RECRUITINGPhase 2INTERVENTIONAL

High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients

Comparison of High vs Standard Dose Influenza Vaccines in Pediatric Solid Organ Transplant Recipients

About This Trial

Influenza virus is a significant pathogen in pediatric solid organ transplant (SOT) recipients. However, these individuals respond poorly to 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. One study compared HD-IIV vs. SD-IIV in adult SOT recipients and noted that HD-IIV was safe and more immunogenic; however, the median post-transplant period was 38 months. A phase I pediatric study comparing a single dose of HD-IIV vs. SD-IIV was safe with higher immunogenicity, but the study was limited by small sample size and median post-transplant vaccine administration was 26 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV one month apart compared to one-dose of SD-IIV revealed modestly increased immunogenicity when given at a median of 18 months post-transplant. Therefore, these studies lack both evaluation in the early post-transplant period and substantive pediatric populations. Additionally, the administration of two-doses of HD-IIV in the same influenza season has not been evaluated in pediatric SOT recipients. Thus, the optimal immunization strategy for pediatric SOT recipients less than 24 months post-transplant is unknown. In addition, immunologic predictors and correlates of influenza vaccine immunogenicity in pediatric SOT recipients have not been well-defined. The central hypothesis of our proposal is that pediatric SOT recipients 1-23 months post-transplant who receive two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have similar safety but higher Hemagglutination Inhibition (HAI) geometric mean titers (GMTs) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD-QIV.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Male or female, 3-17 years of age at time of enrollment 2. Pediatric kidney, heart, and/or liver transplant recipient ≥1 month and \<24 months post-transplant at the time of study immunization - Note: Inclusion of recipients of multiple organs is permitted but is limited to recipients of any combination of organs including kidney, heart and/or liver - Note: Participants undergoing re-transplantation are permitted 3. Anticipated to be available for duration of the study 4. Available by telephone, email, or text message Who Should NOT Join This Trial: 1. Inability (i.e. not able to understand and provide consent) or unwillingness of a participant/parent/legal guardian to give written willing to sign a consent form or comply with study protocol 2. History of severe hypersensitivity to influenza vaccination or anaphylaxis to eggs/egg protein 3. History of severe latex hypersensitivity 4. History of Guillain-Barre syndrome 5. History of lung or intestine transplant 6. HIV positive patients (testing within 24 months of enrollment) 7. Receipt of current season's influenza vaccine post-transplant prior to enrollment in the study 8. Currently pregnant or lactating (females of childbearing age may be enrolled based on self-report, urine pregnancy test must be performed prior to each influenza vaccine) 9. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Male or female, 3-17 years of age at time of enrollment 2. Pediatric kidney, heart, and/or liver transplant recipient ≥1 month and \<24 months post-transplant at the time of study immunization * Note: Inclusion of recipients of multiple organs is permitted but is limited to recipients of any combination of organs including kidney, heart and/or liver * Note: Participants undergoing re-transplantation are permitted 3. Anticipated to be available for duration of the study 4. Available by telephone, email, or text message Exclusion Criteria: 1. Inability (i.e. not able to understand and provide consent) or unwillingness of a participant/parent/legal guardian to give written informed consent or comply with study protocol 2. History of severe hypersensitivity to influenza vaccination or anaphylaxis to eggs/egg protein 3. History of severe latex hypersensitivity 4. History of Guillain-Barre syndrome 5. History of lung or intestine transplant 6. HIV positive patients (testing within 24 months of enrollment) 7. Receipt of current season's influenza vaccine post-transplant prior to enrollment in the study 8. Currently pregnant or lactating (females of childbearing age may be enrolled based on self-report, urine pregnancy test must be performed prior to each influenza vaccine) 9. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Treatments Being Tested

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.

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.

Locations (8)

Stanford University

Stanford, California, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Ann Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Texas Children's Hospital

Houston, Texas, United States