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

Purpose

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.

Condition	Intervention	Phase
Influenza Virus Diseases	Biological: UMN-0501	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
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.

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by UMN Pharma Inc.:

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. [ Time Frame: Day 42: 21 days after 2nd vaccination (42 days after 1st vaccination) ] [ Designated as safety issue: No ]
Frequencies of AEs including vaccine-related reactogenicity events. [ Time Frame: Throughout study period: Day0 to 42 ] [ Designated as safety issue: Yes ]

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. [ Time Frame: Day0, Day 21 and Day 42 ] [ Designated as safety issue: No ]

Enrollment:	90
Study Start Date:	October 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: UMN-0501 45µg Recombinant H5N1 vaccine 45µg	Biological: UMN-0501 2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 45µg three weeks apart Other Names: UMN-0501 UMN-05
Experimental: UMN-0501 90µg Recombinant H5N1 vaccine 90µg	Biological: UMN-0501 2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 90µg three weeks apart Other Names: UMN-0501 UMN-05
Experimental: UMN-0501 135µg Recombinant H5N1 vaccine 135µg	Biological: UMN-0501 2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 135µg three weeks apart Other Names: UMN-0501 UMN-05

Eligibility

Ages Eligible for Study:	20 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980447

Locations

Japan
National Hospital Organization Osaka Minami Medical Center
Kawachinagano City, Osaka, Japan, 586-8521
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, Japan, 152-8902

Sponsors and Collaborators

UMN Pharma Inc.

Investigators

Study Director:	Tetsuo Nakayama, MD, PhD	Kitasato University Kitasato Institute for Life Sciences
Principal Investigator:	Suminobu Ito, MD, PhD	National Hospital Organization

More Information

No publications provided

Responsible Party:	Clinical Development Department, UMN Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00980447 History of Changes
Other Study ID Numbers:	JPIP501-01a
Study First Received:	September 17, 2009
Last Updated:	February 5, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by UMN Pharma Inc.:

H5N1
Vaccine
Influenza H5N1
Avian influenza H5N1
Pandemic

Additional relevant MeSH terms:

Influenza, Human
Virus Diseases
Orthomyxoviridae Infections

RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013