safety and immunogenicity study of an inactivated h5n1 influenza vaccine (whole virion, vero cell derived)

Conditions: Influenza

Summary: the objective of this study is to assess the safety and immunogenicity of 4 different doses of adjuvanted and non-adjuvanted mock-up pandemic influenza vaccine. subjects will be enrolled sequentially into 3 study cohorts with 4 escalating doses of h5n1 hemagglutininin antigen (3.75 µg adjuvanted, 7.5 µg adjuvanted/non-adjuvanted, 15 µg adjuvanted/non-adjuvanted, 30 µg adjuvanted). starting with the lowest dose level, subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. subjects will be monitored for safety and for antibody response to the vaccine. a data safety monitoring board will review and evaluate all the safety data obtained for a dose level before allowing administration of the next (higher) dose.


Eligibility criteria:
inclusion criteria: male and femal subjects who * are 18 to 45 years of age, inclusive, on the day of screening; * have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry; * are clinically healthy, as determined by medical history and physical examination; * agree to keep a daily record of symptoms; * if female and capable of bearing children, have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study. exclusion criteria: subjects who * are at high risk of contracting h5n1 influenza infection (e.g. poultry workers); * suffer from a significant neurological, cardiac, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological or renal disorder; * are unable to lead an independent life as a result of either physical or mental handicap; * suffer from any kind of immunodeficiency; * suffer from a disease or are undergoing a form of treatment 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 inflammatory or degenerative neurological disease (e.g. guillain barré); * have a history of severe allergic reactions or anaphylaxis; * have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating; * have received a blood transfusion or immunoglobulins within 90 days of study entry; * have donated blood or plasma within 30 days of study entry; * have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study; * have undergone systemic corticoid therapy within 30 days prior to study entry; * have a functional or surgical asplenia; * have a known or suspected problem with alcohol or drug abuse; * were administered an investigational drug within six 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 the study investigator. dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator; * if female, are pregnant or lactating.

Keywords: pandemic influenza