LymphomaPhase 3NCT01016548
Evaluation of Influenza H1N1 Vaccine in Adults With Lymphoid Malignancies on Chemotherapy
A Phase 3 study testing AS03-adjuvanted H1N1 pandemic influenza vaccine in people with Lymphoma and Multiple Myeloma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether adults with hematologic malignancies on active systemic therapy or shortly after bone marrow transplantation need one or two doses of adjuvanted vaccine to achieve best possible rates of protection. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Lymphoma, Multiple Myeloma, Influenza A Virus, H1N1 Subtype
- What is being tested?
- AS03-adjuvanted H1N1 pandemic influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Jun 2010
- Phase
- Phase 3
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, ages 20-65
- Diagnosis of lymphoproliferative disorder
- One of the following types of systemic treatment: active chemo/immunotherapy at enrollment or completed within the last 3 months, OR auto/allo stem cell transplant recipient within the past 12 months
- Able to provide consent and comply with trial requirements
Who cannot join
- Systemic hypersensitivity to hen's eggs, thimerosal, gentamicin
- History of life-threatening reaction to prior influenza vaccination
- Thrombocytopenia or bleeding disorder contraindicating IM injection
- Pregnancy
- Laboratory-confirmed infection with H1N1(2009)
- IVIG infusion within the last three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pandemic H1N1(2009) Influenza Vaccine in Adults With Lymphoid Malignancies on Active Systemic Treatment or Post Stem Cell Transplantation
The purpose of this study is to determine whether adults with hematologic malignancies on active systemic therapy or shortly after bone marrow transplantation need one or two doses of adjuvanted vaccine to achieve best possible rates of protection. An additional research question is whether baseline biomarkers of the cellular and humoral immune systems are associated with an antibody response to vaccination.
Read the detailed description
The novel influenza H1N1 virus responsible for a world-wide pandemic throughout 2009 (H1N1(2009)) is expected to cause a second wave of infection during the 2009/10 winter season. Vaccines against H1N1(2009) will be available in early November, 2009. Adults with hematologic disorders are at high risk of influenza-related complications, including death. Given that the vaccination dosing for the pandemic vaccine has been developed on healthy individuals, it is unknown whether this subgroup of patients will respond similarly. We will evaluate the safety and efficacy of the pandemic vaccine in patients with lymphoid malignancies receiving active systemic treatment, or who have recently undergone stem cell transplantation. Patients will be randomized to one or two doses of the approved adjuvanted vaccine; immune responses will be measured to identify the optimal regimen. Also, we will look for an association between biomarkers of the immune system and a response to the vaccine; this will be done by measuring baseline CD3, 4, 8, 19, and 56 cells by flow cytometry.
- Conditions
- Lymphoma, Multiple Myeloma, Influenza A Virus, H1N1 Subtype
- Being tested
- AS03-adjuvanted H1N1 pandemic influenza vaccine
- Keywords
- Lymphoma, Multiple myeloma, Leukemia, Lymphocytic, Chronic, B-Cell, Influenza A Virus, H1N1 Subtype, Influenza Vaccines, Bone Marrow Transplantation
- Medical subject headings
- Lymphoma, Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS03-adjuvanted H1N1 pandemic influenza vaccineBiological
Also called Arepanrix(R), ATC Code J07BB02
One dose constitutes 0.5mL of suspended vaccine via the intramuscular route.
| Study group | Role | What they receive |
|---|---|---|
| Two doses of vaccine | Experimental | Second dose is given 21 days after the initial dose. The same dose and route of administration are used. Receives: Biological: AS03-adjuvanted H1N1 pandemic influenza vaccine |
| One dose of vaccine | Active comparator | Given at baseline only. Receives: Biological: AS03-adjuvanted H1N1 pandemic influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rates.
Measured: Day 0, 21, 42
Secondary outcomes (1)
Adverse events to vaccination.
Measured: Day 7, 21, 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 3
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Investigators
- John Kuruvilla, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016548
- Sponsor's protocol ID
- 09-0780-C
- Other IDs
- INVC-2009-0241
- Status last verified
- Jun 2010
- First submitted
- 18 Nov 2009
- Last updated
- 4 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Carter NJ, Plosker GL. Prepandemic influenza vaccine H5N1 (split virion, inactivated, adjuvanted) [Prepandrix]: a review of its use as an active immunization against influenza A subtype H5N1 virus. BioDrugs. 2008;22(5):279-92. doi: 10.2165/00063030-200822050-00001.
PubMed 18778110Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009 Dec 17;361(25):2405-13. doi: 10.1056/NEJMoa0907413. Epub 2009 Sep 10.
PubMed 19745216Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009 Dec 17;361(25):2424-35. doi: 10.1056/NEJMoa0907650. Epub 2009 Sep 10.
PubMed 19745215Zhu FC, Wang H, Fang HH, Yang JG, Lin XJ, Liang XF, Zhang XF, Pan HX, Meng FY, Hu YM, Liu WD, Li CG, Li W, Zhang X, Hu JM, Peng WB, Yang BP, Xi P, Wang HQ, Zheng JS. A novel influenza A (H1N1) vaccine in various age groups. N Engl J Med. 2009 Dec 17;361(25):2414-23. doi: 10.1056/NEJMoa0908535. Epub 2009 Oct 21.
PubMed 19846844Mazza JJ, Yale SH, Arrowood JR, Reynolds CE, Glurich I, Chyou PH, Linneman JG, Reed KD. Efficacy of the influenza vaccine in patients with malignant lymphoma. Clin Med Res. 2005 Nov;3(4):214-20. doi: 10.3121/cmr.3.4.214.
PubMed 16303886Ljungman P, Nahi H, Linde A. Vaccination of patients with haematological malignancies with one or two doses of influenza vaccine: a randomised study. Br J Haematol. 2005 Jul;130(1):96-8. doi: 10.1111/j.1365-2141.2005.05582.x.
PubMed 15982350
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pandemic H1N1(2009) Influenza Vaccine in Adults With Lymphoid Malignancies on Active Systemic Treatment or Post Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01016548
- Acronym / sponsor ID
- 09-0780-C
- Conditions
- Lymphoma, Multiple Myeloma, Influenza A Virus, H1N1 Subtype
- Keywords
- Lymphoma, Multiple myeloma, Leukemia, Lymphocytic, Chronic, B-Cell, Influenza A Virus, H1N1 Subtype, Influenza Vaccines, Bone Marrow Transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 Nov 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.
The purpose of this study is to determine whether adults with hematologic malignancies on active systemic therapy or shortly after bone marrow transplantation need one or two doses of adjuvanted vaccine to achieve best possible rates of protection. An additional research question is whether baseline biomarkers of the cellular and humoral immune systems are associated with an antibody response to vaccination.
Detailed description
The novel influenza H1N1 virus responsible for a world-wide pandemic throughout 2009 (H1N1(2009)) is expected to cause a second wave of infection during the 2009/10 winter season. Vaccines against H1N1(2009) will be available in early November, 2009. Adults with hematologic disorders are at high risk of influenza-related complications, including death. Given that the vaccination dosing for the pandemic vaccine has been developed on healthy individuals, it is unknown whether this subgroup of patients will respond similarly. We will evaluate the safety and efficacy of the pandemic vaccine in patients with lymphoid malignancies receiving active systemic treatment, or who have recently undergone stem cell transplantation. Patients will be randomized to one or two doses of the approved adjuvanted vaccine; immune responses will be measured to identify the optimal regimen. Also, we will look for an association between biomarkers of the immune system and a response to the vaccine; this will be done by measuring baseline CD3, 4, 8, 19, and 56 cells by flow cytometry.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two doses of vaccine | Experimental | Biological: AS03-adjuvanted H1N1 pandemic influenza vaccineSecond dose is given 21 days after the initial dose. The same dose and route of administration are used. |
| One dose of vaccine | Active comparator | Biological: AS03-adjuvanted H1N1 pandemic influenza vaccineGiven at baseline only. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, ages 20-65
- Diagnosis of lymphoproliferative disorder
- One of the following types of systemic treatment: active chemo/immunotherapy at enrollment or completed within the last 3 months, OR auto/allo stem cell transplant recipient within the past 12 months
- Able to provide consent and comply with trial requirements
Key exclusion criteria (6 listed)
- Systemic hypersensitivity to hen's eggs, thimerosal, gentamicin
- History of life-threatening reaction to prior influenza vaccination
- Thrombocytopenia or bleeding disorder contraindicating IM injection
- Pregnancy
- Laboratory-confirmed infection with H1N1(2009)
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 |
|---|---|---|
| AS03-adjuvanted H1N1 pandemic influenza vaccineAlso: Arepanrix(R), ATC Code J07BB02One dose constitutes 0.5mL of suspended vaccine via the intramuscular route. | Biological | One dose of vaccine, Two doses of vaccine |
Primary outcome
Seroconversion rates.
Time frame: Day 0, 21, 42
1 secondary outcome
Adverse events to vaccination.
Time frame: Day 7, 21, 28.
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 4 Jun 2010.
- Background: PubMed 18778110Carter NJ, Plosker GL. Prepandemic influenza vaccine H5N1 (split virion, inactivated, adjuvanted) [Prepandrix]: a review of its use as an active immunization against influenza A subtype H5N1 virus. BioDrugs. 2008;22(5):279-92. doi: 10.2165/00063030-200822050-00001.
- Background: PubMed 19745216Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009 Dec 17;361(25):2405-13. doi: 10.1056/NEJMoa0907413. Epub 2009 Sep 10.
- Background: PubMed 19745215Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009 Dec 17;361(25):2424-35. doi: 10.1056/NEJMoa0907650. Epub 2009 Sep 10.
- Background: PubMed 19846844Zhu FC, Wang H, Fang HH, Yang JG, Lin XJ, Liang XF, Zhang XF, Pan HX, Meng FY, Hu YM, Liu WD, Li CG, Li W, Zhang X, Hu JM, Peng WB, Yang BP, Xi P, Wang HQ, Zheng JS. A novel influenza A (H1N1) vaccine in various age groups. N Engl J Med. 2009 Dec 17;361(25):2414-23. doi: 10.1056/NEJMoa0908535. Epub 2009 Oct 21.
- Background: PubMed 16303886Mazza JJ, Yale SH, Arrowood JR, Reynolds CE, Glurich I, Chyou PH, Linneman JG, Reed KD. Efficacy of the influenza vaccine in patients with malignant lymphoma. Clin Med Res. 2005 Nov;3(4):214-20. doi: 10.3121/cmr.3.4.214.
- Background: PubMed 15982350Ljungman P, Nahi H, Linde A. Vaccination of patients with haematological malignancies with one or two doses of influenza vaccine: a randomised study. Br J Haematol. 2005 Jul;130(1):96-8. doi: 10.1111/j.1365-2141.2005.05582.x.
- Arepanrix(R) Product Information LeafletLink 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.
John Kuruvilla, MD principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AS03-adjuvanted H1N1 pandemic influenza vaccine in people with Lymphoma and Multiple Myeloma, run by University Health Network, Toronto at 1 site in Canada.
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 6 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 4 Jun 2010. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Seroconversion rates. (time frame: Day 0, 21, 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01016548, which also lists 6 linked publications.
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 4 Jun 2010.