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MT2010-08R Influenza Vaccine Specific Immune Responses After Allogeneic Hematopoietic Cell Transplantation: Are One or Two Vaccine Doses Needed?


N/A
6 Months
N/A
Not Enrolling
Both
Hematopoietic Stem Cell Transplant, Hematologic Malignancy

Thank you

Trial Information

MT2010-08R Influenza Vaccine Specific Immune Responses After Allogeneic Hematopoietic Cell Transplantation: Are One or Two Vaccine Doses Needed?


Inclusion Criteria:



- Patient Population

- HSCT recipients who are greater than 60 days post transplant.

- Age 6 months and older who are greater than 60 days post post allogeneic
hematopoietic cell transplant

- Show neutrophil recovery, platelet count > 50,000/mm3 (may be transfused), no
known disease relapse

- No history of previous allergic reaction to influenza vaccine, known egg allergy
or Guillan-Barre Syndrome

- No flu vaccine in previous 4 months, no Campath in previous 6 months, no
intravenous immune globulin (IVIG) in previous 3 months

- Controls:

- Age 18 to 50 years

- No history of previous allergic reaction to influenza vaccine, known egg allergy
or Guillan-Barre Syndrome

- No flu vaccine in previous 4 months

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Immune Response to Vaccine

Outcome Description:

The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific B and T cell immune responses (baseline compared to Week 8).

Outcome Time Frame:

8 Weeks After Vaccination

Safety Issue:

No

Principal Investigator

Michael Verneris, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2010NTLS050

NCT ID:

NCT01215981

Start Date:

September 2010

Completion Date:

April 2012

Related Keywords:

  • Hematopoietic Stem Cell Transplant
  • Hematologic Malignancy
  • influenza vaccine
  • Neoplasms
  • Influenza, Human
  • Hematologic Neoplasms

Name

Location
Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455