title: The preliminary clinical evaluation of the safety and efficacy of a fertility regulating vaccine.
abstract: Since the mid 1970s, the World Health Organization's Special Programme of Research, Development and Research Training in Human Reproduction, through its Task Force on Vaccines for Fertility Regulation, has been supporting and coordinating the development of a birth control vaccine based on a synthetic peptide representing part of the beta subunit of human chorionic gonadotrophin (beta-hCG). The majority of this work has been carried out in the laboratories of Dr V.C. Stevens at Ohio State University. This hCG vaccine has recently been tested for tolerability and immunogenicity in a phase I clinical trial, and a preliminary evaluation of the vaccine's efficacy in fertile women volunteers is currently being planned. This paper describes the preclinical and clinical testing of this vaccine and the problems and challenges presented by this novel preparation. These have included the need to carry out safety and efficacy studies in the baboon, and the difficulties of designing appropriate preclinical toxicity and immunosafety studies and clinical trial protocols in the absence of previous experience with vaccines of this type.
authors.affiliation: Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, Geneva, Switzerland.
authors.forename: P D
authors.initials: PD
authors.lastname: Griffin
authors.forename: W R
authors.initials: WR
authors.lastname: Jones
mesh_terms: D000818:Animals; D006063:Chorionic Gonadotropin; D004341:Drug Evaluation; D004353:Drug Evaluation, Preclinical; D005193:Family Planning Services / Q000379:methods*; D006801:Humans; D014614:Vaccines, Synthetic
chemical_list: D006063:Chorionic Gonadotropin; D014614:Vaccines, Synthetic