Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This study will evaluate the safety and immunogenicity of VAX161B [STF2.HA5 H5N1], a recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of doses.

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: VAX161 [STF2.HA5 H5N1]	Phase 1

Detailed Description:

The purpose of this study is to test an investigational vaccine known as "VAX161B". VAX161B is a vaccine for the influenza A virus subtype H5N1 avian influenza virus (bird flu). In this study, the subject will receive the VAX161B vaccine at one of five doses to see which does might be the best. VaxInnate want to find out how safe these vaccines are and how well they are tolerated by people who receive them. To measure how effective each type of vaccine is, VaxInnate will test the ability of the body to develop an immune response, which means how well the body recognizes and defends itself against the influenza virus.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	224 participants
Intervention Model:	Single Group Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Prevention
Official Title:	Phase I Study of the Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years
Study Start Date :	June 2012
Actual Primary Completion Date :	June 2013
Actual Study Completion Date :	November 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: VAX161B; Dose escalating study where subjects are treated with VAX161B at one of six dose levels. Subjects will be injected with VAX161B twice during the study at Day 0 and Day 21. The dosages are: 1 mcg; 2.5 mcg; 4 mcg; 6 mcg; 8 mcg; and 12 mcg.	Biological: VAX161 [STF2.HA5 H5N1]; dose escalating, 2 intramuscular doses given 21 days apart

Outcome Measures

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Primary Outcome Measures :

1. Safety [ Time Frame: 1 year ]
   Assess safety, reactogenicity and tolerability. Symptoms will be collected from the memory aid and from the information collected at the clinic visits. All symptoms will be graded according to severity. Response to vaccine will be categorized as local (arm pain, redness, bruising, etc.) or systemic (headache, muscle aches, fatigue, etc.) symptoms. Laboratory tests such as CRP, WBC, LFTs and cytokines collected before and after vaccination will also be analyzed. We will compare the types and severity of symptoms and laboratory results based on vaccine dose.

Secondary Outcome Measures :

1. Immunogenicity [ Time Frame: 6 mos. ]
   To assess serum immune response, sera collected at Days 0, 21, 42 and 180 will be analyzed for HAI, MN, serum IgG anti-HA and serum IgG anti-flagellin by Elisa. The geometric mean, seroconversion and seroprotection rates will be determined.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 49 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• male or female aged 18 - 49 years inclusive
• give written informed consent to participate
• healthy, as determined by medical history, physical examination
• comprehension of the study requirements
• willing to provide multiple blood specimens collected by venipuncture.

Exclusion Criteria:

• Subjects who have a psychiatric illness, a chronic illness that would interfere with participation or interpretation of results
• clinically significant abnormal liver function tests
• positive serology for HBsAg or HCV antibodies
• impaired immune responses
• history of anaphylactic type reaction to injected vaccines
• history of drug or chemical abuse in the year prior to screening
• history of Guillain-Barré Syndrome
• history of chronic obstructive pulmonary disease or history of other lung disease

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219

Sponsors and Collaborators

VaxInnate Corporation

Investigators

Principal Investigator:	Eric Sheldon, MD	Miami Research Associates
Principal Investigator:	Casey Johnson, DO	Johnson County Clin-Trials

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	VaxInnate Corporation
ClinicalTrials.gov Identifier:	NCT01560793 History of Changes
Other Study ID Numbers:	VAX161-01B
First Posted:	March 22, 2012
Last Update Posted:	September 23, 2014
Last Verified:	September 2014

Keywords provided by VaxInnate Corporation:

Influenza; Vaccines; H5N1

Additional relevant MeSH terms:

Influenza, Human; Influenza in Birds; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases	Respiratory Tract Infections; Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs