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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 17
Healthy Volunteers: f
View:

• Male or female, 3-17 years of age at time of enrollment

• 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

• Anticipated to be available for duration of the study

• Available by telephone, email, or text message

Locations
United States
California
Stanford University
RECRUITING
Stanford
Georgia
Children's Healthcare of Atlanta
RECRUITING
Atlanta
Illinois
Ann Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Missouri
Children's Mercy Hospital
RECRUITING
Kansas City
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Pennsylvania
UPMC Children's Hospital of Pittsburgh
RECRUITING
Pittsburgh
Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
RECRUITING
Nashville
Texas
Texas Children's Hospital
RECRUITING
Houston
Time Frame
Start Date: 2024-09-26
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 312
Treatments
Experimental: Two Doses Standard Dose Quadrivalent Inactivated Influenza Vaccine
Two doses of SD-QIV (0.5 mL; 15µg of each influenza antigen) 28-42 days apart
Experimental: Two Doses High Dose Quadrivalent Inactivated Influenza Vaccine
Two doses of HD-QIV (0.7 mL; 60µg of each influenza antigen) 28-42 days apart
Related Therapeutic Areas
Sponsors
Leads: National Institute of Allergy and Infectious Diseases (NIAID)

This content was sourced from clinicaltrials.gov