Phase I Safety and Immunogenicity Study of VAX102 [Flagellin.HuM2e] Influenza Vaccine in Healthy Adults

VaxInnate

Status and phase

Completed

Phase 1

Conditions

Influenza Infection

Treatments

Biological: VAX102 [Flagellin.HuM2e]

Biological: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00603811

Gates grant 42462

VAX102-01

Details and patient eligibility

About

This study will evaluate the safety and immunogenicity of VAX102 [Flagellin.HuM2e], a recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of doses.

Full description

VAX102 is a cross-protective influenza A vaccine based on a recombinant protein expressed in E. coli. The protein comprises Salmonella typhimurium flagellin type 2 (STF2; TLR5 ligand) fused to Human M2e. The active component of the VAX102 vaccine is manufactured by a standard fermentation process. Unlike the HA and NA viral proteins, the amino acid sequence of M2e has remained remarkably stable in all human influenza A virus isolates. Thus an influenza vaccine based on the M2e antigen could elicit cross-protective immunity against most human influenza A virus strains. VAX102 vaccine relies on a single cross-reactive influenza A virus antigen manufactured by a recombinant protein fermentation-production process.

Enrollment

60 patients

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy adults aged 18-49 years inclusive who provide written informed consent to participate.
Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.

Exclusion criteria

Presence of significant acute or chronic, uncontrolled medical or psychiatric illness
Documented influenza infection in the 6 months prior to study entry.
Presently receiving or history of receiving any medications or treatments that affects the immune system
Acute disease within 72 hours prior to vaccinations Investigational product (test article) administrations will occur on Days 0 and 28 (± 3).
In-clinic safety evaluations will be performed at screening, before each test article dose, and at Days 1, 7 (± 2), 14 (± 2), 29, 35 (± 2), 42 (± 2), 60 (± 2), 120 (± 7), and 180 (± 7).
Completion of a Memory Aid for seven days following each vaccine dose will be requested of subjects for use in accurate recall of local and systemic reactions.