Assessing Durable Antibody Response to HPV Vaccination
Status:
Not yet recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
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 D730. 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.