Back to resultsSafety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VAX161 [STF2.HA5 H5N1]
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Vaccines, H5N1
Eligibility 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
Sites / Locations
- Miami Research Associates
- Johnson County Clin-Trials
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VAX161B
Arm Description
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.
Outcomes
Primary Outcome Measures
Safety
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
Immunogenicity
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.
Full Information
NCT ID
NCT01560793
First Posted
February 14, 2012
Last Updated
September 22, 2014
Sponsor
VaxInnate Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01560793
Brief Title
Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years
Official Title
Phase I Study of the Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VaxInnate Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Vaccines, H5N1
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
N/A
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VAX161B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
VAX161 [STF2.HA5 H5N1]
Intervention Description
dose escalating, 2 intramuscular doses given 21 days apart
Primary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Immunogenicity
Description
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.
Time Frame
6 mos.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Sheldon, MD
Organizational Affiliation
Miami Research Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Casey Johnson, DO
Organizational Affiliation
Johnson County Clin-Trials
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Johnson County Clin-Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years
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