Hematologic Malignancy, Hematopoietic Stem Cell Transplant
Conditions
Keywords
influenza vaccine
Brief summary
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.
Interventions
BIOLOGICALInfluenza vaccine
One dose of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With T-Cell Based Immune Response to Vaccine | 8 Weeks After Vaccination | The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific T cell immune responses. Response is defined as 4 times above the background after a filter plate was developed. Response is listed as a number of subjects (evaluable) that successfully responded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With H3 Based Immune Response to Vaccine | 8 Weeks After Vaccination | The secondary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific H3 immune responses (IFN-y Elispot). Response is defined as 4 fold increase in H3N1. Response is listed as a number of subjects (evaluable) that successfully responded. |
Countries
United States
Participant flow
Recruitment details
The original study design included healthy adult volunteers in addition to the HSCT recipients; however, the protocol was modified to exclude the healthy volunteers.
Participants by arm
| Arm | Count |
|---|---|
| HSCT Recipients Who Were Randomized to 1 Vaccine Dose | 33 |
| HSCT Recipients Who Were Randomized to 2 Vaccine Doses | 32 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | HSCT Recipients Who Were Randomized to 1 Vaccine Dose | HSCT Recipients Who Were Randomized to 2 Vaccine Doses | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 9 Participants | 17 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 22 Participants | 47 Participants |
| Region of Enrollment United States | 33 participants | 32 participants | 65 participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 27 Participants |
| Sex: Female, Male Male | 19 Participants | 19 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 32 |
| serious Total, serious adverse events | 0 / 33 | 0 / 32 |
Outcome results
Primary
Number of Subjects With T-Cell Based Immune Response to Vaccine
The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific T cell immune responses. Response is defined as 4 times above the background after a filter plate was developed. Response is listed as a number of subjects (evaluable) that successfully responded.
Time frame: 8 Weeks After Vaccination
Population: One of the 33 participants randomized to receive 1 vaccine dose died prior to the 8 week evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HSCT Recipients Who Were Randomized to 1 Vaccine Dose | Number of Subjects With T-Cell Based Immune Response to Vaccine | 14 Patients |
| HSCT Recipients Who Were Randomized to 2 Vaccine Doses | Number of Subjects With T-Cell Based Immune Response to Vaccine | 15 Patients |
Secondary
Number of Subjects With H3 Based Immune Response to Vaccine
The secondary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific H3 immune responses (IFN-y Elispot). Response is defined as 4 fold increase in H3N1. Response is listed as a number of subjects (evaluable) that successfully responded.
Time frame: 8 Weeks After Vaccination
Population: One of the 33 participants randomized to receive 1 vaccine dose died prior to the 8 week evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HSCT Recipients Who Were Randomized to 1 Vaccine Dose | Number of Subjects With H3 Based Immune Response to Vaccine | 4 Patients |
| HSCT Recipients Who Were Randomized to 2 Vaccine Doses | Number of Subjects With H3 Based Immune Response to Vaccine | 7 Patients |