At a glance
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Assessing Immunological Basis of Durable Antibody Responses to 9-valent HPV Vaccination
In Brief
A Phase 4 clinical trial evaluating Gardasil-9 and Lidocaine injections for HPV. Active but no longer recruiting, targeting 17 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.