Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults
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.
1 other identifier
interventional
90
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2009
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2009
CompletedFirst Posted
Study publicly available on registry
September 21, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFebruary 8, 2010
February 1, 2010
2 months
September 17, 2009
February 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Day 42: 21 days after 2nd vaccination (42 days after 1st vaccination)
Frequencies of AEs including vaccine-related reactogenicity events.
Throughout study period: Day0 to 42
Secondary Outcomes (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.
Day0, Day 21 and Day 42
Study Arms (3)
UMN-0501 45µg
EXPERIMENTALRecombinant H5N1 vaccine 45µg
UMN-0501 90µg
EXPERIMENTALRecombinant H5N1 vaccine 90µg
UMN-0501 135µg
EXPERIMENTALRecombinant H5N1 vaccine 135µg
Interventions
2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 45µg three weeks apart
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMN Pharma Inc.lead
Study Sites (2)
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka, 586-8521, Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, 152-8902, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tetsuo Nakayama, MD, PhD
Kitasato University Kitasato Institute for Life Sciences
- PRINCIPAL INVESTIGATOR
Suminobu Ito, MD, PhD
National Hospital Organization
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 17, 2009
First Posted
September 21, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
February 8, 2010
Record last verified: 2010-02