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PubMed2005

Macrophage inflammatory protein-1alpha expression plasmid enhances DNA vaccine-induced immune responses against HSV-2.

In this study, we examined the effectiveness of macrophage inflammatory protein (MIP)-1alpha cDNA as a HSV-2 DNA vaccine adjuvant. pcDNA3-gD (pgD) and pcDNA3-MIP-1alpha (pMIP-1alpha) were co-injected to examine the modulatory effects of MIP-1alpha on immune phenotype and protection against lethal challenge with HSV-2. We found that Th-cell proliferative responses were dramatically enhanced by co-injection of pgD and pMIP-1alpha compared with injection of pgD alone. The secretion of IL-2 and IFN-gamma was also significantly increased by pgD and pMIP-1alpha co-injection; however, the production of cytokines IL-4 and IL-10 was not affected by co-injection. pgD and pMIP-1alpha co-injection resulted in a moderate enhancement of systemic gD-specific antibody level, but mucosal secretory IgA was markedly enhanced. When BALB/c mice were challenged intravaginally with 100 LD50 of HSV-2 strain Sav, pMIP-1alpha co-injection with pgD improved their survival rate and significantly reduced both the number of mice with lesions and the lesion severity. Therefore, MIP-1alpha cDNA as a HSV-2 DNA vaccine adjuvant drives antigen-specific Th1-type responses, reducing HSV-2-derived morbidity and mortality.

Administration, Intravaginal↗
PubMed2002

The effects of stress on memory cytotoxic T lymphocyte-mediated protection against herpes simplex virus infection at mucosal sites.

Psychological stress has been shown to affect many components of the innate and adaptive immune responses to a variety of pathogens including herpes simplex virus (HSV). Mucosal tissues are clinically relevant sites of infection with HSV as well as with many other common pathogens. However, there is a scarcity of experimental evidence that stress affects mucosal immunity. We have taken advantage of a murine model of HSV-specific immune protection that is mediated by only memory cytotoxic T lymphocytes (CTLm) specific for a single CTL recognition epitope within glycoprotein B of HSV-1 (gB498-505). This CTLm population is elicited by vaccination with a recombinant vaccinia virus, which expresses this epitope in the absence of any other HSV-encoded antigens. We report here that stress reduces the ability of gB498-505-specific CTLm to protect against a lethal intranasal or intravaginal HSV infection. Also, stress decreases the ability of these CTLm to limit virus levels at the mucosal site of infection but does not have a significant effect on the levels of virus in the innervating sensory ganglia. Finally, stress decreases protection against HSV-mediated pathology of the vaginal epithelium. These studies are the first to examine the effects of stress on CTLm activation and function in vivo.

Administration, Intranasal↗
PubMed1992

Effects of vaginally-administered oestriol on post-menopausal urogenital disorders: a cytohormonal study.

Forty post-menopausal women with urogenital disorders who were inpatients in the same geriatric hospital were treated with oestriol (E3) for 6 weeks. For the first 2 weeks 0.5 mg E3 (Leo AB, Sweden) was administered intravaginally every day. Over the following 4 weeks the patients received the same quantity either once or twice weekly as a maintenance dose. Oestrogen influence on the vaginal and urethral epithelium was assessed by means of the karyopyknotic index (KPI), while the degree of maturation of the vaginal epithelium was estimated visually. Urinary bacteria were cultivated. A pronounced and progressive rise in KPI was seen in both the vaginal and the urethral epithelium following daily E3 treatment. However, neither of the two maintenance dosages was sufficient to sustain the initial maturation of the vaginal and urethral epithelium induced by E3, since the KPI returned to pretreatment values within 4 weeks. The effect of E3 administration on the vaginal epithelium was overestimated by the visual assessment method. No changes were seen in urinary bacteria. Medroxyprogesterone acetate was given before and after E3 treatment. None of the women suffered from withdrawal bleeding.

Administration, Intravaginal↗
PubMed1998

A randomized trial comparing vaginal and cervical prostaglandin gel for cervical ripening and labor induction.

OBJECTIVE: To compare the effectiveness of intravaginal and intracervical prostaglandin E2 (PGE2) gel for cervical ripening, defined as an increase of 3 or greater in the Bishop score, and for induction of labor. METHODS: Women with Bishop score 4 or less were assigned randomly to receive either 2 mg PGE2 intravaginally (n = 125) or 0.5 mg intracervically (n = 122). If the Bishop score was 4 or less, another dose of PGE2 was given after 6 hours, and up to two additional doses were given 6 hours apart on the second day. An oxytocin infusion was begun when the Bishop score was 5 or greater in absence of spontaneous labor, or if labor had not begun on the third day. RESULTS: Baseline characteristics of the two groups were similar. Survival analysis showed that time from PGE2 application, to obtain an increase of 3 or greater in the Bishop score, to vaginal delivery was significantly shorter with intravaginal PGE2 (logrank test: P = .003 and < .001 after stratification for parity, respectively). Thirty-one percent of women in the intravaginal gel group required oxytocin for labor induction compared with 63% in the intracervical group (P < .001). There were no significant differences in relation to cesarean delivery rate, Apgar scores at 5 minutes, and arterial umbilical cord pH, although the power of our study was limited to detect differences in proportions of adverse outcomes. CONCLUSION: Vaginal PGE2 gel is more effective than intracervical gel for cervical ripening and labor induction.

Administration, Intravaginal↗
PubMed1990

Effect of intravaginal application of prostaglandin E2 gel on the mechanical properties of the ovine cervix uteri at term.

The extensibility ("creep" or strain per minute) and the stretch modulus (stress per unit strain) of strips of cervical tissue were measured in vitro. Intravaginal application of prostaglandin E2 gel led to a fourfold increase in the extensibility (mean +/- SE, 15.45 +/- 0.26 versus 4.23 +/- 0.86 min-1; p less than 0.05) and a twofold reduction in the stretch modulus (mean +/- SE, 0.66 +/- 0.03 versus 1.28 +/- 0.12 N.mm2; p less than 0.0005). This marked increase in the degree of softening occurred in the absence of an increase in uterine activity or changes in plasma progesterone concentrations.

Administration, Intravaginal↗
PubMed2005

Pre-induction cervical ripening: transcervical foley catheter versus intravaginal misoprostol.

The object of this study was to compare the effectiveness of the intravaginal Misoprostol and transcervical Foley catheters as pre-induction cervical ripening agents, to estimate the proportion of patients achieving vaginal delivery and to compare the complications of labour and foetal outcome between the two groups. The study was a prospective, randomised study of pregnant women, with singleton pregnancies who presented for antenatal care and delivery at the University College Hospital (UCH), Ibadan, Nigeria. Ninety-nine patients were invited to participate and ninety-six (96) agreed. No patient withdrew from the study. The patients were assigned by means of computer-generated random numbers to receive transcervical Foley catheters (Size 16F, with 30 ml balloon capacity) or 50 microg intravaginal Misoprostol (Cytotec tablet, Searle & Co., Chicago). Fifty (50) patients received intravaginal Misoprostol and Forty-six (46) received Transcervical Foley catheters. The proportions of nulliparous, primiparous and multiparous patients were 52, 20 and 28% in the misoprostol group and 43.5, 26.1 and 30.4%, respectively, in the Foley catheter group. The time to achieve a favourable cervical status was significantly shorter in the Misoprostol group, with 98.0% of the subjects attaining Bishop score > or = 6 within 6-12 hours of insertion of the study agent, in contrast to 69.0% of the subjects in the Foley catheters group (P<0.001). Thirteen (26.6%) and three (6.5%) patients in the Misoprostol and Foley catheters groups, respectively, went into labour while undergoing cervical ripening and all had uneventful vaginal deliveries (P<0.05). The induction-delivery interval did not differ significantly between the groups. The incidence of caesarean delivery was 6.0% in the Misoprostol group compared with 2.2% in the Foley catheter group (P=0.62). Instrumental vaginal delivery rates were similar in both groups. Overall, the mode of delivery did not differ significantly between the groups. The number of neonates with 1-minute Apgar score <7 did not differ significantly in both groups and no neonate had 5-minute Apgar score <7. Meconium stained liquor was noticed in 5 (Misoprostol) vs 2 (Foley catheters) patients in labour. None of the neonates had any features suggestive of meconium aspiration. Labour complications were mainly precipitate labour {2 (Misoprostol) vs 1 (Foley catheters) } and 1 patient with transient tachysystole (> or =6 contractions in 10 minutes for two consecutive 10-minute periods) in the Misoprostol group. Hyperstimulation was not noticed in any of the patients in either arm of the study groups. Intravaginal Misoprostol is as effective a pre-induction cervical ripening agent as transcervical Foley catheters, with added advantages of shorter duration of cervical ripening, reduced oxytocin requirement for induction of labour and greater acceptability to patients. The incidence of caesarean sections, other labour complications and the foetal outcome were similar with both methods.

Administration, Intravaginal↗
PubMed2001

A prospective randomized control trial comparing medical and surgical treatment for early pregnancy failure.

A prospective randomized control trial was designed to assess the effectiveness of single dose, 800 microg misoprostol administered p.v. compared with surgical evacuation for the treatment of early pregnancy failure. A total of 80 women with a diagnosis of early pregnancy failure were randomized to study (vaginal misoprostol) and control (surgical curettage) groups. Success of treatment, side-effects as assessed during, immediately after and 10 days after treatment, and patient satisfaction were compared. Intravaginal misoprostol was successful in 82.5% (33 out of 40) of the patients. None of the control group patients required a repeat evacuation. The number of patients who experienced significant abdominal pain following treatment did not differ between the groups. The duration of pain was shorter in the control group; however, they required more analgesics during this short period. The number of patients with significant vaginal bleeding, the duration or severity of bleeding did not show any significant difference between the groups. All 33 patients in the study group who had successful treatment expressed satisfaction, whereas only 58% of the control group did so. In conclusion this randomized control study demonstrated the efficacy and safety of the administration of 800 microg of misoprostol p.v. for the management of early pregnancy failure.

Abortion, Incomplete↗
PubMed2004

[Uterine hyperstimulation following cervix ripening with dinoprostone in a vaginal insert system].

Three women, aged 28, 29 and 31 years, primigravidae, with an unripe cervix and an indication for induction of labour, were administered dinoprostone in a controlled vaginal insert system (VIS). A few hours after the insertion of the VIS strong, prolonged contractions occurred with bradycardia in the foetus, resulting in an emergency caesarean section. The children and the mothers recovered well. A potential adverse drug reaction of prostaglandins is uterine hyperstimulation. The sustained-release intravaginal dinoprostone was expected to be safer than the intravaginal or intracervical application of a prostaglandin gel. But data from the literature are conflicting. The risk of uterine hyperstimulation by prostaglandins including the sustained-release dinoprostone system necessitates a re-evaluation of the indications for induction of labour and the procedures of cervical priming. Up-to-date guidelines are an essential tool for the safe use of prostaglandins in daily obstetric practice.

Administration, Intravaginal↗
PubMed2006

[Acute, hemorrhagic, overgrowing vaginal inflammation caused by Streptococcus agalacitae--case study].

The aim of this study was to discuss a case of an acute, hemorrhagic, overgrowing vaginal inflammation caused by Streptococcus agalacitae. Intravaginal globules based on methylcellulose and gelatin, containing a lactic acid and chitosan complex in mole relation 1:1 to 4:1 and, in succesion, an addition of hydrophilisating substances like: PEG-200, propylene-1,2 glycol or glycerol, were applied in the treatment process. The technology was invented in Fac. of pharmacy. Dep. of Pharmaceutical Technology, Wroclaw Medical Univ, Poland (recipe patent-protected).

Acute Disease↗
PubMed1987

Prostaglandin E2 vaginal gel--a new formulation for the induction of labour.

In order to evaluate the efficacy of prostaglandin E2 gel in the induction of labour it was compared with a routine method of induction by oxytocin titration. A total of 50 patients were randomly allocated to two groups; 25 patients received intravaginal prostaglandin E2 gel and 25 oxytocin infusion. In both groups amniotomy was performed once the patient was in the active phase of labour. Successful outcome was regarded as established labour within 12 hours of commencement of the trial. In the oxytocin group this was achieved in 88% of multiparas and 75% of primigravidas. In the prostaglandin group the outcome was successful in 82% of multiparas and 75% of primigravidas.

Administration, Intravaginal↗
PubMed2003

Cervical ripening and induction of labor by prostaglandin E2: a comparison between intracervical gel and vaginal pessary.

OBJECTIVE: To compare the effectiveness and safety of two formulations of prostaglandin (PG) E2 (gel and pessary) for induction of labor. Primary outcomes were cervical ripening, initiation/duration of labor, and type of delivery. STUDY DESIGN: A total of 115 women with singleton gestations were consecutively enrolled and assigned to receive intracervical PGE2 (dinoprostone 0.5 mg) by gel (n = 66) or PGE2 (dinoprostone 10 mg) by intravaginal pessary (n = 49). RESULTS: Independently from parity, the vaginal pessary induced successful cervical ripening with a slightly higher but not statistically significant occurrence of vaginal delivery with respect to gel induction. The mean time interval from induction to vaginal delivery did not differ between groups, despite being shorter for the pessary group in inducation-delivery intervals > 12 h. No significant differences were found between the groups with respect to patients who required a second course of PGE2 (9% vs. 2%), as well as oxytocin (11% vs. 13%) induction. No significant difference was found in the incidence of uterine hyperstimulation and other adverse reactions in nulliparas, or in fetal and neonatal outcome. CONCLUSION: Independently from parity, both PGE2 administration routes appeared to be effective in achieving cervical ripening, initiation of labor and optimal type of delivery, and showed the same incidence of side-effects.

Administration, Intravaginal↗
PubMed2001

[A prospective randomized trial of the impact of misoprostol (PgE1) on pregnancy rate after intrauterine insemination (IUI) therapy: a preliminary report].

Although the use of prostaglandin plays an important role in the reproductive human physiology, it is still controversial in the reproductive field. Ovarian stimulation as well as intrauterine insemination increased the reproductive goals in certain group of patients. The objective of the present study was to evaluate the prostaglandin effect (misoprostol) in patients under ovarian stimulation and intrauterine insemination and their final outcome in the clinical pregnancy rate. There were a total of 59 ovarian stimulated cycles, the study group (n = 29) received 200 micrograms of prostaglandin E1 (misoprostol) intravaginal after IUI, compared with the control group (n = 30). Demographic characteristics were similar in both groups. There were no differences in age, FSH. LH and E2, hCG day and number of ampoules between groups. However, a significant pregnancy rate was observed between groups (31% study group vs. 20% control group). We concluded that prostaglandin application in stimulated cycles under intrauterine insemination remain a beneficial effect showing in the pregnancy outcome.

Administration, Intravaginal↗
PubMed1987

Sulprostone (Nalador) versus gemeprost (Cervagem) for cervical priming in the termination of pregnancy during the first trimester.

The activity and side-effects of the prostaglandin derivatives, sulprostone and gemeprost were compared, 188 patients were studied, 90 receiving sulprostone 500 micrograms intramuscularly 16 hours pre-operatively and 98 receiving gemeprost 1 mg intravaginally 4 hours pre-operatively. Dilatation of the cervix of more than Hegar 8 was obtained in 80 per cent of the sulprostone group and in about 50 per cent in the gemeprost group. On dilatation before vacuum aspiration, little or no resistance was detected in nearly 80 per cent of both groups. Side-effects occurred in 39.3 per cent of the sulprostone group (usually abdominal pain), and in 22.6 per cent of the gemeprost group and here again abdominal pain was predominant. The results showed that with both sulprostone and gemeprost satisfactory dilatation of the cervix could be obtained. The somewhat better results with sulprostone are obtained at the expense of a higher incidence of side-effects. The administration of gemeprost was also better tolerated by the patients.

Abortion, Induced↗
PubMed1994

Effects of suppression by a progesterone-releasing intravaginal device and subsequent induction by GnRH of the preovulatory LH surge on follicular function in PMSG/PG-treated heifers.

After synchronization of oestrus, normally cyclic heifers (n = 31) received 2500 iu pregnant mares' serum gonadotrophin (PMSG) i.m. and had a progesterone-releasing intravaginal device (PRID) without the oestradiol capsule inserted on day 10 of the oestrous cycle and received 15 mg prostaglandin(PG) i.m. 48 h later. PRIDs were removed 96 h after insertion and 16 heifers received 1.0 mg GnRH i.m. while the controls (n = 15) received 10 ml saline i.m. All heifers were injected with anti-PMSG i.v. 10 later. Peripheral blood concentrations of PMSG, progesterone, oestradiol and LH were compared. Ovaries were collected on death 7 days after the GnRH or saline injection and the number of corpora lutea counted. Heifers were considered to have responded well (> 60 pmol l-1) or poorly (< 60 pmol l-1) to superovulation on the basis of the oestradiol concentration 24 h after PG administration. During PRID treatment, LH concentrations remained at basal values. In the heifers treated with GnRH, a single LH surge occurred 2.3 +/- 0.1 h (SD) after the GnRH injection with a maximum concentration of 14.6 +/- 2.3 (SEM) micrograms l-1 and a duration of 6-8 h. In 12 of the 15 control heifers, LH concentrations remained low (range 0.10-1.94 micrograms l-1) during the 72 h following the saline injection; three controls showed a spontaneous LH surge at 18, 23 and 23 h after the saline injection, respectively, with a maximum concentration of 6.0-12.5 micrograms l-1 and a duration of 10-12 h.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Intravaginal↗
PubMed2000

Evaluation of subchronic (13 weeks) and reproductive toxicity potential of intravaginal gel-microemulsion formulation of a dual-function phenyl phosphate derivative of bromo-methoxy zidovudine (compound WHI-05) in B(6)C(3)F(1) mice.

Heterosexual transmission of human immunodeficiency virus (HIV) accounts for 90% of all new infections worldwide and significantly contributes to new acquired immunodeficiency syndrome (AIDS) cases in the United States. In a systematic effort to develop a microbicidal contraceptive capable of preventing HIV transmission as well as providing fertility control, we previously identified novel phenyl phosphate derivatives of 3'-azido-3'-deoxythymidine (zidovudine) which exhibit potent anti-HIV and spermicidal activities. This study reports the preliminary preclinical study of our lead compound WHI-05, 5-bromo-6-methoxy-5, 6-dihydro-3'-azidothymidine-5'-(p-methoxyphenyl) methoxyalaninyl phosphate, for use as a dual-function topical microbicide. Acute toxicity studies have shown that WHI-05 has no detectable adverse effects on laboratory animals. The 13-week subchronic and reproductive toxicity potential of intravaginal gel-microemulsion formulation of WHI-05 were studied in mice to support its further development as a virucidal spermicide. Groups of 10 female B(6)C(3)F(1) mice were exposed intravaginally to a gel-microemulsion formulation containing 0%, 0.5%, 1.0%, or 2.0% WHI-05, 5 days/week for 13 consecutive weeks. On a molar basis, these concentrations represent 300 to 1200 times their in vitro spermicidal potency, and 1.5x10(4) to 6.1x 10(4) times their in vitro anti-HIV activity. After 13 weeks of intravaginal treatment, one half of treated mice were evaluated for toxicity, and the other half were mated with untreated males to evaluate potential reproductive and developmental effects. Repetitive intravaginal application of WHI-05 to yield a local concentration 6.1x10(4) times higher than its in vitro HIV IC(50) value and 1200 times higher than its spermicidal EC(50)96%), or pup development. These findings collectively show that the experimental dual-function anti-HIV and contraceptive agent, WHI-05, did not cause significant acute or subchronic and reproductive toxicity under the test conditions.

Acquired Immunodeficiency Syndrome↗
PubMed2006

Engineered vaginal lactobacillus strain for mucosal delivery of the human immunodeficiency virus inhibitor cyanovirin-N.

Women are at significant risk of human immunodeficiency virus (HIV) infection, with the cervicovaginal mucosa serving as a major portal for virus entry. Female-initiated preventatives, including topical microbicides, are urgently needed to help curtail the HIV/AIDS pandemic. Here we report on the development of a novel, live microbicide that employs a natural vaginal strain of Lactobacillus jensenii engineered to deliver the potent HIV inhibitor cyanovirin-N (CV-N). To facilitate efficient expression of CV-N by this bacterium, the L. jensenii 1153 genome was sequenced, allowing identification of native regulatory elements and sites for the chromosomal integration of heterologous genes. A CV-N expression cassette was optimized and shown to produce high levels of structurally intact CV-N when expressed in L. jensenii. Lactobacillus-derived CV-N was capable of inhibiting CCR5-tropic HIV(BaL) infectivity in vitro with a 50% inhibitory concentration of 0.3 nM. The CV-N expression cassette was stably integrated as a single copy into the bacterial chromosome and resolved from extraneous plasmid DNA without adversely affecting the bacterial phenotype. This bacterial strain was capable of colonizing the vagina and producing full-length CV-N when administered intravaginally to mice during estrus phase. The CV-N-producing Lactobacillus was genetically stable when propagated in vitro and in vivo. This work represents a major step towards the development of an inexpensive yet durable protein-based microbicide to block the heterosexual transmission of HIV in women.

Administration, Intravaginal↗
PubMed1997

Mucosal immunization with a DNA vaccine induces immune responses against HIV-1 at a mucosal site.

Mucosal immunity is the first defense system in protection against mucosal infection by sexually transmitted diseases and subsequent systemic dissemination of infection. Development of vaccines which can induce protective mucosal immunity would have great promise for preventing sexually transmitted diseases including AIDS. DNA vaccines have recently shown certain advantages over other types of vaccines in safety and elicitation of specific immune responses. We have hypothesized that direct delivery of a DNA plasmid coding the HIV-1 envelope (pcMN160) via mucosal routes will stimulate mucosal immunity against HIV-1. The expression of DNA plasmid inoculated intravaginally was detected in various tissues. Intravaginal inoculation of pcMN160 elicits production of vaginal immunoglobulins which specifically bind to the HIV-1 envelope and neutralize HIV-1 infectivity in vitro. These results indicate the feasibility of inducing mucosal immunity following mucosal inoculation of DNA vaccines. When coupled with systemic inoculation of appropriate DNA constructs, effective mucosal and systemic immunity may be generated.

AIDS Vaccines↗
PubMed1991

Failed induction of labor despite sequential prostaglandin E2 therapy.

Preinduction cervical ripening with prostaglandin E2 (PGE2) is useful in minimizing the chances for a failed induction of labor. The lack of sufficient cervical dilation despite PGE2 and oxytocin therapy is uncommon. This investigation was undertaken to determine reasons for any failed inductions in pregnancies with pregel Bishop scores 4 or lower and requiring delivery within 24 hours. Fifteen (12.1%) of 124 eligible patients had failed inductions despite two 2.5 mg intravaginal doses. A finding in all the failures was a very unfavorable cervix (pregel Bishop score 0 to 2). The need for preterm delivery (33 to 37 weeks) was a common finding in the presence of a very unfavorable cervix. The data suggest that complicated pregnancies requiring delivery within 24 hours and failing to respond to sequential PGE2 therapy in the presence of a very unfavorable cervix may benefit from cesarean section without a prolonged induction.

Administration, Intravaginal↗