NCT02860039

High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant

Comparison of High vs. Standard Dose Flu Vaccine in Pediatric Stem Cell Transplant Recipients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This phase II randomized trial studies how well high dose flu vaccine works in treating children who have undergone done stem cell transplant. Higher dose flu vaccine may build a better immune response and may provide better protection against the flu than the standard vaccine.

Detailed description

PRIMARY OBJECTIVES: I. To determine whether high-dose trivalent inactivated influenza vaccine (HD-TIV) compared with standard dose quadrivalent inactivated influenza vaccine (QIV) will increase the probability of achieving a \>= 4-fold rise in hemagglutination-inhibition (HAI) titers, \>= 1:40 HAI titer, or higher geometric mean titer (GMT) to influenza A antigens in pediatric hematopoietic stem cell transplant (HSCT) recipients. SECONDARY OBJECTIVES: I. To determine whether HD-TIV compared with standard dose QIV will increase the probability of achieving a \>= 4-fold rise in HAI titers, \>= 1:40 HAI titer, or higher GMT titers to influenza B antigens in pediatric HSCT recipients. II. To determine the frequency and severity of solicited local injection site adverse events (e.g. pain/ tenderness, redness, and swelling at injection site) with HD-TIV compared to standard QIV in pediatric HSCT recipients. III. To determine the frequency and severity of solicited systemic adverse events (e.g. fevers, headache, fatigue/malaise, nausea, body ache/myalgia, general activity level, and vomiting) with HD-TIV compared to standard dose QIV in pediatric HSCT recipients. IV. To define the relationship between HAI titers, in vivo T and B cell phenotype, and in vitro influenza-specific T and B cell response in pediatric HSCT recipients receiving either HD-TIV or standard dose QIV. V. To correlate HAI responses to microneutralization responses. VI. To compare the persistent HAI and microneutralization (MN) titers for all four antigen seven months after the last vaccine dose to assess for persistence of antibody titers. VII. To compare influenza detection by PCR during influenza season in pediatric HSCT recipients receiving either HD-TIV or standard dose QIV. VIII. To assess HAI and MN response in children vaccinated during year 1 and revaccinated during year 2 using the same antigen dose. OUTLINE: Patients are randomized to 1 of 2 treatment groups. GROUP I (Experimental): Patients receive HD-TIV intramuscularly (IM) on day 0 and day 28. GROUP II (Standard): Patients receive standard dose QIV IM on day 0 and day 28. After completion of study treatment, patients are followed up at 28-42 days, and at 7 months.

Conditions

• Hematopoietic Cell Transplantation Recipient
• Malignant Neoplasm
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent Influenza Vaccine	High dose Trivalent Influenza Vaccine given intramuscular
BIOLOGICAL	Quadrivalent Influenza Vaccine	Standard dose Quadrivalent Influenza Vaccine given intramuscular
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2016-09-01
• Primary completion: 2021-12-01
• Completion: 2024-09-01
• First posted: 2016-08-09
• Last updated: 2024-10-22
• Results posted: 2022-04-14

Locations

9 sites across 1 country: United States