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NCT05215327 · ClinicalTrials.gov registry record · Phase 2
High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients
A Phase 2 study of Influenza and Immunization; Infection, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 270
- Enrollment target
- 1
- Study location
NCT05215327 is a Phase 2 study of Influenza and Immunization; Infection that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 270 participants, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05215327, a Phase 2 study of Influenza and Immunization; Infection, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 270 participants
- Enrollment target
- 1
- Study location
Study Summary
Lung allograft recipients have a higher burden of influenza disease and greater associated morbidity and mortality compared with healthy controls. Induction and early maintenance immunosuppression is thought to impair immunogenicity to standard dose inactivated influenza vaccine. This early post-transplant period is when immunity is most desirable, since influenza disease during this time frame is associated with adverse consequences. Thus, strategies to reduce severe influenza disease in this highly susceptible population are critical. No trials in lung transplant recipients have evaluated two doses of HD-IIV within the same influenza season as a strategy to improve immunogenicity and durability of influenza prevention. Furthermore, no influenza vaccine trials have focused on enrollment of subjects at early post-transplant timepoints. Very few studies have been performed in solely lung allograft recipients. Immunosuppression intensity is highest in lung patients, thereby limiting comparisons to recipients of heart, liver, and kidney transplants. Therefore, studies to assess both HD-IIV and two-dose strategies in the same influenza season in post-lung transplant recipients are greatly needed. The central hypothesis of our proposal is that lung allograft recipients who are 1-35 months post-transplant and receiving two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have higher HAI geometric mean titers (GMT) to influenza antigens compared to those receiving two doses of SD-QIV. To test this hypothesis and address the above critical knowledge gaps, we propose to conduct a phase II, multi-center, randomized, double-blind, controlled immunogenicity and safety trial comparing the administration of two doses of HD-QIV to two doses of SD-QIV in lung allograft recipients 1-35 months post-transplant. The results of this clinical trial will address significant knowledge gaps regarding influenza vaccine strategies (e.g., one vs. two doses and HD-QIV vs. SD-Q
Conditions Studied
Interventions
- BIOLOGICAL Standard Dose Quadrivalent Inactivated Influenza Vaccine
- BIOLOGICAL High Dose Quadrivalent Inactivated Influenza Vaccine
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2022-11-08 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05215327
The ClinicalTrials.gov registry entry for NCT05215327 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 270 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Standard Dose Quadrivalent Inactivated Influenza Vaccine is the first listed.
NCT05215327 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT05215327 about?
NCT05215327 is a clinical study titled "High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients". Lung allograft recipients have a higher burden of influenza disease and greater associated morbidity and mortality compared with healthy controls. Induction and early maintenance immunosuppression is thought to impair immunogenicity to standard dose inactivated influenza vaccine. This early post-tra...
What is the current status of trial NCT05215327?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 270 participants. The study started on 2022-11-08. Estimated completion is 2027-12-31.
What conditions does trial NCT05215327 study?
This clinical trial studies the following conditions: Influenza, Immunization; Infection, Transplantation Infection.
What interventions are being tested in trial NCT05215327?
The interventions under investigation include: Standard Dose Quadrivalent Inactivated Influenza Vaccine (BIOLOGICAL), High Dose Quadrivalent Inactivated Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05215327?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05215327 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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