NCT00369031

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2006

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

April 15, 2008

Status Verified

April 1, 2008

Enrollment Period

1.2 years

First QC Date

August 24, 2006

Last Update Submit

April 14, 2008

Conditions

HIV Infections

Keywords

HIVvaccinenasal immunization

Outcome Measures

Primary Outcomes (1)

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

    32 weeks

Secondary Outcomes (6)

  • To determine the frequency of vaccine-related local and systemic adverse events after intramuscular immunization up to week 32

    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

    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

    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

    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

    32 weeks

  • +1 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

Human Immunodeficiency Virus glycoprotein 140 (vaccine)

Biological: Human Immunodeficiency Virus glycoprotein 140 (vaccine)

2

ACTIVE COMPARATOR

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

Biological: HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant

3

ACTIVE COMPARATOR

Labile Toxin mutant LTK63 adjuvant

Biological: Labile Toxin mutant LTK63 adjuvant

Interventions

Human Immunodeficiency Virus glycoprotein 140 (vaccine)BIOLOGICAL

Human Immunodeficiency Virus glycoprotein 140 (vaccine) alone nasally

1
HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvantBIOLOGICAL

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

2
Labile Toxin mutant LTK63 adjuvantBIOLOGICAL

Labile Toxin mutant LTK63 adjuvant alone

3

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George's Vaccine Institute

London, England, SW17 0RE, United Kingdom

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • David JM Lewis, MD

    St George's, University of London, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2006

First Posted

August 29, 2006

Study Start

September 1, 2006

Primary Completion

November 1, 2007

Study Completion

March 1, 2008

Last Updated

April 15, 2008

Record last verified: 2008-04

Locations

GB(1)