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Safety Study Of Nasal HIV Vaccine Adjuvanted With LTK63

Primary Purpose

HIV Infections

Status
Terminated
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Human Immunodeficiency Virus glycoprotein 140 (vaccine)
HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant
Labile Toxin mutant LTK63 adjuvant
Sponsored by
St George's, University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, vaccine, nasal immunization

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St George's Vaccine Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Human Immunodeficiency Virus glycoprotein 140 (vaccine)

Human Immunodeficiency Virus glycoprotein 140 (vaccine) + Labile Toxin mutant LTK63 adjuvant

Labile Toxin mutant LTK63 adjuvant

Outcomes

Primary Outcome Measures

To determine the frequency of vaccine-related local and systemic adverse events after nasal immunisation up to week 32

Secondary Outcome Measures

To determine the frequency of vaccine-related local and systemic adverse events after intramuscular immunization up to week 32
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
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
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
To determine the frequency of subjects with a serum T-cell response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32
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

Full Information

First Posted
August 24, 2006
Last Updated
April 14, 2008
Sponsor
St George's, University of London
Collaborators
Richmond Pharmacology Limited, Novartis Vaccines, European Union
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1. Study Identification

Unique Protocol Identification Number
NCT00369031
Brief Title
Safety Study Of Nasal HIV Vaccine Adjuvanted With LTK63
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Terminated
Why Stopped
Safety issues
Study Start Date
September 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
St George's, University of London
Collaborators
Richmond Pharmacology Limited, Novartis Vaccines, European Union

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, vaccine, nasal immunization

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Human Immunodeficiency Virus glycoprotein 140 (vaccine)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Human Immunodeficiency Virus glycoprotein 140 (vaccine) + Labile Toxin mutant LTK63 adjuvant
Arm Title
3
Arm Type
Active Comparator
Arm Description
Labile Toxin mutant LTK63 adjuvant
Intervention Type
Biological
Intervention Name(s)
Human Immunodeficiency Virus glycoprotein 140 (vaccine)
Intervention Description
Human Immunodeficiency Virus glycoprotein 140 (vaccine) alone nasally
Intervention Type
Biological
Intervention Name(s)
HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant
Intervention Description
Human Immunodeficiency Virus glycoprotein 140 (vaccine) + Labile Toxin mutant LTK63 adjuvant nasally
Intervention Type
Biological
Intervention Name(s)
Labile Toxin mutant LTK63 adjuvant
Intervention Description
Labile Toxin mutant LTK63 adjuvant alone
Primary Outcome Measure Information:
Title
To determine the frequency of vaccine-related local and systemic adverse events after nasal immunisation up to week 32
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
To determine the frequency of vaccine-related local and systemic adverse events after intramuscular immunization up to week 32
Time Frame
32 weeks
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David JM Lewis, MD
Organizational Affiliation
St George's, University of London, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
St George's Vaccine Institute
City
London
State/Province
England
ZIP/Postal Code
SW17 0RE
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.vaccine.ac.uk
Description
St George's Vaccine Institute Home website

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Safety Study Of Nasal HIV Vaccine Adjuvanted With LTK63

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