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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560793
• Other study ID #: VAX161-01B
• Status: Completed
• Phase: Phase 1
• First received: February 14, 2012
• Last updated: September 22, 2014
• Start date: June 2012
• Est. completion date: November 2013

Study information

• Verified date: September 2014
• Source: VaxInnate Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: November 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• VAX161 [STF2.HA5 H5N1]
dose escalating, 2 intramuscular doses given 21 days apart

Locations

Country	Name	City	State
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Miami Research Associates	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VaxInnate Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	No