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

NCT03179761 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: VICC CTT 1733NCI-2017-00466
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hematopoietic Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity

  Point estimates and 95% confidence intervals for proportion of subjects achieving seroprotection (≥1:40 HAI titer) and seroconversion (4-fold or greater rise in HAI titers from visit 1) for Influenza A antigens.

  Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.

Secondary Outcomes (4)

• HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity

  Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.

• Solicited Local Injection Site Adverse Events

  Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.

• Solicited Systemic Adverse Events

  Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.

• Percentage of Individuals in Each Group That Test Positive for Influenza by PCR

  Nasal swabs were collected at each study visit or within 48 hours if a subject presented with influenza-like symptoms throughout the duration of the study.

Other Outcomes (2)

• B Cell Response Assessed by Mass Cytometry and In-vitro Functionality Assays

  Visit 1 cell counts (baseline) were measured on day 0; visit 2 cell counts were measured 28-42 days after visit 1; visit 3 cell counts were measured 28-42 days after visit 2; and visit 4 cell counts were measured 138-222 days after visit 2.

• T Cell Response Assessed by Mass Cytometry and In-vitro Functionality Assays

  Visit 1 cell counts (baseline) were measured on day 0; visit 2 cell counts were measured 28-42 days after visit 1; visit 3 cell counts were measured 28-42 days after visit 2; and visit 4 cell counts were measured 138-222 days after visit 2.

Study Arms (2)

Group I (HD-TIV)

EXPERIMENTAL

Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.

Other: Laboratory Biomarker Analysis; Biological: Trivalent Influenza Vaccine

Group 2(SD-QIV)

ACTIVE COMPARATOR

Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.

Biological: Quadrivalent Inactivated Influenza Vaccine; Other: Laboratory Biomarker Analysis

Interventions

Quadrivalent Inactivated Influenza Vaccine BIOLOGICAL

Standard Dose Quadrivalent Influenza Vaccine given intramuscularly

Group 2(SD-QIV)

Laboratory Biomarker Analysis OTHER

Correlative studies

Group 2(SD-QIV); Group I (HD-TIV)

Trivalent Influenza Vaccine BIOLOGICAL

High Dose Trivalent Influenza Vaccine given intramuscularly

Group I (HD-TIV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Allogeneic HSCT recipients who are 3-23 months post-transplant;
• ≥ 18 years of age;
• Available for duration of study;
• Patients with stable GVHD for at least 4 weeks will be eligible (stable is defined as no major change in systemic immunosuppressive therapy for worsening GVHD; adjustment of actual dose to obtain a stable target level is acceptable).
• Can be reached by telephone and/or electronic communication
• Subjects must have a platelet count of ≥30,000 to receive the immunizations. Patients requiring platelet transfusions are eligible to enroll and must have a platelet count ≥30,000 within 72 hours prior to their immunization, or platelet count ≥75,000 without transfusion documented within 30 days for subjects \<12 months post- transplant and within 90 days for subjects 12-23 months post-transplant.

You may not qualify if:

• History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein;
• History of Guillain-Barre syndrome;
• Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerism is permitted);
• History of receiving current seasonal influenza vaccine post-transplant;
• Pregnant female;
• History of proven influenza disease after September 1, 2018 prior to enrollment;
• Non-allogeneic (e.g. autologous) or syngeneic hematopoietic SCT recipients;
• History of known active infection with HIV
• History of cirrhosis
• History of known latex hypersensitivity;
• Subjects who have received stem cell boost or delayed donor lymphocyte infusion within 90 days of enrollment, including day of enrollment
• Receipt of. IVIG/SCIG \<28 days prior to vaccination
• Criteria for temporarily delaying vaccine administration: The following conditions are temporary or self-limiting, and a subject may be included in the study once the condition has resolved, provided that the subject is otherwise eligible:
• Fever ≥100.4ºF/38.0ºC (oral measurement), or an acute illness within 48 hours of enrollment
• Receipt of any live vaccines within four weeks or any inactivated vaccines within two weeks prior to potential study vaccination.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead

Study Sites (4)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Natasha Halasa, MD, MPH
• Organization: Vanderbilt-Ingram Cancer Center

[email protected]

800-811-8480

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 7, 2017
• Study Start: October 9, 2017
• Primary Completion: February 15, 2022
• Study Completion: October 1, 2024
• Last Updated: December 4, 2024
• Results First Posted: January 12, 2023

Record last verified: 2024-11

Locations

US (4)