Phase I Clinical Trial of a World Health Organisation Birth Control Vaccine

Milestones in contraceptive vaccines development and hurdles in their application

“…Table 2). 140 Follow-up of the immunized women for 6 mo did not reveal any important adverse reactions. In the group of women immunized with the highest dose of vaccine, potentially contraceptive levels of antibodies to hCG were generated.…”

“…In the group of women immunized with the highest dose of vaccine, potentially contraceptive levels of antibodies to hCG were generated. 140 Encouraged by the findings from Phase I clinical trials of CTP of β-hCG based birth control vaccine, WHO initiated Phase II clinical trials in Sweden. However, due to unacceptable adverse reactions in the vaccinated women, the continuation of Phase II clinical trial was abandoned.…”

Development of Vaccine Adjuvants: A Historical Perspective

“…Use of alternative waterin-oil emulsion systems have been examined with a birth control vaccine based on peptide antigen and a saline/or MDP-squalene emulsion showing clinical promise [252]. A similar approach for veterinary vaccines was taken with Titer Max, where saline was emulsifi ed into squalene with the block copolymer CRL8941 [253].…”

The development of contraceptive vaccines

“…The phase II trials were carried out in India, with informed written consent obtained from healthy females aged [20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35]. Three primary injections were given at 6 week intervals, and boosters administered when necessary to maintain antibody titres above 50ng/ml of hCG bioneutralising specific antibody.…”

“…This peptide sequence was conjugated to diphtheria toxoid as a carrier, and the adjuvant consisted of squalene, muramyl dipeptide and Arlacel A. Phase I clinical trials were conducted in Australia in the mid 1980's and demonstrated that the vaccine was able to induce antibodies which bound to native hCG [27]. However, phase II clinical trials using a reformulated immunogen at a higher dose were abandoned due to an inflammatory reaction occurring at the injection site in some individuals [28].…”