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

NCT01675284 | Completed Phase 1

• 1 other identifier: CT-AI-11
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (3)

• Serum antibody titers to H5N1 virus

  Day 0

• Serum antibody titers to H5N1 virus

  Day 21

• Serum antibody titers to H5N1 virus

  Day 42

Study Arms (3)

Low Dosage AT-301

EXPERIMENTAL

7.5 µg hemagglutinin (HA)

Biological: AT-301

Middle Dosage AT-301

EXPERIMENTAL

15 µg hemagglutinin (HA)

Biological: AT-301

High Dosage AT-301

EXPERIMENTAL

30 µg hemagglutinin (HA)

Biological: AT-301

Interventions

AT-301 BIOLOGICAL

Inactivated H5N1 Influenza Virion Vaccine

High Dosage AT-301; Low Dosage AT-301; Middle Dosage AT-301

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medigen Biotechnology Corporation: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 31255574 DERIVED

MeSH Terms

Conditions

Influenza in Birds

Condition Hierarchy (Ancestors)

Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Bird Diseases; Animal Diseases

Study Officials

• Pan-Chyr Yang, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 29, 2012
• Study Start: August 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 25, 2013

Record last verified: 2013-10

Locations

TW (1)