Status:
COMPLETED
Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant.
Lead Sponsor:
Inova Health Care Services
Conditions:
Influenza, Human
Transplantation Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Influenza infection in recipients of solid organ transplants recipients while on maintenance immunosuppressant therapy is associated with increased morbidity and mortality. Although influenza vaccinat...
Detailed Description
A potential strategy to enhance immune responses to influenza vaccine in this patient population could be to use different strengths of TIV. One of the pathways that can improve the immunogenicity of ...
Eligibility Criteria
Inclusion
- All adults age ≥18 years of age following solid organ transplants (kidney, heart and lung) of all races and gender unless as specified in the exclusion criteria.
- At least 30 days after organ transplantation of kidney, heart, or lung.
- In good health as determined by a) medical history, b) physical examinations, c) clinical judgment of the investigator team.
- Informed consent will be obtained from all the subjects before enrollment into the study, after the nature of the study has been fully explained to the satisfaction of the participant.
- Non-English speaking persons will be included ONLY if consent can be obtained with the help of the translator or interpreter.
Exclusion
- Less than 30 days after transplantation procedure.
- Post operative complications of any type.
- Transplant organ dysfunction and/or under evaluation for possible infection.
- Recent acute transplant rejection and treatment for rejection for the past 30 days.
- Receiving another investigational drug or biologic for transplant.
- Previous history of allergic reaction to influenza vaccine, chicken egg or other unknown allergic reactions to flu vaccine or other vaccines.
- Acute ongoing respiratory illness.
- Bleeding diathesis or on anticoagulation therapy.
- Major surgery (pre-arranged) planned during the study period.
- Any condition that may preclude the participant from completion of study related activities; such as planned travel, or out of the state of residence and not able to return for follow-up visits or relocation of residence.
- Females of reproductive age unless proven to be urine HCG negative at the time of participation.
- Recent opportunistic infection, such as CMV, EBV, BK viral reactivation, or any other documented or laboratory confirmed opportunistic infection or on treatment for confirmed infection.
- Vulnerable subjects such as aged less than 18 years, pregnant women, nursing home residents or other institutionalized persons, students, employees, prisoners, and persons who may not be able to make independent decisions or is considered to have a cognitive impairment, or non-English speaking in the absence of a reliable interpreter or translator.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01808456
Start Date
October 1 2013
End Date
December 1 2016
Last Update
July 22 2022
Active Locations (1)
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1
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042