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

Sponsor

Medigen Biotechnology Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT01675284

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

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 :

Aug 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Serum antibody titers to H5N1 virus [Day 0]
Serum anti-HA antibody titers and neutralizing antibody titers.
Serum antibody titers to H5N1 virus [Day 21]
Serum anti-HA antibody titers and neutralizing antibody titers.
Serum antibody titers to H5N1 virus [Day 42]
Serum anti-HA antibody titers and neutralizing antibody titers.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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