Clinical trial NCT00895544: Immunogenicity and Safety Study of a Single Prime-Boost Vaccination Schedule With a H5N1 Influenza Vaccine in Adults
Official title: An Open-Label Phase 1/2 Study to Assess the Immunogenicity and Safety of a Single Prime-Boost Vaccination Schedule With a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in Healthy Volunteers Aged 18 to 59 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza
Avian Influenza
Lead sponsor: Resilience Government Services, Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-08
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of the study is to assess the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult population when administered according to a single prime-boost schedule.


Eligibility criteria: Inclusion Criteria:

Male and female subjects will be eligible for participation in this study if they:

* are 18 to 59 years of age, inclusive, on the day of screening
* have an understanding of the study and its procedures, agree to its provisions, and give written informed consent prior to study entry
* are generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination
* are physically and mentally capable of participating in the study and follow its procedures
* agree to keep a daily record of symptoms for the duration of the study
* if female of childbearing potential: have a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study

Exclusion Criteria:

Subjects will be excluded from participation in this study if they:

* have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine
* are at high risk of contracting H5N1 influenza infection (e.g. poultry workers)
* currently have or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
* have any inherited or acquired immunodeficiency
* have a disease or are currently undergoing a form of treatment or were undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (\> 800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs
* have a history of severe allergic reactions or anaphylaxis
* have a rash, dermatological condition or tattoos which may interfere with injection site reaction rating
* have received any blood products or immunoglobulins within 90 days prior to study entry
* have donated blood or plasma within 30 days prior to study entry
* have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study
* have a functional or surgical asplenia
* have a known or suspected problem with alcohol or drug abuse
* were administered an investigational drug within 6 weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
* are a member of the team conducting this study or are in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study
* if female: are pregnant or lactating

Primary outcomes:
measure: Number of subjects with antibody response to the vaccine strain associated with protection 21 days after the booster vaccination defined as titer measured by microneutralization test >= 1:20.
timeFrame: 21 days
Secondary outcomes:
measure: Number of subjects with antibody response associated with protection 21, 42, 180 and 360 days after the priming vaccination and 21 days after the booster vaccination
timeFrame: at the timepoints stated above
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: General Hospital of Vienna (AKH Wien), Dept. of Clinical Pharmacology
city: Espoo
country: Finland
facility: Espoon rokotetutkumusklinikka
city: Helsinki
country: Finland
facility: Etelä - Helsingin rokotetutkimusklinikka
Study officials:
affiliation: Baxter Healthcare Corporation
name: Gerald Aichinger, MD
role: STUDY_DIRECTOR
References: