Immunologic Response After Pandemic Influenza A (H1N1) Vaccine in Onco- Hematologic Patients

This study has been completed.
Sponsor:
Collaborator:
University of Milan
Information provided by:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier:
NCT01394640
First received: July 11, 2011
Last updated: July 29, 2011
Last verified: October 2009
  Purpose

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)

Study procedures: Onco-hematological patients will perform a blood sample collection before the vaccination, on day +21 after vaccination , on day +50 and on day +90. At the end of the collection, the investigators will perform immunological test to evaluate the antibody titer and the cellular response. The titer of antibodies against the vaccine strain will be measured in all samples by hemagglutination-inhibition (HI) assays with the use of turkey erythrocytes and according to EMEA guidelines. Response criteria will be the achievement of a protective title of HI test > 1:40. In addition, the investigators will evaluate: geometric mean titers and a fourfold titer increase compared with prevaccination titers. Cellular-mediated response will be analysed by flow-cytometry. A control cohort of healthy volunteers who received A(H1N1) vaccine will perform the same blood sample collection.

Evaluation of clinical response: Oncologic and hematologic patients will be followed as outpatients or inpatients according to routine controls for their disease. In case that symptoms of the upper airways or influenza-like symptoms develop, the symptoms will be recorded in the clinical database, nasal and pharyngeal swaps will be performed according to the doctor who is taking care of the patient. In order to evaluate the clinical efficacy of the vaccination, the swaps will be tested for A (H1N1) influenza virus infection. No further studies will be performed after 3 months from the vaccination.


Condition Intervention
Lymphoma
Multiple Myeloma
Myeloproliferative Disease
Biological: Reassortant vaccine virus NYMC X-179A (New York Medical College, New York) derived form the A/california/7/2009 (H1N1) virus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Immunologic Response After Pandemic Influenza A (H1N1) Vaccine in Oncologic and Hematologic Patients

Resource links provided by NLM:


Further study details as provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:

Primary Outcome Measures:
  • 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 [ Time Frame: Day 0, 30, 60, 90 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To assess virus specific cell mediated response (by flow-cytometry evaluation) in onco-hematologic patients and controls and whether this response changes over time. [ Time Frame: 0, 30, 60, 90 ] [ Designated as safety issue: No ]
    Cellular-mediated response will be analysed by incubating CD3+ cells with influenza A Antigens and evaluation of: 1) cellular expansion by flow-cytometry analysis of dilution of carboxyfluorescein succinimidyl ester (CFSE); 2) IFN-gamma production by ELISPOT.

  • To assess whether controls or patients develop influenza like illness or symptoms. [ Time Frame: Day 0, 30, 60, 90 ] [ Designated as safety issue: No ]

    Subjects will be required to report the occurrence of symptoms suggestive for an influenza-like illness. An influenza-like illness is defined as an oral temperature of more than 38°C or a history of fever or chills and at least one influenza-like symptom.

    In case of symptoms of the upper airways or influenza-like symptoms, nasal and pharyngeal swaps will be performed and tested for A (H1N1) influenza virus infection.



Biospecimen Retention:   Samples Without DNA

Serum and blood sample


Enrollment: 124
Study Start Date: October 2009
Study Completion Date: January 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy Volunteers
Healthy people without any serious comorbidity (no immunosuppressive treatment, no autoimmune disease, no cancer) receiving the same vaccine
Biological: Reassortant vaccine virus NYMC X-179A (New York Medical College, New York) derived form the A/california/7/2009 (H1N1) virus
The vaccine was administered intramuscularly as a single dose of 7.5 ug of hemagglutinin antigen.
Other Name: Vaccine against A/H1N1 influenza
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.
Biological: Reassortant vaccine virus NYMC X-179A (New York Medical College, New York) derived form the A/california/7/2009 (H1N1) virus
The vaccine was administered intramuscularly as a single dose of 7.5 ug of hemagglutinin antigen.
Other Name: Vaccine against A/H1N1 influenza

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy, nonpregnant adults, or patients affected by hematologic malignancies and older than 18 years, were eligible.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394640

Locations
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
University of Milan
Investigators
Principal Investigator: Paolo Corradini, MD Fondazione IRCCS Istituto Nazionale dei Tumori
  More Information

Publications:
Responsible Party: Prof Paolo Corradini, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT01394640     History of Changes
Other Study ID Numbers: INT 72/09
Study First Received: July 11, 2011
Last Updated: July 29, 2011
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Myeloproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases

ClinicalTrials.gov processed this record on September 30, 2014