NCT06799494

HPV Vaccine Reduced Dose

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• HPV

Interventions

Type	Name	Description
BIOLOGICAL	Gardasil-9	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.
DRUG	Lidocaine injection	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.
DRUG	Lorazepam	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.

Timeline

• Start date: 2025-08-06
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-01-29
• Last updated: 2025-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study