NCT02522754

Development of an Intranasal Proteosome Influenza Vaccine

Study to Determine if Intranasal Proteosome-Adjuvanted Trivalent Influenza Vaccine is Safe, Immunogenic and Efficacious in the Influenza Human Viral Challenge Model

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Hvivo · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A study to compare multiple dosage regimes of a protesomal intranasal vaccine.

Detailed description

A Proteosome-adjuvanted trivalent inactivated influenza vaccine (P-TIV) administered intra-nasally was shown to be effective, safe, well tolerated, immunogenic - in both systemic and mucosal compartments - and effective at preventing influenza illness. In two separate studies using the Human Viral Challenge Model, subjects were selected for susceptibility to A/Panama/2007/1999 (H3N2) virus and then dosed with one of three regimens: (A/New Caledonia/20/1999 (H1N1), A/Panama/2007/1999 (H3N2), B/Victoria/504/2000 or B/Shangdong/7/1997) or placebo via a nasal spray. One or two doses were given, 14 days apart, before subjects were challenged with \~8.5 x 105 EID¬50 of A/Panama/2007/1999 (H3N2) virus. Immune responses to the vaccine antigens were measured, namely serum IgG (via the aemagglutination inhibition assay (HAI)) and nasal wash secretory IgA (sIgA) antibodies (via ELISA). Viral titres in nasal washes and symptoms of influenza illness were assessed after viral challenge and compared.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Placebo Protesomal Vaccine	Intranasal vaccine Protesomal Vaccine
BIOLOGICAL	Experimental: Protesomal Vaccine 1 x 30 µg	Experimental: Protesomal Vaccine 1 x 30 µg
BIOLOGICAL	Experimental: Protesomal Vaccine 2 x 30 µg	Experimental: Protesomal Vaccine 2 x 30 µg
BIOLOGICAL	Experimental: Protesomal Vaccine 2 x 15 µg	Experimental: Protesomal Vaccine 2 x 15 µg

Timeline

• Start date: 2002-01-01
• Primary completion: 2004-01-01
• Completion: 2004-01-01
• First posted: 2015-08-13
• Last updated: 2015-08-13