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Safety Study Of Nasal HIV Vaccine Adjuvanted With LTK63

NCT ID: NCT00369031

Last Updated: 2008-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-03-31

Brief Summary

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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

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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

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HIV Infections

Keywords

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HIV vaccine nasal immunization

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Human Immunodeficiency Virus glycoprotein 140 (vaccine)

Group Type EXPERIMENTAL

Human Immunodeficiency Virus glycoprotein 140 (vaccine)

Intervention Type BIOLOGICAL

Human Immunodeficiency Virus glycoprotein 140 (vaccine) alone nasally

2

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

Group Type ACTIVE_COMPARATOR

HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant

Intervention Type BIOLOGICAL

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

3

Labile Toxin mutant LTK63 adjuvant

Group Type ACTIVE_COMPARATOR

Labile Toxin mutant LTK63 adjuvant

Intervention Type BIOLOGICAL

Labile Toxin mutant LTK63 adjuvant alone

Interventions

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Human Immunodeficiency Virus glycoprotein 140 (vaccine)

Human Immunodeficiency Virus glycoprotein 140 (vaccine) alone nasally

Intervention Type BIOLOGICAL

HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant

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

Intervention Type BIOLOGICAL

Labile Toxin mutant LTK63 adjuvant

Labile Toxin mutant LTK63 adjuvant alone

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Richmond Pharmacology Limited

INDUSTRY

Sponsor Role collaborator

Novartis Vaccines

INDUSTRY

Sponsor Role collaborator

European Union

OTHER

Sponsor Role collaborator

St George's, University of London

OTHER

Sponsor Role lead

Responsible Party

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SGUL

Principal Investigators

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David JM Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

St George's, University of London, UK

Locations

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St George's Vaccine Institute

London, England, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://www.vaccine.ac.uk

St George's Vaccine Institute Home website

Other Identifiers

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C86P1

Identifier Type: -

Identifier Source: secondary_id

FP6-2002-LIFESCIHEA-2.3 503240

Identifier Type: -

Identifier Source: secondary_id

2005-005983-10

Identifier Type: -

Identifier Source: org_study_id