Cervical Cancer PreventionNCT07530679

Study on the Safety, Humoral Immune Response, and Memory B Cell Response Characteristics of Sequential 9-Valent HPV Vaccination

A study testing 9-valent HPV vaccination at months 0 and 6 and 9-valent HPV vaccination at months 0 , 1 and 6 in people with Cervical Cancer Prevention, run by Jiangsu Province Centers for Disease Control and Prevention.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

This is a single-center, prospective, open-label, partially randomized, matched-controlled trial designed as a cohort study. The study plans to enroll 360 healthy female participants aged 18 to 45 years, divided into three groups: a three-dose sequential group, a two-dose sequential group, and a primary immunization… Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cervical Cancer Prevention
What is being tested?: 9-valent HPV vaccination at months 0 and 6 and 9-valent HPV vaccination at months 0 , 1 and 6
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 360 participants
Where: No sites listed yet
Study dates: 12 Apr 2026to 31 Dec 2028
Phase: Interventional
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 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

1. Female volunteers, aged 18-45 years at the time of receiving the first trial vaccine dose;
2. Volunteers (and their legal guardians) are able to understand the study procedures and are capable of complying with protocol requirements (such as collecting biological samples, filling out diary cards, and attending follow-up visits on schedule), and have signed the informed consent form;
3. Adult female volunteers agree not to plan a pregnancy and to use effective contraception within 8 months after completing the first dose, or are women who have undergone tubal ligation, subtotal hysterectomy for benign lesions, or removal of benign ovarian tumors;
For participants in the sequential group, the following additional criteria must be met:
4. Previously completed the full three-dose schedule of XinKeNing, XiRuiShi, and WoZeHui [full three-dose schedule is defined as completing the second and third doses within 12 months after the first dose];
5. The interval between the last dose of XinKeNing, XiRuiShi, or WoZeHui and the enrollment date is ≥ 12 months.

Who cannot join

1. Axillary temperature > 37.0°C;
2. Positive urine pregnancy test in adult female volunteers, or being currently pregnant or breastfeeding;
3. Use of any other investigational or unregistered product (drug or vaccine) within 30 days prior to study vaccination, or planned use of other investigational or unregistered products or participation in another clinical study during the study period;
4. Long-term (continuous for more than 14 days) use of immunosuppressants or other immunomodulatory medications within 6 months prior to vaccination. Systemic administration of corticosteroid medications is excluded, while topical use (e.g., ointments, eye drops, inhalers, or nasal sprays) is permitted;
5. Use of immunoglobulins and/or blood products within 3 months prior to vaccination, or planned use within 7 months after the first dose, with the exception of emergency post-exposure use of tetanus immunoglobulin and rabies immunoglobulin;
6. Receipt of an inactivated vaccine within 7 days, or a live vaccine within 14 days, prior to study vaccination;

Show all 14Show fewer

7. Experienced fever (axillary temperature ≥38.0°C) within 3 days prior to vaccination, or any serious acute illness requiring systemic antibiotic or antiviral therapy within the past 5 days, or taken medication containing antipyretic ingredients within the past 24 hours;
8. Previous vaccination with any HPV vaccine other than Cecolin, Cervarix, or Walvax;
9. Suffering from severe immunodeficiency diseases, severe primary diseases of vital organs, cancer (or precancerous lesions), autoimmune diseases (including systemic lupus erythematosus, rheumatoid arthritis, immunodeficiency caused by asplenia or splenectomy due to any reason, and other autoimmune diseases considered by the investigator to potentially affect the immune response);
10. History of severe allergies, including severe adverse reactions to previous vaccinations such as anaphylactic shock, acute urticaria, dyspnea, angioedema, or allergy to any component of the study vaccine (aluminum adjuvant, polysorbate, sodium dihydrogen phosphate, disodium hydrogen phosphate);
11. Asthma that has been unstable in the past two years, requiring emergency treatment, hospitalization, oral or intravenous corticosteroids;
12. Coagulation abnormalities or bleeding disorders;
13. Epilepsy, excluding febrile seizures under 2 years of age, alcohol-related seizures in the 3 years prior to abstinence, or simple epilepsy that has not required treatment in the past 3 years;
14. Any medical, psychological, social, occupational, or other conditions that, in the judgment of the investigator after reviewing the volunteer's medical history and relevant physical examination, may interfere with the conduct of the clinical study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mingwei Wei contact

#86-25-83759912

jscdc_wmw@163.com

About this study

Official title: A Study on the Safety, Humoral Immune Response, and Memory B Cell Response Characteristics of Sequential Vaccination With 9-Valent Human Papillomavirus Vaccine (Escherichia Coli) and Bivalent HPV 16/18 Vaccine

As blinding is not feasible in this study, a prospective, open-label, partially randomized, controlled trial design is adopted. A combination of randomized and non-randomized (i.e., partially randomized) enrollment methods is used to balance study feasibility with intergroup comparability.

Participants in the three-dose sequential group and the primary immunization group will receive one dose of the nine-valent HPV vaccine at months 0, 1, and 6, while those in the two-dose sequential group will receive the nine-valent HPV vaccine at months 0 and 6. Before the second and third doses, investigators must confirm that participants do not meet the criteria for early withdrawal or for postponement of the second and third doses. After each vaccination, a 30-minute safety observation will be conducted at the vaccination site to monitor for adverse events (AEs). Subsequently, the study visit procedures will be followed, including collection of solicited AEs within 7 days post-vaccination, unsolicited AEs within 30 days, and serious AEs (SAEs) throughout the study period. Participants will also complete other scheduled study visits, including safety observations and immunogenicity blood sampling at various time points before and after vaccination.

The study aims to evaluate the immune response characteristics and safety of sequential vaccination with different doses of the nine-valent HPV vaccine (three doses at 0, 1, 6 months and two doses at 0, 6 months) in healthy female participants who have previously completed vaccination with the bivalent HPV vaccine.

Conditions: Cervical Cancer Prevention
Being tested: 9-valent HPV vaccination at months 0 and 6, 9-valent HPV vaccination at months 0 , 1 and 6

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

9-valent HPV vaccination at months 0 and 6Biological
Administer the 9-valent HPV vaccine at month 0 and month 6 according to the immunization schedule
9-valent HPV vaccination at months 0 , 1 and 6Biological
Administer the 9-valent HPV vaccine at month 0, 1 and month 6 according to the immunization schedule

Study groups in NCT07530679
Study group	Role	What they receive
Two-dose sequential vaccination group	Experimental	Individuals with prior 2-valent HPV vaccination will receive 2 sequential 9-valent doses at months 0, and 6. Receives: Biological: 9-valent HPV vaccination at months 0 and 6
Three-dose sequential vaccination group	Experimental	Individuals with prior 2-valent HPV vaccination will receive 3 sequential 9-valent doses at months 0, 1, and 6 Receives: Biological: 9-valent HPV vaccination at months 0 , 1 and 6
Primary immunization group	Active comparator	Individuals with no history of HPV vaccination will receive three doses of the 9-valent HPV vaccine according to the 0, 1, 6-month schedule Receives: Biological: 9-valent HPV vaccination at months 0 , 1 and 6

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric mean concentrations (GMC) of neutralizing antibody levels against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58;
Measured: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
Incidence of adverse reactions/events within 7 days after each dose of vaccination;
Measured: Within 7 days after each dose of vaccination

Secondary outcomes (13)

Neutralizing antibody positive for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Measured: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
Seroconversion rates for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Measured: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
IgG binding antibody GMC for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Measured: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
IgG binding antibody positivity rates for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Measured: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
IgG binding antibody seroconversion rates for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Measured: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
Neutralizing antibody GMC for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Measured: 1 Month post-dose 2 (i.e., 2 months after the first dose; 3-dose sequential & primary groups) and 1 Month post-dose 1 (i.e., 1 month after the first dose; 2-dose sequential group)
Neutralizing antibody Positivity rates for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Measured: 1 Month post-dose 2 (i.e., 2 months after the first dose; 3-dose sequential & primary groups) and 1 Month post-dose 1 (i.e., 1 month after the first dose; 2-dose sequential group)
Neutralizing antibody seroconversion rates for HPV 6, 11,16, 18, 31, 33, 45, 52, 58
Measured: 1 Month post-dose 2 (3-dose sequential & primary groups) and 1 Month post-dose 1(2-dose sequential group)
IgG binding antibody GMC for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Measured: 1 Month post-dose 2 (i.e., 2 months after the first dose; 3-dose sequential & primary groups) and 1 Month post-dose 1 (i.e., 1 month after the first dose; 2-dose sequential group)
IgG binding antibody positivity rates for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Measured: 1 Month post-dose 2 (i.e., 2 months after the first dose; 3-dose sequential & primary groups) and 1 Month post-dose 1 (i.e., 1 month after the first dose; 2-dose sequential group)
IgG binding antibody seroconversion rates for HPV 6, 11, 16,18, 31, 33,45, 52, 58
Measured: 1 Month post-dose 2 (i.e., 2 months after the first dose; 3-dose sequential & primary groups) and 1 Month post-dose 1 (i.e., 1 month after the first dose; 2-dose sequential group)
Incidence of adverse events within 30 days after each dose of vaccination
Measured: within 30 days after each dose of vaccination
Incidence of serious adverse events throughout the study period, as well as pregnancy events and outcomes
Measured: through study completion, an average of 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Apr 202631 Dec 2028

First posted15 Apr 2026
Study start12 Apr 2026 (estimated)
Primary completion30 Jun 2027 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cervical Cancer PreventionStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 360 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07530679
Sponsor's protocol ID: JSVCT-ZL06
Status last verified: Apr 2026
First submitted: 1 Apr 2026
Last updated: 15 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Mingwei Wei

#86-25-83759912

jscdc_wmw@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Recruiting
Use Misoprostol to Optimize Prevention of Cervical Cancer
Cervical Cancers
Recruiting
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS7 Zimbabwe
HIV (Human Immunodeficiency Virus), HPV

All Cervical Cancer Prevention trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study on the Safety, Humoral Immune Response, and Memory B Cell Response Characteristics of Sequential Vaccination With 9-Valent Human Papillomavirus Vaccine (Escherichia Coli) and Bivalent HPV 16/18 Vaccine
ClinicalTrials.gov ID: NCT07530679
Acronym / sponsor ID: JSVCT-ZL06
Conditions: Cervical Cancer Prevention
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 360 participants (estimated)
Lead sponsor: Jiangsu Province Centers for Disease Control and PreventionResearch network
Study start: 12 Apr 2026 (estimated)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 15 Apr 2026 (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.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Two-dose sequential vaccination group	Experimental	Biological: 9-valent HPV vaccination at months 0 and 6Individuals with prior 2-valent HPV vaccination will receive 2 sequential 9-valent doses at months 0, and 6.
Three-dose sequential vaccination group	Experimental	Biological: 9-valent HPV vaccination at months 0 , 1 and 6Individuals with prior 2-valent HPV vaccination will receive 3 sequential 9-valent doses at months 0, 1, and 6
Primary immunization group	Active comparator	Biological: 9-valent HPV vaccination at months 0 , 1 and 6Individuals with no history of HPV vaccination will receive three doses of the 9-valent HPV vaccine according to the 0, 1, 6-month schedule

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

1. Female volunteers, aged 18-45 years at the time of receiving the first trial vaccine dose;
2. Volunteers (and their legal guardians) are able to understand the study procedures and are capable of complying with protocol requirements (such as collecting biological samples, filling out diary cards, and attending follow-up visits on schedule), and have signed the informed consent form;
3. Adult female volunteers agree not to plan a pregnancy and to use effective contraception within 8 months after completing the first dose, or are women who have undergone tubal ligation, subtotal hysterectomy for benign lesions, or removal of benign ovarian tumors;
4. Previously completed the full three-dose schedule of XinKeNing, XiRuiShi, and WoZeHui [full three-dose schedule is defined as completing the second and third doses within 12 months after the first dose];
5. The interval between the last dose of XinKeNing, XiRuiShi, or WoZeHui and the enrollment date is ≥ 12 months.

Key exclusion criteria (14 listed)

1. Axillary temperature > 37.0°C;
2. Positive urine pregnancy test in adult female volunteers, or being currently pregnant or breastfeeding;
3. Use of any other investigational or unregistered product (drug or vaccine) within 30 days prior to study vaccination, or planned use of other investigational or unregistered products or participation in another clinical study during the study period;
4. Long-term (continuous for more than 14 days) use of immunosuppressants or other immunomodulatory medications within 6 months prior to vaccination. Systemic administration of corticosteroid medications is excluded, while topical use (e.g., ointments, eye drops, inhalers, or nasal sprays) is permitted;
5. Use of immunoglobulins and/or blood products within 3 months prior to vaccination, or planned use within 7 months after the first dose, with the exception of emergency post-exposure use of tetanus immunoglobulin and rabies immunoglobulin;

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
9-valent HPV vaccination at months 0 and 6Administer the 9-valent HPV vaccine at month 0 and month 6 according to the immunization schedule	Biological	Two-dose sequential vaccination group
9-valent HPV vaccination at months 0 , 1 and 6Administer the 9-valent HPV vaccine at month 0, 1 and month 6 according to the immunization schedule	Biological	Primary immunization group, Three-dose sequential vaccination group

Primary outcome

Geometric mean concentrations (GMC) of neutralizing antibody levels against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58;
Time frame: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
Incidence of adverse reactions/events within 7 days after each dose of vaccination;
Time frame: Within 7 days after each dose of vaccination

13 secondary outcomes

Neutralizing antibody positive for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Time frame: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
Seroconversion rates for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Time frame: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
IgG binding antibody GMC for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Time frame: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
IgG binding antibody positivity rates for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Time frame: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
IgG binding antibody seroconversion rates for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Time frame: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
Neutralizing antibody GMC for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Time frame: 1 Month post-dose 2 (i.e., 2 months after the first dose; 3-dose sequential & primary groups) and 1 Month post-dose 1 (i.e., 1 month after the first dose; 2-dose sequential group)
Neutralizing antibody Positivity rates for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Time frame: 1 Month post-dose 2 (i.e., 2 months after the first dose; 3-dose sequential & primary groups) and 1 Month post-dose 1 (i.e., 1 month after the first dose; 2-dose sequential group)
Neutralizing antibody seroconversion rates for HPV 6, 11,16, 18, 31, 33, 45, 52, 58
Time frame: 1 Month post-dose 2 (3-dose sequential & primary groups) and 1 Month post-dose 1(2-dose sequential group)
IgG binding antibody GMC for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Time frame: 1 Month post-dose 2 (i.e., 2 months after the first dose; 3-dose sequential & primary groups) and 1 Month post-dose 1 (i.e., 1 month after the first dose; 2-dose sequential group)
IgG binding antibody positivity rates for HPV 6, 11, 16, 18, 31, 33, 45, 52, 58
Time frame: 1 Month post-dose 2 (i.e., 2 months after the first dose; 3-dose sequential & primary groups) and 1 Month post-dose 1 (i.e., 1 month after the first dose; 2-dose sequential group)
IgG binding antibody seroconversion rates for HPV 6, 11, 16,18, 31, 33,45, 52, 58
Time frame: 1 Month post-dose 2 (i.e., 2 months after the first dose; 3-dose sequential & primary groups) and 1 Month post-dose 1 (i.e., 1 month after the first dose; 2-dose sequential group)
Incidence of adverse events within 30 days after each dose of vaccination
Time frame: within 30 days after each dose of vaccination
Incidence of serious adverse events throughout the study period, as well as pregnancy events and outcomes
Time frame: through study completion, an average of 7 months

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 Apr 2026.
Individual participant dataSharing planned: No

Related trials for Cervical Cancer Prevention

Recruiting
Use Misoprostol to Optimize Prevention of Cervical Cancer
Cervical Cancers
Recruiting
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS7 Zimbabwe
HIV (Human Immunodeficiency Virus), HPV

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.

Mingwei Wei contact

#86-25-83759912

jscdc_wmw@163.com

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 15 Apr 2026. 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?

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?

Contact Mingwei Wei (#86-25-83759912, jscdc_wmw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric mean concentrations (GMC) of neutralizing antibody levels against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; (time frame: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)). The study lists 2 primary outcomes in all. 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 NCT07530679.

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 Apr 2026.