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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Influenza

Intervention / Treatment
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* Biological: Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intramuscular injection of whole virion, Vero cell-derived influenza vaccine containing 7.5 µg of H5N1 HA antigen per 0.5 mL in a non-adjuvanted formulation | Biological: Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation<br>* Subjects will be randomized 1:1 to receive two intramuscular injections of the whole virion, Vero cell-derived influenza vaccine containing either 3.75 mg or 7.5 mg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation on Day 0 and Day 21.<br>|
| Experimental: 2<br>Intramuscular injection of whole virion, Vero cell-derived influenza vaccine containing 3.75 µg of H5N1 HA antigen per 0.25 mL in a non-adjuvanted formulation | Biological: Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation<br>* Subjects will be randomized 1:1 to receive two intramuscular injections of the whole virion, Vero cell-derived influenza vaccine containing either 3.75 mg or 7.5 mg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation on Day 0 and Day 21.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pandemic influenza