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

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: VAX161 [STF2.HA5 H5N1]

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 Type: Interventional
• Enrollment (Actual): 224
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 mos.

Collaborators and Investigators

• Sponsor: VaxInnate Corporation
• Investigators: Principal Investigator: Casey Johnson, DO, Johnson County Clin-Trials

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: February 14, 2012
• First Submitted That Met QC Criteria: March 20, 2012
• First Posted (Estimate): March 22, 2012

Study Record Updates

• Last Update Posted (Estimate): September 23, 2014
• Last Update Submitted That Met QC Criteria: September 22, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Influenza; Vaccines; H5N1
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Influenza in Birds
• Other Study ID Numbers: VAX161-01B