Avian Influenza, Bird Flu, Influenza A(H5N1)
Conditions
Keywords
Avian Influenza, Influenza A Virus Subtype H5N1, Inactivated H5N1 Influenza Virion Vaccine, Phase I, Preventive H5N1 vaccination
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALAT-301
Inactivated H5N1 Influenza Virion Vaccine
Sponsors
Medigen Biotechnology Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female ≥20 and ≤60 years of age * In good health as determined by medical history, physical examination, and clinical judgment of the investigator * Willing and able to comply with all required study visits and follow-up required by this protocol * Must provide written informed consent
Exclusion criteria
* Known or potential exposure to avian influenza virus or any H5N1 HA antigen vaccine * Had any influenza vaccine within 6 months * Administered with any vaccine within 30 days * A history of hypersensitivity to vaccines or inflammatory or degenerative neurological disease * Receiving chronic administration of immunosuppressants or other immune-modifying drugs within 6 months * Known HIV, hepatitis B (HBsAg) or hepatitis C seropositivity * Any medical illness including clinically significant acute pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests * Receiving immunoglobulins and/or any blood products within the three months * Acute disease at the time of enrolment * Psychiatric, addictive, or any disorder, which may compromise the ability to give a truly informed consent for participation of this study or adequate compliance * Breast feeding or pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Signs and symptoms solicited by vaccination | A 7-day follow-up period after each vaccine administration | 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. |
| Signs and symptoms unsolicited by vaccination | A 21-day follow-up period after each vaccine administration | 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. |
| Occurrence of adverse events and serious adverse events | Up to 180 days after the first vaccine administration | Occurrence of overall adverse events and serious adverse events up to 180 days after the first administered vaccine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum antibody titers to H5N1 virus | Day 0 | Serum anti-HA antibody titers and neutralizing antibody titers. |
Countries
Taiwan
Outcome results
None listed