Clinical trial NCT06799494: HPV Vaccine Reduced Dose
Official title: Comparing the Antibody and B Cell Responses Induced by 1- or 2-dose 9-valent HPV (9vHPV) Vaccination in Healthy Adults
Conditions: HPV
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.
Interventions:
description: 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.<br/>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.
name: Gardasil-9
other_name: 9-valent HPV vaccine (9vHPV)
HPV Vaccine
type: Biological
description: 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.
name: Lidocaine injection
other_name: Lidocaine 1% Injectable Solution
type: Drug
description: 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.
name: Lorazepam
type: Drug
Study arms:
design_group_description: Participants will receive one dose of the 9-valent HPV (9vHPV) vaccine by intramuscular injection on Day 0.<br/>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, 1095±14, 1460±14, 1825±30 (Visit 15), and ≥84 days from Visit 15 (Optional Visit 17).<br/>Axillary lymph node sampling by fine needle aspiration (FNA) will be done 3 times per group on Day 30±5, 180±5 (Visit 5), Visit 5 + 30±5 days.<br/>Bone marrow sampling will be done for all groups at Days 730±14 and 1825±30.
design_group_title: One dose of the 9-valent HPV vaccine
design_group_type: Experimental
design_group_description: Participants will receive two doses of the 9vHPV vaccine on Day 0 and a second dose 6 months later.<br/>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, 1095±14, 1460±14, 1825±30 (Visit 15), and ≥84 days from Visit 15 (Optional Visit 17).<br/>Axillary lymph node sampling by fine needle aspiration (FNA) will be done 3 times per group on Day 30±5, 180±5 (Visit 5), Visit 5 + 30±5 days.<br/>Bone marrow sampling will be done for all groups at Days 730±14 and 1825±30.
design_group_title: Two doses of the 9-valent HPV vaccine
design_group_type: Active Comparator
Sponsor: Emory University
Collaborators: Merck Sharp & Dohme LLC
Drug name mappings:
name: 九价人乳头瘤病毒疫苗(酿酒酵母)  (默沙东)
lang: CN
name: Human papillomavirus 9-valent vaccine, recombinant (Merck Sharp & Dohme)
lang: EN
name: 組換え沈降9 価ヒトパピローマウイルス様粒子ワクチン（酵母由来）
lang: JP
name: 利多卡因
lang: CN
name: Lidocaine
lang: EN
name: リドカイン
lang: JP
name: 劳拉西泮
lang: CN
name: Lorazepam
lang: EN
name: ロラゼパム
lang: JP