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

VaxInnate

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Biological: VAX161 [STF2.HA5 H5N1]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01560793

VAX161-01B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Triple Blind

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224 participants in 1 patient group

VAX161B

Experimental group

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.

Treatment:

Biological: VAX161 [STF2.HA5 H5N1]