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

Phase 1

Completed

• Conditions: Avian Influenza; Influenza A(H5N1); Bird Flu
• Interventions: Biological: AT-301

• Registration Number: NCT01675284
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-26
• Study First Posted: 2012-08-29
• Primary Completion: 2013-03
• Study Completion: 2013-05
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-23
• Last Update Posted: 2013-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Middle Dosage AT-301	AT-301	15 µg hemagglutinin (HA)
Low Dosage AT-301	AT-301	7.5 µg hemagglutinin (HA)
High Dosage AT-301	AT-301	30 µg hemagglutinin (HA)

Primary Outcome Measures

Name	Time	Method
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.
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.
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

Name	Time	Method
Serum antibody titers to H5N1 virus	Day 42	Serum anti-HA antibody titers and neutralizing antibody titers.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan