Broader HPV shield: could a 9-Type vaccine strengthen protection after the 2-Type shot?
NCT ID NCT07785843
First seen Aug 25, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This trial tests whether the 9-valent HPV vaccine (V503) can trigger a strong immune response against nine HPV types in Chinese females aged 10 to 45 who previously received the bivalent (2-type) HPV vaccine. Participants will receive either the 9-valent vaccine or a placebo, and researchers will measure antibody responses and monitor safety. The goal is to see if the broader vaccine can extend protection beyond the two types covered by the earlier vaccine.
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 (HPV) vaccine (V503, GARDASIL 9)
- What this could lead to
- If successful, this could expand protection against nine HPV types for women who previously received the two-type vaccine, potentially reducing cervical and other HPV-related cancers.
- What could go wrong
- The trial is in a specific population (Chinese females) and results may not generalize. Safety and immune response are still being evaluated, and the vaccine may not provide additional benefit for all.
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
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 930 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Oct 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
10 to 45 years
- Sex
-
Female participants only
- Healthy volunteers
-
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: The main inclusion criteria include but are not limited to the following: * For participants to be enrolled in prior 2vHPV (bivalent human papillomavirus \[HPV\] vaccine) vaccine groups: has received at least one dose of any one of the three currently marketed 2vHPV vaccines, with the last dose administered at least one year prior to Day 1. * For participants to be enrolled in HPV vaccine naïve groups: has never received any HPV vaccine. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections. * Has a history of abnormal Pap test showing low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL) or atypical squamous cells - undetermined significance (ASC-US), atypical squamous cells - cannot exclude HSIL (ASC-H), atypical glandular cells, or biopsy showing CIN, AIS, or cervical cancer. * Has a history of external genital wart, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), AIN, vulvar cancer, vaginal cancer, or anal cancer. * Has a history of a positive test for HPV (including HPV types not in the vaccine). * Is currently immunocompromised or has been diagnosed as having 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 condition. * Has a history of splenectomy. * Has received, is receiving, or plans to receive the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), tumor necrosis factor alpha (TNF-α) antagonists, monoclonal antibody therapies (including rituximab \[Rituxan™\]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a participant will be excluded if the participant is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of corticosteroids (orally or parenterally) lasting at least 1 week within 12 months prior to enrollment. Participants using inhaled, nasal, or topical corticosteroids are considered eligible for the study. * Has received, is receiving, or plans to receive any immune globulin product (including RhoGAM™ \[Ortho-Clinical Diagnostics\]) or blood derived product other than IVIG. * Has participated in an HPV vaccine clinical trial and has received either active agent or placebo. * Has received any marketed HPV vaccine other than the 2vHPV vaccines.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Papillomavirus infections are added.
By submitting, you agree to our Terms of use
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.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A new strategy to prevent cervical cancer: community follow-up for HPV shots
- Can a daily supplement help the body clear HPV?
- Could a Light-Activated cream replace surgery for cervical precancer?
- Enzyme-HPV link in cervical disease explored
- New 9-Valent HPV vaccine aims to shield chinese women from more Cancer-Causing strains
- HPV vaccine shows promise for chinese women and girls in large trial