Safety and Immunogenicity Profile of Human Papillomavirus-16/18 AS04 Adjuvant Cervical Cancer Vaccine: A Randomized Controlled Trial in Healthy Adolescent Girls of Bangladesh

Abstract

AimBangladesh 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.ProcedureThis 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.ResultsFifty 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.ConclusionsThe 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.

Immunogenicity and safety of human papillomavirus (HPV) vaccination in Asian populations from six countries: a meta-analysis

“…Most of the studies (N = 7) provided their clinical trial registration numbers (31)(32)(33)(34)(35)38,39). In addition, almost all studies (N = 9) included only women (30)(31)(32)(33)(34)(35)(36)38,39). In general, the age of participants in the studies varied considerably from 9 to 45 years.…”

Adverse events following school-based vaccination of girls with quadrivalent human papillomavirus vaccine in Slovenia, 2009 to 2013

“…The bivalent vaccine (Cervarix), containing VLP antigens for HPV types 16 and 18, was licensed for preventing precancerous cervical lesions and cervical cancer [1,2] in September 2007. In February 2015, the nine-valent HPV vaccine (Gardasil 9), containing four HPV VLPs that are in the qHPV (6,11,16, and 18) plus five additional HPV VLP types (31,33, 45, 52, and 58), was recommended for approval in Europe for use in the prevention of cervical, vulvar, vaginal, and anal cancer, genital warts and precancerous lesions of the cervix, vulva, vagina, and anus [3]. Neither of the vaccines protect against HPV types for which the individual is already seropositive at the time of vaccination [4].…”

“…The most common AEFI was injectionrelated local reaction [8,9]. Fever, nausea, vomiting, dizziness, myalgia and diarrhoea were the most commonly reported systemic symptoms [8,10,11]. Severe AEFIs, such as severe headache with hypertension and bronchospasm were described in 0.5% [8].…”

Human Papilloma Virus Vaccine: Future of Cervical Cancer Prevention

“…4 In another study that led to approval of Gardasil and Cervarix, these vaccines were found t o p r ovide nearly 1 0 0% p r otection against persistent cervical infections with HPV types 16 and 18 and t he cervical cell changes t hat these persistent infections can cause. 21 A clinical trial of Gardasil in men indicated that it can prevent anal cell changes caused by persistent infection and genital warts. 22 Although these two vaccines give 5-year protection, long-term studies of vaccine efficacy t hat are still in p r ogress will help scientists b e tter understand t he total duration of protection.…”