MedTrace Logo

Safety Study Of Nasal HIV Vaccine Adjuvanted With LTK63

NCT00369031 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2008-04-15

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

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

Sponsors & Collaborators

  • Richmond Pharmacology Limited

    collaborator INDUSTRY

  • Novartis Vaccines

    collaborator INDUSTRY

  • European Union

    collaborator OTHER

  • St George's, University of London

    lead OTHER

Principal Investigators

  • David JM Lewis, MD · St George's, University of London, UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2007-11-30
Completion
2008-03-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00369031 on ClinicalTrials.gov