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

This study has been completed.
Sponsor:
Information provided by:
St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT01000246
First received: October 22, 2009
Last updated: December 17, 2009
Last verified: December 2009
  Purpose

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).


Condition Intervention
Mamma Carcinoma
Heart Failure
Biological: influenza virus vaccine (influvac or vaxigrip)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Response to Influenza Virus Vaccination in Patients Immunocompromised Due to Chemotherapy

Resource links provided by NLM:


Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:
  • Adequate rise in antibody titre [ Time Frame: three weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antibody titres against the influenza virus before and after vaccination [ Time Frame: three weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000246

Locations
Netherlands
Maxima Medisch Centrum
Eindhoven, Noord-Brabant, Netherlands, 5600 PD
Medisch Centrum Alkmaar
Alkmaar, Noord-Holland, Netherlands, 1800 AM
Spaarne Ziekenhuis
Hoofddorp, Noord-Holland, Netherlands, 2134 TM
Meander Medisch Centrum
Amersfoort, Utrecht, Netherlands, 3800 BM
Tergooiziekenhuizen
Blaricum, Utrecht, Netherlands, 1201 DA
Sint Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435 EM
Maasstadziekenhuis
Rotterdam, Zuid-Holland, Netherlands, 3075 EA
Martini Hospital Groningen
Groningen, Netherlands, 9700 RM
Sponsors and Collaborators
St. Antonius Hospital
Investigators
Principal Investigator: Okke de Weerdt, Drs Sint Antonius Hospital Nieuwegein
Study Director: Douwe Biesma, Prof, Dr UMC Utrecht
  More Information

No publications provided

Responsible Party: O. de Weerdt, internist, Sint Antonius Hospital Nieuwegein
ClinicalTrials.gov Identifier: NCT01000246     History of Changes
Other Study ID Numbers: RIFLUVAC, version 2, 21-08-09
Study First Received: October 22, 2009
Last Updated: December 17, 2009
Health Authority: Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by St. Antonius Hospital:
mammacarcinoma
breastcancer
chemotherapy
heart failure
influenza virus vaccine

Additional relevant MeSH terms:
Carcinoma
Heart Failure
Influenza, Human
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Heart Diseases
Cardiovascular Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014