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Emory UniversityHPV Vaccine Reduced Dose Phase 4 100 Vaccine Study
Clinical Trial NCT06799494 is designed to study Basic Science for HPV. It is a Phase 4 interventional study that is recruiting, having started on August 6, 2025, with plans to enroll 100 participants. Led by Emory University, it is expected to complete by September 1, 2028. The latest data from ClinicalTrials.gov was last updated on August 20, 2025.
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 ty...
Show MoreDetailed Description
This study aims to determine whether a single-dose HPV vaccination produces the same immune response as a two- or three-dose HPV vaccination.
The 1-dose HPV vaccination was recently recommended by the World Health Organization (WHO) for people with healthy immune systems aged 9-20 years. To learn whether 1-dose HPV vaccination makes the same immune responses as 2- or 3-dose HPV vaccination in humans, there is a need...
Show MoreOfficial Title
Comparing the Antibody and B Cell Responses Induced by 1- or 2-dose 9-valent HPV (9vHPV) Vaccination in Healthy Adults
Conditions
HPVOther Study IDs
- STUDY00008623
NCT ID Number
Start Date (Actual)
2025-08-06
Last Update Posted
2025-08-20
Completion Date (Estimated)
2028-09
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Keywords
HPV Prevention
HPV Vaccine
Immune responses
HPV Vaccine
Immune responses
Primary Purpose
Basic Science
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalOne 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, 1095±14, 1460±14, 1825±30 (Visit 15), and ≥84 days from Visit 15 ...Show More | 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...Show More 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. |
Active ComparatorTwo 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, 1095±14, 1460±14, 1825±30 (Visit 15), and ≥84 days from Visit 15 (Optiona...Show More | 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...Show More 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 Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Frequency of plasma cells specific for HPV16/18 virus like particles (VLPs) | 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 | 730 days after receiving the first vaccine dose |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Frequency of memory B cells specific for HPV16/18 VLPs | Frequency of memory B cells specific for HPV16/18 VLPs per total memory B cells in PBMC in per protocol participants of the 1- and 2-dose 9vHPV arms. | Baseline (Day 0), Day 30, Day 180, Day 210, Day 365, and Day 730 post-intervention |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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 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 anti-coagulant 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.
Emory University398 active studies to exploreMerck Sharp & Dohme LLC707 active studies to exploreStudy Responsible Party
Erin Scherer, PhD, Principal Investigator, Assistant Professor, Emory University
Study Central Contact
Contact: Erin Scherer, PhD, 404-712-6904, [email protected]
Contact: Daniel Graciaa, MD, 404-712-1370, [email protected]
1 Study Locations in 1 Countries
Georgia
Hope Clinic of the Emory Vaccine Center, Decatur, Georgia, 30030, United States
Recruiting