Could a single HPV shot match the standard regimen?
NCT ID NCT06799494
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This trial tests whether a single dose of the 9-valent HPV vaccine triggers the same immune response as two doses in healthy adults aged 18 to 45. Researchers will measure antibody and B cell responses in blood, lymph nodes, and bone marrow. The goal is to understand how the vaccine generates long-lasting immunity, which could help design simpler vaccination schedules and better vaccines.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Gardasil-9 (9-valent HPV vaccine)
- What this could lead to
- If one dose works as well as two or three, it could simplify HPV vaccination, making it cheaper and easier to deliver, and potentially increase global vaccination rates.
- What could go wrong
- This is a small, early-phase study focused on immune markers, not on preventing cancer directly. The immune response from one dose may not be as durable or protective as the standard regimen, and the results may not apply to all populations.
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 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Sep 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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18 to 45 years
- Sex
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Anyone
- 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: * Individuals aged 18-45 years (inclusive), as the HPV vaccine is approved for this age range in adults * BMI \< 35 * Able to understand and give informed consent (in American English). * In good health based on physical examination, vital signs, medical history, and the investigator's clinical judgment. * Available and willing to participate for the duration of this study * Willing to undergo lymph node fine-needle aspiration and bone marrow aspiration * Willing to consent to the future use of remaining (residual) samples/specimens with IRB review * Willing to defer completion of the recommended 9vHPV series Exclusion Criteria: * Ever received a dose of an HPV vaccine * HPV 6, 11, 16, 18, 31, 33, 45, 52, or 58 seropositivity * Any history of genital warts, an abnormal Pap smear, or a positive HPV DNA test * Known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products * Known allergy or history of anaphylaxis to yeast or products containing yeast. * Any allergy to lidocaine. * Pregnancy or breastfeeding. * Participants who believe they cannot tolerate the lymph node fine needle aspirate or bone marrow aspirate procedures without general sedation * Any history of lymphoma involving axillary nodes, any history of breast cancer, bilateral inflammatory process of upper arms in the past 2 weeks, prior breast or axillary biopsy and/or surgery that, in the opinion of the investigator, would affect the immune response results. * Local infection, lymphadenitis, or rash in the targeted area. * Received any vaccine from 14 days before the vaccine dose until 30 days after each vaccine dose\* (\*An individual initially excluded from study participation based on one or more of the time-limited exclusion criteria (fever, receipt of other vaccines) may be reconsidered for enrollment once the condition has resolved as long as the participant continues to meet all other entry criteria) * Volunteers with fever (≥100.4 F or 38°C regardless of the route) within 3 days before vaccination\*. (\*An individual initially excluded from study participation based on one or more of the time-limited exclusion criteria (fever, receipt of other vaccines) may be reconsidered for enrollment once the condition has resolved as long as the participant continues to meet all other entry criteria) * History of or presence of severe co-morbidities as determined by the investigator, including autoimmune disease, or clinically significant cardiac, pulmonary, gastrointestinal, hepatic, rheumatologic, renal disease, thrombocytopenia, and grade 4 hypertension\*\* (\*\*Grade 4 hypertension per CTCAE criteria is defined as life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive) * History of a bleeding disorder or currently taking anticoagulant products\*\*\* (e.g., warfarin, direct thrombin inhibitors, heparin products, etc.), anti-platelet products, and/or NSAIDs including aspirin. (\*\*\*including in the past week; however, an individual who is initially excluded from study participation based on one or more of the time-limited exclusion criteria may be reconsidered for enrollment once the condition has resolved as long as the participant continues to meet all other entry criteria) * History of active malignancy other than squamous cell or basal cell skin cancer, unless there was a surgical excision considered to have achieved a cure. * Current and/or expected immunosuppression due to cancer, receipt of chemotherapy, radiation therapy, and other immunosuppressive therapies (including anti-TNF therapy). * Known or suspected congenital or acquired immunodeficiency, including functional or anatomic asplenia, or recent history or current use of immunosuppressive therapy\*\*\*\*. (\*\*\*\*Anti-cancer chemotherapy or radiation therapy within the preceding 3 years, or long-term (≥2 weeks within the previous 3 months) systemic corticosteroid therapy (e.g., prednisone at a dosage of ≥20 mg per day or on alternative days). Intranasal or topical prednisone (or equivalent) is allowed) * Known chronic infections including, but not limited to, HIV, tuberculosis, hepatitis B or C. * Is post-organ, bone marrow, and/or stem cell transplant, whether or not on chronic immunosuppressive therapy. * Received blood products or immunoglobulin 3 months before study entry or planned use during this study. * Had major surgery (per the investigator's judgment) within 4 weeks before study entry or planned major surgery during this study. * Insulin-dependent diabetes\*\*\*\*\* mellitus type 1 or type 2 requiring therapy. (\*\*\*\*\*History of isolated gestational diabetes is not an exclusion criterion) * Received experimental therapeutic agents within 12 months before the first vaccine dose or plans to receive any experimental therapeutic agents 12 months after the first vaccine dose that, at the investigator's discretion, would interfere with the safety or objectives of the study. COVID-19 vaccines that fall under FDA EUA will be treated as approved vaccines for this study. * Is currently participating or plans to participate in another clinical study that would involve the receipt of an investigational product or undergo a procedure that, in the investigator's opinion, would interfere with the safety or objectives of the study. * Current diagnosed or self-reported alcohol abuse, drug abuse, or psychiatric conditions that, in the opinion of the investigator, would preclude compliance with the study. * Social, occupational, or any other condition that, in the investigator's discretion, might interfere with compliance with the 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 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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Hope Clinic of the Emory Vaccine Center
RECRUITINGDecatur, Georgia, 30030, United States
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Other studies related to the condition(s) this trial covers.
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