LymphomaPhase 2NCT00307710
Influenza Vaccination in Patients Receiving Antineoplastic Therapy for Non-Hodgkin's Lymphoma
A Phase 2 study testing Trivalent Baculovirus-expressed Influenza HA vaccine in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: To assess the trend in immunogenic response across patients administered either licensed trivalent inactivated influenza vaccine (TIV) or one of three doses (15, 45 or 135 μg) of trivalent recombinant baculovirus expressed hemagglutinin vaccines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Trivalent Baculovirus-expressed Influenza HA vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Feb 2007
- Phase
- Phase 2
- 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 non-Hodgkin's B-cell lymphoma (NHL) including follicular, large cell and Mantle cell lymphoma will be included.
- Patients in complete clinical remission and determined to have no evidence of active disease (NED).
- Patients greater than or equal to 18 years of age who have given informed consent and signed the IRB approved informed consent.
- Ambulatory, medically stable persons; community dwelling; able to give informed consent and available for all study visits; able to understand and comply with planned study procedures; ECOG performance status of less than or equal to 2.
- Medically stable subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but their symptoms/signs are controlled with medical therapy.
- Patients with a non-metastatic secondary solid tumor or malignancies not currently (< 3 months) being treated will be included.
Who cannot join
- Patients with Hodgkin's disease, and T-cell lymphoma.
- Patients undergoing antineoplastic therapy.
- Patients who have received chemotherapy within the past 3 months.
- Individuals who were given rituximab (ibritumomab tiuxetan) in < 6 months.
- Patients receiving systemic corticosteroids and/or high-dose inhaled steroids (>800 mcg per day of beclomethasone dipropionate or equivalent).
- Splenectomized individuals will not be included.
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- Known allergy to eggs or other components of vaccine (e.g., thimerosal).
- Acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses (including but not limited to the following: acute febrile illness, known chronic liver disease; significant renal disease; oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV dyspnea; unstable or progressive neurologic disorder; insulin-dependent diabetes mellitus).
- Concomitant use of investigational vaccines and/or other medications within 4 weeks prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products prior to study completion.
- Previous exposure to parenteral immunoglobulins or other blood product within 6 months prior to enrollment into the study.
- Subject is enrolled in a conflicting clinical trial.
- Use of experimental vaccines or medications within one month of study entry.
- Any acute or chronic condition which in the opinion of the investigator would render vaccination unsafe or interfere with the evaluation of response.
- Patients with a known history or risk factors (IV drug abuse or casual sex within the past year) of Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Evaluation of the Reactogenicity and Immunogenicity of Different Doses of Trivalent Baculovirus-expressed Influenza HA Vaccine in Adults With Non-Hodgkin's B-cell Lymphoma: A Phase II, Double-Blind Pilot Study - Version 4
Primary Objective:
To assess the trend in immunogenic response across patients administered either licensed trivalent inactivated influenza vaccine (TIV) or one of three doses (15, 45 or 135 μg) of trivalent recombinant baculovirus expressed hemagglutinin vaccines. Immunogenic response is defined as a 4-fold or greater increase in serum antibody.
Secondary Objective:
To determine the safety and tolerability of 3 doses (15 μg HA per virus, 45 μg HA per virus, and 135 μg HA per virus) of recombinant baculovirus-expressed HA vaccine in patients with non-Hodgkin's B-cell lymphoma.
Read the detailed description
Influenza is a common respiratory infection caused by viruses. Standard influenza vaccines may not be as effective at protecting cancer patients as the general population from getting influenza. New technology has been developed that allows stronger (and hopefully more effective) influenza vaccines to be developed. This research study will test an experimental influenza vaccine.
If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to receive either standard inactivated influenza vaccine or one of three doses of the experimental vaccine. You will have an equal chance of being assigned to any of the four treatment groups. Neither your physician, the study doctor, or you will know which vaccine or dose you received. In case of an emergency, the study doctor can find out which vaccine and dose you received.
Before the injection is given, a blood test will be taken to measure your antibodies (substances that fight infection). About two teaspoons of blood will be taken for this blood test. The vaccine will be given as a one time injection in the arm. After you are given the injection, you will be observed for 20 minutes in the clinic before you are sent home. Everyone taking part in this study will be asked to keep a symptom diary and temperature log for 1 week after the injection. After 7 days, you will return for review of the diary and any symptoms you may have had.
At 4 and 8 weeks after the influenza vaccine is given, most patients will have a blood test to learn the amount of immunity against the influenza virus they have developed. About two teaspoons of blood will be required for this test. A few patients may not be eligible for the eight week blood collection and will be instructed by the study nurse about future visits to UTMDACC. Six months after you have received the vaccine, you will be contacted by one of the study personnel to ask you if you had any serious side effects that might be from the study vaccine. Once you have received this follow-up telephone call, your participation in this study will be completed.
This is an investigational study. The standard vaccine used in this study is FDA approved and commercially available. The experimental vaccine is authorized for use in research only. About 100 patients will take part in this study. All will be enrolled at UTMDACC.
This protocol is partially funded by a research contract from the National Institutes of Health (NIH) to Baylor College of Medicine.
- Conditions
- Lymphoma
- Being tested
- Trivalent Baculovirus-expressed Influenza HA vaccine
- Keywords
- Non-Hodgkin's Lymphoma, Influenza Vaccination, Trivalent Baculovirus-Expressed Influenza HA vaccine, Antineoplastic Therapy
- Medical subject headings
- Lymphoma, Lymphoma, Non-Hodgkin, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent Baculovirus-expressed Influenza HA vaccineBiological
Receive either standard inactivated influenza vaccine or one of three doses of the experimental vaccine, vaccine dose 15, 45 or 135 μg HA per virus, intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| A: Trivalent Subvirion Vaccine | Experimental | Group A: Trivalent subvirion vaccine - standard inactivated influenza vaccine by intramuscular injection. Receives: Biological: Trivalent Baculovirus-expressed Influenza HA vaccine |
| B: Vaccine 15 μg | Experimental | Group B: Trivalent rHA0 vaccine 15 μg per rHA0 (total 45 μg rHA0) Receives: Biological: Trivalent Baculovirus-expressed Influenza HA vaccine |
| C: Vaccine 45 μg | Experimental | Group C: Trivalent rHA0 vaccine 45 μg per rHA0 (total 135 μg rHA0) Receives: Biological: Trivalent Baculovirus-expressed Influenza HA vaccine |
| D: Vaccine 135 μg | Experimental | Group D: Trivalent rHA0 vaccine 135 μg per rHA0 (total 405 μg rHA0) Receives: Biological: Trivalent Baculovirus-expressed Influenza HA vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenic response across patients administered either licensed trivalent inactivated influenza vaccine (TIV) or one of three doses (15, 45 or 135 μg) of trivalent recombinant baculovirus expressed hemagglutinin vaccines.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startAug 2004
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Amar Safdar, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307710
- Sponsor's protocol ID
- 2004-0340
- Other IDs
- DMID 04-036
- Status last verified
- Jul 2012
- First submitted
- 24 Mar 2006
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Reactogenicity and Immunogenicity of Different Doses of Trivalent Baculovirus-expressed Influenza HA Vaccine in Adults With Non-Hodgkin's B-cell Lymphoma: A Phase II, Double-Blind Pilot Study - Version 4
- ClinicalTrials.gov ID
- NCT00307710
- Acronym / sponsor ID
- 2004-0340
- Conditions
- Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Influenza Vaccination, Trivalent Baculovirus-Expressed Influenza HA vaccine, Antineoplastic Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2004
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 28 Mar 2006 (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.
Primary Objective:
To assess the trend in immunogenic response across patients administered either licensed trivalent inactivated influenza vaccine (TIV) or one of three doses (15, 45 or 135 μg) of trivalent recombinant baculovirus expressed hemagglutinin vaccines. Immunogenic response is defined as a 4-fold or greater increase in serum antibody.
Secondary Objective:
To determine the safety and tolerability of 3 doses (15 μg HA per virus, 45 μg HA per virus, and 135 μg HA per virus) of recombinant baculovirus-expressed HA vaccine in patients with non-Hodgkin's B-cell lymphoma.
Detailed description
Influenza is a common respiratory infection caused by viruses. Standard influenza vaccines may not be as effective at protecting cancer patients as the general population from getting influenza. New technology has been developed that allows stronger (and hopefully more effective) influenza vaccines to be developed. This research study will test an experimental influenza vaccine.
If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to receive either standard inactivated influenza vaccine or one of three doses of the experimental vaccine. You will have an equal chance of being assigned to any of the four treatment groups. Neither your physician, the study doctor, or you will know which vaccine or dose you received. In case of an emergency, the study doctor can find out which vaccine and dose you received.
Before the injection is given, a blood test will be taken to measure your antibodies (substances that fight infection). About two teaspoons of blood will be taken for this blood test. The vaccine will be given as a one time injection in the arm. After you are given the injection, you will be observed for 20 minutes in the clinic before you are sent home. Everyone taking part in this study will be asked to keep a symptom diary and temperature log for 1 week after the injection. After 7 days, you will return for review of the diary and any symptoms you may have had.
At 4 and 8 weeks after the influenza vaccine is given, most patients will have a blood test to learn the amount of immunity against the influenza virus they have developed. About two teaspoons of blood will be required for this test. A few patients may not be eligible for the eight week blood collection and will be instructed by the study nurse about future visits to UTMDACC. Six months after you have received the vaccine, you will be contacted by one of the study personnel to ask you if you had any serious side effects that might be from the study vaccine. Once you have received this follow-up telephone call, your participation in this study will be completed.
This is an investigational study. The standard vaccine used in this study is FDA approved and commercially available. The experimental vaccine is authorized for use in research only. About 100 patients will take part in this study. All will be enrolled at UTMDACC.
This protocol is partially funded by a research contract from the National Institutes of Health (NIH) to Baylor College of Medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A: Trivalent Subvirion Vaccine | Experimental | Biological: Trivalent Baculovirus-expressed Influenza HA vaccineGroup A: Trivalent subvirion vaccine - standard inactivated influenza vaccine by intramuscular injection. |
| B: Vaccine 15 μg | Experimental | Biological: Trivalent Baculovirus-expressed Influenza HA vaccineGroup B: Trivalent rHA0 vaccine 15 μg per rHA0 (total 45 μg rHA0) |
| C: Vaccine 45 μg | Experimental | Biological: Trivalent Baculovirus-expressed Influenza HA vaccineGroup C: Trivalent rHA0 vaccine 45 μg per rHA0 (total 135 μg rHA0) |
| D: Vaccine 135 μg | Experimental | Biological: Trivalent Baculovirus-expressed Influenza HA vaccineGroup D: Trivalent rHA0 vaccine 135 μg per rHA0 (total 405 μg rHA0) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with non-Hodgkin's B-cell lymphoma (NHL) including follicular, large cell and Mantle cell lymphoma will be included.
- Patients in complete clinical remission and determined to have no evidence of active disease (NED).
- Patients greater than or equal to 18 years of age who have given informed consent and signed the IRB approved informed consent.
- Ambulatory, medically stable persons; community dwelling; able to give informed consent and available for all study visits; able to understand and comply with planned study procedures; ECOG performance status of less than or equal to 2.
- Medically stable subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but their symptoms/signs are controlled with medical therapy.
Key exclusion criteria (14 listed)
- Patients with Hodgkin's disease, and T-cell lymphoma.
- Patients undergoing antineoplastic therapy.
- Patients who have received chemotherapy within the past 3 months.
- Individuals who were given rituximab (ibritumomab tiuxetan) in < 6 months.
- Patients receiving systemic corticosteroids and/or high-dose inhaled steroids (>800 mcg per day of beclomethasone dipropionate or equivalent).
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 |
|---|---|---|
| Trivalent Baculovirus-expressed Influenza HA vaccineReceive either standard inactivated influenza vaccine or one of three doses of the experimental vaccine, vaccine dose 15, 45 or 135 μg HA per virus, intramuscular injection. | Biological | A: Trivalent Subvirion Vaccine, B: Vaccine 15 μg, C: Vaccine 45 μg, D: Vaccine 135 μg |
Primary outcome
Immunogenic response across patients administered either licensed trivalent inactivated influenza vaccine (TIV) or one of three doses (15, 45 or 135 μg) of trivalent recombinant baculovirus expressed hemagglutinin vaccines.
Time frame: 3 Years
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 31 Jul 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Amar Safdar, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trivalent Baculovirus-expressed Influenza HA vaccine in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
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 6 inclusion and 14 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 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Immunogenic response across patients administered either licensed trivalent inactivated influenza vaccine (TIV) or one of three doses (15, 45 or 135 μg) of trivalent recombinant baculovirus expressed hemagglutinin vaccines. (time frame: 3 Years). 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 31 Jul 2012.