The focus of this study is to evaluate the safety, reactogenicity and humoral immune responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30 µg HA to human subjects.
Since 1997, avian H5N1 influenza in Southeast Asia has caused several human infections and has a high mortality rate. Experts warn that the next influenza pandemic is imminent and could be severe and prevention and control will depend on the rapid production and worldwide distribution of specific pandemic influenza candidate vaccines. An H5N1 influenza vaccine was successfully produced from whole virus grown in MDCK (Madin-Darby canine kidney) cells. These purified inactivated vaccine antigens were safe and could induce immune responses in animal studies. Moreover, when formulated in aluminum phosphate a stronger response was generated even at low doses in animals (Chong et al., 2008; Hu et al., 2008). However, further investigations are necessary before their human safety and immunogenicity can be established. This human phase I clinical study, therefore, evaluates the safety and immunogenicity of adjuvanted H5N1 virion influenza vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
36
Inactivated H5N1 Influenza Virion Vaccine
National Taiwan University Hospital
Taipei, Taiwan
Signs and symptoms solicited by vaccination
Percentage, intensity, and relationship to vaccination of solicited local and general signs and symptoms during a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each administered vaccine.
Time frame: A 7-day follow-up period after each vaccine administration
Signs and symptoms unsolicited by vaccination
Percentage, intensity, and relationship to vaccination of unsolicited local and general signs and symptoms during a 21-day follow-up period (i.e. day of vaccination and 20 subsequent days) after each administered vaccine.
Time frame: A 21-day follow-up period after each vaccine administration
Occurrence of adverse events and serious adverse events
Occurrence of overall adverse events and serious adverse events up to 180 days after the first administered vaccine.
Time frame: Up to 180 days after the first vaccine administration
Serum antibody titers to H5N1 virus
Serum anti-HA antibody titers and neutralizing antibody titers.
Time frame: Day 0
Serum antibody titers to H5N1 virus
Serum anti-HA antibody titers and neutralizing antibody titers.
Time frame: Day 21
Serum antibody titers to H5N1 virus
Serum anti-HA antibody titers and neutralizing antibody titers.
Time frame: Day 42
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