Mamma CarcinomaRIFLUVACNCT01000246
Response to Influenza Virus Vaccination in Patients Immunocompromised Due to Chemotherapy
A study testing influenza virus vaccine (influvac or vaxigrip) in people with Mamma Carcinoma and Heart Failure, run by St. Antonius Hospital at 8 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mamma Carcinoma, Heart Failure
- What is being tested?
- influenza virus vaccine (influvac or vaxigrip)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 8 sitesNetherlands
- Study dates
- Oct 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Netherlands8 sites
Medisch Centrum Alkmaar
Alkmaar, North Holland, 1800 AM
Meander Medisch Centrum
Amersfoort, Utrecht, 3800 BM
Tergooiziekenhuizen
Blaricum, Utrecht, 1201 DA
Maxima Medisch Centrum
Eindhoven, North Brabant, 5600 PD
Martini Hospital Groningen
Groningen, Provincie Groningen, 9700 RM
Spaarne Ziekenhuis
Hoofddorp, North Holland, 2134 TM
Sint Antonius Hospital
Nieuwegein, Utrecht, 3435 EM
Maasstadziekenhuis
Rotterdam, South Holland, 3075 EA
About this study
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).
Read the 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.
- Conditions
- Mamma Carcinoma, Heart Failure
- Being tested
- influenza virus vaccine (influvac or vaxigrip)
- Keywords
- mammacarcinoma, breastcancer, chemotherapy, heart failure, influenza virus vaccine
- Medical subject headings
- Heart Failure, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
influenza virus vaccine (influvac or vaxigrip)Biological
Also called Influvac, MA number RVG 22289, ATC code J07BB02, Vaxigrip, MA number RVG 22306, ATC code J07BB02
one i.m. dose of 0.5 mL
| Study group | Role | What they receive |
|---|---|---|
| influenza vaccine day 4 | Experimental | influenza vaccine day 4 of chemotherapy Receives: Biological: influenza virus vaccine (influvac or vaxigrip) |
| influenza vaccine day 16 | Experimental | influenza vaccine day 16 of chemotherapy Receives: Biological: influenza virus vaccine (influvac or vaxigrip) |
| influenza vaccine | Active comparator | influenza vaccine in patients with heartfailure Receives: Biological: influenza virus vaccine (influvac or vaxigrip) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate rise in antibody titre
Measured: three weeks
Secondary outcomes (1)
Antibody titres against the influenza virus before and after vaccination
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mamma CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Okke de Weerdt, Drs, Principal investigator, Sint Antonius Hospital NieuwegeinDouwe Biesma, Prof, Dr, Study director, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000246
- Sponsor's protocol ID
- RIFLUVAC
- Other IDs
- version 2, 21-08-09
- Acronym
- RIFLUVAC
- Status last verified
- Dec 2009
- First submitted
- 22 Oct 2009
- Last updated
- 18 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Influenza Virus Vaccination in Patients Immunocompromised Due to Chemotherapy
- ClinicalTrials.gov ID
- NCT01000246
- Acronym / sponsor ID
- RIFLUVAC / RIFLUVAC
- Conditions
- Mamma Carcinoma, Heart Failure
- Keywords
- mammacarcinoma, breastcancer, chemotherapy, heart failure, influenza virus vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| influenza vaccine day 4 | Experimental | Biological: influenza virus vaccine (influvac or vaxigrip)influenza vaccine day 4 of chemotherapy |
| influenza vaccine day 16 | Experimental | Biological: influenza virus vaccine (influvac or vaxigrip)influenza vaccine day 16 of chemotherapy |
| influenza vaccine | Active comparator | Biological: influenza virus vaccine (influvac or vaxigrip)influenza vaccine in patients with heartfailure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| influenza virus vaccine (influvac or vaxigrip)Also: Influvac, MA number RVG 22289, ATC code J07BB02, Vaxigrip, MA number RVG 22306, ATC code J07BB02one i.m. dose of 0.5 mL | Biological | influenza vaccine, influenza vaccine day 16, influenza vaccine day 4 |
Primary outcome
Adequate rise in antibody titre
Time frame: three weeks
1 secondary outcome
Antibody titres against the influenza virus before and after vaccination
Time frame: three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Okke de Weerdt, Drs principal investigator
Sint Antonius Hospital Nieuwegein
Douwe Biesma, Prof, Dr study director
UMC Utrecht
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing influenza virus vaccine (influvac or vaxigrip) in people with Mamma Carcinoma and Heart Failure, run by St. Antonius Hospital at 8 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate rise in antibody titre (time frame: three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2009.