Prevaccination Study of Cervical Human Papillomavirus Types in Yangtze River Delta Area, China
NCT ID: NCT01487681
Last Updated: 2011-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
4000 participants
OBSERVATIONAL
2011-11-30
2013-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Prevalence of HPV infection varies considerably across the world, and data were limited from less-developed countries. Knowledge of the detail pattern of HPV type-specific distribution in each region will be essential for public health policy decisions. This will also form the basis for determining which types should be included in future generation HPV vaccines targeted to specific regions.
While most studies were focus on ICC and high-grade cervical lesions, the association between HPV types and the progression of CIN1 has rarely been studied. CIN1 is an insensitive histopathological sign of HPV infection, most of which will spontaneously regress to normal with host immune system. However, some genotypes have been described as being more persistent and associated with progression from low-grade lesions to high-grade lesions, even ICC. Geographical data on type-specific prevalence of HPV in CIN1 with appropriately designed prospective studies would be helpful in identifying types preferentially associated with progression to malignancy and accurately predicting the future impact of vaccination in specific regions.
Free vaccination supported by the government appears to be unlikely at present in China. Thus, individuals need to pay the cost of vaccines for themselves presently. Yangtze River Delta Area is the most economically developed regions in China, and people here may become the largest vaccinated population at their own expense in China. To the best of the investigators knowledge, no multi-center study on HPV type-specific distribution and their associations with ICC and its precursors is available in Yangtze River Delta Area, China, which highlights the need for timely study in this region before large scale vaccination programs are carried out.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Currently, two prophylactic vaccines, a quadrivalent (Gardasil®, Merck \& Co. Inc) and a bivalent (Cervarix™, GlaxoSmithKline) vaccine, are employed for the prevention of genital HPV infection in more than 100 countries, and showed high efficacy for the prevention of target HPV related CIN2+. Merck is also conducting a Phase III trial of a vaccine protecting against nine types. As the prophylactic efficacy is type-restricted and not all the different types of HPV are covered by currently available vaccines, determining the type-specific HPV distribution and their associations with ICC and its precursors would provide essential information in assessment of HPV vaccination program impact. What is more, it is possible that the decrease in the prevalence of the target types of these vaccines could affect the distribution of other types, so the baseline information is also important for monitoring possible changes in type-specific HPV distribution after vaccination has been introduced.
Previous meta-analyses had showed that in ICC, HPV 16 was most common, followed by HPV 18, while HPV 16/18 prevalence was 52% among high-grade cervical lesions. However, the prevalence of HPV infection varies considerably across the world, and data were limited from less-developed countries, let alone multi-center studies. Knowledge of the detail pattern of HPV type-specific distribution in each region will be essential for public health policy decisions. This will also form the basis for determining which types should be included in future generation HPV vaccines targeted to specific regions. A tailed HPV vaccine according to regional prevalence would best serve the population in primary prevention for ICC.
On the other side, while most studies were focus on ICC and high-grade cervical lesions, the association between HPV types and the progression of CIN1 has rarely been studied. CIN1 is an insensitive histopathological sign of HPV infection, most of which will spontaneously regress to normal with host immune system. However, some genotypes have been described as being more persistent and associated with progression from low-grade lesions to high-grade lesions, even ICC. Geographical data on type-specific prevalence of HPV in CIN1 with appropriately designed prospective studies would be helpful in identifying types preferentially associated with progression to malignancy and accurately predicting the future impact of vaccination in specific regions.
Recently, a randomized, double-blind trial testing the safety and efficacy of the quadrivalent vaccine (Gardasil®, Merck \& Co. Inc) in Chinese women (V501-041-00) has been conducting and is proposed to be finished in three years. The bivalent vaccine (Cervarix™, GlaxoSmithKline) also has applied the phase III double-blind, randomized controlled trial in Chinese women. These prophylactic vaccines might be licensed and commercially available in China after trials finish. However, free vaccination supported by the government appears to be unlikely at present according to current economic status of China. Thus, individuals at least presently need to pay the cost of vaccines for themselves.
Yangtze River Delta Area, including Shanghai city, Zhejiang Province and Jiangsu Province, is the most economically developed regions in China. According to media report, the total GDP in Yangtze River Delta area was approximated 1.064 trillion U.S. dollars in 2010, and the per capita GDP has exceeded 4,000 U.S. dollars since 2005. As people here have the highest health awareness and needs, they may become the largest vaccinated population at their own expense in China. To the best of our knowledge, no multi-center study on HPV type-specific distribution and their associations with ICC and its precursors is available in Yangtze River Delta Area, China, except for the mono-center study in Zhejiang Province, which highlights the need for timely study in this region before large scale vaccination programs are carried out.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Invasive cervical cancer
No interventions assigned to this group
Cervical intraepithelial neoplasia 2/3
No interventions assigned to this group
Cervical intraepithelial neoplasia 1
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xing Xie, MD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xing Xie, MD
Professor of Obstetrics and Gynecology，Director of Women's hospital, School of medicine, Zhejiang University
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xing Xie, Professor
Role: STUDY_DIRECTOR
Women's Hospital School Of Medicine Zhejiang University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Women's hospital, School of medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Xing Xie, Professor
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IISP 40192
Identifier Type: -
Identifier Source: org_study_id