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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Influenza

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

VAX161 [STF2.HA5 H5N1]

Intervention Type BIOLOGICAL

dose escalating, 2 intramuscular doses given 21 days apart

Interventions

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VAX161 [STF2.HA5 H5N1]

dose escalating, 2 intramuscular doses given 21 days apart

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes