, with emphasis on tests to be performed before human clinical trials can start.
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