NCT03179761

High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II studies the side effects of high-dose trivalent influenza vaccine or standard-dose quadrivalent inactivated influenza and how well they work in treating adult patients undergoing stem cell transplant. Season influenza can cause more severe infections in patients who have had a stem cell transplant since their immune system doesn't work as well. Influenza vaccine may provide better protection against flu in adults.

Detailed description

PRIMARY OBJECTIVES: I. To determine whether high dose (HD)-trivalent influenza vaccine (TIV) compared with standard dose (SD)-quadrivalent inactivated influenza vaccine (QIV) will increase the probability of achieving a \>= 4-fold rise in hemagglutination inhibition assay (HAI) titer, \>= 1:40 HAI titer, or a higher geometric mean titer (GMT) titer to influenza A antigens in adult hematopoietic cell transplantation (HSCT) recipients. SECONDARY OBJECTIVES: I. To determine whether HD-TIV compared with SD-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 adult 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 SD-QIV in adult 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 SD-QIV in adult 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 adult HSCT recipients receiving either HD-TIV or SD-QIV. V. To correlate HAI responses to microneutralization responses. VI. To compare the persistent HAI and microneutralization assay (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 polymerase chain reaction (PCR) during influenza season in adult HSCT recipients receiving either HD-TIV or standard dose QIV. OUTLINE: Patients are randomized into 1 of 2 groups. GROUP I: Patients receive HD-TIV intramuscularly once at baseline and once between 28-42 days. GROUP II: Patients receive SD-QIV intramuscularly once at baseline and once between 28-42 days. After completion of study treatment, patients are contacted at 1-3 and 8-10 days after each vaccination visit.

Conditions

• Hematopoietic Cell Transplantation

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Inactivated Influenza Vaccine	Standard Dose Quadrivalent Influenza Vaccine given intramuscularly
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Trivalent Influenza Vaccine	High Dose Trivalent Influenza Vaccine given intramuscularly

Timeline

• Start date: 2017-10-09
• Primary completion: 2022-02-15
• Completion: 2024-10-01
• First posted: 2017-06-07
• Last updated: 2024-12-04
• Results posted: 2023-01-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study