Safety Study Of Nasal HIV Vaccine Adjuvanted With LTK63

This study has been terminated.
(Safety issues)
Sponsor:
Collaborators:
Richmond Pharmacology Limited
Novartis Vaccines
European Union
Information provided by:
St George's, University of London
ClinicalTrials.gov Identifier:
NCT00369031
First received: August 24, 2006
Last updated: April 14, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: Human Immunodeficiency Virus glycoprotein 140 (vaccine)
Biological: HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant
Biological: Labile Toxin mutant LTK63 adjuvant
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by St George's, University of London:

Primary Outcome Measures:
  • To determine the frequency of vaccine-related local and systemic adverse events after nasal immunisation up to week 32 [ Time Frame: 32 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the frequency of vaccine-related local and systemic adverse events after intramuscular immunization up to week 32 [ Time Frame: 32 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: September 2006
Study Completion Date: March 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369031

Locations
United Kingdom
St George's Vaccine Institute
London, England, United Kingdom, SW17 0RE
Sponsors and Collaborators
St George's, University of London
Richmond Pharmacology Limited
Novartis Vaccines
European Union
Investigators
Principal Investigator: David JM Lewis, MD St George's, University of London, UK
  More Information

Additional Information:
No publications provided

Responsible Party: David Lewis, Principal Investigator, SGUL
ClinicalTrials.gov Identifier: NCT00369031     History of Changes
Other Study ID Numbers: 2005-005983-10, C86P1, FP6-2002-LIFESCIHEA-2.3 503240
Study First Received: August 24, 2006
Last Updated: April 14, 2008
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by St George's, University of London:
HIV
vaccine
nasal immunization

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Krestin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 28, 2014