Safety and immunogenicity profile of human papillomavirus-16/18 AS04 adjuvant cervical cancer vaccine: a randomized controlled trial in healthy adolescent girls of Bangladesh.

AIM: Bangladesh has the highest level of incidence and mortality rates due to cervical cancer among women. The prevalence of cervical cancer in Bangladeshi women is 25-30/100,000. Human papillomavirus is an important cause of cervical cancer. The study was conducted to assess the immunogenicity and safety profile of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccines in healthy Bangladeshi girls aged 9-13 years. Procedure This was a randomized (3:1) controlled trial with two parallel groups, the vaccine and control groups, that included 67 participants in Bangladesh. Subjects were given GlaxoSmithKline human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine (and controls no vaccine) at the first day of vaccination (Day 0), at 1- and 6-month schedule and followed up until 7 months. Blood samples were taken for human papillomavirus antibody at enrollment and 1 month post-schedule at Month 7 from both subjects and controls. Safety data were gathered throughout the study period. RESULTS: Fifty subjects received vaccine at Day 0, 1 month and 6 months. All subjects were initially sero-negative in the vaccine group, and developed sero-conversion for human papillomavirus-16 and -18 antibodies except for one at Month 7. Seventeen controls did not receive vaccine. Clients were followed up for serious medically important events and blood samples were taken for human papillomavirus antibody detection at Day 0 and Month 7. Sero-conversion was found in 97.5% of subjects and no sero-conversion was found in the controls. Bivalent human papillomavirus vaccine was generally well tolerated, with no vaccine-related serious adverse experiences. CONCLUSIONS: The human papillomavirus-16/18 AS04-adjuvanted vaccine was generally well tolerated and highly immunogenic when administered to young adolescent females and could be a promising tool for the prevention and control of cervical cancer in Bangladesh.

Serum vitamin E, C and A status in pre-eclampsia and eclampsia patients, and their correlation with blood pressure: a study in Dhaka, Bangladesh.

The aim of this study was to determine serum concentrations of vitamin E, C and A in pre-eclampsia and eclampsia patients, and to analyse their relationship with blood pressure. It was a cross-sectional case controlled study comprising forty-four pre-eclampsia, fifty eclampsia, and thirty-five normo-tensive pregnant women of singleton gestations in their third trimester from two hospitals in Dhaka, Bangladesh. HPLC and spectrophotometric methods were employed to determine the serum concentrations of vitamin E, A, and C. SPSS software package was used to analyse the data. Serum vitamin C was found to be significantly higher (F=6.266, p=0.003) in the pre-eclampsia group than in the pregnant control and eclampsia groups, while serum vitamin E and A in patients and control did not differ significantly. Vitamin C levels in the pre-eclampsia group were found to be influenced by their maternal age (F(2,41)=3.197, p=0.05), and found to be positively related to the maternal age (r =0.250 and p=0.106). In the pre-eclampsia group, vitamin E showed a positive significant relationship with systolic pressure (beta coefficient= 0.303, P=0.052, R2=0.101) and diastolic pressure (beta co-efficient=0.459, P=0.002, R2=0.211). In the eclampsia group, vitamin C showed a negative significant relationship with systolic blood pressure (beta co-efficient=-0.502, P=0.000, R2=0.302) but in the case of diastolic pressure, the relationship was reversed (beta co-efficient=0.443, P=0.001, R2=0.237).