Last updated on May 2020

Analysis of Bone Marrow and Blood B Cell Immune Responses to Influenza Vaccination


Brief description of study

This is a Phase IV open label and single arm study enrolling up to 55 healthy males and non-pregnant females in a single site, 18-49 years old, inclusive. The study is designed to assess the humoral response to influenza vaccination and the longevity of humoral immunity to influenza vaccination in healthy adults. The study duration is up to 4 years. After 1 year, subjects will be offered the opportunity to participate in the study for up to 3 consecutive years provided eligibility criteria is met each year. Subjects who elect to continue in the study after first year of participation will be rescreened to verify continued eligibility and re-consented prior to subsequent participation. The primary study objective is to investigate the longevity of humoral immunity to influenza virus in humans.

Detailed Study Description

This is a Phase IV open label and single arm study enrolling up to 55 healthy males and non-pregnant females in a single site, 18-49 years old, inclusive. The study is designed to assess the humoral response to influenza vaccination and the longevity of humoral immunity to influenza vaccination in healthy adults. The laboratory technique will characterize persistence and clonotype of antigen specific B-cells and plasmablasts in blood and bone marrow. Enrolled subjects will receive licensed seasonal inactivated influenza vaccine (administered as a part of the study). The vaccine will be administered according to the package insert, and study participants will donate serial samples of blood and bone marrow aspirate for immunology monitoring. Safety will be assessed from the time of study enrollment through the last study visit, via monitoring of vital signs, change in health status, and targeted physical exam with safety labs prior to each bone marrow aspirate procedure. Repeated measurements of humoral immunity will be obtained at 7 days, 14 days, 28 days, 90 days and at one year post vaccination to assess the magnitude, clonal diversity and persistence of B-cell responses to influenza vaccination. The study duration is up to 4 years. After 1 year, subjects will be offered the opportunity to participate in the study for up to 3 consecutive years provided eligibility criteria is met each year. Subjects who elect to continue in the study after first year of participation will be rescreened to verify continued eligibility and re-consented prior to subsequent participation. Re-enrolling subjects will receive new subject identifiers and will count towards the total enrollment number for subsequent years of participation. A separate subject record will be maintained each year a subject re-enrolls in the study. Enrollment for the next year will begin with the availability of the seasonal flu vaccine. For subjects who elect to re-enroll in the study, the Day 365 visit (+/- 3 month window) would also be the Day 0 visit for the subsequent year. The primary study objective is to investigate the longevity of humoral immunity to influenza virus in humans. The secondary study objective is the longitudinal tracking of vaccine-induced B cell responses with special emphasis on broadly neutralizing HA stem-reactive responses.

Clinical Study Identifier: NCT02485639

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