Safety and Immunogenicity Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)

Ology Bioservices

Status and phase

Completed

Phase 2

Phase 1

Conditions

Influenza

Treatments

Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00349141

810501

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.