HPV Vaccine Reduced Dose Study
This study is looking at whether receiving one dose of the Gardasil-9 HPV vaccine creates the same immune protection as receiving two or three doses. Researchers will study your immune response in your blood, lymph nodes (small glands that are part of your immune system), and bone marrow (spongy tissue inside your bones that makes blood cells). You can join if you are between 18 and 45 years old, have a healthy body mass index (BMI) of 32 or less, and are in good overall health. The main goal is to measure specific immune cells related to HPV 730 days (about two years) after your first vaccine dose. The study's current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 100 participants. It is not specified if it is randomized or blinded.
- What's involved
- You will have blood drawn for screening. If eligible, you will receive the Gardasil-9 vaccine in 1 or 2 doses. You will have additional blood draws and lymph node biopsies (fine needle aspiration) three times, and bone marrow biopsies from your hip bone.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your immune response will be measured for up to 730 days (about two years) after your first vaccine dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06799494
HPV Vaccine Reduced Dose
Recruiting
PHASE4Ages 18–45InterventionalBasic scienceEmory UniversityInvestigator-initiated
~100 participants
Updated 2025-08-20 on ClinicalTrials.gov
What's tested:Gardasil-9Lidocaine injectionLorazepam
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of plasma cells specific for HPV16/18 virus like particles (VLPs)
Measured over 730 days after receiving the first vaccine dose
Conditions
Where it's being run
1 sites across 1 statesGeorgia1
Study leadership
- Erin Scherer, PhD · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Individuals aged 18-45 years old (inclusive), as the HPV vaccine is approved for this age range in adults
BMI ≤ 32
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
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 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.
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 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.
What this trial measures
- Frequency of plasma cells specific for HPV16/18 virus like particles (VLPs)730 days after receiving the first vaccine dose
Frequency of plasma cells specific for HPV16/18 virus-like particles (VLPs) per total IgG-secreting plasma cells in bone marrow in per-protocol participants of the 1- and 2-dose 9vHPV arms