Cervical CancerNCT06776055
Long-term Follow-up of Bivalent Human Papillomavirus (HPV) Vaccine Study in Women
An observational study of Cervical Cancer and Vulvar Cancer, run by Shanghai Zerun Biotechnology Co.,Ltd at 9 sites in China.
Trial summary
This extension study aims to evaluate the long-term protection and immune response of the bivalent HPV vaccine in women aged 18-30 who participated in a previous efficacy study (311-HPV-1003). Participants will be monitored over two years, with two visits at 96 and 120 months after their initial vaccination. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Vulvar Cancer, Vaginal Cancer
- What is being tested?
- HPV-16/18 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,372 participants
- Where
- 9 sitesChina
- Study dates
- 27 Mar 2023to Jun 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants in this long-term follow-up study were originally enrolled in the 311-HPV-1003 study and are drawn from multiple clinical sites across four provinces in China, including Guangxi, Hebei, Henan, and Shanxi. These participants represent a community-based sample of healthy women who received at least one dose of the Bivalent HPV vaccine or Placebo during the original study.
Who may be able to join
- Have the ability to understand and provide informed consent by signing the informed consent form (non-illiterate).
- Have the ability to comply with protocol requirements, such as attending scheduled visits and responding to follow-up phone calls.
- Prior enrollment in the 311-HPV-1003 study, with at least one dose of the study vaccine administered.
- At least one documented gynecological visit between 6 and 48 months during the previous 311-HPV-1003 study.
- Refrain from vaginal intercourse for 48 hours and avoid behaviors such as vaginal douching or using vaginal medications that could interfere with gynecological examinations or sample collection for 72 hours prior to each gynecological visit.
Who cannot join
- Participants who received another HPV vaccine during the prior 311-HPV-1003 study or between the end of that study and enrollment in this extension study.
- Participants diagnosed with HPV 16- or 18-related CIN2+ by an independent pathology expert panel during the prior 311-HPV-1003 study, or who were definitively diagnosed with HPV 16- or 18-related CIN2+ through external testing after the prior study ended.
- Participants who, at baseline in the 311-HPV-1003 study, tested positive for both HPV 16 and 18 antibodies, or were positive for both HPV 16 and 18 (by Cobas 4800), or whose cytology was not normal or of low-grade changes.
- Participants who are pregnant at the time of gynecological visits or within three months prior to the visit.
- Participants with any other factors deemed unsuitable for participation in the clinical trial, as determined by the investigator.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Daming Center for Disease Control and Prevention
Daming, Hebei
Dingxing Center for Disease Control and Prevention
Dingxing, Hebei
Lingchuan Center for Disease Control and Prevention
Lingchuan, Guangxi
Puyang Center for Disease Control and Prevention
Puyang, Henan
Quanzhou Center for Disease Control and Prevention
Quanzhou, Guangxi
Wenxian Center for Disease Control and Prevention
Wenquan, Henan
Xiangfen County People's Hospital
Xincheng, Shanxi
Xing'an Center for Disease Control and Prevention
Xing’an, Guangxi
Zhengding Center for Disease Control and Prevention
Zhengding, Hebei
About this study
Official title: A Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Protective Efficacy and Immunogenic Persistence of the Bivalent Human Papillomavirus Vaccine (Pichia Pastoris) Administered to Healthy Females Aged 18-30 During the 311-HPV-1003 Study
This extension study aims to evaluate the long-term protection and immune response of the bivalent HPV vaccine in women aged 18-30 who participated in a previous efficacy study (311-HPV-1003). Participants will be monitored over two years, with two visits at 96 and 120 months after their initial vaccination. No additional vaccine doses will be given. Cervical samples will be obtained for ThinPrep Cytologic Testing (TCT) and HPV DNA typing. If applicable, participants meeting referral criteria for colposcopy will undergo the procedure during these visits, and tissue samples will be collected from those requiring a biopsy. Blood samples will be drawn from an immunology subset for antibody testing.The study includes data collection from multiple sites across China to assess the vaccine's long-term efficacy in preventing HPV-related cervical diseases and its durability over time.
- Conditions
- Cervical Cancer, Vulvar Cancer, Vaginal Cancer, CIN - Cervical Intraepithelial Neoplasia, Human Papillomavirus Infection
- Being tested
- HPV-16/18 vaccine, Placebo
- Keywords
- Bivalent HPV vaccine, Long-term protective efficacy
- Medical subject headings
- Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Uterine Cervical Dysplasia, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV-16/18 vaccineBiological
Recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast)
PlaceboBiological
Placebo containing the same formulation as the active vaccine (Type 16 and 18 L1 proteins, Yeast) but without the active substance.
| Study group | Role | What they receive |
|---|---|---|
| HPV-2 vaccine group | Participants received the bivalent HPV vaccine (0.5 mL in a 3-dose regimen) in the base study (NCT02733068). No study vaccination will be administered in long-term follow-up study . Receives: Biological: HPV-16/18 vaccine | |
| Placebo group | Participants received the placebo (0.5 mL in a 3-dose regimen) in the base study (NCT02733068). No study vaccination will be administered in long-term follow-up study . Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Protective Efficacy Against HPV-16 and/or HPV-18-Related Cervical Intraepithelial Neoplasia (CIN) Grade 2 or Higher (CIN2+), Adenocarcinoma In Situ (AIS), and Cervical Cancer
Measured: Up to 96 months and 120 months after initial vaccination in base study.
Secondary outcomes (3)
Cumulative protective efficacy against cytological HPV-16 and/or HPV-18 infection
Measured: Up to 96 months and 120 months after initial vaccination in base study.
Cumulative protective efficacy against HPV-16 and/or HPV-18-related CIN1+
Measured: Up to 96 months and 120 months after initial vaccination in base study.
HPV 16/18 neutralizing antibody GMT and seropositivity rates
Measured: At 96 months and 120 months after initial vaccination in base study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start27 Mar 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- Prospective
- Enrolment
- 5,372 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yuxi Zerun Biotechnology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776055
- Sponsor's protocol ID
- 311-HPV-1003-EXTEND
- Other IDs
- 311-HPV-1003-EXTEND
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Protective Efficacy and Immunogenic Persistence of the Bivalent Human Papillomavirus Vaccine (Pichia Pastoris) Administered to Healthy Females Aged 18-30 During the 311-HPV-1003 Study
- ClinicalTrials.gov ID
- NCT06776055
- Acronym / sponsor ID
- 311-HPV-1003-EXTEND
- Conditions
- Cervical Cancer, Vulvar Cancer, Vaginal Cancer, CIN - Cervical Intraepithelial Neoplasia, Human Papillomavirus Infection
- Keywords
- Bivalent HPV vaccine, Long-term protective efficacy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,372 participants (actual)
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Yuxi Zerun Biotechnology Co., Ltd.
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 15 Jan 2025 (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.
This extension study aims to evaluate the long-term protection and immune response of the bivalent HPV vaccine in women aged 18-30 who participated in a previous efficacy study (311-HPV-1003). Participants will be monitored over two years, with two visits at 96 and 120 months after their initial vaccination. No additional vaccine doses will be given. Cervical samples will be obtained for ThinPrep Cytologic Testing (TCT) and HPV DNA typing. If applicable, participants meeting referral criteria for colposcopy will undergo the procedure during these visits, and tissue samples will be collected from those requiring a biopsy. Blood samples will be drawn from an immunology subset for antibody testing.The study includes data collection from multiple sites across China to assess the vaccine's long-term efficacy in preventing HPV-related cervical diseases and its durability over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV-2 vaccine group | – | Biological: HPV-16/18 vaccineParticipants received the bivalent HPV vaccine (0.5 mL in a 3-dose regimen) in the base study (NCT02733068). No study vaccination will be administered in long-term follow-up study . |
| Placebo group | – | Biological: PlaceboParticipants received the placebo (0.5 mL in a 3-dose regimen) in the base study (NCT02733068). No study vaccination will be administered in long-term follow-up study . |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants in this long-term follow-up study were originally enrolled in the 311-HPV-1003 study and are drawn from multiple clinical sites across four provinces in China, including Guangxi, Hebei, Henan, and Shanxi. These participants represent a community-based sample of healthy women who received at least one dose of the Bivalent HPV vaccine or Placebo during the original study.
Key inclusion criteria (5 listed)
- Have the ability to understand and provide informed consent by signing the informed consent form (non-illiterate).
- Have the ability to comply with protocol requirements, such as attending scheduled visits and responding to follow-up phone calls.
- Prior enrollment in the 311-HPV-1003 study, with at least one dose of the study vaccine administered.
- At least one documented gynecological visit between 6 and 48 months during the previous 311-HPV-1003 study.
- Refrain from vaginal intercourse for 48 hours and avoid behaviors such as vaginal douching or using vaginal medications that could interfere with gynecological examinations or sample collection for 72 hours prior to each gynecological visit.
Key exclusion criteria (5 listed)
- Participants who received another HPV vaccine during the prior 311-HPV-1003 study or between the end of that study and enrollment in this extension study.
- Participants diagnosed with HPV 16- or 18-related CIN2+ by an independent pathology expert panel during the prior 311-HPV-1003 study, or who were definitively diagnosed with HPV 16- or 18-related CIN2+ through external testing after the prior study ended.
- Participants who, at baseline in the 311-HPV-1003 study, tested positive for both HPV 16 and 18 antibodies, or were positive for both HPV 16 and 18 (by Cobas 4800), or whose cytology was not normal or of low-grade changes.
- Participants who are pregnant at the time of gynecological visits or within three months prior to the visit.
- Participants with any other factors deemed unsuitable for participation in the clinical trial, as determined by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV-16/18 vaccineRecombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast) | Biological | HPV-2 vaccine group |
| PlaceboPlacebo containing the same formulation as the active vaccine (Type 16 and 18 L1 proteins, Yeast) but without the active substance. | Biological | Placebo group |
Primary outcome
Cumulative Protective Efficacy Against HPV-16 and/or HPV-18-Related Cervical Intraepithelial Neoplasia (CIN) Grade 2 or Higher (CIN2+), Adenocarcinoma In Situ (AIS), and Cervical Cancer
Time frame: Up to 96 months and 120 months after initial vaccination in base study.
3 secondary outcomes
Cumulative protective efficacy against cytological HPV-16 and/or HPV-18 infection
Time frame: Up to 96 months and 120 months after initial vaccination in base study.
Cumulative protective efficacy against HPV-16 and/or HPV-18-related CIN1+
Time frame: Up to 96 months and 120 months after initial vaccination in base study.
HPV 16/18 neutralizing antibody GMT and seropositivity rates
Time frame: At 96 months and 120 months after initial vaccination in base study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Vulvar Cancer, run by Shanghai Zerun Biotechnology Co.,Ltd at 9 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Protective Efficacy Against HPV-16 and/or HPV-18-Related Cervical Intraepithelial Neoplasia (CIN) Grade 2 or Higher (CIN2+), Adenocarcinoma In Situ (AIS), and Cervical Cancer (time frame: Up to 96 months and 120 months after initial vaccination in base study.). 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 15 Jan 2025.