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Response to Influenza Virus Vaccination in Patients Immunocompromised Due to Chemotherapy (RIFLUVAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01000246
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : December 18, 2009
Sponsor:
Information provided by:
St. Antonius Hospital

Tracking Information
First Submitted Date  ICMJE October 22, 2009
First Posted Date  ICMJE October 23, 2009
Last Update Posted Date December 18, 2009
Study Start Date  ICMJE October 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
Adequate rise in antibody titre [ Time Frame: three weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
Antibody titres against the influenza virus before and after vaccination [ Time Frame: three weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Response to Influenza Virus Vaccination in Patients Immunocompromised Due to Chemotherapy
Official Title  ICMJE Response to Influenza Virus Vaccination in Patients Immunocompromised Due to Chemotherapy
Brief Summary Patients treated with chemotherapy or immunosuppressives are at higher risk of influenza infection and mortality and morbidity are higher compared to healthy adults. Vaccination against the influenza virus can prevent these complications. In this study it is investigated whether vaccination during chemotherapy is effective in reaching protective serum antibody concentrations and the relation between time of vaccination (day 4 +/- 1 day versus day 16 +/- 1 day of the chemotherapy cycle).
Detailed Description

This study will be conducted to answer the question whether vaccination during chemotherapy induces an adequate antibody response in oncology patients. Moreover, the effect of the timing of the vaccination during a chemotherapy cycle will be evaluated. In the mamma carcinoma patients, the effect of early versus late vaccination during a chemotherapy cycle will be studied. It was chosen to vaccinate in the early group at day 4 +/- 1 day; the immediate influence of the chemotherapy on the vaccination response is expected to have passed by then and patients will not already have their nadir. Late vaccination was defined as vaccination on day 16 +/- 1 day of the cycle. It is expected that the white blood cell and platelet counts by then are normalised.

In order to define a relatively homogenous patient population with mamma carcinoma, in this study patients will be recruited who are treated in the adjuvant setting with FEC-containing regimens (5-fluorouracil 500 mg/m2, epirubicin 100 mg/m2 and cyclophosphamid 500 mg/m2). The results of vaccination in these immunocompromised groups will be compared to the serological response to vaccination in persons who receive the influenza vaccination due to heart failure. Studies have shown that, although cytotoxic T-cell responses might be diminished, the rise in haemagglutinin inhibition titres in patients with heart failure vaccinated against influenza can be compared to the response to vaccination in otherwise healthy persons. These patients with heart failure will therefore be used as a control group. Patients with heart failure who are on treatment with immunosuppressives like prednisolone will not be included, because prednisolone diminishes the response to vaccination. The heart failure patients will be vaccinated according to the standard influenza vaccination protocol in the Netherlands.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Mamma Carcinoma
  • Heart Failure
Intervention  ICMJE Biological: influenza virus vaccine (influvac or vaxigrip)
one i.m. dose of 0.5 mL
Other Names:
  • Influvac, MA number RVG 22289, ATC code J07BB02
  • Vaxigrip, MA number RVG 22306, ATC code J07BB02
Study Arms  ICMJE
  • Experimental: influenza vaccine day 4
    influenza vaccine day 4 of chemotherapy
    Intervention: Biological: influenza virus vaccine (influvac or vaxigrip)
  • Experimental: influenza vaccine day 16
    influenza vaccine day 16 of chemotherapy
    Intervention: Biological: influenza virus vaccine (influvac or vaxigrip)
  • Active Comparator: influenza vaccine
    influenza vaccine in patients with heartfailure
    Intervention: Biological: influenza virus vaccine (influvac or vaxigrip)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 22, 2009)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with mamma carcinoma treated with FEC-containing triweekly chemotherapy at moment of vaccination
  • Patients with heart failure and therefore having an indication for the influenza vaccination
  • Age ≥ 18 years
  • Signing of informed consent

Exclusion Criteria:

  • Fever at time of vaccination defined as a temperature of ≥ 38.5 °C.
  • Previous/known allergic reaction to any of the components of the vaccines given, for example hypersensitivity to egg protein
  • Thrombocytopenia (defined as < 50 * 109/L ) at moment of vaccination
  • Treatment with prednisolone on moment of vaccination.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01000246
Other Study ID Numbers  ICMJE RIFLUVAC
version 2, 21-08-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party O. de Weerdt, internist, Sint Antonius Hospital Nieuwegein
Study Sponsor  ICMJE St. Antonius Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Okke de Weerdt, Drs Sint Antonius Hospital Nieuwegein
Study Director: Douwe Biesma, Prof, Dr UMC Utrecht
PRS Account St. Antonius Hospital
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP