Could 2 HPV vaccine doses be enough for women 27-45? new trial aims to find out.
NCT ID NCT05672927
First seen Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 3 times
Summary
This study compares the immune response from 2 doses versus the standard 3 doses of the HPV vaccine in women aged 27-45. About 618 participants will be randomly assigned to receive either 2 or 3 doses, and their antibody levels will be checked over 12 months. If 2 doses prove noninferior, it could lead to a simpler vaccination schedule for this age group.
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 HPV vaccine
- What this could lead to
- If 2 doses work as well as 3, it could simplify HPV vaccination for women in this age group, making it easier and cheaper to get protected.
- What could go wrong
- This is a Phase 4 study, but it only measures short-term antibody responses, not long-term cancer prevention. The results may not change current guidelines.
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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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 618 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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27 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. Females 27-45 years old. 2. Ability to give informed consent. 3. Has not received any prior doses of the HPV vaccine. This will be verified by the person and state registry (Immtrac), as well as the person's electronic medical record. 4. Reliable telephone access for the duration of the project. 5. Can read and speak in either English or Spanish. 6. Identified source of funding for vaccine such as Medicaid, private health insurance, Texas Healthy Women program, etc. 7. Reports consistent use of reliable birth control and plans to continue its use through study month 13. Exclusion criteria: 1. Currently pregnant or plans to become pregnant or donate eggs in the next 13 months. Any subjects with positive pregnancy tests at the initial visit will be disqualified from the study and advised to seek prenatal care. 2. Has an immunodeficiency or autoimmune disease such as HIV infection, lymphoma, leukemia, lupus, rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition. 3. Currently receiving treatment or medication that can suppress immune function including radiation therapy, chemotherapy, cyclosporin, leflunomide (Arava), TNF-α antagonists, monoclonal antibody therapies (including rituximab \[Rituxan\]), intravenous gamma globulin (IVIG), antilymphocyte sera, other therapy known to interfere with the immune response, or systemic corticosteroids (by mouth or intramuscular injection). Those using or have used steroids that are inhaled, placed in the eye, applied on the skin, or injected into the joint/soft tissue will be considered eligible for the study. 4. History of splenectomy 5. Known allergies to any vaccine components, including aluminum, yeast or Benzonase. 6. Febrile at ≥100°F in the 24 hours prior to vaccination. The patients may be rescheduled for a later date. 7. History of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections. 8. History of \>10 sexual partners in their lifetime at time of enrollment 9. Plans to move out of the Galveston/Houston area in the 13 months following study entry.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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University of Texas Medical Branch
RECRUITINGGalveston, Texas, 77555, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a daily supplement help the body fight off HPV?
- At-Home HPV tests could save lives of women with HIV
- New immune therapy aims to train body to clear HPV
- Could a tiny HPV shot still protect? small study tests lower dose
- New Self-Sampling and digital colposcopy could speed up cervical cancer detection
- Text reminders help get young kids vaccinated on time