Condition: Immunization; Infection · Transplantation Infection · Influenza · Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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 …
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| 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 |
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Source record: clinicaltrials.gov/study/NCT05947071