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New treatment option for HPV
Official title HPV Vaccine Reduced Dose
ClinicalTrials.gov ID: NCT06799494
What this study is testing
What is Gardasil-9?
Gardasil-9 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for hpv.
Also referred to as HPV Vaccine, 9-valent HPV vaccine (9vHPV).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to answer the question: does 1-dose HPV vaccination generate the same immune responses compared to 2- or 3-dose HPV vaccination? This will be done by studying the immune response in blood, lymph nodes, and bone marrow.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility criteria
- 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
- 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...
- 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...
- 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...
- 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...
- History of a bleeding disorder or currently taking anti-coagulant products\ \ \ (e.g. warfarin, direct thrombin inhibitors, heparin products, etc.), anti-platelet products, and/or NSAIDs including aspirin. (\ \ \...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Decatur, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Decatur, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.