One-dose HPV vaccine versus two- and three-dose schedules

Comparing the Antibody and B Cell Responses Induced by 1- or 2-dose 9-valent HPV (9vHPV) Vaccination in Healthy Adults

This study will see if one dose of the HPV vaccine gives the same immune response as two or three doses in healthy adults aged 18 to 45.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Emory University (Academic / other)
• Drugs / interventions: chemotherapy, radiation, prednisone
• Locations: 1 site (Decatur, Georgia)
• Trial ID: NCT06799494 on ClinicalTrials.gov

What this trial studies

Healthy adults without prior HPV vaccination or evidence of past HPV infection will receive approved Gardasil-9 vaccine according to a one-, two-, or three-dose schedule. Researchers will collect blood, perform fine needle aspiration of an axillary lymph node at three time points, and obtain bone marrow samples to measure antibody-producing and memory immune cells. Participants will undergo screening and be followed with additional blood draws and procedures; some local anesthetic or short-acting medication may be used for procedures. The study aims to link cellular and antibody measures across blood, lymph node, and bone marrow to determine whether a single dose produces durable immune responses similar to multi-dose schedules.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-45 who have never received an HPV vaccine, test negative for antibodies to key HPV types, have no history of HPV-related disease, and are willing to undergo lymph node and bone marrow sampling.

Not a fit: People who have previously received any HPV vaccine, have evidence of past HPV infection or positive HPV antibodies, are outside the 18-45 age range, or cannot tolerate invasive procedures are unlikely to benefit from joining this protocol.

Why it matters

Potential benefit: If one dose produces comparable long-term immune responses, vaccination could become simpler, more accessible, and less costly for patients.

How similar studies have performed: Population-level and vaccine-effectiveness data (including WHO recommendations for younger age groups) support one-dose protection in adolescents, but detailed lymph node and bone marrow immune-response data in adults are limited and this sampling approach is relatively novel.

Eligibility criteria

Inclusion 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

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 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.

Where this trial is running

Decatur, Georgia

• Hope Clinic of the Emory Vaccine Center — Decatur, Georgia, United States (Recruiting)

Study contacts

• Principal investigator: Erin Scherer, PhD — Emory University
• Study coordinator: Erin Scherer, PhD

Conditions HPV; HPV Prevention; HPV Vaccine; Immune responses