Influenza Clinical Trial
Official title:
An Open-Label Phase I/II Study to Assess the Safety and Immunogenicity of Two Doses of a Vero Cell Derived, Whole Virus Clade 2 H5N1 Influenza Vaccine in Healthy Volunteers Aged 21 to 45 Years
The objectives of this Phase I/II study are to assess the safety and immunogenicity of two different dose levels of a non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. Subjects will be randomized 1:1 to receive two intramuscular injections (21 days apart) of the vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation. Subjects will be monitored for safety and for antibody response to the vaccine. A data safety monitoring board will review the safety data after the first and second vaccination.
Status | Completed |
Enrollment | 110 |
Est. completion date | February 2008 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Are 21 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 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 - Agree to keep a daily record of symptoms for the duration of the study - If female and capable of bearing children, have a negative urine pregnancy test result within 24 hours of the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study. Exclusion Criteria: - Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza virus - Are at high risk of contracting H5N1 influenza infection (e.g. poultry workers) - Suffer from or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder - Suffer from any inherited or acquired immunodeficiency - Test positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HbsAg) or Hepatitis C Virus (HCV) - 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 syndrome) - 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 or site conducting the study - If female: are pregnant or lactating |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Hong Kong | University of Hong Kong, Queen Mary Hospital | Hong Kong | |
Hong Kong | Chinese University of Hong Kong, Prince of Wales Hospital | Shatin | |
Singapore | Changi General Hospital | Singapore | |
Singapore | National University Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Nanotherapeutics, Inc. |
Hong Kong, Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization (MN) test >= 1:20 | 21 days after the second vaccination (= Day 42 in the study) | No |
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