Human Papillomavirus VaccinesNCT05932563
Study on the Epidemiological Characteristics of Female HPV Vaccination in China
An observational study of Human Papillomavirus Vaccines and Adverse Effect, run by Fujian Maternity and Child Health Hospital at 6 sites in China.
Trial summary
Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, studies have confirmed that carcinogenic HPV type continuous infection leads to higher incidence of condyloma acuminatum and… Read more about this study
- Who is it for?
- Ages 9 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Vaccines, Adverse Effect, Epidemiology
- Type of treatment
- Vaccines
- How many people
- 1,700 participants
- Where
- 6 sitesChina
- Study dates
- 1 Jan 2023to 31 Dec 2024
- 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 9 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women 9 to 45 years of age who have a sexual history and are about to receive their first dose of HPV vaccine, or have had HPV genotyping results for nearly 1 year before receiving HPV vaccine.
Who may be able to join
- -
- The retrospective cohort must meet the following conditions:
- HPV typing results before HPV vaccination;
- Willing to go to the main center of Fujian Provincial Maternal and Child Health Hospital or branch center for free examination.
- Prospective cohort population must meet the following conditions:
- Female, 9-45 years old (sexual life history);
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- In the next two years, I am willing to go to the main center of Fujian Provincial Maternal and Child Health Hospital or sub-centers for free check-ups;
- Will receive the first dose of HPV vaccine;
- There is no abnormal psychological or physical condition before HPV vaccination.
Who cannot join
- Subjects who have previously received another commercially available HPV vaccine, or participated in a clinical study of HPV vaccine, or participated in a clinical study of another vaccine within the past 6 months;
- Women who plan to become pregnant within the next two years;
- Are immune deficient or have been diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, SLE, rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune disease, and have received immunosuppressive therapy within the past 6 months;
- Subjects with a history of epilepsy, psychosis, medically treatable major depression, convulsions or convulsions, or subjects with a family history of psychosis;
- Subjects with spleen insufficiency, functional spleen insufficiency, and any disease that results in spleen insufficiency or splenectomy;
- During the follow-up period, they were not willing to return to the main center or sub-center of the Fujian Maternal and Child Health Hospital to collect cervical exuded cells and/or peripheral blood samples, such as 30-60 days or 12 months after the last HPV vaccination.
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- Pregnant or lactating women;
- Asexual life history;
- The investigator believes that there are other factors that are not suitable for participants to participate in clinical trials.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan
Yu Zhang
- Recruiting
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, 350001
Binhua Dong, +8613599071900, dbh18-jy@126.com
- Recruiting
Fujian Provincial Center for Disease Control and Prevention
Fuzhou, Fujian
Weiyi Pan
- Recruiting
Fuzhou Shanghai street community health Service center
Fuzhou, Fujian
Lanzhen Cheng
- Recruiting
Shenzhen Maternal and Child Health Hospital
Shenzhen, Guangdong
Zheng Zheng
- Recruiting
Hubei Maternal and Child HealthCare Hospital
Wuhan, Hubei
Hongning Cai
About this study
Official title: Study on the Epidemiological Characteristics of Female Different HPV Vaccination in China
Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, studies have confirmed that carcinogenic HPV type continuous infection leads to higher incidence of condyloma acuminatum and cervical cancer, while increasing the risk of oropharyngeal cancer, vaginal cancer and other related cancers. Human papillomavirus vaccines have been widely used worldwide to prevent cancers of the lower reproductive tract, such as cervical, anal and vulvar cancers. According to the type, it is divided into domestic two-valent (Vantage), imported two-valent (GlaxoSmithKline), four-valent (Merck) and nine-valent (Merck)HPV vaccines. All four vaccines prevent high-risk HPV 16/18 infection, and there are differences between the quadrivalent and nine-valent HPV vaccine prevention genotypes. The protection rate, immunizing target and immunizing procedure of different valence number are slightly different. Studies have shown that after women receive HPV vaccine, the incidence of arm redness, swelling, fever, pain and other adverse reactions is high, often accompanied by menstrual disorders, sleep problems, emotional irritability, fever, dizziness, headache and other adverse reactions. However, the causal relationship between HPV vaccination and symptoms after vaccination at different prices is controversial, and there is little research in this area. Therefore, we intend to design a multicenter, bidirectional cohort study to investigate the relationship between HPV vaccination with different valence numbers and adverse reactions after vaccination in Chinese women, and to further explore the unknown potential factors affecting the protective effect of HPV vaccine.
Read the detailed description
Based on the database with HPV typing results before HPV vaccination, this study will follow up the population's epidemiological characteristics such as adverse reaction symptoms after HPV vaccination through telephone or face to face, and collect 1 cervical exfoliated cell and 1 peripheral blood tube (5ml) for HPV genotyping detection and HPV neutralizing antibody detection. Meanwhile, participants were recruited in different regions of China for a period of three months. Follow-up was performed at the time of the first dose of HPV vaccine, 1 month after the third dose, and 12 months after the third dose. The corresponding questionnaire was filled in during enrollment and follow-up, and one cervical exfoliated cell was collected at each of the three follow-up visits for HPV genotyping. At the same time, the peripheral blood tubes were collected one month after the third injection to evaluate the effect of HPV vaccine neutralizing antibodies. The multi-center cohort study was conducted to explore the unknown potential factors affecting the protective effect of HPV vaccine, and the relationship between HPV vaccine with different price and adverse reactions after vaccination in Chinese women.
- Conditions
- Human Papillomavirus Vaccines, Adverse Effect, Epidemiology, China, Woman
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The HPV vaccine group | For retrospective cohort population: This study will be based on the database with HPV typing results before HPV vaccination, and the epidemiological characteristics such as adverse reaction symptoms after HPV vaccination in this population will be followed up by telephone or face-to-face, and 1 cervical exfoliated cell and 1 peripheral blood tube will be collected within 1-12 months after HPV vaccination. For the prospective cohort: All subjects will be enrolled at the time of the first dose of HPV vaccine, followed up 30-60 days after the last dose of HPV vaccine and 12 months after the last dose of HPV vaccine. One cervical exfoliated cell was collected at enrollment and two follow-up visits, and one peripheral blood tube was collected at 30-60 days follow-up after the last dose of HPV vaccine. | |
| Unvaccinated HPV group | Exfoliated cervical cells were collected to test for HPV genotyping, or HPV genotyping results had been available for nearly 1 year prior to enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Papillomavirus (HPV) genotyping tests
All participants were tested for human oncovirus (HPV) genotyping prior to the first dose of HPV vaccination
Measured: Baseline (Before the first dose of HPV vaccination)
Human Papillomavirus (HPV) genotyping tests
Prospective cohort subjects underwent Human Papillomavirus (HPV) genotyping tests at one month after the third dose of HPV vaccination
Measured: one month after the third dose of HPV vaccination
Human Papillomavirus (HPV) genotyping tests
Prospective cohort subjects underwent Human Papillomavirus (HPV) genotyping tests at 12-month after the third dose of HPV vaccination
Measured: 12-month after the third dose of HPV vaccination
HPV vaccine neutralizing antibody detection
Prospective cohort subjects were tested for neutralizing antibodies to the HPV vaccine at one month after the third dose of HPV vaccination
Measured: one month after the third dose of HPV vaccination
Human Papillomavirus (HPV) genotyping tests
Participants in the retrospective cohort were tested for human oncovirus (HPV) genotyping 1-12 months after the third dose of HPV vaccination
Measured: 1 to 12 months after the third dose of HPV vaccination
HPV vaccine neutralizing antibody detection
Participants in the retrospective cohort were tested for HPV vaccine neutralizing antibodies 1-12 months after the third dose of HPV vaccine
Measured: 1 to 12 months after the third dose of HPV vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binhua Dong, Fujian Maternity and Child Health Hospital
- Investigators
- Pengming Sun, PhD, Study chair, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932563
- Sponsor's protocol ID
- HVAC2301
- Status last verified
- Jun 2023
- First submitted
- 26 May 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Epidemiological Characteristics of Female Different HPV Vaccination in China
- ClinicalTrials.gov ID
- NCT05932563
- Acronym / sponsor ID
- HVAC2301
- Conditions
- Human Papillomavirus Vaccines, Adverse Effect, Epidemiology, China, Woman
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- Fujian Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jul 2023 (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.
Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, studies have confirmed that carcinogenic HPV type continuous infection leads to higher incidence of condyloma acuminatum and cervical cancer, while increasing the risk of oropharyngeal cancer, vaginal cancer and other related cancers. Human papillomavirus vaccines have been widely used worldwide to prevent cancers of the lower reproductive tract, such as cervical, anal and vulvar cancers. According to the type, it is divided into domestic two-valent (Vantage), imported two-valent (GlaxoSmithKline), four-valent (Merck) and nine-valent (Merck)HPV vaccines. All four vaccines prevent high-risk HPV 16/18 infection, and there are differences between the quadrivalent and nine-valent HPV vaccine prevention genotypes. The protection rate, immunizing target and immunizing procedure of different valence number are slightly different. Studies have shown that after women receive HPV vaccine, the incidence of arm redness, swelling, fever, pain and other adverse reactions is high, often accompanied by menstrual disorders, sleep problems, emotional irritability, fever, dizziness, headache and other adverse reactions. However, the causal relationship between HPV vaccination and symptoms after vaccination at different prices is controversial, and there is little research in this area. Therefore, we intend to design a multicenter, bidirectional cohort study to investigate the relationship between HPV vaccination with different valence numbers and adverse reactions after vaccination in Chinese women, and to further explore the unknown potential factors affecting the protective effect of HPV vaccine.
Detailed description
Based on the database with HPV typing results before HPV vaccination, this study will follow up the population's epidemiological characteristics such as adverse reaction symptoms after HPV vaccination through telephone or face to face, and collect 1 cervical exfoliated cell and 1 peripheral blood tube (5ml) for HPV genotyping detection and HPV neutralizing antibody detection. Meanwhile, participants were recruited in different regions of China for a period of three months. Follow-up was performed at the time of the first dose of HPV vaccine, 1 month after the third dose, and 12 months after the third dose. The corresponding questionnaire was filled in during enrollment and follow-up, and one cervical exfoliated cell was collected at each of the three follow-up visits for HPV genotyping. At the same time, the peripheral blood tubes were collected one month after the third injection to evaluate the effect of HPV vaccine neutralizing antibodies. The multi-center cohort study was conducted to explore the unknown potential factors affecting the protective effect of HPV vaccine, and the relationship between HPV vaccine with different price and adverse reactions after vaccination in Chinese women.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The HPV vaccine group | – | –For retrospective cohort population: This study will be based on the database with HPV typing results before HPV vaccination, and the epidemiological characteristics such as adverse reaction symptoms after HPV vaccination in this population will be followed up by telephone or face-to-face, and 1 cervical exfoliated cell and 1 peripheral blood tube will be collected within 1-12 months after HPV vaccination. For the prospective cohort: All subjects will be enrolled at the time of the first dose of HPV vaccine, followed up 30-60 days after the last dose of HPV vaccine and 12 months after the last dose of HPV vaccine. One cervical exfoliated cell was collected at enrollment and two follow-up visits, and one peripheral blood tube was collected at 30-60 days follow-up after the last dose of HPV vaccine. |
| Unvaccinated HPV group | – | –Exfoliated cervical cells were collected to test for HPV genotyping, or HPV genotyping results had been available for nearly 1 year prior to enrollment |
Who may qualify
- Ages
- 9 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women 9 to 45 years of age who have a sexual history and are about to receive their first dose of HPV vaccine, or have had HPV genotyping results for nearly 1 year before receiving HPV vaccine.
Key inclusion criteria (9 listed)
- -
- HPV typing results before HPV vaccination;
- Willing to go to the main center of Fujian Provincial Maternal and Child Health Hospital or branch center for free examination.
- Female, 9-45 years old (sexual life history);
- In the next two years, I am willing to go to the main center of Fujian Provincial Maternal and Child Health Hospital or sub-centers for free check-ups;
Key exclusion criteria (9 listed)
- Subjects who have previously received another commercially available HPV vaccine, or participated in a clinical study of HPV vaccine, or participated in a clinical study of another vaccine within the past 6 months;
- Women who plan to become pregnant within the next two years;
- Are immune deficient or have been diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, SLE, rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune disease, and have received immunosuppressive therapy within the past 6 months;
- Subjects with a history of epilepsy, psychosis, medically treatable major depression, convulsions or convulsions, or subjects with a family history of psychosis;
- Subjects with spleen insufficiency, functional spleen insufficiency, and any disease that results in spleen insufficiency or splenectomy;
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
Human Papillomavirus (HPV) genotyping tests
Time frame: Baseline (Before the first dose of HPV vaccination)
All participants were tested for human oncovirus (HPV) genotyping prior to the first dose of HPV vaccination
Human Papillomavirus (HPV) genotyping tests
Time frame: one month after the third dose of HPV vaccination
Prospective cohort subjects underwent Human Papillomavirus (HPV) genotyping tests at one month after the third dose of HPV vaccination
Human Papillomavirus (HPV) genotyping tests
Time frame: 12-month after the third dose of HPV vaccination
Prospective cohort subjects underwent Human Papillomavirus (HPV) genotyping tests at 12-month after the third dose of HPV vaccination
HPV vaccine neutralizing antibody detection
Time frame: one month after the third dose of HPV vaccination
Prospective cohort subjects were tested for neutralizing antibodies to the HPV vaccine at one month after the third dose of HPV vaccination
Human Papillomavirus (HPV) genotyping tests
Time frame: 1 to 12 months after the third dose of HPV vaccination
Participants in the retrospective cohort were tested for human oncovirus (HPV) genotyping 1-12 months after the third dose of HPV vaccination
HPV vaccine neutralizing antibody detection
Time frame: 1 to 12 months after the third dose of HPV vaccination
Participants in the retrospective cohort were tested for HPV vaccine neutralizing antibodies 1-12 months after the third dose of HPV vaccine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
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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.
Pengming Sun, PhD study chair
Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Vaccines and Adverse Effect, run by Fujian Maternity and Child Health Hospital at 6 sites in China.
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 9 inclusion and 9 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 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Binhua Dong (13599071900, dbh18-jy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Papillomavirus (HPV) genotyping tests (time frame: Baseline (Before the first dose of HPV vaccination)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.