A Phase 4 interventional study of Gardasil-9 and Lidocaine injection in HPV, sponsored by Emory University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Emory University · Phase 4, Interventional, and Basic science
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 types that cause 90% of cancer cases. While this vaccine generates high levels of antibodies that last for > 10 years, understanding of how this occurs is limited, and studying this immune response will help design new and better vaccines.
The study population consists of healthy adult (age 18-45) participants who have not previously received an HPV vaccine, do not have antibodies against certain types of HPV, do not have a history of HPV infection or disease (such as genital warts, abnormal pap test, or HPV DNA test), and do not have contraindications to study procedures. Populations of increased concern are not being enrolled.
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 to study the immune response to the HPV vaccine in the blood (where antibodies are), in the lymph nodes (where immune cells that make antibodies get activated), and in the bone marrow (where long-lived cells that produce antibodies are found). After informed consent, participants will have blood drawn for screening tests. If they are eligible, they will receive the FDA-approved HPV vaccine. The vaccine will be given in 1 or 2 doses, but participants will have the opportunity to receive the full vaccine series at the end of the study. Participants will have additional blood draws and undergo fine needle aspiration (FNA) of a lymph node in the axilla (armpit) at 3 different times. Later, they will have bone marrow aspiration procedures during which marrow is sampled from the hip bone through a needle. Researchers will use this knowledge to inform public health decisions about the broader use of 1-dose HPV vaccination.
Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 (Visit 10), ≥84 days from Visit 10 (Optional Visit 12), 1095±14 (Optional Visit 13), 1460±14 (Optional Visit 14), 1825±30 (Optional Visit 16), and ≥84 days from Visit 16 (Optional Visit 18). Axillary lymph node sampling by fine-needle aspiration (FNA) will be done 3 times per group on Day 30±5, 180±5 (Visit 5), and Visit 5 + 30±5 days. Bone marrow sampling will be done for all groups at Days 730±14 and 1825±30.
Biological: Gardasil-9 · Drug: Lidocaine injection · Drug: Lorazepam
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 (Visit 10), ≥84 days from Visit 10 (Optional Visit 12), 1095±14 (Optional Visit 13), 1460±14 (Optional Visit 14), 1825±30 (Optional Visit 16), and ≥84 days from Visit 16 (Optional Visit 18). Axillary lymph node sampling by fine-needle aspiration (FNA) will be done 3 times per group on Day 30±5, 180±5 (Visit 5), and Visit 5 + 30±5 days. Bone marrow sampling will be done for all groups at Days 730±14 and 1825±30.
Biological: Gardasil-9 · Drug: Lidocaine injection · Drug: Lorazepam
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 sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, \<7 mcg yeast protein, and water for injection. The product does not contain a preservative or antibiotics. 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. After thorough agitation, GARDASIL 9 is a white, cloudy liquid.
Also known as: HPV Vaccine, 9-valent HPV vaccine (9vHPV)
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.
Also known as: Lidocaine 1% Injectable Solution
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.
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
Time frame: 730 days after receiving the first vaccine dose
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.
Time frame: Baseline (Day 0), Day 30, Day 180, Day 210, Day 365, and Day 730 post-intervention
Plan to share: Yes — The research team will share de-identified demographic, ELISPOT, pseudovirus neutralization, ELISA, flow cytometry, sc-RNA-seq, paired immunoglobulin repertoire sequencing, monoclonal antibody neutralization, and the monoclonal antibody heavy and light chain sequence data utilized in our publications. Data will be made publicly available in relevant repositories and easy to find in their publications.
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
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