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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00980447
Recruitment Status : Completed
First Posted : September 21, 2009
Last Update Posted : February 8, 2010
Information provided by:
UMN Pharma Inc.

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.

Condition or disease Intervention/treatment Phase
Influenza Virus Diseases Biological: UMN-0501 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : October 2009
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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 Name: 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 Name: 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 Name: UMN-05

Primary Outcome Measures :
  1. 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) ]
  2. Frequencies of AEs including vaccine-related reactogenicity events. [ Time Frame: Throughout study period: Day0 to 42 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00980447

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

Responsible Party: Clinical Development Department, UMN Pharma Inc. Identifier: NCT00980447     History of Changes
Other Study ID Numbers: JPIP501-01a
First Posted: September 21, 2009    Key Record Dates
Last Update Posted: February 8, 2010
Last Verified: February 2010

Keywords provided by UMN Pharma Inc.:
Influenza H5N1
Avian influenza H5N1

Additional relevant MeSH terms:
Influenza, Human
Influenza in Birds
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs