Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04671823
Status:
UNKNOWN
Last Update Posted:
2020-12-23
First Post:
2020-12-11
Brief Title:
Changes in the Prevalence of Oncogenic HPV Types
Sponsor:
Kanazawa Medical University
Organization:
Kanazawa Medical University
Study Overview
Official Title:
Changes in the Prevalence of Oncogenic HPV Types After Introduction of Prophylactic HPV Vaccine Program in Japan
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In Japan nationwide prophylactic HPV vaccination was implemented in 2010 a bivalent vaccine was given from 2010 to 2012 and a quadrivalent vaccine from 2012 However the program essentially ceased in June 2013
1 Our first objective is to examine the prevalence of 6 11 16 18 31 33 45 52 and 58 targeted by the nonavalent HPV vaccine in young Japanese women and identify changes in the prevalence of these HPV types from 2011- 2012 as reported in JHERS-2016 Sasagawa T J Med Virol 2016 to the present time 2020-2021 Especially the investigators will focus on the prevalence of HPV16 and 18 in women aged 21-26 years and compare these data to those of the previous study
2 The investigators will assess the prevalence of HPV16 and 18 in women aged 16-18 years and compare these data to those of the HPV vaccine era 2010-2013
3 The investigators will explore the prevalence of other high-risk HPV types 35 39 51 56 59 and 68 11 probable high-risk types 26 3034 53 66 67 69 70 73 82 and 85 and SILs in Japanese young women since these types might be causative HPV types for cervical cancer in the future after world-wide HPV vaccination
Currently it is unclear whether HPV vaccination has reduced the prevalence of HPV16 and 18 in Japan Our previous study JHERS-2016 performed during 2011-2012 Sasagawa T J Med Virol 2016 the only population-based study on HPV prevalence at the commencement of prophylactic HPV vaccination in Japan included prevalence data for HPV types 6 11 16 and 18 and the associated cervical abnormalities The investigators hypothesize that the prevalence of HPV16 and 18 and the associated diseases SILs decreased significantly in women aged 21-26 years in the present vaccinated group compared to that in similar aged women in 2010-2012 who were unvaccinated In contrast the prevalence of HPV and associated diseases may not differ in women aged 27-39 years between the two eras such subjects may thus serve as a negative control group Also HPV prevalence may be higher in present women aged 16-18 years than in women in that age range during the vaccine era as the former group have not been vaccinated against HPV
The prevalence rates of the other unique high-risk types namely HPV35 39 51 56 59 and 68 and probable high-risk types HPV26 20 34 53 66 67 67 70 73 82 and 85 are unlikely to have been affected by HPV vaccination However it is important to monitor the prevalences of these types and the associated SILs because the types numbered above may become more significant as currently common HPV types are eliminated in the near future
1 Our first objective is to examine the prevalence of 6 11 16 18 31 33 45 52 and 58 targeted by the nonavalent HPV vaccine in young Japanese women and identify changes in the prevalence of these HPV types from 2011- 2012 as reported in JHERS-2016 Sasagawa T J Med Virol 2016 to the present time 2020-2021 Especially the investigators will focus on the prevalence of HPV16 and 18 in women aged 21-26 years and compare these data to those of the previous study
2 The investigators will assess the prevalence of HPV16 and 18 in women aged 16-18 years and compare these data to those of the HPV vaccine era 2010-2013
3 The investigators will explore the prevalence of other high-risk HPV types 35 39 51 56 59 and 68 11 probable high-risk types 26 3034 53 66 67 69 70 73 82 and 85 and SILs in Japanese young women since these types might be causative HPV types for cervical cancer in the future after world-wide HPV vaccination
Currently it is unclear whether HPV vaccination has reduced the prevalence of HPV16 and 18 in Japan Our previous study JHERS-2016 performed during 2011-2012 Sasagawa T J Med Virol 2016 the only population-based study on HPV prevalence at the commencement of prophylactic HPV vaccination in Japan included prevalence data for HPV types 6 11 16 and 18 and the associated cervical abnormalities The investigators hypothesize that the prevalence of HPV16 and 18 and the associated diseases SILs decreased significantly in women aged 21-26 years in the present vaccinated group compared to that in similar aged women in 2010-2012 who were unvaccinated In contrast the prevalence of HPV and associated diseases may not differ in women aged 27-39 years between the two eras such subjects may thus serve as a negative control group Also HPV prevalence may be higher in present women aged 16-18 years than in women in that age range during the vaccine era as the former group have not been vaccinated against HPV
The prevalence rates of the other unique high-risk types namely HPV35 39 51 56 59 and 68 and probable high-risk types HPV26 20 34 53 66 67 67 70 73 82 and 85 are unlikely to have been affected by HPV vaccination However it is important to monitor the prevalences of these types and the associated SILs because the types numbered above may become more significant as currently common HPV types are eliminated in the near future
Detailed Description:
Recently HPV prevalence has decreased dramatically in the USA Markowitz LE Pediatrics 2019 Surprisingly the nonavalent vaccine optimally decreased the prevalence of the most common high-risk HPV types and also reduced the incidence of premalignant cervical lesions Mariani L Int J Gynaecol Obstet 2017 The data thus suggest that both the bivalent and quadrivalent HPV vaccines eliminate HPV16- and 18-associated cervical cancers
Regrettably in Japan use of the bivalent and quadrivalent prophylactic HPV vaccines almost ceased by government decree in June 2013 Hanley JBS Lancet 2015 However about 70 of girls aged 13-18 years were immunized with these vaccines during 2010-2012 A small decrease in cervical intraepithelial neoplasia grade 3 CIN3 has been observed in 20-year-old Japanese women who underwent HPV vaccination Yagi A Vaccine 2019The investigators recently found nationwide unpublished data suggesting that the incidence of condyloma has decreased in Japanese women aged in their early twenties but has apparently increased in males The decrease in women may be attributable to quadrivalent HPV vaccination which protects against HPV6 and 11 infections Further work is necessary as statistical analysis is lacking and the proportion of quadrivalent vaccinations among all vaccinations is unknown in Japan
The investigators earlier reported a high prevalence of HPV infection and associated cervical abnormalities in 6628 women aged 16-50 years The work was performed from October 2011 to March 2012 and was reported in JHERS-2016 Sasagawa T J Med Virol 2016 The investigators recorded demographic information including age marital status any history of or current sexually transmitted disease STD any cervical abnormalities and any other gynecological problems HPV genotyping 31 types and the Pap test were performed for all subjects This is the only study that has investigated HPV prevalence and cervical SILs in the general population The information collected included sexual details and any history of HPV vaccination Routine gynecological examination the Pap test employing liquid-based cytology LBC and HPV genotyping of LBC samples were performed These data allow us to compare the status of women in the vaccine and present no-vaccine era
It is possible to essentially eliminate cervical cancer by implementation of nanovalent HPV vaccination and careful cancer screening HPV testing However some specialists suggest that reductions in certain HPV types might induce increases in other HPV types that are not targeted by vaccination and not tested during cancer screening Not only the existing 13 high-risk HPV types but also other HPV types considered to probably or possibly associated with high risk are found in some cervical cancer tissues Halec G J Pathology 2014 The investigators also found such HPV types in high-grade SILs as reported in JHERS-2016 Sasagawa T J Med Virol 2016 and a recent publication Sakamoto J Papillomavirus Res 2019 Therefore in the present project the investigators will document the prevalence of all oncogenic HPV types including the 13 recognized high-risk types and the probable high-risk types HPV26 30 34 53 66 67 69 70 73 82 and 85
Regrettably in Japan use of the bivalent and quadrivalent prophylactic HPV vaccines almost ceased by government decree in June 2013 Hanley JBS Lancet 2015 However about 70 of girls aged 13-18 years were immunized with these vaccines during 2010-2012 A small decrease in cervical intraepithelial neoplasia grade 3 CIN3 has been observed in 20-year-old Japanese women who underwent HPV vaccination Yagi A Vaccine 2019The investigators recently found nationwide unpublished data suggesting that the incidence of condyloma has decreased in Japanese women aged in their early twenties but has apparently increased in males The decrease in women may be attributable to quadrivalent HPV vaccination which protects against HPV6 and 11 infections Further work is necessary as statistical analysis is lacking and the proportion of quadrivalent vaccinations among all vaccinations is unknown in Japan
The investigators earlier reported a high prevalence of HPV infection and associated cervical abnormalities in 6628 women aged 16-50 years The work was performed from October 2011 to March 2012 and was reported in JHERS-2016 Sasagawa T J Med Virol 2016 The investigators recorded demographic information including age marital status any history of or current sexually transmitted disease STD any cervical abnormalities and any other gynecological problems HPV genotyping 31 types and the Pap test were performed for all subjects This is the only study that has investigated HPV prevalence and cervical SILs in the general population The information collected included sexual details and any history of HPV vaccination Routine gynecological examination the Pap test employing liquid-based cytology LBC and HPV genotyping of LBC samples were performed These data allow us to compare the status of women in the vaccine and present no-vaccine era
It is possible to essentially eliminate cervical cancer by implementation of nanovalent HPV vaccination and careful cancer screening HPV testing However some specialists suggest that reductions in certain HPV types might induce increases in other HPV types that are not targeted by vaccination and not tested during cancer screening Not only the existing 13 high-risk HPV types but also other HPV types considered to probably or possibly associated with high risk are found in some cervical cancer tissues Halec G J Pathology 2014 The investigators also found such HPV types in high-grade SILs as reported in JHERS-2016 Sasagawa T J Med Virol 2016 and a recent publication Sakamoto J Papillomavirus Res 2019 Therefore in the present project the investigators will document the prevalence of all oncogenic HPV types including the 13 recognized high-risk types and the probable high-risk types HPV26 30 34 53 66 67 69 70 73 82 and 85
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None