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

Avian Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675284
• Other study ID #: CT-AI-11
• Status: Completed
• Phase: Phase 1
• First received: August 22, 2012
• Last updated: October 23, 2013
• Start date: August 2012
• Est. completion date: May 2013

Study information

• Verified date: October 2013
• Source: Medigen Biotechnology Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Food and Drug Administration, Department of Health, Executive Yuan
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Avian Influenza
• Bird Flu
• Influenza A(H5N1)
• Influenza, Human

Intervention

Biological:
• AT-301
Inactivated H5N1 Influenza Virion Vaccine

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Medigen Biotechnology Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	A 7-day follow-up period after each vaccine administration	Yes
Primary	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.	A 21-day follow-up period after each vaccine administration	Yes
Primary	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.	Up to 180 days after the first vaccine administration	Yes
Secondary	Serum antibody titers to H5N1 virus	Serum anti-HA antibody titers and neutralizing antibody titers.	Day 0	No
Secondary	Serum antibody titers to H5N1 virus	Serum anti-HA antibody titers and neutralizing antibody titers.	Day 21	No
Secondary	Serum antibody titers to H5N1 virus	Serum anti-HA antibody titers and neutralizing antibody titers.	Day 42	No