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Lancet. 1988 Jun 11;1(8598):1295-8.

Phase I clinical trial of a World Health Organisation birth control vaccine.

Author information

1
Department of Obstetrics and Gynaecology, Flinders Medical Centre, Adelaide, Australia.

Abstract

A birth control vaccine incorporating a synthetic peptide antigen representing the aminoacid sequence 109-145 of the C-terminal region of the beta subunit of human chorionic gonadotropin (hCG-beta) was submitted to a phase 1 clinical trial. Thirty surgically sterilised female volunteers, divided into five equal groups for different vaccine doses, received two intramuscular injections six weeks apart. Over a six-month follow-up there were no important adverse reactions, and potentially contraceptive levels of antibodies to hCG developed in all subjects. In the highest vaccine dose group, the results gave promise of a contraceptive effect of six months' duration.

PIP:

A Phase I clinical trial of the immunogenicity and safety of a vaccine against the C-terminal region of the beta subunit of human chorionic gonadotropin (hCG-B) demonstrated a dose-related immune response. The antigen was a synthetic peptide of the C 109-145 region of hCG-B, conjugated to diphtheria toxoid, and administered in a water-soluble synthetic adjuvant in a saline-oil emulsion. This vaccine had been previously tested for toxicity in laboratory animals and for immunogenicity, safety and contraceptive effectiveness in baboons. 30 previously sterilized women were given 2 injections 6 weeks apart, ranging from 50 to 1000 mcg of the antigen. Each woman tested free of HLA B27 antigen and reacted negative to the diphtheria toxoid skin test. Based on calculated contraceptive antibody binding level of 0.52 nmol/l, all subjects mounted an effective antibody response for at least 6 months. 2 subjects in the group given 1000 mcg who were followed for 9 and 10 months maintained this level of antibody. 12 women showed an anamnestic response to diphtheria toxoid, while 8 did not. The only adverse reactions were mild, transient pain at the injection site. Several women who received unstable adjuvant experienced more severe myalgia. Menstrual changes appeared in 5 subjects: early menopause in 1, spotting in 3 and menorrhagia in 1 woman. Only transient positive findings were seen in some sera screened for autoantibodies. This preliminary trial indicates that anti-hCG vaccine is a hopeful reversible contraceptive.

PMID:
2453766
DOI:
10.1016/s0140-6736(88)92117-4
[Indexed for MEDLINE]

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