Clinical trial NCT01258023: Seasonal Flu Vaccine in Adult Transplant Recipients
Official title: A Phase II Study to Evaluate the Immunogenicity, Safety and Tolerability of a Seasonal Influenza Vaccine Including H1N1 in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Immunocompromised
Transplanted
Lead sponsor: HepNet Study House, German Liverfoundation
Sponsor class: NETWORK
First posted: 2010-12-10
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The trial investigates the efficacy of adjuvanted seasonal influenza including H1N1 Fluad (R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered once the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.


Eligibility criteria: Inclusion Criteria:

Transplant Recipients:

* Adult subjects 18-60 years of age who have undergone prior renal, cardiac, liver, lung, or bone marrow transplantation for any reason, more than 3 months prior to enrolment
* Patients able to visit the outpatient clinic with a life expectancy of at least one year
* Patients who receive any immunosuppressive treatment currently taken to prevent organ rejection

Healthy Adults:

* Adult subjects 18-60 years of age
* Healthy individuals as determined by medical history, physical assessment and clinical judgment of the investigator
* Within the same age category (+/- 5 years) than the incidental transplanted patient

Transplant Recipients and Healthy Adults:

* Individuals who are able to comply with all study procedures and are available for all clinic visits scheduled in the study
* Women of child-bearing potential (WOCBP) must have used an acceptable contraceptive method for at least 2 months prior to study entry until 3 weeks after vaccination: Female of childbearing potential is defined as a post onset of menarche or pre-menopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: (1) menopause at least 2 years earlier, (2) tubal ligation at least 1 year earlier, or (3) total hysterectomy
* Acceptable birth control methods are defined as one or more of the following: Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring, Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse, Intrauterine device (IUD, Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry

Exclusion Criteria:

* Individuals who received any vaccine within 30 days prior to study entry
* Individuals who received a H1N1 or seasonal influenza vaccination less than 6 months prior to the study
* Influenza diagnosed by a physician within 4 months prior to the study start
* Pregnant or lactating females
* History of an anaphylactic (i.e. life-threatening) reaction to any of the components of the vaccines, including egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)
* Subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study
* History of or any current illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
* Temperature is ≥ 38 °C or oral temperature ≥ 38.5 °C within 3 days of intended study vaccination
* Administration of parenteral immunoglobulin compound - including HBIg, blood products, and/or plasma derivatives within 6 months prior to Visit 1 or planned during the full length of the study
* HIV infection, as previously determined or reported
* History of progressive or severe neurological disorders (including Guillain-Barré syndrome and convulsions, but excluding febrile convulsions)
* Subjects participating in another clinical trial and / or receiving investigational drug

Primary outcomes:
measure: Seroconversion and Seroprotection after 21 days
timeFrame: 21 days
Secondary outcomes:
measure: comparison of vaccine efficacy in transplanted versus healthy subjects
timeFrame: 21 and 42 days
measure: assessment of primary and secondary outcomes with the two other strains
timeFrame: 21 and 42 days
measure: safety issues as number of participants with adverse events
timeFrame: 21 and 42 days and 9 months
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medical School Hannover
Study officials:
References: