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.     

The best management of superficial bladder tumours: Comparing TUR alone versus TUR combined with intravesical chemotherapy modalities?

To compare retrospectively the recurrence rates of TUR alone versus different intravesical chemotherapy modalities in superficial bladder cancer cases, 187 patients with stage Ta and T₁ bladder tumours were treated with transurethral resection followed by adjuvant intravesical chemotherapy with mitomycin, BCG or epirubicin or by transurethral resection alone. All patients in this study had historically proven transurethrally resectable primary, category Ta and T₁ transitional cell carcinoma (TCC) of the bladder. Group I included transurethral resection alone, and the other groups included intravesical mitomycin-C(Group II), BCG (Group III) and epirubicin (Group IV) therapies after transurethral resection. 146 male and 41 female patients (78% male and 22% female patients) in this study were diagnosed as primary TCC bladder tumours. Only 52 of them were stage Ta and 135 of them were stage T₁ bladder tumours. Examining the histological grade of the bladder tumours, 88 (47%) of the patients had grade I, 53 (28%) had grade IIa, 30 (16%) had grade IIb and remaining 16 (9%) had grade III bladder cancers. The recurrence rates were 25% for Group I, 23.8% for Group II, 26.2% for Group III and 22.7% for Group IV. These values were given with disregarding the grade and volume of the bladder tumours. For solitary, less than 3 cm low grade tumours (grade I, IIa) recurrence rates were 16% for Group I, 15.4% for Group II, 17.8% for Group III, 17.2% for Group IV (p> 0.05). As a result of this retrospective study, for patients with low grade, stage Ta and T₁ tumours TUR alone may be the best treatment modality. Although intravesical chemotherapy is effective in decreasing short-term incidences of tumour recurrence, it has not decreased long-term incidences of tumour recurrence. The high cost and adverse side effects of intravesical chemotherapy should also be taken into consideration in superficial, single, low grade tumours of bladder. This revised version was published online in August 2006 with corrections to the Cover Date.     

Performing Testicular or Epididymal Sperm Retrieval Prior to the Injection of hCG

Purpose: Our purpose was to determine the feasibility and efficacy of performing testicular or epididymal sperm retrieval prior to the injection of human chorionic gonadotropin (hCG). Methods: This report deals with 87 sperm-positive percutaneous epididymal sperm aspiration (PESA), percutaneous testicular sperm aspiration (PTSA), or testicular sperm extraction (TESE) cycles. All sperm retrieval procedures were performed prior to administration of hCG to the women. Retrieved spermatozoa were cultured in vitro in simple medium for approximately 40 hr prior to intracyto-plasmic sperm injection. Results: In all but one cycle in which TESE was performed for nonobstructive azoospermia, motile sperm were available for ICSI. The overall fertilization rate was 53%. Pregnancy rate per transfer and implantation rate per embryo were 41.2 and 15.7%, respectively. Conclusions: Satisfactory fertilization and pregnancy rates can be achieved when PESA, PTSA, or TESE is performed prior to the injection of hCG followed by in vitro culture of spermatozoa approximately 40 hr before ICSI. Scheduling of testicular or epididymal sperm retrieval cases in this way appears to ease the workload on laboratory and operating room personnel. Furthermore, withholding hCG when sperm is absent may obviate the unnecessary risk of ovarian hyperstimulation when spermatozoa cannot be retrieved.     

Complementary findings in clinical and epidemiologic features of mumps and mumps meningoencephalitis in children without mumps vaccination

BACKGROUND: Mumps vaccine has not yet been included in the routine vaccination programme, for this reason mumps is still one of the most common infections for children in Turkey. One of the major complication of mumps is meningoencephalitis, which although usually heals spontaneously, it may cause neurologic complications. METHODS: This study was undertaken to investigate epidemiologic and demographic characteristics in children with mumps and mumps meningoencephalitis and clinical/laboratory findings in children with mumps meningoencephalitis diagnosed over a 11 year period. A total of 2422 mumps and 135 mumps meningoencephalitis cases were covered in this study which constitutes one of the largest series of mumps meningoencephalitis in the literature. The mean age of mumps and mumps meningoencephalitis cases were 6.6 +/- 2.7 and 7.6 +/- 2.6 years, respectively. RESULTS: There was a male predominance both among the cases of mumps and mumps meningoencephalitis. The age and seasonal distributions were similar in the mumps and mumps meningoencephalitis groups. The most common symptoms of mumps meningoencephalitis were fever (97%), vomiting (94%) and headache (88.8%). The mean cerebrospinal fluid (CSF) total cell count and lymphocyte count were 540 +/- 460/mm(3) and 300 +/- 330/mm(3), respectively. The mean CSF protein and glucose levels were found to be 56.97 +/- 27.94 mg/dL and 53.67 +/- 15.46 mg/dL, respectively. The mean of CSF/blood glucose ratio was 0.53 +/- 0.16. The mean duration of hospitalization in mumps meningoencephalitis cases was found to be 5.1 +/- 2.4 days and this was longer in boys (P < 0.05). CONCLUSION: In patients with mumps meningoencephalitis, higher CSF protein levels and lower CSF glucose/blood glucose ratio were associated with longer hospitalization periods. There was no death.     

The long-term effects of low-dose 17beta-estradiol and dydrogesterone hormone replacement therapy on 24-h ambulatory blood pressure in hypertensive postmenopausal women: a 1-year randomized, prospective study.

OBJECTIVE: The aim of this study was to assess the long-term effects of low-dose oral hormone replacement therapy (HRT) on 24-h blood pressure in hypertensive postmenopausal women. STUDY DESIGN: In this 12-month, prospective study, 66 postmenopausal women with mild or moderate hypertension were randomly assigned to receive either HRT with 1 mg/day micronized 17beta-estradiol sequentially combined with 10 mg/day dydrogesterone for 14 days of each 28-day cycle, or no therapy. Ambulatory blood pressure measurements were recorded for a 24-h period at baseline and after 12 months of treatment or follow-up. RESULTS: Blood pressure did not differ significantly between the groups at baseline. After 12 months, there were falls in 24-h systolic, diastolic and mean arterial blood pressure in both the HRT and control groups; only the fall in mean arterial blood pressure in the HRT group achieved statistical significance (-2.0 +/- 0.8 mmHg, p < 0.01). While there was no significant decrease in daytime systolic or mean arterial blood pressure in either group, a significant decrease in diastolic blood pressure (-1.8 +/- 10 mmHg, p < 0.001) was observed in the HRT group. Night-time systolic and mean arterial blood pressure also decreased significantly (p < 0.001) in the HRT group (-3.0 +/- 1.5 mmHg and -2.2 +/- 0.6 mmHg, respectively), but no significant change was observed in the control group. Conclusion: Low-dose oral HRT caused significant falls in both daytime and night-time ambulatory blood pressure in postmenopausal women with mild or moderate hypertension.     

Erratum to: Evaluation of cardiac functions in juvenile systemic lupus erythematosus with two-dimensional speckle tracking echocardiography

Clinical Rheumatology -