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Randomized Controlled Trial
. 2012 Jan;42(1):36-41.
doi: 10.1093/jjco/hyr173.

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

Sabera Khatun  1 , Syed Md Akram Hussain, Sameena Chowdhury, Jannatul Ferdous, Fawzia Hossain, Sultana Razia Begum, Munira Jahan, Shahina Tabassum, Shahla Khatun, A B M Fazlul Karim
Affiliations
Randomized Controlled Trial

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

Sabera Khatun et al. Jpn J Clin Oncol. 2012 Jan.

Abstract

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.

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Figures

Figure 1.
Figure 1.
Age distribution of vaccine and control groups.
Figure 2.
Figure 2.
Distribution of level of education of vaccinated and control groups.
Figure 3.
Figure 3.
Percentage of one or more adverse effects by doses.
Figure 4.
Figure 4.
Percentage of adverse effect in subjects after first dose.
Figure 5.
Figure 5.
Percentage of adverse effect in subjects after second dose.
Figure 6.
Figure 6.
Percentage of adverse effect in subjects after third dose.
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