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

A Multicenter, Double-blind, Randomized, Escalating Dose-ranging Study to Investigate the Safety and Immunogenicity of the VAX102 Influenza Vaccine in Healthy Adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00603811

Enrollment

Registered

2008-01-29

Start date

2007-09-30

Completion date

2008-10-31

Last updated

2014-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza Infection

Keywords

Influenza vaccines, M2e

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.

Interventions

BIOLOGICALVAX102 [Flagellin.HuM2e]

dose ranging, 2 i.m. doses given 28 days apart

BIOLOGICALPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 49 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Safety (local and systemic reactogenicity, laboratory tests and AEs)	6 months

Secondary

Measure	Time frame
Immunogenicity after prime and boost (serum IgG to M2e antigen)	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026