High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients
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|ClinicalTrials.gov Identifier: NCT05215327|
Recruitment Status : Recruiting
First Posted : January 31, 2022
Last Update Posted : November 23, 2022
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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.
|Condition or disease||Intervention/treatment||Phase|
|Immunization; Infection Transplantation Infection Influenza||Biological: High Dose Quadrivalent Inactivated Influenza Vaccine Biological: Standard Dose Quadrivalent Inactivated Influenza Vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The primary goal of this study is to compare influenza vaccine immunogenicity and safety between two doses of HD-QIV and two doses of SD-QIV in a population of lung transplant recipients. The study will be powered on a comparison of the primary immunogenicity outcome. A nominal level of α = 0.05 (two-sided) will be used to determine statistical significance|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||All study staff, and subjects will be blinded to which vaccine the subject will receive, except for an un-blinded vaccinator. This individual will not inform the study team or the subjects which vaccine they administered to the subject. The un-blinded vaccinator will not participate in any other study activities. If the study vaccine is provided in a blinded manner, then research staff will be able to administer the vaccine, and an un-blinded vaccinator will not be necessary. The pharmacy will be un-blinded and will have a record of which vaccine was given to each subject.|
|Official Title:||Comparison of High Dose vs. Standard Dose Influenza Vaccines in Lung Allograft Recipients|
|Actual Study Start Date :||November 7, 2022|
|Estimated Primary Completion Date :||July 2027|
|Estimated Study Completion Date :||December 2027|
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
Biological: High Dose Quadrivalent Inactivated Influenza Vaccine
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.
Other Name: Fluzone High Dose
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
Biological: Standard Dose Quadrivalent Inactivated Influenza Vaccine
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.
Other Name: Fluzone
- Geometric Mean Titers of influenza vaccine antibodies. [ Time Frame: Day 56 (post-vaccination) ]Antibody titers will be measured by hemagglutination inhibition assay.
- The number of participants reporting solicited injection site reactions and systemic reactions. [ Time Frame: Within 7 days post-vaccination ]Post-vaccination local adverse events (pain, tenderness, swelling/induration, erythema/redness, swelling/induration size, and erythema/redness size) and systemic adverse events (Fatigue/malaise, headache, nausea, body ache/myalgia (not at the injection site), general activity level, vomiting, and fever).
- Geometric Mean Titers Ratio of influenza vaccine antibodies (post-/pre-vaccination). [ Time Frame: Day 56 (post-vaccination) ]Antibody titers will be measured by hemagglutination inhibition assay.
- The number of participants achieving seroprotection and seroconversion for influenza virus. [ Time Frame: Day 56 (post-vaccination) ]Antibody titers will be measured by hemagglutination inhibition assay. Seroconversion is defined as ≥ 4-fold rise in hemagglutination inhibition assay titers. Seroprotection is defined as ≥1:40 hemagglutination inhibition assay titer.
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|Ages Eligible for Study:||16 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05215327
|Contact: Natasha Halasa, MD, MPHfirstname.lastname@example.org|
|Contact: Laura Stewart, PhDemail@example.com|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Natasha Halasa, MD, MPH 615-322-2250 firstname.lastname@example.org|
|Principal Investigator: Natasha Halasa, MD|
|Principal Investigator: Anil Trindade, MD|
|Principal Investigator:||Natasha Halasa, MD. MPH||Vanderbilt University Medical Center|
|Responsible Party:||Natasha Halasa, Professor of Pediatric Infectious Diseases, Vanderbilt University Medical Center|
|Other Study ID Numbers:||
|First Posted:||January 31, 2022 Key Record Dates|
|Last Update Posted:||November 23, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Physiological Effects of Drugs