High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT05215327
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Immunization; Infection
  • Influenza
  • Transplantation Infection

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High Dose Quadrivalent Inactivated Influenza Vaccine — BIOLOGICAL
    Fluzone High-Dose (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus is further purified and then suspended in sodium phosphatebuffered isotonic sodium chloride solution. The Fluzone High-Dose process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration.
  • Standard Dose Quadrivalent Inactivated Influenza Vaccine — BIOLOGICAL
    Fluzone ® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by two influenza A subtype viruses and two type B viruses contained in the vaccine.

Study Details

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 Dates

Start date
Nov 8, 2022
Status verified
Dec 2025
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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

Primary Outcome Measure

Geometric Mean Titers of influenza vaccine antibodies. [ Time Frame: Day 56 (post-vaccination) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Natasha Halasa, MD, MPH
[email protected]
615-322-2250
Natasha Halasa, MD (PRINCIPAL_INVESTIGATOR)
Anil Trindade, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By research site
Vanderbilt University Medical Center· Nashville, TN

Related Studies