High vs Standard 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: Phase 2

Waitlist Available

Sponsor: Vanderbilt University Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The influenza virus is a significant cause of morbidity in adult solid organ transplant (SOT) recipients. However, these individuals show a suboptimal response to vaccines including the standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. The first study compared HD-IIV vs. SD-IIV in adult SOT and noted HD-IIV was safe and reported higher immunogenicity; however, the median post-transplant period was 38 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV a month apart compared to one-dose SD-IIV revealed increased immunogenicity, with a median post-transplantation period of 18 months. Therefore, these studies lack evaluation in the early post-transplantation period in this vulnerable population when influenza disease is most severe. The administration of two-doses of HD-IIV in the same influenza season has also not been studied in SOT recipients. Moreover, the vast majority of SOT influenza vaccinations studies have not substantively evaluated prolonged immunogenicity. Thus, the optimal immunization strategy for SOT recipients less than 12 months post-transplant is poorly-defined. In addition, the immunologic predictors and correlates of influenza vaccine immunogenicity in SOT recipients have not been defined. The investigators hypothesize that adult solid organ transplant recipients that are 1-11 months out from transplant and are receiving high-dose inactivated influenza vaccine will have higher hemagglutination inhibition (HAI) geometric mean titers to influenza A antigens compared to adult SOT recipients receiving standard-dose inactivated influenza vaccine. To test this hypothesis and address the above critical knowledge gaps, The investigators propose to conduct a phase II multicenter randomized controlled trial comparing either two doses HD-IIV, two doses of SD-IIV, or one-dose of HD-IIV in adult kidney, heart, and liver SOT recipients 1-11 months post-transplantation. The results of this study will address significant gaps in knowledge regarding influenza vaccine strategies and immune responses in adult SOT recipients and will guide vaccine recommendations in this vulnerable population.

Eligibility Criteria

Adults aged 18+ who are 1-11 months post solid organ transplant (kidney, heart, liver) can join this trial. They must be reachable for follow-ups and not pregnant or have had lung/intestine transplants, severe vaccine allergies, low platelets, Guillain-Barre syndrome, HIV, or recent immunoglobulin therapy.

Inclusion Criteria

I have received a solid organ transplant, such as a kidney, heart, or liver.

I can be contacted by phone, email, or text.

I had an organ transplant between 1 and 12 months ago.

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Exclusion Criteria

History of known severe latex hypersensitivity

You had a bad reaction to a flu shot in the past or have a severe allergy to eggs or egg products.

I have an active HIV infection.

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Treatment Details

Interventions

High Dose Quadrivalent Inactivated Influenza Vaccine (Virus Vaccine)
Standard Dose Quadrivalent Inactivated Influenza Vaccine (Virus Vaccine)

Trial OverviewThe study is testing if a high-dose flu vaccine gives better immunity than the standard dose in new organ transplant recipients. Participants will get either two high doses, two standard doses or one high dose of the flu shot to see which works best.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Two Doses Standard Dose Quadrivalent Inactivated Influenza VaccineExperimental Treatment1 Intervention

two doses of 0.5 mL SD-IIV (15µg of each influenza antigen) 28-42 days apart

Group II: Two Doses High Dose Quadrivalent Inactivated Influenza VaccineExperimental Treatment1 Intervention

two doses of 0.7 mL HD-IIV (60µg of each influenza antigen) 28-42 days apart

Group III: One Dose High Dose Quadrivalent Inactivated Influenza VaccineExperimental Treatment1 Intervention

one dose of 0.7 mL HD-IIV (60µg of each influenza antigen) followed by placebo 28-42 days later

High Dose Quadrivalent Inactivated Influenza Vaccine is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Fluzone High-Dose for: