Fawzia Hossain

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.

Comparison between Visual Inspection of Cervix and Cytology Based Screening Procedures in Bangladesh

BACKGROUND Cervical cancer continues to be a major problem in Bangladesh with approximately 18,000 new cases annually of which over 10,000 women die from it. Visual inspection of the cervix after 3-5% acetic acid (VIA) application is a simple and easy to learn method for cervical cancer screening, although cytology-based screening is more often applied in developed countries where it has successfully reduced the prevalence of cervical cancer. OBJECTIVE To compare the efficacy of VIA and cytology-based primary methods for cervical cancer screening in Bangladesh. MATERIALS AND METHODS This hospital based comparative study was conducted at the VIA centre and Colposcopy Clinic of Bangabandhu Sheikh Mujib Medical University (BSMMU) from October 2008 to October 2010. RESULTS Among 650 women, 74 (11.4%) were VIA+ve and 8 (1.2%) had abnormalities in their Pap smear reports. During colposcopy, 38 (7.7%) women had different grades of CIN and 4 (0.6%) had cervical cancer. The gold standard histology findings proved 20 women had CIN I, 14 had CIN II/II and 4 had cervical cancer. Among the 38 histology diagnosed abnormalities, VIA test could identify 30 abnormalities including two cervical cancers. However, Pap smear could detect only 8 cases of histological abnormalities (2 low grade and 6 had high grade lesion) and it missed all the cervical cancer cases. The sensitivity and specificity of VIA were 88.9% and 52.1%. The positive predictive value (PPV) and negative predictive value (NPV) were 41.0%, and 92.6% respectively. Moreover, the sensitivity, specificity, PPV and NPV of Pap smear were 33.3%, 95.8%, 75.0% and 79.3%, respectively. CONCLUSIONS VIA test should be used as the primary screening tool even with its low sensitivity and specificity in low resource countries like Bangladesh. False positive results may be greater, but overtreatment can be minimized by colposcopy evaluation of the VIA positive women.

Pattern and predictors of dyslipidemia in patients with type 2 diabetes mellitus

Dyslipidemia is a major risk factor for macro-vascular complications in patients with type 2 diabetes mellitus (T2DM). Present study explored pattern and predictors of dyslipidemia in Bangladeshi T2DM patients. The cross-sectional study is conducted among 366 consecutive eligible T2DM patients aged >30 years, BIRDEM diabetic hospital, during July-to-December 2010. Physical examination, diabetic profile, lipid profile and serum createnine was performed. Adjusted odds ratio and confidence limit were generated through binary logistic regression. Most frequent form (59.3%) of dyslipidemia is low HDL. Duration of T2DM is significantly correlated with TC (P<0.05), HDL (P<0.05) and LDL (P<0.05) in both male and female. Glycemic control in terms of HbA1c >7% appeared as predictor of dyslipidemia (P<0.01). Duration T2DM is associated with increased risk of having higher TC (P<0.05), LDL (P<0.05) and lower HDL (P<0.01) and does not seem to affect triglyceride (P>0.05). T2DM with comorbid hypertension seems to predict hyper tri-glyceridemia and lower HDL. Both TC-HDL ratio and LDL-HDL ratio appeared as good predictor of all four parameters of dyslipidemia (P<0.01). The characteristic features of diabetic dyslipidemia are low HDL, high triglyceride and LDL cholesterol level. Low HDL level is the most frequent type of abnormality. Poor glycemic control, prolonged duration, coexisting hypertension predicts dyslipidemia in T2DM.