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Clinical Trial 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-7), on D0 (before vaccination), D1, D7, D14, D30, D60 (before vaccination), D61, D67, D74, D90, D180 (before vaccination), D187, D194, D210, D365, and 730. Saliva samples for antibody testing will be collected on D0 (before vaccination), D30, D60 (before vaccination), D90, D180 (before vaccination), D210, D365, and D730. Axillary lymph node sampling by fine needle aspiration will be done in all groups at D-30 and 2 additional times in per group. Group 1 will have lymph node sampling done D14 and D30 after the first dose. Group 2 will have lymph node sampling done D74 and D90. Group 3 will have lymph node sampling D194 and D210. Bone marrow sampling will be done for all groups at D730.

Clinical Trial 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, they need to study early immune responses in lymph nodes, which is where cells that make antibodies (B cells) are activated by the vaccine. They 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 they 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 find and study these cells making antibodies against HPV, so they can better understand how they contribute to long-lasting antibody levels. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05031078
Study type Interventional
Source Emory University
Contact Erin Scherer, Ph.D.
Phone 404-712-6904
Email [email protected]
Status Not yet recruiting
Phase Phase 4
Start date September 2021
Completion date September 2024

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