Adult Stem Cell Hematopoetic Transplant
Conditions
Brief summary
Hypothesis 1: The safety profile in adult allogeneic stem cell hematopoietic transplant (SCT) recipients after high dose (HD) trivalent inactivated influenza vaccine (TIV) will not be significantly different from adult stem cell transplant recipients receiving standard dose (SD) TIV. * Specific Aim 1: To compare safety profile of high dose trivalent inactivated influenza vaccine to standard dose trivalent inactivated influenza vaccine in adult hematopoietic stem cell transplant recipients. Hypothesis 2: Adult stem cell transplant recipients who received the higher dose trivalent influenza vaccine will have a greater frequency of (at least a 4-fold) rise in antibody titers to influenza antigens compared to those who receive standard dose trivalent influenza vaccine. * Specific Aim 2: To compare humoral immune responses of adult hematopoietic stem cell transplant recipients influenza virus antigens included in trivalent influenza vaccine after high dose or standard dose trivalent influenza vaccine.
Interventions
BIOLOGICALHigh-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
0.5 ml of HD-TIV on visit 1
BIOLOGICALStandard Dose Trivalent Inactivated Flu Vaccine
Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.
Sponsors
Vanderbilt-Ingram Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Allogeneic hematopoietic stem cell transplant recipients who are \>6 post-transplant * greater than or equal to 18 years of age * Available for duration of study * If patients are on immunosuppressive therapy for treatment of graft versus host disease (GVHD): only those on stable doses for at least 4 weeks or on tapering doses will be eligible.
Exclusion criteria
* History of hypersensitivity to previous influenza vaccination or hypersensitivity to eggs/egg protein * History of Guillain-Barre syndrome * Evidence of hematologic malignancy or disease relapse post-transplant (mixed chimerisms and molecular evidence of disease is permitted) * Non-allogeneic (e.g. autologous) hematopoietic SCT recipients * History of receiving 2011 - 2012 influenza vaccine * History of proven influenza disease after September 1, 2011. * Pregnant females * Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol * Have any condition that the investigator believes may interfere with successful completion of the study * Platelet count less than 50,000 cells/μL * History of known infection with HIV, Hepatitis B or Hepatitis C * History of known latex hypersensitivity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients | Day of TIV to 7 days after TIV | Patients were questioned about the following adverse events related to TIV: Local: pain, tenderness, swelling/induration, or erythema at injection site. Systemic: fatigue/malaise, headache, nausea, vomiting, body ache not at injection site, fever \>= 100.4 degrees Fahrenheit, or change in activity level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses | Before TIV and 28-42 days after TIV | Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant receiving either HD or SD TIV who had blood drawn at pre-vaccination and at 28-42 days post-vaccination and who experienced a 4-fold rise in each of three post-vaccination influenza antibody titers, relative to their baseline titers. Trivalent vaccine is for the H1N1/H3N2/B influenzas. A 4-fold rise in type-specific antibody titer is considered adequate antibody response to the specific influenza virus |
Countries
United States
Participant flow
Recruitment details
This phase X, double-blind study was conducted from September 2011 - April 2012.
Pre-assignment details
Forty-seven patients consented to participate in this study, three were determined ineligible.
Participants by arm
| Arm | Count |
|---|---|
| High-Dose Trivalent Inactivated Influenza Vaccine Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine
High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1 | 29 |
| Standard Dose Trivalent Inactivated Flu Vaccine Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine.
Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1. | 15 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
Baseline characteristics
| Characteristic | Standard Dose Trivalent Inactivated Flu Vaccine | High-Dose Trivalent Inactivated Influenza Vaccine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 27 Participants | 41 Participants |
| Age Continuous | 49 years STANDARD_DEVIATION 14 | 50 years STANDARD_DEVIATION 12 | 50 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 15 participants | 29 participants | 44 participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 16 Participants |
| Sex: Female, Male Male | 10 Participants | 18 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 29 | 5 / 15 |
| serious Total, serious adverse events | 11 / 29 | 7 / 15 |
Outcome results
Primary
Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients
Patients were questioned about the following adverse events related to TIV: Local: pain, tenderness, swelling/induration, or erythema at injection site. Systemic: fatigue/malaise, headache, nausea, vomiting, body ache not at injection site, fever \>= 100.4 degrees Fahrenheit, or change in activity level.
Time frame: Day of TIV to 7 days after TIV
Population: Patients who received either the high-dose TIV or the standard dose TIV
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-Dose Trivalent Inactivated Influenza Vaccine | Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients | Systemic Adverse Events | 14 participants |
| High-Dose Trivalent Inactivated Influenza Vaccine | Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients | Local Adverse Events | 18 participants |
| Standard Dose Trivalent Inactivated Flu Vaccine | Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients | Local Adverse Events | 4 participants |
| Standard Dose Trivalent Inactivated Flu Vaccine | Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients | Systemic Adverse Events | 7 participants |
Secondary
Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses
Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant receiving either HD or SD TIV who had blood drawn at pre-vaccination and at 28-42 days post-vaccination and who experienced a 4-fold rise in each of three post-vaccination influenza antibody titers, relative to their baseline titers. Trivalent vaccine is for the H1N1/H3N2/B influenzas. A 4-fold rise in type-specific antibody titer is considered adequate antibody response to the specific influenza virus
Time frame: Before TIV and 28-42 days after TIV
Population: Patients who received either the high-dose or the standard dose TIV and who had blood drawn for HAI titers before TIV and at 28-42 days after TIV. Data not available for 5 HD and 1 SD patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-Dose Trivalent Inactivated Influenza Vaccine | Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses | H1N1 Influenza | 12 participants |
| High-Dose Trivalent Inactivated Influenza Vaccine | Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses | H3N2 Influenza | 10 participants |
| High-Dose Trivalent Inactivated Influenza Vaccine | Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses | B Influenza | 10 participants |
| Standard Dose Trivalent Inactivated Flu Vaccine | Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses | H1N1 Influenza | 5 participants |
| Standard Dose Trivalent Inactivated Flu Vaccine | Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses | H3N2 Influenza | 5 participants |
| Standard Dose Trivalent Inactivated Flu Vaccine | Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses | B Influenza | 6 participants |