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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00395720
Recruitment Status : Completed
First Posted : November 3, 2006
Last Update Posted : March 28, 2011
Information provided by:
University of Oxford

Brief Summary:
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 or disease Intervention/treatment Phase
Tuberculosis HIV Infections Biological: MVA85A (TB vaccine) Biological: MVA 85A Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2006
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Data on adverse events [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Immune responses [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00395720

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

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Responsible Party: Dr Helen McShane, University of Oxford Identifier: NCT00395720    
Other Study ID Numbers: TB010
First Posted: November 3, 2006    Key Record Dates
Last Update Posted: March 28, 2011
Last Verified: March 2011
Keywords provided by University of Oxford:
HIV Therapeutic Vaccine
Additional relevant MeSH terms:
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Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs