Clinical trial NCT01666782: Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Influenza Viral Infections
Keywords: Influenza vaccine
Oncology
Chemotherapy
Lead sponsor: Rochester General Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2012-08-16
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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)

Primary outcomes:
measure: 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.
timeFrame: Baseline and 28 days
Secondary outcomes:
measure: The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
timeFrame: 28 days
measure: The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
timeFrame: Baseline and 28 days
measure: Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.
timeFrame: 7 days
measure: Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
timeFrame: 7 days
measure: Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.
timeFrame: 28 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Rochester
country: United States
facility: Lipson Cancer Center Linden Oaks Medical Campus
state: New York
Study officials:
affiliation: Rochester General Hospital
name: Saad Jamshed, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.