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Durability of Vaccine Responses

StatusRecruiting
PhasePhase 4
Started2023-04-11
View on ClinicalTrials.gov ↗

Amendment history

2026-07-16
Study Status v7
Primary completion date2026-09-30→2027-09
Completion date2026-09-30→2027-09
2025-06-26
Study Status, Study Design v6
Primary completion date2025-09-30→2026-09-30
Completion date2025-09-30→2026-09-30
Enrollment target60→66
2025-02-11
Study Identification, Study Status, Sponsor/Collaborators v5
Collaborators1 to 2 entries
Coefficient Giving
Study title-37 characters
Systems Biological Assessment of the Durability of Vaccine Responses
2024-05-13
Study Status v4
Re-verified, no change to tracked fields
2024-01-14
Study Status, Study Description, Outcome Measures v3
Secondary endpoints6 entries, revised
Frequency of adverse events until day 7 after finelymph needlenode aspirationsampling and/or bone marrow aspiration Severity of adverse events until day 7 after finelymph needlenode aspirationsampling and/or bone marrow aspiration
Study description+112 characters
[...] ampling visits, one or two procedures will be performed: A) Fine-needleLymph aspirationnode sampling during which an expert, guided by imaging, will take fine needle aspirates/ core biopsies from a lymph node. B) Bone marrow aspirate during which an expert will aspirate a small amount of bone marrow. TheseLymph node sampling procedures will be performed no more than two times each and bone marrow aspirations will be performed no more than three times each on the same participant. Other study procedures include a co [...] e immune system has responded to the vaccination over time. RemainingThe remaini [...] [...]
Show 2 earlier versions
2023-04-20
Study Status, Contacts/Locations v2
Study sitesdetails revised at 2 of 3 sites
2023-04-19
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-04-01→confirmed 2023-04-11
Study sitesdetails revised at 3 of 3 sites
2023-03-25
Original filing
The ability of the vaccines today to generate a long-lasting protection against infections varies greatly from one vaccine to another. The yellow fever vaccine (YF-17D) is one of the most successful vaccines ever developed, having been administered to over 600 million people globally. A single vaccination is known to induce durable protection over several decades. In contrast, the quadrivalent influenza vaccine (QIV) generates an immunity that wanes quickly with no long-lasting protection. Currently, the duration of immune protection for new vaccines is difficult to predict during vaccine product development and can only be ascertained by a "wait and see" approach. This is due, in part, to the fact that some of the signals that activate a durable immune system protection remain unknown. This study aims to provide a better understanding of this problem by vaccinating willing participants with either the FDA-approved yellow fever vaccine or the quadrivalent influenza vaccine and collecting baseline and follow-up biologic samples to compare how the immune system reacts.
Trial Details
NCT Number NCT05801978
Lead Sponsor Emory University
Collaborators: Defense Advanced Research Projects Agency, Open Philanthropy
Conditions Vaccine Response
Enrollment 66 participants
Start Date 2023-04-11
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-17