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Response to Influenza Virus Vaccination in Patients Immunocompromised Due to Chemotherapy

NCT ID: NCT01000246

Last Updated: 2009-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Mamma Carcinoma Heart Failure

Keywords

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mammacarcinoma breastcancer chemotherapy heart failure influenza virus vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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influenza vaccine day 4

influenza vaccine day 4 of chemotherapy

Group Type EXPERIMENTAL

influenza virus vaccine (influvac or vaxigrip)

Intervention Type BIOLOGICAL

one i.m. dose of 0.5 mL

influenza vaccine day 16

influenza vaccine day 16 of chemotherapy

Group Type EXPERIMENTAL

influenza virus vaccine (influvac or vaxigrip)

Intervention Type BIOLOGICAL

one i.m. dose of 0.5 mL

influenza vaccine

influenza vaccine in patients with heartfailure

Group Type ACTIVE_COMPARATOR

influenza virus vaccine (influvac or vaxigrip)

Intervention Type BIOLOGICAL

one i.m. dose of 0.5 mL

Interventions

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influenza virus vaccine (influvac or vaxigrip)

one i.m. dose of 0.5 mL

Intervention Type BIOLOGICAL

Other Intervention Names

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Influvac, MA number RVG 22289, ATC code J07BB02 Vaxigrip, MA number RVG 22306, ATC code J07BB02

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Antonius Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sint Antonius Hospital Nieuwegein

Principal Investigators

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Okke de Weerdt, Drs

Role: PRINCIPAL_INVESTIGATOR

Sint Antonius Hospital Nieuwegein

Douwe Biesma, Prof, Dr

Role: STUDY_DIRECTOR

UMC Utrecht

Locations

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Maxima Medisch Centrum

Eindhoven, North Brabant, Netherlands

Site Status

Medisch Centrum Alkmaar

Alkmaar, North Holland, Netherlands

Site Status

Spaarne Ziekenhuis

Hoofddorp, North Holland, Netherlands

Site Status

Martini Hospital Groningen

Groningen, Provincie Groningen, Netherlands

Site Status

Maasstadziekenhuis

Rotterdam, South Holland, Netherlands

Site Status

Meander Medisch Centrum

Amersfoort, Utrecht, Netherlands

Site Status

Tergooiziekenhuizen

Blaricum, Utrecht, Netherlands

Site Status

Sint Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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version 2, 21-08-09

Identifier Type: -

Identifier Source: secondary_id

RIFLUVAC

Identifier Type: -

Identifier Source: org_study_id