Influenza Vaccine Post Allogeneic Transplant

University of Minnesota (UMN)

Status: Terminated

Conditions: Hematologic Malignancy; Hematopoietic Stem Cell Transplant

Treatments: Biological: Influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01215981

1007M86296 (Other Identifier)

2010NTLS050

MT2010-08R (Other Identifier)

Details and patient eligibility

About

Study Design:

This is a randomized, single center study to evaluate immune responses to the seasonal influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who receive one vaccine or two vaccine doses one month apart. In addition, a cohort of healthy adult volunteers will be recruited as controls to confirm immune response to a single influenza vaccine.

Enrollment: 68 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Participants Receiving 1 Dose of Vaccine

Active Comparator group

Description:

Control group participants (healthy volunteers): * 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 and/or HSCT recipients who are greater than 60 days post transplant.

Treatment:

Biological: Influenza vaccine

Biological: Influenza vaccine

Participants Receiving 2 Doses of Vaccine

Active Comparator group

Description:

Hematopoietic stem cell transplant (HSCT) recipients who are greater than 60 days post transplant.

Treatment:

Biological: Influenza vaccine

Biological: Influenza vaccine