Comparing high and standard dose influenza vaccines in pediatric organ transplant recipients
Comparison of High vs Standard Dose Influenza Vaccines in Pediatric Solid Organ Transplant Recipients
This study is testing whether a higher dose of the flu vaccine works better and is safe for kids aged 3 to 17 who have recently received an organ transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 312 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) NIH |
| Locations | 8 sites (Stanford, California and 7 other locations) |
| Trial ID | NCT05947071 on ClinicalTrials.gov |
What this trial studies
This phase II, multi-center, double-blind, randomized controlled trial aims to evaluate the immunogenicity and safety of high-dose quadrivalent inactivated influenza vaccine (HD-QIV) versus standard-dose quadrivalent inactivated influenza vaccine (SD-QIV) in pediatric solid organ transplant (SOT) recipients. The study will enroll approximately 312 participants aged 3-17 years who are between 1 and 23 months post-transplant. Participants will receive two doses of either HD-QIV or SD-QIV, and the primary outcome will be the comparison of Hemagglutination Inhibition (HAI) geometric mean titers between the two groups. The study will also assess the safety profile of the vaccines and explore correlations between baseline immunophenotypic markers and post-vaccine immune responses.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients aged 3-17 years who are solid organ transplant recipients and are between 1 and 23 months post-transplant.
Not a fit: Patients who have a history of severe hypersensitivity to influenza vaccination or other specified exclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved immune responses to influenza vaccination in pediatric organ transplant recipients, enhancing their protection against influenza infections.
How similar studies have performed: Previous studies have shown that high-dose influenza vaccines can be more immunogenic in adult SOT recipients, suggesting potential success in pediatric populations as well.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Stanford, California and 7 other locations
- Stanford University — Stanford, California, United States (Recruiting)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
- Ann Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
- Children's Mercy Hospital — Kansas City, Missouri, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
- Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States (Recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.