We report here results of clinical trials on a birth control vaccine, consisting of a heterospecies dimer of the .3 subunit of human chorionic gonadotropin (hCG) associated noncovalently with the a subunit of ovine luteinizing hormone and coijugated to tetanus and diphtheria toxoids as carriers, that induces antibodies of high avidity (Ka 1010 M-) against hCG. Fertile women exposed to conception over 1224 cycles recorded only one pregnancy at antibody titers of >50 ng/ml (hCG bioneutralization capacity). The antibody response declines with time; fertility was regained when titers fell to <35 ng/ml. This study presents evidence of the feasibility of a vaccine for control of human fertility.A number of contraceptive methods are available; they do not, however, suit all potential users. There is need to develop additional methods, in particular those that are reversible, require only periodic intake, and do not disturb menstrual regularity or bleeding. Vaccines regulating fertility offer promising prospects to meet these specifications. The rationale for these vaccines is to induce the formation of antibodies and/or cell-mediated immunity to intercept selectively a process critical to the success of reproduction. A number of potential antigens are being investigated (1-7). Among these are hormones, which play an important role in the regulation of fertility. Human chorionic gonadotropin (hCG) is an early signal of conception and is considered essential for establishment and maintenance of early pregnancy. An advantage in choosing hCG as a target for immunocontraception is that its inactivation would not interfere with other physiological processes in the female, such as ovulation and production of sex steroid hormones.Carrier conjugation with tetanus toxoid (TT) was proposed as a strategy to overcome the immunological tolerance of a woman against hCG (8). This initial prototype vaccine (/3hCG-TT adsorbed on alum) had limitations. It induced high antibody titers in only a small percentage of women, and those with low titers were not protected from pregnancy (9). Three changes were made to enhance immunogenicity.(i) An adjuvant, the sodium phthalyl derivative of lipopolysaccharide, was included in the first injection. This nonpyrogenic adjuvant is usable in aqueous phase (10). Its use doubled, on average, anti-hCG titers and increased the frequency of high responders.(ii) The intrinsic immunogenicity of (3hCG was enhanced by associating it noncovalently with the a subunit of ovine luteinizing hormone (LH) to form a heterospecies dimer (HSD), a laboratory-made hormone that attains a conformation which recognizes receptors on target tissues (whereas isolated subunits do not) and generates a steroidogenic response even superior to that by hCG (11). HSD linked to carriers was indeed found to be more immunogenic than ,8hCG in rats and monkeys (12). Moreover, the antibodies had better capacity to neutralize the bioactivity of hCG (11,13 It was important to determine whether the antibodies induced by the HSD-and 8hC...
An analytical study of 441 patients with lichen planus is presented. Lichen planus occurrence was 76% of conditions seen at this institution. The sex ratio was 3:2. Most patients having the disease were in the 3rd decade of life. Lichen planus vulgaris (common type) was seen in 329 (74%) patients, lichen planus hypertrophicus in 56 (13%), lichen planus actinicus in 33 (7.5%), lichen planus follicularis in 8 (2%), lichen planus atrophicus in 8 (2%) and lichen planus pemphigoides in 7 (1.5%) patients. Mucous membrane involvement was seen in 127 (29%) cases and nail involvement in only 7 (1.5%).
Objective: Exclusive breastfeeding is recommended till 6 months age. Factors regulating the breastmilk iron and lactoferrin levels are incompletely known. Considering high prevalence of nutritional anemia in lactating mothers, we studied the iron status of lactating mothers, their breastmilk iron and lactoferrin levels to determine any relationship between them. Design: Prospective study with 6 months follow-up. Setting: Tertiary care referral hospital. Subjects: Hundred nonanemic and 100 anemic mothers with their babies recruited at birth. Fifty-two nonanemic and 50 anemic mothers and their babies completed the 6-month follow-up. Interventions: Hemoglobin (Hb), total iron binding capacity (TIBC), percent transferrin saturation (%TS), serum iron (SI) and serum ferritin measured on day 1 and 6 months postpartum. Breastmilk iron and lactoferrin measured on day 1, 14 weeks and 6 months after delivery. Results: Breastmilk iron decreased progressively from day 1 to 14 weeks and at 6 months in both groups, but no significant difference was noted between nonanemic and anemic mothers (P40.05). Significant decline in breastmilk lactoferrin concentration from day 1 to 14 weeks in nonanemic and anemic mothers (Po0.001) noted. Hemoglobin, TIBC, %TS, SI and serum ferritin of both groups had no correlation with breastmilk iron and lactoferrin concentration on day 1, 14 weeks and 6 months after delivery. Conclusions: Breastmilk iron and lactoferrin concentration had no relationship with the mother's Hb and iron status.
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