Singh M, Das S K, Suri S, Singh O, Talwar G P
Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi.
Am J Reprod Immunol. 1998 Jun;39(6):395-8. doi: 10.1111/j.1600-0897.1998.tb00376.x.
Phase II clinical trials with the heterospecies dimer of beta hCG and alpha-subunit of ovine luteinizing hormone (HSD)-human chorionic gonadotrophin (hCG) vaccine showed that pregnancy was prevented at and above 50 ng/ml titers, whereas conceptions occurred below 35 ng/ml of hCG bioneutralization capacity. The effect of below-protective threshold anti-hCG antibodies on the progression of pregnancy and the normality of progeny was studied.
Four women enrolled by informed consent in the Phase II trials. The women studied were immunized with the HCG vaccine and did not receive booster injections in consideration of their desire to have another child. They were examined clinically at least once every month until delivery. The babies were followed up from 2 to 3.5 years, and their anthropometric indices were compared with elder siblings.
The pregnancies progressed to 35 to 38 weeks with the usual obstetric problems, and the children developed normally.
The anti-fertility effect of the HSD-hCG vaccine is reversible and low titers of antibodies below the protective threshold have no apparent side effects on the progression of pregnancy and on the early development of the progeny.
β人绒毛膜促性腺激素（β-hCG）与绵羊促黄体生成素α亚基（HSD）-人绒毛膜促性腺激素（hCG）疫苗的异种二聚体进行的II期临床试验表明，当滴度达到及高于50 ng/ml时可预防妊娠，而当hCG生物中和能力低于35 ng/ml时会发生受孕。研究了低于保护阈值的抗hCG抗体对妊娠进展和子代正常性的影响。
4名女性在II期试验中经知情同意入组。所研究的女性接种了hCG疫苗，考虑到她们想要再生育一个孩子，未接受加强注射。每月至少对她们进行一次临床检查直至分娩。对婴儿进行了2至3.5年的随访，并将其人体测量指标与年长的兄弟姐妹进行比较。
妊娠进展至35至38周，伴有常见的产科问题，且儿童发育正常。
HSD-hCG疫苗的抗生育作用是可逆的，低于保护阈值的低滴度抗体对妊娠进展和子代早期发育无明显副作用。
