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

Primary Purpose

Bird Flu, Avian Influenza, Influenza A(H5N1)

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
AT-301
Sponsored by
Medigen Biotechnology Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bird Flu focused on measuring Avian Influenza, Influenza A Virus Subtype H5N1, Inactivated H5N1 Influenza Virion Vaccine, Phase I, Preventive H5N1 vaccination

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low Dosage AT-301

Middle Dosage AT-301

High Dosage AT-301

Arm Description

7.5 µg hemagglutinin (HA)

15 µg hemagglutinin (HA)

30 µg hemagglutinin (HA)

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Serum antibody titers to H5N1 virus
Serum anti-HA antibody titers and neutralizing antibody titers.
Serum antibody titers to H5N1 virus
Serum anti-HA antibody titers and neutralizing antibody titers.
Serum antibody titers to H5N1 virus
Serum anti-HA antibody titers and neutralizing antibody titers.

Full Information

First Posted
August 22, 2012
Last Updated
October 23, 2013
Sponsor
Medigen Biotechnology Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01675284
Brief Title
A Phase I Study to Evaluate the Safety, Reactogenicity, and Humoral Immune Responses to an Inactivated H5N1 Influenza Vaccine
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 Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medigen Biotechnology Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bird Flu, Avian Influenza, Influenza A(H5N1)
Keywords
Avian Influenza, Influenza A Virus Subtype H5N1, Inactivated H5N1 Influenza Virion Vaccine, Phase I, Preventive H5N1 vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dosage AT-301
Arm Type
Experimental
Arm Description
7.5 µg hemagglutinin (HA)
Arm Title
Middle Dosage AT-301
Arm Type
Experimental
Arm Description
15 µg hemagglutinin (HA)
Arm Title
High Dosage AT-301
Arm Type
Experimental
Arm Description
30 µg hemagglutinin (HA)
Intervention Type
Biological
Intervention Name(s)
AT-301
Intervention Description
Inactivated H5N1 Influenza Virion Vaccine
Primary Outcome Measure Information:
Title
Signs and symptoms solicited by vaccination
Description
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
Title
Signs and symptoms unsolicited by vaccination
Description
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
Title
Occurrence of adverse events and serious adverse events
Description
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
Secondary Outcome Measure Information:
Title
Serum antibody titers to H5N1 virus
Description
Serum anti-HA antibody titers and neutralizing antibody titers.
Time Frame
Day 0
Title
Serum antibody titers to H5N1 virus
Description
Serum anti-HA antibody titers and neutralizing antibody titers.
Time Frame
Day 21
Title
Serum antibody titers to H5N1 virus
Description
Serum anti-HA antibody titers and neutralizing antibody titers.
Time Frame
Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pan-Chyr Yang, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
31255574
Citation
Cheng A, Hsieh SM, Pan SC, Li YH, Hsieh EF, Lee HC, Lin TW, Lai KL, Chen C, Shi-Chung Chang S, Chang SC. The safety and immunogenicity of a cell-derived adjuvanted H5N1 vaccine - A phase I randomized clinical trial. J Microbiol Immunol Infect. 2019 Oct;52(5):685-692. doi: 10.1016/j.jmii.2019.03.009. Epub 2019 May 18.
Results Reference
derived

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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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