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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Influenza, Virus Diseases

Intervention / Treatment
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* Biological: UMN-0501
* Biological: UMN-0501
* Biological: UMN-0501


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UMN-0501 45µg<br>Recombinant H5N1 vaccine 45µg | Biological: UMN-0501<br>* 2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 45µg three weeks apart<br>* Other names: UMN-05;|
| Experimental: UMN-0501 90µg<br>Recombinant H5N1 vaccine 90µg | Biological: UMN-0501<br>* 2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 90µg three weeks apart<br>* Other names: UMN-05;|
| Experimental: UMN-0501 135µg<br>Recombinant H5N1 vaccine 135µg | Biological: UMN-0501<br>* 2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 135µg three weeks apart<br>* Other names: UMN-05;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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H5N1, Vaccine, Influenza H5N1, Avian influenza H5N1, Pandemic