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

Purpose

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	Intervention	Phase
Influenza	Biological: VAX161 [STF2.HA5 H5N1]	Phase 1


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by VaxInnate Corporation:

Primary Outcome Measures:

Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 6 mos. ] [ Designated as safety issue: No ]
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.


Enrollment:	224
Study Start Date:	June 2012
Study Completion Date:	November 2013
Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560793

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

No publications provided


Responsible Party:	VaxInnate Corporation
ClinicalTrials.gov Identifier:	NCT01560793 History of Changes
Other Study ID Numbers:	VAX161-01B
Study First Received:	February 14, 2012
Last Updated:	September 22, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by VaxInnate Corporation:


Influenza Vaccines H5N1

Additional relevant MeSH terms:


Influenza, Human Orthomyxoviridae Infections RNA Virus Infections	Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

ClinicalTrials.gov processed this record on February 27, 2015