Evaluation of endocrine parameters in clinical trials with beta-hCG vaccine.
This report presents data on various endocrine parameters with respect to pituitary-ovarian axis in-depth in control vs 18 subjects immunized with three beta-hCG based vaccine formulations. Hormonal parameters such as TSH, PRL, ACTH, progesterone, cortisol, T3 and T4 were measured by RIA in sera in control pre-vaccine cycles as well as at 3, 6, and 12 months after primary vaccine immunization. In 6 women urinary E1G, PdG, LH and FSH were measured by ELISA/RIA tests on early morning urine (EMU) samples collected throughout the menstrual cycle in control vs post-booster vaccine cycles. The results indicated that none of the beta-hCG vaccine formulations altered the pituitary peptide or steroid hormone levels in blood at any time during the period of study. Serum P concentration was adequate and indicative of ovulatory cycle in almost all the cycles during the study. The in-depth study on urinary excretion pattern and levels of gonadotropins and E1G and PdG throughout the control vs post-vaccine booster cycles conclusively showed that pituitary-ovarian axis was not adversely affected by the vaccine.
Shahani
S
S
Department of Endocrinology, T.N. Medical College, Bombay, India.
Patel
K L
KL
Merchant
P
P
D000324:Adrenocorticotropic Hormone / Q000097:blood; D000328:Adult; D006063:Chorionic Gonadotropin / Q000008:administration & dosage / Q000276:immunology / Q000494:pharmacology*; D018997:Chorionic Gonadotropin, beta Subunit, Human; D004797:Enzyme-Linked Immunosorbent Assay; D004970:Estrone / Q000031:analogs & derivatives / Q000652:urine; D005260:Female; D005640:Follicle Stimulating Hormone / Q000652:urine; D006728:Hormones / Q000097:blood* / Q000652:urine; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D007986:Luteinizing Hormone / Q000652:urine; D008597:Menstrual Cycle / Q000187:drug effects*; D010053:Ovary / Q000187:drug effects / Q000378:metabolism; D010446:Peptide Fragments / Q000008:administration & dosage / Q000276:immunology / Q000494:pharmacology*; D010902:Pituitary Gland / Q000187:drug effects / Q000378:metabolism; D011374:Progesterone / Q000097:blood; D011388:Prolactin / Q000097:blood; D011863:Radioimmunoassay; D013972:Thyrotropin / Q000097:blood; D013974:Thyroxine / Q000097:blood; D014284:Triiodothyronine / Q000097:blood; D014612:Vaccines
D006063:Chorionic Gonadotropin; D018997:Chorionic Gonadotropin, beta Subunit, Human; D006728:Hormones; D010446:Peptide Fragments; D014612:Vaccines; D014284:Triiodothyronine; C015856:estrone-3-glucuronide; D004970:Estrone; D011374:Progesterone; D000324:Adrenocorticotropic Hormone; D011388:Prolactin; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone; D013972:Thyrotropin; D013974:Thyroxine; D006854:Hydrocortisone