Recruiting

HPV Vaccination

Sponsor:

Emory University

Code:

NCT06799494

Conditions

HPV

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Gardasil-9

Lidocaine injection

Lorazepam

Study Details

Brief summary:

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.

Human papillomaviruses (HPV) cause cancers (cervical, anal, oropharyngeal, vulvar, vaginal, and penile), and the current HPV vaccine is highly effective at preventing disease by HPV types that cause 90% of cancer cases. While this vaccine generates high levels of antibodies that last for > 10 years, understanding of how this occurs is limited, and studying this immune response will help design new and better vaccines.

The study population consists of healthy adult (age 18-45) participants who have not previously received an HPV vaccine, do not have antibodies against certain types of HPV, do not have a history of HPV infection or disease (such as genital warts, abnormal pap test, or HPV DNA test), and do not have contraindications to study procedures. Populations of increased concern are not being enrolled.

Conditions

HPV

Study ID

NCT06799494

Start date

Aug 6, 2025

Status verified date

Aug, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: One dose of the 9-valent HPV vaccine

Participants will receive one dose of the 9-valent HPV (9vHPV) vaccine by intramuscular injection on Day 0.

Participants will be asked to donate blood samples for immunologic testing at screening (from Day -60 to -1), on Day 0 (before vaccination), 7±1, 30±5, 180±5 (before vaccination; Visit 5), Visit 5 + 7±1 days, Visit 5 + 30±5 days, 365±14, 730±14 (Visit 10), ≥84 days from Visit 10 (Optional Visit 12), 1095±14 (Optional Visit 13), 1460±14 (Optional Visit 14), 1825±30 (Optional Visit 16), and ≥84 days from Visit 16 (Optional Visit 18).

Axillary lymph node sampling by fine-needle aspiration (FNA) will be done 3 times per group on Day 30±5, 180±5 (Visit 5), and Visit 5 + 30±5 days.

Bone marrow sampling will be done for all groups at Days 730±14 and 1825±30.

active comparator: Two doses of the 9-valent HPV vaccine

Participants will receive two doses of the 9vHPV vaccine on Day 0 and a second dose 6 months later.

Participants will be asked to donate blood samples for immunologic testing at screening (from Day -60 to -1), on Day 0 (before vaccination), 7±1, 30±5, 180±5 (before vaccination; Visit 5), Visit 5 + 7±1 days, Visit 5 + 30±5 days, 365±14, 730±14 (Visit 10), ≥84 days from Visit 10 (Optional Visit 12), 1095±14 (Optional Visit 13), 1460±14 (Optional Visit 14), 1825±30 (Optional Visit 16), and ≥84 days from Visit 16 (Optional Visit 18).

Axillary lymph node sampling by fine-needle aspiration (FNA) will be done 3 times per group on Day 30±5, 180±5 (Visit 5), and Visit 5 + 30±5 days.

Bone marrow sampling will be done for all groups at Days 730±14 and 1825±30.

Interventions

Gardasil-9

The 9-valent HPV VLP vaccine is a sterile liquid suspension prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the aluminum-containing adjuvant and the final purification buffer. The 9-valent HPV vaccine, or Gardasil-9, is a sterile suspension for intramuscular administration. Each 0.5-mL dose of the vaccine also contains approximately 500 mcg of aluminum (provided as AAHS), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, <7 mcg yeast protein, and water for injection. The product does not contain a preservative or antibiotics.

Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap. After thorough agitation, GARDASIL 9 is a white, cloudy liquid.

Lidocaine injection

Lidocaine 1% will be injected intradermally and subcutaneously into the margin of the lymph node to be sampled to numb the area. To confer local anesthesia, 1-2% will be injected into the tissue surrounding the area where the bone marrow will be removed.

Lorazepam

Lorazepam, an FDA-approved benzodiazepine, will be administered as an anxiolytic before the bone marrow aspirate procedure per the clinician who will perform the procedure. If needed, lorazepam will be administered sublingually per manufacturer dosing recommendations.

Primary outcome measure

  • Frequency of plasma cells specific for HPV16/18 virus like particles (VLPs) [ Time Frame: 730 days after receiving the first vaccine dose ]

Central Contacts and Locations

Central contacts

Erin Scherer, PhD

404-712-6904emscher@emory.edu

Daniel Graciaa, MD

404-712-1370dsgraci@emory.edu

Locations

Hope Clinic of the Emory Vaccine Center

Recruiting

Decatur, Georgia, United States, 30030

More Information

Sponsor

Emory University

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • HPV Prevention
  • HPV Vaccine
  • Immune responses

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-08-31.