Comparison of High Dose vs. Standard Dose Influenza Vaccines in Lung Allograft Recipients

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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-QIV) and immune responses in lung transplant recipients and will guide vaccine recommendations during the post-transplant period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Natasha Halasa, MD, MPH
natasha.halasa@vumc.org
615-322-2250
Backup
Laura Stewart, PhD
laura.s.stewart@vumc.org
615-343-0218
Time Frame
Start Date: 2022-11-08
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 270
Treatments
Experimental: Two Doses High Dose Quadrivalent Inactivated Influenza Vaccine
two doses of HD-QIV (0.7 mL; 60µg of each influenza antigen) 28-42 days apart
Experimental: Two Doses Standard Dose Quadrivalent Inactivated Influenza Vaccine
receive two doses of SD-QIV (0.5 mL; 15µg of each influenza antigen) 28-42 days apart
Related Therapeutic Areas
Sponsors
Collaborators: NYU Langone Health, University of Washington, Emory University, Northwestern University Feinberg School of Medicine, University of Alabama at Birmingham, Duke University, Baylor College of Medicine
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov