Safety, tolerability and immunogenicity of a Haemophilus influenzae type b vaccine containing aluminum phosphate adjuvant administered at 2, 3 and 4 months of age

The primary aim of this study was to assess the tolerability and immunogenicity of a new Haemophilus influenzae type b (Hib)/AlPO4 (CHIRON, SpA) vaccine, in two-month-old healthy infants. Twenty-three subjects were enrolled and administered the new Hib vaccine containing AlPO4 adjuvant at two, three and four months of age concomitantly with diphtheria-pertussis-tetanus (DPT) and hepatitis B vaccines according to the local program. Children were observed for 30 minutes after each immunization for any immediate local and systemic reactions. An active surveillance for side effects was performed on the 2nd and 7th days following each immunization by telephone. Families also filled out diaries for the first seven days. From the 2nd day to the next immunization only data about adverse events necessitating a physician's visit or about serious adverse events were collected. Blood samples were obtained before the first immunization and one month after the third dose for evaluation of anti-polyribosylribitol phosphate (PRP) antibody response. Local reactions at the Hib site were mild and less frequent compared to those observed at the DPT site. Systemic reactions noted after the three immunizations were fever in 70 percent, irritability in 48 percent, persistent crying in 26 percent, change in eating habits in 22 percent, diarrhea in 17 percent, sleepiness in 17 percent, vomiting in 9 percent, and unusual crying in 4 percent of the cases. There was no serious adverse event. One hundred percent and 95 percent of children achieved an anti-PRP antibody response over 0.15 microg/ml and 1.0 microg/ml, respectively. The geometric mean titer was 15 microg/ml and the geometric mean ratio 84. It was concluded that the new (Hib)/AlPO4 vaccine is safe and well tolerated, and induced a good PRP antibody response in healthy two-month-old infants.     

Effect of aluminum adjuvants on safety and immunogenicity of Haemophilus influenzae type b-CRM197 conjugate vaccine

OBJECTIVE: The present study was carried out to evaluate the safety and immunogenicity of the Haemophilus influenzae type b-CRM197 (Hib-CRM197) conjugate vaccine in relation to the change of adjuvant from aluminum hydroxide to aluminum phosphate (AlPO4). METHODS: The present study was a clinical phase II, observer-blind, randomized, multicenter, controlled study. Subjects were healthy infants aged 6-12 weeks, eligible for expanded program of immunization (EPI) routine vaccination and admitted to Hacettepe University Department of Social Pediatrics and Gülveren Health Center, Ankara. A total of 520 healthy infants were randomized in a 2:2:1 ratio to receive at either Chiron Hib/AlPO4 vaccine or VaxemHib (aluminum hydroxide adjuvant) vaccine or HibTiter (no adjuvant). Vaccines were administered simultaneously with routine diphtheria, tetanus and pertussis (DTaP) and oral polio vaccine (OPV) vaccines at 2, 4 and 6 months of age. Blood samples for anti-plain polysaccharide (PRP) antibody measurement were collected before the first vaccination and 1 month after the last vaccination. After each vaccination parents filled out a diary for 7 days. RESULTS: Out of 520 subjects enrolled, 514 received three doses and were included for safety analysis. Local and systemic reactions occurred with low and similar frequencies in all groups. Only erythema was more common in Chiron Hib/AlPO4 vaccine (19, 10, 11% in Chiron Hib/AlPO4, VaxemHib and HibTiter, respectively, P < 0.05). Nine serious adverse events were reported in seven cases of which none were related to vaccines. A total of 504 subjects were included in the immunogenicity analysis. The three vaccines were highly immunogenic and equivalent in terms of percentage of acquisition of long-term protective levels. The anti-PRP geometric mean titers were 9.9, 8.3 and 5.14 micro g/mL, respectively (P < 0.05). CONCLUSIONS: The use of aluminum compounds adjuvants in Hib-CRM197 conjugate vaccines does not impact the safety profile, while it does increase the magnitude of anti-PRP antibody titers.     

Effect of postpartum counseling on postpartum contraceptive use

Objective The aim of this study was to evaluate the effect of postpartum counseling on postpartum contraceptive use. Methods One hundred and forty-three women who delivered between 1 January 2004 and 31 September 2004 and counseled about postpartum contraception were included in the study. The participants were interviewed by telephone. Age, gravidity, parity, and mode of delivery of the participants were recorded. Their method of contraception before pregnancy, their decision on the contraceptive method after counseling and the method actually used were asked. Results Just after postpartum counseling, 47 women (32.9%) decided to use the intrauterine device (IUD), 23 (16.1%) condoms, 16 (11.2%) progestin injections, 7 (4.9%) oral contraceptives, and 7 (4.9%) coitus interruptus for contraception. Thirty-six women (25.2%) did not decide on any method of use. At the time of the telephone interview the actual method used was learned. Fifty-one women (35.7%) were using coitus interruptus, 45 women (31.5%) condoms, and 14 (9.8%) the IUD. Sixteen women (11.2%) were reported as not using any methods. Conclusion In spite of postpartum counseling, a high majority of the women appeared to use traditional and less effective contraceptive methods.     

Effects of neuronal and inducible NOS inhibitor 1-[2-(trifluoromethyl) phenyl] imidazole (TRIM) in unpredictable chronic mild stress procedure in mice

Nitric oxide is an intracellular messenger which is involved in several functions and pathologies such as depression, anxiety, learning and memory. In many studies nitric oxide synthase inhibitors (NOSI) were shown to possess antidepressant-like effects in animal models of depression. The aim of this study is to investigate the effects of a selective neuronal and inducible nitric oxide synthase inhibitor TRIM (30 mg/kg/day, 35 days) in mice subjected to unpredictable chronic mild stress and then compare it's effect with a conventional selective serotonin reuptake inhibitor fluoxetine (15 mg/kg/day, 35 days). Stressed vehicle animals showed a significant disturbed coat state when compared with nonstressed animals and this effect was reversed by TRIM or fluoxetine. Both TRIM and fluoxetine prevented the stress-induced deficit in the grooming behaviour in the splash test. TRIM and fluoxetine also significantly decreased the attack frequency when compared to the stressed control group in the resident-intruder test. These results support the assumption that NOS inhibitors can be a new class of antidepressant drugs possibly acting on neuronal NOS.     

Intra-Left Atrial Mechanical Delay Detected by Tissue Doppler Echocardiography Can Be a Useful Marker for Paroxysmal Atrial Fibrillation

Objectives: There are some clinical and echocardiographic parameters to predict paroxysmal atrial fibrillation (PAF), but more sensitive predictors are needed. Tissue Doppler imaging may be a sensitive method for this purpose. Methods: Thirty-four patients with PAF and 31 control subjects were studied. Time intervals from the beginning of P-wave to beginning of A-wave from lateral and septal mitral and right ventricular tricuspid annuli in tissue Doppler imaging were recorded. The differences between these intervals gave the mechanical delays between/within the corresponding atria. Results: There were no differences between groups with regard to age. PAF patients were found to have increased left atrial dimension and intra-left atrial mechanical delay. Twenty-five milliseconds was calculated as cutoff value to predict PAF. P-wave dispersion was found to be increased in PAF. Conclusions: This study shows an increase in intra-left atrial mechanical delay in PAF patients. This method can be used as an early marker to detect PAF.     

Evaluation of penile hemodynamic status and adjustment of treatment alternatives in Peyronie's disease

Aim: Erectile dysfunction may be observed in up to 80% of patients with Peyronie's disease. An objective evaluation of the erectile function is attempted to work out in patients with Peyronie's disease. Methods: Penile deformity, sexual function and penile vascular status were analyzed in 123 patients with Peyronie's disease, who had not received any pertinent treatment. Results: Penile deformity, palpable plaque and pain on erection were seen in 112 (91%), 97(78.8%) and 27 (21.9%) of the 123 patients, respectively. Of the 76 patients evaluated by color Doppler ultrasounography, veno-occlusive dysfunction as the vascular component for erectile dysfunction was found in 17 (22.3%), arterial insufficiency in 10(13.1%) and a mixed picture in 23 (30.2%). Conclusion: The documentation of penile erectile function and the determination of the vascular status using color Doppler ultrasonography can guide the appropriate therapeutic choice.     

Isolated Septum Pellucidum Agenesis in an Adult

Septum pellucidum agenesis is frequently associated with other cerebral malformations. Its isolated agenesis is quite rare. In the literature, all reported cases were diagnosed in early childhood. The authors present an unusual case of isolated septum pellucidum agenesis detected in adulthood with computed tomography and magnetic resonance imaging.     

The effects of acute phase proteins on serum albumin,transferrin and haemoglobin in haemodialysis patients

In the present study, the effects of C-reactive protein (CRP) and ferritin on serum albumin, transferrin and haemoglobin (Hb) were assessed to investigate the relationship between inflammation, hypoalbuminaemia and anaemia in haemodialysis patients. A total of 117 patients who were followed at three haemodialysis units in Kocaeli were enrolled. The mean age was 47.83 +/- 16.85 years. The median time on dialysis was 26 (minimum 1, maximum 209) months. Serum CRP albumin and ferritin concentrations were measured in our laboratory and transferrin, urea reduction ratio (URR) and Kt/V were calculated. There was significant inverse correlation between serum CRP level and albumin (p<0.001), serum CRP and Hb (p<0.001), and serum transferrin and ferritin (p<0.05). There was significant positive correlation between serum albumin and Hb (p<0.001), serum CRP and ferritin (p<0.05), and transferrin and URR (p<0.05). Our findings suggest that inflammation is a contributor in the development of hypoalbuminaemia and anaemia in haemodialysis patients as well as malnutrition and inadequate dialysis.     

Effects of hyperbaric oxygen therapy on distraction osteogenesis

Investigators in the present study explored the effects of hyperbaric oxygen (HBO) therapy on distraction osteogenesis in a rabbit limb-lengthening model. HBO treatment was provided to participants in a small animal pressure chamber once a day during the latent period of distraction osteogenesis at 2.5 absolute atmospheres of pressure. Bone mineral density measurements were obtained through torsional testing. The control group received no HBO treatment. Animals were killed 8 wk postoperatively for biomechanical testing. There was a statistically significant increase in bone mineral density in the HBO group compared with that in the non-HBO group, but no statistically significant differences were observed between biomechanical parameters of the 2 groups. The investigators suggest that these results must be further studied through histologic examination to determine the stepwise effects of HBO during and after collagen synthesis.