Immunologic Response After Pandemic Influenza A (H1N1) Vaccine in Onco- Hematologic Patients
Evaluation of Immunologic Response After Pandemic Influenza A (H1N1) Vaccine in Oncologic and Hematologic Patients
1 other identifier
observational
124
1 country
1
Brief Summary
Primary objective 1\) To assess whether oncologic and hematologic patients develop a protective immunological response after pandemic Influenza A (H1N1) vaccine Secondary objectives
- 1.To compare the levels of antibody response against A (H1N1) influenza virus between oncologic and hematologic patients relative to a cohort of healthy volunteers
- 2.To assess the incidence of A (H1N1) infection in vaccinated oncologic and hematologic patients in comparison with a cohort of vaccinated healthy volunteers. To assess the clinical symptoms attributable to influenza infection in vaccinated oncologic and hematological patients and healthy volunteers.
- 3.To compare the levels of antibody response against A (H1N1) influenza virus between the following subgroups: patients with ongoing chemotherapy; patients who have completed the chemotherapy treatment; patients treated with autologous or allogeneic peripheral blood hematopoietic stem cell transplant (PBSCT)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 11, 2011
CompletedFirst Posted
Study publicly available on registry
July 14, 2011
CompletedJanuary 9, 2024
January 1, 2024
7 months
July 11, 2011
January 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
To assess antibody response (antibody titer > 1:40 or four-fold increase, geometric mean titer) in onco-hematologic patients and controls and whether this response changes over time
The antibody titers against virus A/H1N1 will be measured in all samples by means of hemagglutination-inhibition (HI) assays with the use of turkey erythrocytes and according to EMEA guidelines. Antibody titers in control, patients and in different patient subgroups will be compared on different time points.
Day 0, 30, 60, 90
Secondary Outcomes (2)
To assess virus specific cell mediated response (by flow-cytometry evaluation) in onco-hematologic patients and controls and whether this response changes over time.
0, 30, 60, 90
To assess whether controls or patients develop influenza like illness or symptoms.
Day 0, 30, 60, 90
Study Arms (2)
Healthy Volunteers
Healthy people without any serious comorbidity (no immunosuppressive treatment, no autoimmune disease, no cancer) receiving the same vaccine
Onco-hematologic patients
Patients with lymphoma or myeloproliferative diseases or multiple myeloma either receiving chemotherapy or in follow-up or treated with allogeneic hematopoietic stem cell transplant.
Interventions
The vaccine was administered intramuscularly as a single dose of 7.5 ug of hemagglutinin antigen.
Eligibility Criteria
Healthy, nonpregnant adults, or patients affected by hematologic malignancies and older than 18 years, were eligible.
You may qualify if:
- Age ≥18 years
- Oncologic and hematologic patient with the plan of receiving the A (H1N1) vaccine
- Control Group: a silent history for oncologic and hematologic diseases; planned of receiving the A (H1N1) vaccine
- Written informed consent
You may not qualify if:
- Infusion of human Immunoglobulin ongoing or within prior 30 days
- Therapy with monoclonal or polyclonal antibodies ongoing or within prior 30 days
- Therapy with IL-1 or IL-2 or IFN-gamma ongoing or within prior 30 days
- Autologous PBSCT less than 1 month or Allogeneic PBSCT less than 6 months
- Pregnancy or lactation
- Type I hypersensitivity
- Ongoing Anticoagulant therapy or platelets \< 50000/ul
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Paolo Corradinilead
Study Sites (1)
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Related Publications (3)
Kunisaki KM, Janoff EN. Influenza in immunosuppressed populations: a review of infection frequency, morbidity, mortality, and vaccine responses. Lancet Infect Dis. 2009 Aug;9(8):493-504. doi: 10.1016/S1473-3099(09)70175-6.
PMID: 19628174BACKGROUNDZhu 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.
PMID: 19846844BACKGROUNDGreenberg 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.
PMID: 19745216BACKGROUND
Biospecimen
Serum and blood sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Corradini, MD
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 11, 2011
First Posted
July 14, 2011
Study Start
October 1, 2009
Primary Completion
May 1, 2010
Study Completion
January 1, 2011
Last Updated
January 9, 2024
Record last verified: 2024-01