Immunogenicity and Safety Study of a Single Prime-Boost Vaccination Schedule With a H5N1 Influenza Vaccine in Adults

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Influenza, Avian Influenza

Intervention / Treatment
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* Biological: Influenza vaccine (whole virion, Vero cell derived)
* Biological: Influenza vaccine (whole virion, Vero cell derived)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 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>Day 0: Single priming vaccination with Dose A of whole virion, Vero cell-derived influenza vaccine (Vietnam strain) - Day 360: Randomization to booster vaccination with Dose B of whole virion, Vero cell-derived influenza vaccine (Indonesia strain) | Biological: Influenza vaccine (whole virion, Vero cell derived)<br>* Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose B (Indonesia strain) for booster vaccination (Day 360)<br>|
| Experimental: 2<br>Day 0: Single priming vaccination with Dose A of whole virion, Vero cell-derived influenza vaccine (Vietnam strain) - Day 360: Randomization to booster vaccination with Dose A of whole virion, Vero cell-derived influenza vaccine (Indonesia strain) | Biological: Influenza vaccine (whole virion, Vero cell derived)<br>* Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose A (Indonesia strain) for booster vaccination (Day 360)<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 booster vaccination defined as titer measured by microneutralization test >= 1:20. |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | at the timepoints stated above |