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

NCT ID: NCT01675284

Last Updated: 2013-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Bird Flu Avian Influenza Influenza A(H5N1)

Keywords

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Avian Influenza Influenza A Virus Subtype H5N1 Inactivated H5N1 Influenza Virion Vaccine Phase I Preventive H5N1 vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Low Dosage AT-301

7.5 µg hemagglutinin (HA)

Group Type EXPERIMENTAL

AT-301

Intervention Type BIOLOGICAL

Inactivated H5N1 Influenza Virion Vaccine

Middle Dosage AT-301

15 µg hemagglutinin (HA)

Group Type EXPERIMENTAL

AT-301

Intervention Type BIOLOGICAL

Inactivated H5N1 Influenza Virion Vaccine

High Dosage AT-301

30 µg hemagglutinin (HA)

Group Type EXPERIMENTAL

AT-301

Intervention Type BIOLOGICAL

Inactivated H5N1 Influenza Virion Vaccine

Interventions

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AT-301

Inactivated H5N1 Influenza Virion Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medigen Biotechnology Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pan-Chyr Yang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 31255574 (View on PubMed)

Other Identifiers

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CT-AI-11

Identifier Type: -

Identifier Source: org_study_id