NCT05031078

Assessing Durable Antibody Response to HPV Vaccination

Assessing Immunological Basis of Durable Antibody Responses to 9-valent HPV Vaccination

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Human papillomaviruses (HPV) cause cervical, anal, oropharyngeal, vulvar, vaginal, and penile cancers. There are over 200 types of HPV; 12 are known to cause cancer. The current HPV vaccine is a subunit vaccine, meaning it is made of only part of the virus (a protein) and cannot infect humans. The HPV vaccine is highly effective at preventing disease by HPV types that cause 90% of cancer cases and 90% of genital warts cases in women and men who do not have ongoing or prior HPV infection. Most vaccines protect by generating antibodies. Importantly, the HPV vaccine, first approved in 2006, has been shown to make high levels of antibodies against HPV that last for \>10 years. The durability of HPV vaccine antibody levels is exceptional compared to other approved and experimental subunit vaccines whose antibody levels drop more rapidly. However, how the HPV vaccine - let alone any vaccine - generates long-lasting antibodies is not understood. Understanding how vaccines make high levels of long-lasting antibodies will help the efforts to successfully and reliably design new vaccines that make these highly desired responses (like vaccines against new pandemics). The investigators designed this study to better understand how the HPV vaccine generates such high levels of long-lasting antibodies in humans. To do this, the investigators need to study early immune responses in lymph nodes, which is where cells that make antibodies (B cells) are activated by the vaccine. The investigators will also need to study immune responses in blood. For example, to measure the levels of antibodies in blood and also the levels of cells that help B cells (helper T cells). As the HPV vaccine can protect against oropharyngeal cancer, the study team aim to understand the level of antibodies in the saliva and how the antibodies compare to blood. Finally, antibodies themselves are not long-lived as proteins, but the cells that make these antibodies are (specialized B cells called plasma cells). Plasma cells are found in the bone marrow. It is important that the research team finds and study these cells making antibodies against HPV, so the investigators can better understand how they contribute to long-lasting antibody levels.

Conditions

• HPV

Interventions

Type	Name	Description
BIOLOGICAL	Gardasil-9	Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180 The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. 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.
DRUG	Lidocaine injections	1-2% lidocaine injections. 1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 1-2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg.

Timeline

• Start date: 2021-12-21
• Primary completion: 2024-10-23
• Completion: 2026-05-01
• First posted: 2021-09-01
• Last updated: 2025-10-23
• Results posted: 2025-10-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study