An interventional study of 9-valent HPV vaccination at months 0 and 6 and 9-valent HPV vaccination at months 0 , 1 and 6 in Cervical Cancer Prevention, sponsored by Jiangsu Province Centers for Disease Control and Prevention. Not yet recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Jiangsu Province Centers for Disease Control and Prevention · Not applicable, Interventional, and Prevention
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 group, with 120 participants in each group. All participants will be stratified by two age subgroups (18-26 years and 27-45 years) to ensure demographic balance across groups.
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 360 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Jiangsu Province Centers for Disease Control and Prevention is the lead sponsor of 77 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For participants in the sequential group, the following additional criteria must be met:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals with prior 2-valent HPV vaccination will receive 2 sequential 9-valent doses at months 0, and 6.
Biological: 9-valent HPV vaccination at months 0 and 6
Individuals with prior 2-valent HPV vaccination will receive 3 sequential 9-valent doses at months 0, 1, and 6
Biological: 9-valent HPV vaccination at months 0 , 1 and 6
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
Biological: 9-valent HPV vaccination at months 0 , 1 and 6
Administer the 9-valent HPV vaccine at month 0 and month 6 according to the immunization schedule
Administer the 9-valent HPV vaccine at month 0, 1 and month 6 according to the immunization schedule
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
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
Memory B Cell Frequency and Breadth Index for HPV Types 6,11,16,18,31,33,45,52,58 Using [Flow Cytometry]
Time frame: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
Reactivation Capacity of HPV-Specific Memory B Cells (Recall Response)
Time frame: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
Secretory Function of HPV-Specific Memory B Cells (Recall Response)
Time frame: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
Single B Cell Cloning Efficiency Measured by FACS-Based Single B Cell Sorting
Time frame: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
Recombinant Antibody Production Yield Measured by Recombinant Expression Assay
Time frame: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
Broad-Spectrum Neutralizing Activity of Candidate Monoclonal Antibodies Measured by Pseudovirus-Based Neutralization Assay
Time frame: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
Epitope Characterization of Candidate Monoclonal Antibodies Measured by Peptide Mapping and Competitive ELISA
Time frame: 7 months after the first dose (i.e., 1 month after completion of the full vaccination series)
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Plan to share: No
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Jiangsu Province Centers for Disease Control and Prevention