Clinical trial NCT00603811: Phase I Safety and Immunogenicity Study of VAX102 [Flagellin.HuM2e] Influenza Vaccine in Healthy Adults
Official title: A Multicenter, Double-blind, Randomized, Escalating Dose-ranging Study to Investigate the Safety and Immunogenicity of the VAX102 Influenza Vaccine in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza Infection
Keywords: Influenza vaccines
M2e
Lead sponsor: VaxInnate Corporation
Sponsor class: INDUSTRY
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2008-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety (local and systemic reactogenicity, laboratory tests and AEs)
timeFrame: 6 months
Secondary outcomes:
measure: Immunogenicity after prime and boost (serum IgG to M2e antigen)
timeFrame: 6 months
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Johnson County Clinical Trials
state: Kansas
city: Galveston
country: United States
facility: Sealy Vaccine Center, UTMB
state: Texas
Study officials:
affiliation: UTMB
name: Christine Turley, MD
role: PRINCIPAL_INVESTIGATOR
References: