Papillomavirus VaccinesNCT04671823
Changes in the Prevalence of Oncogenic HPV Types
An observational study of Papillomavirus Vaccines and Papillomavirus Infections, run by Kanazawa Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Vaccines, Papillomavirus Infections
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 39 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Japanese women (aged 16-39 years) who seek cervical cancer screening or gynecological consultations.
Who may be able to join
- Japanese women who seek cervical cancer screening or gynecological consultations
- Women with benign conditions
- 16-39 year-old
- Women must be sexually experienced, as defined by sexual contact (oral-genital or genital-genital) with at least one male or female partner.
Who cannot join
- Women with STDs
- Women with premalignant lesions of the cervicovaginal tract
- Women suffering from any cancer
- Women with any severe acute or chronic disease, and/or psychological problems
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Changes in the Prevalence of Oncogenic HPV Types After Introduction of Prophylactic HPV Vaccine Program in Japan
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.
- 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.
- 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).
- 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, 30,34, 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.
Read more
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.
Read the 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, 2019).The 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 6,628 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).
- Conditions
- Papillomavirus Vaccines, Papillomavirus Infections
- Keywords
- Human Papillomavirus, Papillomavirus Vaccines, Papillomavirus Infections
- Medical subject headings
- Papillomavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of HPV types targeted by the nonavalent HPV vaccine
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study startDec 2020 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Papillomavirus VaccinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanazawa Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Toshiyuki Sasagawa, Kanazawa Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671823
- Sponsor's protocol ID
- I547
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sasagawa T, Maehama T, Ideta K, Irie T; Fujiko Itoh J-HERS Study Group. Population-based study for human papillomavirus (HPV) infection in young women in Japan: A multicenter study by the Japanese human papillomavirus disease education research survey group (J-HERS). J Med Virol. 2016 Feb;88(2):324-35. doi: 10.1002/jmv.24323.
PubMed 26147986
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Prevalence of Oncogenic HPV Types After Introduction of Prophylactic HPV Vaccine Program in Japan
- ClinicalTrials.gov ID
- NCT04671823
- Acronym / sponsor ID
- I547
- Conditions
- Papillomavirus Vaccines, Papillomavirus Infections
- Keywords
- Human Papillomavirus, Papillomavirus Vaccines, Papillomavirus Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Kanazawa Medical UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Dec 2020 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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).
- 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, 30,34, 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, 2019).The 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 6,628 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Japanese women (aged 16-39 years) who seek cervical cancer screening or gynecological consultations.
Key inclusion criteria (4 listed)
- Japanese women who seek cervical cancer screening or gynecological consultations
- Women with benign conditions
- 16-39 year-old
- Women must be sexually experienced, as defined by sexual contact (oral-genital or genital-genital) with at least one male or female partner.
Key exclusion criteria (4 listed)
- Women with STDs
- Women with premalignant lesions of the cervicovaginal tract
- Women suffering from any cancer
- Women with any severe acute or chronic disease, and/or psychological problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of HPV types targeted by the nonavalent HPV vaccine
Time frame: 12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Background: PubMed 26147986Sasagawa T, Maehama T, Ideta K, Irie T; Fujiko Itoh J-HERS Study Group. Population-based study for human papillomavirus (HPV) infection in young women in Japan: A multicenter study by the Japanese human papillomavirus disease education research survey group (J-HERS). J Med Virol. 2016 Feb;88(2):324-35. doi: 10.1002/jmv.24323.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillomavirus Vaccines and Papillomavirus Infections, run by Kanazawa Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Toshiyuki Sasagawa (+81-76-218-8143, tsasa@kanazawa-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of HPV types targeted by the nonavalent HPV vaccine (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04671823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.