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A Phase I Study to Evaluate the Safety, Reactogenicity, and Humoral Immune Responses to an Inactivated H5N1 Influenza Vaccine

This study is currently recruiting participants.
Verified August 2012 by Medigen Biotechnology Corporation
Sponsor:
Information provided by (Responsible Party):
Medigen Biotechnology Corporation
ClinicalTrials.gov Identifier:
NCT01675284
First received: August 22, 2012
Last updated: August 26, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Bird Flu
Avian Influenza
Influenza A(H5N1)
 Biological: AT-301
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase I, Prospective, Randomized, Open Label, Observer-Blind, Single Center Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an Inactivated H5N1 Influenza Vaccine Produced in Madin-Darby Canine Kidney (MDCK) Cells

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu
U.S. FDA Resources

Further study details as provided by Medigen Biotechnology Corporation:

Primary Outcome Measures:
  • Signs and symptoms solicited by vaccination [ Time Frame: A 7-day follow-up period after each vaccine administration ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: A 21-day follow-up period after each vaccine administration ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 180 days after the first vaccine administration ] [ Designated as safety issue: Yes ]
    Occurrence of overall adverse events and serious adverse events up to 180 days after the first administered vaccine.


Secondary Outcome Measures:
  • Serum antibody titers to H5N1 virus [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Serum anti-HA antibody titers and neutralizing antibody titers.

  • Serum antibody titers to H5N1 virus [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    Serum anti-HA antibody titers and neutralizing antibody titers.

  • Serum antibody titers to H5N1 virus [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    Serum anti-HA antibody titers and neutralizing antibody titers.


Estimated Enrollment: 36
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dosage AT-301
7.5 µg hemagglutinin (HA)
 Biological: AT-301
Inactivated H5N1 Influenza Virion Vaccine
Experimental: Middle Dosage AT-301
15 µg hemagglutinin (HA)
 Biological: AT-301
Inactivated H5N1 Influenza Virion Vaccine
Experimental: High Dosage AT-301
30 µg hemagglutinin (HA)
 Biological: AT-301
Inactivated H5N1 Influenza Virion Vaccine

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675284

Contacts
Contact: Stanley Chang, MD, PhD +886-2-2653-5200 ext 880 sscchang@medigen.com.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Pan-Chyr Yang, MD, PhD         pcyang@ntu.edu.tw    
Contact: Szu-Min Hsieh, MD         hsmaids@hotmail.com    
Principal Investigator: Pan-Chyr Yang, MD, PhD            
Sub-Investigator: Chong-Jen Yu, MD, PhD            
Sub-Investigator: Szu-Min Hsieh, MD            
Sub-Investigator: Jen-Chih Tsai, MD            
Sub-Investigator: Ni-Jiin Shen, MD            
Sponsors and Collaborators
Medigen Biotechnology Corporation
Investigators
Principal Investigator: Pan-Chyr Yang, MD, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Medigen Biotechnology Corporation
ClinicalTrials.gov Identifier: NCT01675284     History of Changes
Other Study ID Numbers: CT-AI-11
Study First Received: August 22, 2012
Last Updated: August 26, 2012
Health Authority: Taiwan: Food and Drug Administration, Department of Health, Executive Yuan

Keywords provided by Medigen Biotechnology Corporation:
Avian Influenza
Influenza A Virus Subtype H5N1
Inactivated H5N1 Influenza Virion Vaccine
Phase I
Preventive H5N1 vaccination

Additional relevant MeSH terms:
Influenza in Birds
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013