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Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy (IMMUNE)

Primary Purpose

Cancer, Influenza Viral Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Standard Trivalent Influenza Vaccine
High-Dose Influenza Vaccine
Sponsored by
Saad Jamshed MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer focused on measuring Influenza vaccine, Oncology, Chemotherapy

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years old to less than 65 years old
  2. Subjects with malignancy must be receiving chemotherapy
  3. Medically stable
  4. Able to understand and willingness to sign a written informed consent
  5. Able to comply with study procedures
  6. Life expectancy of more than 3 months

  7. Adequate organ function:

    • ANC >1000/mm3
    • Platelet >100,000/uL
    • Creatinine <2 mg/dL
    • AST and ALT <3 times the ULN

Exclusion Criteria:

  1. Allergy to eggs
  2. Prior allergy to Influenza Vaccine
  3. History of Guillain-Barre Syndrome
  4. Current febrile illness
  5. Other immunosuppressive disease (recipients of solid organ transplant, uncontrolled HIV)
  6. Autologous or Allogenic Stem Cell Transplant with in a year
  7. Current immunotherapy or immunochemotherapy in the last 6 months (rituximab or ofatumumab)

Sites / Locations

  • Rochester General Hospital
  • Lipson Cancer Center Linden Oaks Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-Dose Influenza Vaccine

Standard Trivalent Influenza Vaccine

Arm Description

Outcomes

Primary Outcome Measures

The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.
Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.

Secondary Outcome Measures

The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.
The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
Seroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination.
Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.
Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine
Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.
Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine

Full Information

First Posted
August 14, 2012
Last Updated
May 23, 2016
Sponsor
Saad Jamshed MD
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01666782
Brief Title
Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy
Acronym
IMMUNE
Official Title
A Randomized Pilot Study Comparing High-Dose Influenza Vaccine to Standard-Dose Influenza Vaccine in Adult Oncology Patients Less Than 65 Years Receiving Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Saad Jamshed MD
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The safety and immunogenicity of high dose influenza vaccine has not been studied in young patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and safety of high dose influenza to standard dose influenza vaccine in adult oncology patients who are younger than 65 years old receiving chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Influenza Viral Infections
Keywords
Influenza vaccine, Oncology, Chemotherapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-Dose Influenza Vaccine
Arm Type
Experimental
Arm Title
Standard Trivalent Influenza Vaccine
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Standard Trivalent Influenza Vaccine
Other Intervention Name(s)
Fluzone
Intervention Description
Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
Intervention Type
Biological
Intervention Name(s)
High-Dose Influenza Vaccine
Other Intervention Name(s)
Fluzone High-Dose
Intervention Description
Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
Primary Outcome Measure Information:
Title
The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.
Description
Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.
Time Frame
Baseline and 28 days
Secondary Outcome Measure Information:
Title
The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
Description
Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.
Time Frame
28 days
Title
The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
Description
Seroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination.
Time Frame
Baseline and 28 days
Title
Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.
Description
Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine
Time Frame
7 days
Title
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
Description
Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine
Time Frame
7 days
Title
Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.
Description
Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old to less than 65 years old Subjects with malignancy must be receiving chemotherapy Medically stable Able to understand and willingness to sign a written informed consent Able to comply with study procedures Life expectancy of more than 3 months Adequate organ function: ANC >1000/mm3 Platelet >100,000/uL Creatinine <2 mg/dL AST and ALT <3 times the ULN Exclusion Criteria: Allergy to eggs Prior allergy to Influenza Vaccine History of Guillain-Barre Syndrome Current febrile illness Other immunosuppressive disease (recipients of solid organ transplant, uncontrolled HIV) Autologous or Allogenic Stem Cell Transplant with in a year Current immunotherapy or immunochemotherapy in the last 6 months (rituximab or ofatumumab)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saad Jamshed, MD
Organizational Affiliation
Rochester General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Lipson Cancer Center Linden Oaks Medical Campus
City
Rochester
State/Province
New York
ZIP/Postal Code
14625
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26721330
Citation
Jamshed S, Walsh EE, Dimitroff LJ, Santelli JS, Falsey AR. Improved immunogenicity of high-dose influenza vaccine compared to standard-dose influenza vaccine in adult oncology patients younger than 65 years receiving chemotherapy: A pilot randomized clinical trial. Vaccine. 2016 Jan 27;34(5):630-635. doi: 10.1016/j.vaccine.2015.12.037. Epub 2015 Dec 22.
Results Reference
derived

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Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy

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