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Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults

Primary Purpose

Influenza, Virus Diseases

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

UMN-0501

About this trial

This is an interventional prevention trial for Influenza focused on measuring H5N1, Vaccine, Influenza H5N1, Avian influenza H5N1, Pandemic

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adult as determined by medical history, physical examination, laboratory test, and clinical judgment of the investigator.
Males and females aged 20-40 years.
Provides signed informed consent form after received a detailed explanation of the study protocol prior to any study procedures.

Exclusion Criteria:

Body Mass Index (BMI) 30 kg/m2 and above.
Has a history of a A/H5N1 influenza virus infection and subjects had received other A/H5N1 influenza vaccine.
Has a history of allergic reaction by food and medicine including vaccine, and acute fever illness (greater than 39.0C) within 2 days of vaccination.
Has a history of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM).
Has severe allergic diseases.
Has asthma.
Has a history of convulsions.
Has a history of any serious disease.
Known impairment of imune function.
Known rheumatism and autoimmune disease.
Receipt of medicines that would affect evaluation of immunogenicity.
Receipt of any live virus vaccination or receipt of any inactivated vaccine/toxoid prior to enrollment.
Blood donation prior to enrollment.
Receipt of another investigation agent prior to enrollment.
History of alcohol or drug abuse.
Females who are pregnant or potentially childbearing or are breastfeeding.
Ineligible subject based on the judgement of the investigator.

Sites / Locations

National Hospital Organization Osaka Minami Medical Center
National Hospital Organization Tokyo Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

UMN-0501 45µg

UMN-0501 90µg

UMN-0501 135µg

Arm Description

Recombinant H5N1 vaccine 45µg

Recombinant H5N1 vaccine 90µg

Recombinant H5N1 vaccine 135µg

Outcomes

Primary Outcome Measures

Number of subjects who achieve seroconversion, seroprotection, GMTs and GMT ratio to baseline, 21 days after the 2nd vaccination defined by serum neutralizing and HAI titers against the influenza H5N1 A/Vietnam/1203/2004 virus.

Frequencies of AEs including vaccine-related reactogenicity events.

Secondary Outcome Measures

To explore T-cell response in the subset of subjects after each vaccination as determined by proliferation and cytokine production capacity of T-cells re-stimulate by H5N1 A/Vietnam/1203/2004 recombinant virus antigens.

Full Information

NCT ID

NCT00980447

First Posted

September 17, 2009

Last Updated

February 5, 2010

Sponsor

UMN Pharma Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00980447

Brief Title

Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults

Official Title

A Multicenter, Non-Blinded, Dose Escalation Study to Evaluate the Immunogenicity, Safety and Optimal Dose of Three Doses Regimen of Recombinant Influenza H5N1 Vaccine, After Two Vaccinations Given 3 Weeks Apart, in Healthy Young Adults.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

UMN Pharma Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004). The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per patient with a 3 week interval between vaccination in healthy young adults. Immunogenicity will be confirmed by both microneutralization (MN) antibody and hemagglutination inhibition (HAI) titer levels in the serums of subjects after receiving different doses of UMN-0501. There will be three dose groups with 30 subjects per group for a total of 90 healthy young adults aged 20-40 years enrolled in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Virus Diseases

Keywords

H5N1, Vaccine, Influenza H5N1, Avian influenza H5N1, Pandemic

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

UMN-0501 45µg

Arm Type

Experimental

Arm Description

Recombinant H5N1 vaccine 45µg

Arm Title

UMN-0501 90µg

Arm Type

Experimental

Arm Description

Recombinant H5N1 vaccine 90µg

Arm Title

UMN-0501 135µg

Arm Type

Experimental

Arm Description

Recombinant H5N1 vaccine 135µg

Intervention Type

Biological

Intervention Name(s)

UMN-0501

Other Intervention Name(s)

UMN-05

Intervention Description

2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 45µg three weeks apart

Intervention Type

Biological

Intervention Name(s)

UMN-0501

Other Intervention Name(s)

UMN-05

Intervention Description

2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 90µg three weeks apart

Intervention Type

Biological

Intervention Name(s)

UMN-0501

Other Intervention Name(s)

UMN-05

Intervention Description

2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 135µg three weeks apart

Primary Outcome Measure Information:

Title

Time Frame

Day 42: 21 days after 2nd vaccination (42 days after 1st vaccination)

Title

Frequencies of AEs including vaccine-related reactogenicity events.

Time Frame

Throughout study period: Day0 to 42

Secondary Outcome Measure Information:

Title

Time Frame

Day0, Day 21 and Day 42

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy adult as determined by medical history, physical examination, laboratory test, and clinical judgment of the investigator. Males and females aged 20-40 years. Provides signed informed consent form after received a detailed explanation of the study protocol prior to any study procedures. Exclusion Criteria: Body Mass Index (BMI) 30 kg/m2 and above. Has a history of a A/H5N1 influenza virus infection and subjects had received other A/H5N1 influenza vaccine. Has a history of allergic reaction by food and medicine including vaccine, and acute fever illness (greater than 39.0C) within 2 days of vaccination. Has a history of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM). Has severe allergic diseases. Has asthma. Has a history of convulsions. Has a history of any serious disease. Known impairment of imune function. Known rheumatism and autoimmune disease. Receipt of medicines that would affect evaluation of immunogenicity. Receipt of any live virus vaccination or receipt of any inactivated vaccine/toxoid prior to enrollment. Blood donation prior to enrollment. Receipt of another investigation agent prior to enrollment. History of alcohol or drug abuse. Females who are pregnant or potentially childbearing or are breastfeeding. Ineligible subject based on the judgement of the investigator.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tetsuo Nakayama, MD, PhD

Organizational Affiliation

Kitasato University Kitasato Institute for Life Sciences

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Suminobu Ito, MD, PhD

Organizational Affiliation

National Hospital Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Hospital Organization Osaka Minami Medical Center

City

Kawachinagano City

State/Province

Osaka

ZIP/Postal Code

586-8521

Country

Japan

Facility Name

National Hospital Organization Tokyo Medical Center

City

Meguro-ku

State/Province

Tokyo

ZIP/Postal Code

152-8902

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults

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