Evaluating the safety and efficacy of placental antigen vaccines for fertility regulation
Clinical and Experimental Immunology 33(2): 360-375
1978
ISSN/ISBN: 0009-9104 PMID: 102479 Document Number: 499740
Immunization as a prophylactic measure is now so widely accepted that it has been suggested that one method of fertility regulation which might have wide appeal as well as great ease of service delivery would be an anti-fertility vaccine. It is essential, since they are to be used by healthy people, that all methods of fertility regulation be thoroughly tested from the point of view of safety. In the case of an anti-fertility vaccine, which represents a totally new area of intervention and whose effects are intentionally of long duration, this is even more important. This document, which was developed by the WHO Special Program of Research, Development and Research Training in Human Reproduction, in consultation with immunologists, toxicologists, immunopathologists, reproductive biologists and 3 drug regulatory agencies, represents an attempt to define the parameters to be examined and the methodology which might be employed in such a safety evaluation. Discussed are the evaluation of efficacy and safety of placental antigen vaccines and of a human chorionic gonadotropin peptide vaccine.