High-Dose Flu Vaccine for Solid Organ Transplant Recipients
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Minnesota
Must not be taking: ATG, Carfilzomib, Rituximab, others
Disqualifiers: Pregnancy, Severe allergy, Prednisone, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
In solid organ transplant (SOT) the receipt of influenza vaccine in an influenza season is associated with decreased disease severity as demonstrated by the presence of pneumonia and ICU admissions. Different strategies have been assessed to optimize vaccine efficacy and immunogenicity of the influenza vaccine in the solid organ transplant recipient (SOTR). The primary objective of the study is to evaluate the immunogenicity of 2 doses of the high dose influenza vaccine utilizing neutralizing antibody assays. A control group receiving 1 HD influenza vaccine will be included.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you have received certain medications like ATG, carfilzomib, rituximab, or basiliximab in the past 3 months, you cannot participate.
Is the high-dose flu vaccine safe for humans?
The high-dose flu vaccine, known as Fluzone High-Dose Quadrivalent, has been studied for safety in both children and adults. Most reported side effects are mild, such as injection site reactions, fever, headache, and nausea. Serious side effects are rare, and no new safety concerns have been identified in recent reviews.12345
How does the drug Fluzone High-Dose Quadrivalent differ from other treatments for solid organ transplant recipients?
Eligibility Criteria
This trial is for adults over 18 who had a solid organ transplant (like liver, lung, heart, kidney, pancreas) more than a year ago. They must be able to consent and participate in all study activities. People can't join if they've recently received certain immune therapies or high-dose steroids, are pregnant, or have had severe allergies to flu vaccines.Inclusion Criteria
I am over 18 and had an organ transplant more than a year ago.
I had my transplant surgery over a year ago.
I am willing and able to follow all study requirements.
See 1 more
Exclusion Criteria
I have received basiliximab in the last 3 months.
I have received ATG or carfilzomib in the last 3 months.
You are pregnant.
See 3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either one or two doses of the high dose influenza vaccine, with a control group receiving a placebo after the first dose
3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of pneumonia, hospitalization, ICU admissions, and death rates
2 years
Treatment Details
Interventions
- Fluzone High-Dose Quadrivalent (Vaccine)
Trial OverviewThe trial is testing the effectiveness of giving two doses of Fluzone High-Dose Quadrivalent influenza vaccine compared to just one dose in people who have received solid organ transplants. The goal is to see which strategy better stimulates the body's defenses against the flu.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: booster groupExperimental Treatment1 Intervention
Participants who have undergone a solid organ transplant will receive two doses of an inactivated high dose influenza vaccine
Group II: Control groupActive Control1 Intervention
Participants who have undergone a solid organ transplant will receive one dose of inactivated high dose influenza vaccine followed by a placebo injection
Fluzone High-Dose Quadrivalent is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Fluzone High-Dose Quadrivalent for:
- Prevention of disease caused by influenza A subtype viruses and type B virus
🇪🇺 Approved in European Union as Fluzone High-Dose Quadrivalent for:
- Prevention of disease caused by influenza A subtype viruses and type B virus
🇨🇦 Approved in Canada as Fluzone High-Dose Quadrivalent for:
- Prevention of disease caused by influenza A subtype viruses and type B virus
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
Safety and immunogenicity of high doses of quadrivalent influenza vaccine in children 6 months through [2021]Quadrivalent high-dose inactivated influenza vaccine (Fluzone® High-Dose Quadrivalent, IIV4-HD) was licensed in the USA in 2019 for adults ≥ 65 years of age. This Phase II study examined safety and immunogenicity of 3 dose formulations of IIV4-HD in healthy children. In a randomized, modified double-blind, active-controlled trial in the USA and Canada, 661 children aged 6 months through
Postmarketing safety surveillance of high-dose quadrivalent influenza vaccine: Reports to the Vaccine Adverse Event Reporting System. [2022]On November 4, 2019, the Food and Drug Administration approved high-dose quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent; QIV-HD) for active immunization for the prevention of influenza disease in individuals 65 years of age and older. A prelicensure randomized, active-controlled, modified double-blind trial did not reveal any major differences in adverse events following QIV-HD versus Fluzone High-Dose (trivalent). To improve our understanding of the safety profile of QIV-HD, we reviewed and summarized reports of adverse events after QIV-HD to the Vaccine Adverse Event Reporting System (VAERS). From July 30, 2020 through June 30, 2021, VAERS received 2,122 reports after QIV-HD. The vast majority (2,018; 95.1%) were non-serious and included events that had been observed in the prelicensure clinical trial, such as injection site reactions, fever, headache, and nausea. The most common serious events included Guillain-Barré syndrome, cellulitis or other local reactions, constitutional signs/symptoms (e.g., fever), and cardiovascular events. Our review did not reveal any new safety concerns. This information may enable policy makers, health officials, clinicians, and patients to make a more informed decision regarding vaccination strategies.
Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults ≥65 years of age: A phase 3 randomized clinical trial. [2020]A high-dose, split-virion inactivated trivalent influenza vaccine (IIV3-HD; Fluzone® High-Dose, Sanofi Pasteur) is available for adults ≥65 years of age. This study examined the safety and immunogenicity of a quadrivalent high-dose split-virion inactivated influenza vaccine (IIV4-HD).
Exposure to quadrivalent influenza vaccine during pregnancy: Results from a global pregnancy registry. [2022]The Fluzone® Quadrivalent (IIV4, Sanofi Pasteur) Pregnancy Registry was created to monitor vaccine safety during pregnancy (clinicaltrials.gov, NCT01945424). Here, we describe maternal, pregnancy, obstetrical and neonatal outcomes after vaccine exposure in pregnant women between August 2013 and September 2019.
High-Dose Inactivated Influenza Vaccine Quadrivalent for Older Adults. [2021]To review the efficacy and safety of the high-dose inactivated influenza vaccine quadrivalent (HD-IIV4) in the prevention of influenza in older adults.
A cautionary tale of multiple-dose drug products: Fluticasone and salmeterol combination inhaler waste. [2021]Some drugs can only be dispensed in multiple-dose containers. Multiple-dose packaging may pose a problem for hospitals in terms of drug wastage and cost. Oral inhalers, such as fluticasone propionate and salmeterol combination inhalers, are only available as multiple-dose formats in Canada.
Effect of double dose oseltamivir on clinical and virological outcomes in children and adults admitted to hospital with severe influenza: double blind randomised controlled trial. [2021]To investigate the validity of recommendations in treatment guidelines to use higher than approved doses of oseltamivir in patients with severe influenza.
Does low-dose seretide reverse chronic obstructive pulmonary disease and are the benefits sustained over time? An open-label Swedish crossover cohort study between 1999 and 2005. [2017]Chronic obstructive pulmonary disease (COPD) still poses a formidable challenge to patients and clinicians alike. A fixed-dose dry powder combination inhaler, Seretide/Advair, containing salmeterol and fluticasone, is licensed in the European Community for the treatment of moderate to severe COPD in the strength of 50/500 microg twice daily (BID). Several studies have investigated the effects of this combination and show improved forced expiratory volume in 1 s (FEV(1)), quality of life, and a decrease of exacerbations. Most of the studies have run for less than 1 year. The aim of this investigator-initiated, independent study was to elucidate if the combination containing 50 microg of salmeterol and 250 microg of fluticasone BID could be shown to have the same beneficial effect as the higher dosage, and if the effect could be sustained over time.
Improved safety with equivalent asthma control in adults with chronic severe asthma on high-dose fluticasone propionate. [2019]High-dose inhaled corticosteroids (ICS) have been associated with the same side-effects as oral corticosteroids. Beclomethasone dipropionate (BDP) and budesonide (BUD) in doses greater than 2000 microg/day are used regularly in severe asthma, despite the fact that safety and efficacy data at such high doses are limited. Fluticasone propionate (FP) has been promoted as being twice as potent clinically as BDP or BUD at doses of 2000 microg/day or less with a similar safety profile. The aim of this study was to compare the efficacy and safety of FP with BDP and BUD in 133 symptomatic adult asthmatics requiring at least 1750 microg/day of BDP or BUD.
Equivalent Systemic Exposure to Fluticasone Propionate/Salmeterol Following Single Inhaled Doses from Advair Diskus and Wixela Inhub: Results of Three Pharmacokinetic Bioequivalence Studies. [2021]Background: Wixela® Inhub® was developed to deliver inhaled fluticasone propionate/salmeterol (FP/S) combination as a substitutable generic equivalent to Advair® Diskus®. These studies aimed to confirm the pharmacokinetic bioequivalence (BE) of FP/S after single doses of Wixela Inhub (test [T]) and Advair Diskus (reference [R]). Methods: Three open-label, randomized, two-way crossover, single-dose studies in healthy subjects (N = 66 each) compared the systemic exposure of FP and salmeterol after inhalation from three dose strengths of FP/S (100/50, 250/50, or 500/50 μg) delivered from T and R. Primary BE endpoints were the area under the plasma concentration-time curve from time = 0 to the last measurable concentration (AUC(0-t)) and the maximum observed plasma concentration (Cmax) for both FP and S. The BE acceptance criteria specified that the 90% confidence intervals (CIs) of the geometric mean T/R ratios for AUC(0-t) and Cmax can be contained within 0.80-1.25 for both FP and salmeterol. Results: Wixela Inhub met the acceptance criteria for BE for FP and salmeterol at each dose strength. Estimated AUC(0-t) and Cmax geometric mean ratios (T/R [90% CI]) for FP were, respectively, 1.04 (1.00-1.08) and 0.92 (0.87-0.96) for 100/50 μg FP/S, 1.07 (1.02-1.13) and 1.01 (0.95-1.07) for 250/50 μg, and 0.97 (0.92, 1.00) and 0.90 (0.86-0.93) for 500/50 μg. Estimated AUC(0-t) and Cmax ratios for salmeterol were, respectively, 1.08 (1.04-1.11) and 1.00 (0.94-1.04) for 100/50 μg FP/S, 1.03 (0.99-1.07) and 0.93 (0.87-1.00) for 250/50 μg, and 1.00 (0.96-1.04) and 0.86 (0.81-0.91) for 500/50 μg. FP/S at all doses via both T and R was comparably well tolerated. Conclusions: Wixela Inhub was bioequivalent to Advair Diskus at all three dose strengths for both FP and S, providing direct evidence of equivalent systemic safety and indirect evidence for equivalent pulmonary deposition.