NCT00369031

Safety Study Of Nasal HIV Vaccine Adjuvanted With LTK63

A Phase I, Open Label, Parallel Group Trial To Evaluate Safety And Immunogenicity Of Three Nasal Immunisations Using A Fixed Dose-Level Of HIV gp140 V2 Loop Deleted Protein Adjuvanted With LTK63 Followed By Intramuscular Boosting With HIV gp140 V2 Loop Deleted Protein Adjuvanted With MF59 When Administered To Healthy Adults

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: St George's, University of London · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether an HIV vaccine given as three nasal immunisations with a protein from HIV virus mixed with a toxoid adjuvant, followed by two intramuscular immunisations with the same protein mixed with a liquid adjuvant, causes untoward adverse reactions when administered to healthy adult volunteers. An initial evaluation of immune responses to the vaccine will also be undertaken.

Detailed description

The purpose of this study is to determine whether an HIV vaccine given as three nasal immunisations with a protein from HIV virus mixed with a toxoid adjuvant, followed by two intramuscular immunisations with the same protein mixed with a liquid adjuvant, causes untoward adverse reactions when administered to healthy adult volunteers. An initial evaluation of immune responses to the vaccine will also be undertaken by measuring gp140- and LTK63-specific IgG and IgA in cervical secretions, vaginal secretions, serum and nasal wash. IFNg secretion of T cells in response to gp140 peptide stimulation will be undertaken along with neutralising assays.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	Human Immunodeficiency Virus glycoprotein 140 (vaccine)	Human Immunodeficiency Virus glycoprotein 140 (vaccine) alone nasally
BIOLOGICAL	HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant	Human Immunodeficiency Virus glycoprotein 140 (vaccine) + Labile Toxin mutant LTK63 adjuvant nasally
BIOLOGICAL	Labile Toxin mutant LTK63 adjuvant	Labile Toxin mutant LTK63 adjuvant alone

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-11-01
• Completion: 2008-03-01
• First posted: 2006-08-29
• Last updated: 2008-04-15

Locations

1 site across 1 country: United Kingdom