Clinical trial NCT01000246: Response to Influenza Virus Vaccination in Patients Immunocompromised Due to Chemotherapy
Official title: Response to Influenza Virus Vaccination in Patients Immunocompromised Due to Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mamma Carcinoma
Heart Failure
Keywords: mammacarcinoma
breastcancer
chemotherapy
heart failure
influenza virus vaccine
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2009-10-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adequate rise in antibody titre
timeFrame: three weeks
Secondary outcomes:
measure: Antibody titres against the influenza virus before and after vaccination
timeFrame: three weeks
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum
state: Noord-Brabant
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
state: Noord-Holland
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis
state: Noord-Holland
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
state: Utrecht
city: Blaricum
country: Netherlands
facility: Tergooiziekenhuizen
state: Utrecht
city: Nieuwegein
country: Netherlands
facility: Sint Antonius Hospital
state: Utrecht
city: Rotterdam
country: Netherlands
facility: Maasstadziekenhuis
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Martini Hospital Groningen
Study officials:
affiliation: Sint Antonius Hospital Nieuwegein
name: Okke de Weerdt, Drs
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Douwe Biesma, Prof, Dr
role: STUDY_DIRECTOR
References: