NCT00921206

Study to Investigate the Immune Response to Two Doses of VAX102 Healthy Adults

Open-label Study to Investigate the Humoral and Cellular Immune Response to Two Doses of VAX102 Influenza Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: VaxInnate Corporation · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The objective is to assess the humoral and cellular immune response of the VAX102 vaccine delivered IM and SC in a prime-boost regimen at dose levels 1 µg or 2 µg in healthy adults against the influenza A virus M2e antigen after each vaccination.

Detailed description

The primary objective is to assess the humoral and cellular immune response of the VAX102 vaccine delivered IM and SC in a prime-boost regimen at dose levels 1 µg or 2 µg in healthy adults against the influenza A virus M2e antigen after each vaccination. The magnitude and quality of the M2e-specific B and T cells will be measured. B cell responses will be evaluated on pre-dose Days 0, 28 and post-dose Days 7, 35, 42 and 60. T cell responses will be measured on pre-dose Days 0, 28 and post-dose Days 14, 42 and 60. IgG M2e antibody will be measured on Days 0, 7, 14, 28, 35. 42 and 60. The secondary objective is to assess the safety, reactogenicity, and tolerability of the VAX102 vaccine delivered IM or SC at dose levels 1 µg or 2 µg, in a prime-boost dosing regimen, in healthy adults 18-49 years of age, inclusive.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	VAX102	1 ug i.m. compared to 2 ug s.c.

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-10-01
• Completion: 2009-12-01
• First posted: 2009-06-16
• Last updated: 2014-09-23

Locations

1 site across 1 country: United States