Safety Study Of Nasal HIV Vaccine Adjuvanted With LTK63

April 14, 2008 updated by: St George's, University of London

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, SW17 0RE
        • St George's Vaccine Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • They are adult volunteers, 18 to 45 years of age, who have signed an informed consent form following a detailed written explanation of participation in the protocol.
  • They are volunteers who are in good health as determined by medical history, physical examination and clinical judgement.
  • They are available for the duration of the study
  • They are women who, if capable of becoming pregnant during the study, have agreed to have a pregnancy test immediately before immunisation, and to use appropriate contraception methods during the whole study period.

Exclusion Criteria:

  • They have hypersensitivity to any component of the vaccines used in this study.
  • They are found to be HIV antibody positive at the time of initial screening
  • They have a known or suspected history of nasal disease, malignancy or abnormality, or any nasal disease, malignancy or abnormality discovered at time of screening.
  • They have a known or suspected history of severe seasonal allergies and allergic rhinitis (requiring medication), recurrent nose bleeds, asthma, or cardio-pulmonary disease, or any of these conditions discovered at time of screening.
  • They present in the samples obtained at the screening visit:
  • a clinically significant amount of protein or haemoglobin in the urine sample, determined by urine dipstick:
  • a clinically significant abnormality in the haematological or biochemical assays
  • An abnormal value will be defined by the ranges quoted in the St George's Pathology Services Handbook.
  • They have a known impairment of immune function or are receiving immunosuppressive therapy (including systemic or inhaled steroids, but excluding topical).
  • They are receiving any medications via nasal route.
  • They have any acute infections (including fever greater than or equal to 38°C) or any chronic disease.
  • They are women capable of becoming pregnant who do not agree to have pregnancy testing before application of study products, or who do not agree to take appropriate contraception measures during the whole study period. Appropriate contraception shall include physician-prescribed oral, injected or implanted hormonal agents; barrier contraceptives used in conjunction with spermicidal agents; or intrauterine devices only.
  • They present a current problem with substance abuse or with a history of substance abuse which, in the opinion of the investigator, might interfere with participation in the study.
  • They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
  • They have received an investigational agent within 3 months prior to study entry.
  • They cannot speak fluent English, or are planning to leave the area of the study site prior to the end of the study period, or are likely not to complete the study.
  • They have a weight (W)/height (H) index (WHI) less than 18.5 or greater than 40

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Human Immunodeficiency Virus glycoprotein 140 (vaccine)
Biological: Human Immunodeficiency Virus glycoprotein 140 (vaccine)
Human Immunodeficiency Virus glycoprotein 140 (vaccine) alone nasally
ACTIVE_COMPARATOR: 2
Human Immunodeficiency Virus glycoprotein 140 (vaccine) + Labile Toxin mutant LTK63 adjuvant
Biological: HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant
Human Immunodeficiency Virus glycoprotein 140 (vaccine) + Labile Toxin mutant LTK63 adjuvant nasally
ACTIVE_COMPARATOR: 3
Labile Toxin mutant LTK63 adjuvant
Biological: Labile Toxin mutant LTK63 adjuvant
Labile Toxin mutant LTK63 adjuvant alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the frequency of vaccine-related local and systemic adverse events after nasal immunisation up to week 32
Time Frame: 32 weeks
32 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the frequency of vaccine-related local and systemic adverse events after intramuscular immunization up to week 32
Time Frame: 32 weeks
32 weeks
To determine the frequency of subjects mounting a serum IgG neutralising antibody response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32
Time Frame: 32 weeks
32 weeks
To determine the frequency of subjects mounting a nasal wash gp140-specific IgA response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32
Time Frame: 32 weeks
32 weeks
To determine the frequency of female subjects mounting a vaginal secretions IgA response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32
Time Frame: 32 weeks
32 weeks
To determine the frequency of subjects with a serum T-cell response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32
Time Frame: 32 weeks
32 weeks
To determine frequency of subjects mounting a serum IgG response, nasal IgA response and vaginal IgA response to LTK63 at weeks 0, 4, 8, 10, 12, 16, 28 & 32
Time Frame: 32 weeks
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St George's, University of London

Collaborators

Novartis Vaccines
European Union
Richmond Pharmacology Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (ACTUAL)

November 1, 2007

Study Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

August 24, 2006

First Submitted That Met QC Criteria

August 24, 2006

First Posted (ESTIMATE)

August 29, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 15, 2008

Last Update Submitted That Met QC Criteria

April 14, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-005983-10
  • C86P1
  • FP6-2002-LIFESCIHEA-2.3 503240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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