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

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ClinicalTrials.gov Identifier: NCT01675284
Recruitment Status : Completed
First Posted : August 29, 2012
Last Update Posted : October 25, 2013
Sponsor:
Information provided by (Responsible Party):
Medigen Biotechnology Corporation

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : August 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Signs and symptoms solicited by vaccination [ Time Frame: 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.

  2. Signs and symptoms unsolicited by vaccination [ Time Frame: 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.

  3. Occurrence of adverse events and serious adverse events [ Time Frame: 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 Outcome Measures :
  1. Serum antibody titers to H5N1 virus [ Time Frame: Day 0 ]
    Serum anti-HA antibody titers and neutralizing antibody titers.

  2. Serum antibody titers to H5N1 virus [ Time Frame: Day 21 ]
    Serum anti-HA antibody titers and neutralizing antibody titers.

  3. Serum antibody titers to H5N1 virus [ Time Frame: Day 42 ]
    Serum anti-HA antibody titers and neutralizing antibody titers.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675284


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
Medigen Biotechnology Corporation
Investigators
Principal Investigator: Pan-Chyr Yang, MD, PhD National Taiwan University Hospital

Responsible Party: Medigen Biotechnology Corporation
ClinicalTrials.gov Identifier: NCT01675284     History of Changes
Other Study ID Numbers: CT-AI-11
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013

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, Human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs