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

December 17, 2009 updated by: St. Antonius Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700 RM
        • Martini Hospital Groningen
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5600 PD
        • Maxima Medisch Centrum
    • Noord-Holland
      • Alkmaar, Noord-Holland, Netherlands, 1800 AM
        • Medisch Centrum Alkmaar
      • Hoofddorp, Noord-Holland, Netherlands, 2134 TM
        • Spaarne Ziekenhuis
    • Utrecht
      • Amersfoort, Utrecht, Netherlands, 3800 BM
        • Meander Medisch Centrum
      • Blaricum, Utrecht, Netherlands, 1201 DA
        • Tergooiziekenhuizen
      • Nieuwegein, Utrecht, Netherlands, 3435 EM
        • Sint Antonius Hospital
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3075 EA
        • Maasstadziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: influenza vaccine day 4
influenza vaccine day 4 of chemotherapy
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
Experimental: influenza vaccine day 16
influenza vaccine day 16 of chemotherapy
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
Active Comparator: influenza vaccine
influenza vaccine in patients with heartfailure
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adequate rise in antibody titre
Time Frame: three weeks
three weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Antibody titres against the influenza virus before and after vaccination
Time Frame: three weeks
three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital

Investigators

  • Principal Investigator: Okke de Weerdt, Drs, Sint Antonius Hospital Nieuwegein
  • Study Director: Douwe Biesma, Prof, Dr, UMC Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 22, 2009

First Submitted That Met QC Criteria

October 22, 2009

First Posted (Estimate)

October 23, 2009

Study Record Updates

Last Update Posted (Estimate)

December 18, 2009

Last Update Submitted That Met QC Criteria

December 17, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIFLUVAC
  • version 2, 21-08-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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