Assessing Durable Antibody Response to HPV Vaccination

Running, not enrolling · Phase 4

Conditions studied: HPV

In brief

This is a single center, longitudinal cohort study in which subjects will receive 9-valent HPV vaccine according to package insert (i.e., one dose of 9-valent HPV vaccine on day (D) 0 followed by a second dose 2 months later and a third dose 6 months later). Immune responses in the blood, saliva, bone marrow, and lymph nodes will be assessed in subjects receiving the HPV vaccine. Blood samples for immunologic testing will be collected at screening (from D-60 to D-45), on D0 (before vaccination), D1 (optional visit), D7±1, D14±5, D30±5, D60±5 (Visit 8, before vaccination), Visit 8 +1 day (optional visit), Visit 8 + 7±1 days, Visit 8 + 14±5 days, Visit 8 + 30±5 days, D180±5 (Visit 13, before vaccination), Visit 13 + 7±1 days, Visit 13 + 14±5 days, Visit 13 + 30±5 days, D365±14, D730±14, D1095±14, D1460±14, D1825±30. Saliva samples for antibody testing will be collected on D0 (before vaccination), D30, D60 (before vaccination), Visit 8 + 30±5 days, D180 (before vaccination), Visit 13 + 30±5 days, D365, and D730. Axillary lymph node sampling by fine needle aspiration will be done 3 times per group. Group 1 will have lymph node sampling done D-30 to D0, D14, and D30. Group 2 will have lymph node sampling done D60, Visit 8 + 14±5 days, and Visit 8 + 30±5 days. Group 3 will have lymph node sampling D180, Visit 13 + 14±5 days, and Visit 13 + 30±5 days. Bone marrow sampling will be done for all groups at D730±14 and D1825±30.

Key facts

Study ID

NCT05031078

Run by

Emory University

People needed

17

Starts

2021-12-21

Expected to finish

2026-05-01

Last updated by the study team

2025-10-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify 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 (provided in American English).
• Must be in good health based on physical examination, vital signs, medical history, and the investigator's clinical judgment.
• Must be available and willing to participate for the duration of this study
• Must be willing to undergo lymph node fine needle aspiration and bone marrow aspiration
• Must be willing to consent to the future use of remaining (residual) samples/specimens.

You may not qualify 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
• Has known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products
• Has known allergy or history of anaphylaxis to yeast or products containing yeast
• Any allergy to lidocaine.
• Pregnancy or breast feeding.
• Subjects who believe they cannot tolerate the lymph node fine needle aspirate or bone marrow aspirate procedures without 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 targeted area.
• Received any vaccine from 14 days before vaccine dose until 30 days after each vaccine dose.*
• An individual who is 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 subject continues to meet all other entry criteria.
• Volunteers with fever (≥100.4 F or 38°C regardless of the route) within 3 days prior to vaccination.*
• An individual who is 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 subject 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 subject continues to meet all other entry criteria
• Has history of active malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure.
• Current and/or expected immunosuppression due to cancer, receipt of chemotherapy, radiation therapy, and any other immunosuppressive therapies (including anti-TNF therapy).
• Has 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) are allowed.
• Known chronic infections including, but not limited to, known 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 in the 3 months before study entry or planned use during this study.

Where it is running

• The Hope Clinic of Emory University — Atlanta, Georgia, United States
• Winship Cancer Institute — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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