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

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ClinicalTrials.gov Identifier: NCT01666782
Recruitment Status : Completed
First Posted : August 16, 2012
Results First Posted : May 24, 2016
Last Update Posted : June 24, 2016
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Saad Jamshed MD, Rochester General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer Influenza Viral Infections Biological: Standard Trivalent Influenza Vaccine Biological: High-Dose Influenza Vaccine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
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 Start Date : August 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: High-Dose Influenza Vaccine Biological: High-Dose Influenza Vaccine
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.
Other Name: Fluzone High-Dose
Active Comparator: Standard Trivalent Influenza Vaccine Biological: Standard Trivalent Influenza Vaccine
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.
Other Name: Fluzone


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: Baseline and 28 days ]
    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 :
  1. The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old. [ Time Frame: 28 days ]
    Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.

  2. The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old. [ Time Frame: Baseline and 28 days ]
    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.

  3. Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines. [ Time Frame: 7 days ]
    Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine

  4. Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines. [ Time Frame: 7 days ]
    Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine

  5. Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines. [ Time Frame: 28 days ]
    Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666782


Locations
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United States, New York
Rochester General Hospital
Rochester, New York, United States, 14621
Lipson Cancer Center Linden Oaks Medical Campus
Rochester, New York, United States, 14625
Sponsors and Collaborators
Saad Jamshed MD
Sanofi
Investigators
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Principal Investigator: Saad Jamshed, MD Rochester General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Saad Jamshed MD, Principal Investigator, Rochester General Hospital
ClinicalTrials.gov Identifier: NCT01666782    
Other Study ID Numbers: CIC 1336-B12-1
First Posted: August 16, 2012    Key Record Dates
Results First Posted: May 24, 2016
Last Update Posted: June 24, 2016
Last Verified: May 2016
Keywords provided by Saad Jamshed MD, Rochester General Hospital:
Influenza vaccine
Oncology
Chemotherapy
Additional relevant MeSH terms:
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Influenza, Human
Virus Diseases
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs