The Safety and Immunogenicity of a TB Vaccine; MVA85A, in Healthy Volunteers Who Are Infected With HIV

This study has been completed.
Sponsor:
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00395720
First received: November 2, 2006
Last updated: March 25, 2011
Last verified: March 2011
  Purpose

This study is designed to evaluate the safety of MVA85A in healthy volunteers in the UK who are infected with HIV. In phase I studies, a single vaccination with MVA85A, when administered at a dose of 5 x 10^7pfu intradermally, has been shown to be safe in both mycobacterially naïve individuals, those previously vaccinated with BCG and latently infected individuals. Additionally, 5 x 10^7 pfu MVA containing HIV antigens administered twice, 4 weeks apart, in HIV positive individuals, is safe. We will use 5 x 107 pfu MVA85A intradermally in this study. Subjects will be identified from HIV clinics in the Oxford Radcliffe Hospitals NHS Trust and also from Swindon and Marlborough NHS Trust and St. Mary's Hospital NHS Trust if our recruitment targets are not met.


Condition Intervention Phase
Tuberculosis
HIV Infections
Biological: MVA85A (TB vaccine)
Biological: MVA 85A
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 Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Are Infected With HIV

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Data on adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immune responses [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Group 1 (10 volunteers): 5 x 10^7 pfu
Biological: MVA85A (TB vaccine)
Intradermal vaccine
Other Name: TB vaccine
Biological: MVA 85A
Intradermal vaccine
Other Names:
  • TB Vaccine
  • modified vaccinia virus Ankara
Active Comparator: 2
Group 2 (10 volunteers): 1 x 10^8 pfu
Biological: MVA85A (TB vaccine)
Intradermal vaccine
Other Name: TB vaccine
Biological: MVA 85A
Intradermal vaccine
Other Names:
  • TB Vaccine
  • modified vaccinia virus Ankara

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults aged 18 to 50 years
  • Willingness to allow the investigators to discuss the volunteer's medical history with the volunteer's HIV lead physician (and GP, if appropriate)
  • BCG vaccinated
  • HIV antibody positive; diagnosed at least 6 months previously
  • CD4 count >350; nadir CD4 not < 300
  • HIV viral load not > 100,000 copies per millilitre
  • Written informed consent

Exclusion Criteria:

  • Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or on urinalysis
  • Any ARV therapy within the past 6 months
  • Any AIDS defining illness
  • CXR showing TB or evidence of other active infection
  • Prior receipt of a recombinant MVA or Fowlpox vaccine
  • Use of any investigational or non-registered drug, live vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period
  • Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisolone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
  • Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine (including evidence of cardiovascular disease, history of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ), history of insulin requiring diabetes mellitus, any ongoing chronic illness requiring ongoing specialist supervision (e.g., gastrointestinal), and chronic or active neurological disease)
  • History of > 2 hospitalisations for invasive bacterial infections (pneumonia, meningitis)
  • Suspected or known current drug and/or alcohol abuse (as defined by an alcohol intake of >42 units a week)
  • Seropositive for hepatitis B surface antigen (HBsAg) and/ or hepatitis C (antibodies to HCV)
  • Evidence of serious psychiatric condition
  • Any other on-going chronic illness requiring hospital specialist supervision
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
  • Pregnant/lactating female and any female who is willing or intends to become pregnant during the study
  • Any history of anaphylaxis in reaction to vaccination
  • PI assessment of lack of willingness to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the participant's risk of suffering an adverse outcome
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00395720

Locations
United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Helen McShane, Dr University of Oxford
  More Information

Publications:

Responsible Party: Dr Helen McShane, University of Oxford
ClinicalTrials.gov Identifier: NCT00395720     History of Changes
Other Study ID Numbers: TB010
Study First Received: November 2, 2006
Last Updated: March 25, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:
TB
Tuberculosis
HIV
Vaccine
MVA85A
HIV Therapeutic Vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Tuberculosis
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
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 16, 2014