Can a broader HPV vaccine boost protection after the original shot?
NCT ID NCT07530679
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will test if giving a 9-valent HPV vaccine to women who previously received the bivalent HPV vaccine is safe and boosts their immune response. Researchers will enroll 360 healthy women aged 18-45 and compare two different dosing schedules (two doses vs. three doses) against a standard three-dose schedule in women not previously vaccinated. The goal is to see if the broader vaccine can provide additional protection against more HPV types.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 9-valent human papillomavirus vaccine
- What this could lead to
- If successful, this could show that a single booster or two-dose schedule of the 9-valent HPV vaccine is safe and effective for women already vaccinated with the bivalent vaccine, potentially simplifying future vaccination programs.
- What could go wrong
- This is an early-stage, open-label study with only 360 participants, so results may not apply to everyone. The study is not yet recruiting, and the immune response measured may not directly translate to long-term cancer prevention.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 360 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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