Response to Influenza Virus Vaccination in Patients Immunocompromised Due to Chemotherapy (RIFLUVAC)
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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 |
- Adequate rise in antibody titre [ Time Frame: three weeks ] [ Designated as safety issue: No ]
- 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:
|
|
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:
|
|
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:
|
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 |
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| 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 | |
| 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 May 23, 2013