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Response to Influenza Virus Vaccination in Patients Immunocompromised Due to Chemotherapy

18 Years
Not Enrolling
Mamma Carcinoma, Heart Failure

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Trial Information

Response to Influenza Virus Vaccination in Patients Immunocompromised Due to Chemotherapy

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.

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Adequate rise in antibody titre

Outcome Time Frame:

three weeks

Safety Issue:


Principal Investigator

Okke de Weerdt, Drs

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sint Antonius Hospital Nieuwegein


Netherlands: Medicines Evaluation Board (MEB)

Study ID:




Start Date:

October 2009

Completion Date:

December 2009

Related Keywords:

  • Mamma Carcinoma
  • Heart Failure
  • mammacarcinoma
  • breastcancer
  • chemotherapy
  • heart failure
  • influenza virus vaccine
  • Carcinoma
  • Heart Failure
  • Influenza, Human