High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients

Recruiting now · Phase 2

Conditions studied: Immunization; Infection, Transplantation Infection, Influenza

In brief

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-QIV) and immune responses in lung transplant recipients and will guide vaccine recommendations during the post-transplant period.

Key facts

Study ID

NCT05215327

Run by

Vanderbilt University Medical Center

People needed

270

Starts

2022-11-08

Expected to finish

2027-12-31

Last updated by the study team

2025-12-08

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Lung allograft recipients
• Age ≥16 years at time of enrollment
• ≥1 month (30 days) and <36 months post-lung transplant
• Anticipated to be available for duration of the study
• Can be reached by telephone, email, or text message

You may not qualify if…

• Recipient of multi-organ, extra-pulmonary, and/or hematopoietic stem cell transplant
• Recipient of a re-do lung transplant
• History of severe hypersensitivity to previous influenza vaccination or anaphylaxis to eggs/egg protein
• History of Guillain-Barre syndrome
• HIV positive patients, by history or documentation from previous test
• History of known severe latex hypersensitivity
• History of receiving the current season's influenza vaccine post-transplant prior to enrollment in the study
• Pregnant female
• Proven influenza disease after September 1st and before first study vaccine (patient can still receive the second influenza vaccination despite proven influenza disease once enrolled)
• CMVIG/IVIG/SCIG receipt within 28 days of each vaccine
• Receipt of rituximab or other B-cell depleting antibody (including proteasome inhibitors) therapy within 3-months of 1st study vaccine (Day 0).
• Receipt of augmented T-cell depleting therapy within 3-months of 1st study vaccine (Day 0)
• Investigator concern about study participation

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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