A Phase I Study of a New Tuberculosis (TB) Vaccine, MVA85A, in Healthy Volunteers 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: NCT00731471
Recruitment Status : Completed
First Posted : August 11, 2008
Last Update Posted : March 28, 2011
Centre Hospitalier Universitaire Le Dantec, Dakar, Senegal
Information provided by:
University of Oxford

Brief Summary:
This is an open Phase I study of a candidate TB vaccine, MVA85A, in healthy subjects who are infected with HIV. It is designed to study the safety and immunogenicity of the vaccine.

Condition or disease Intervention/treatment Phase
Tuberculosis Biological: MVA85A Phase 1

Detailed Description:
This study is designed to evaluate the safety of MVA85A in healthy volunteers in Senegal who are infected with HIV. In phase I studies, a single vaccination with MVA85A, when administered at a dose of 5 x 107pfu intradermally, has been shown to be safe in both mycobacterially naïve individuals, those previously vaccinated with BCG and latently infected individuals. We will use 1 x 10^8 pfu MVA85A intradermally in this study. A trial in BCG vaccinated subjects showed that the higher dose (1 x 10^8 pfu MVA85A) induced a significantly higher immune response but did not have a higher AE profile. In addition, because of a variable immune response, the trial in HIV positive subjects in the UK is split into two groups, the first getting 5 x 10^7 pfu and the second getting 1 x 10^8 pfu MVA85A. It has, therefore, been decided to use the higher dose in order to maximise the immune response whilst maintaining a good safety profile.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group 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 : August 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

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Arm Intervention/treatment
Experimental: 1
12 Healthy adults infected with HIV
Biological: MVA85A
Modified vaccinia virus Ankara expressing antigen 85A from Mycobacterium tuberculosis. Both arms will receive two vaccinations six months apart.

Experimental: 2
12 HIV+ adults on antiretroviral therapy
Biological: MVA85A
Modified vaccinia virus Ankara expressing antigen 85A from Mycobacterium tuberculosis. Both arms will receive two vaccinations six months apart.

Primary Outcome Measures :
  1. Safety of MVA85A [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Immunogenicity of MVA85A [ Time Frame: Six months ]

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:   No

Inclusion Criteria:

  • Healthy adults aged 18 to 50 years
  • Resident in or near Dakar for the duration of the study
  • Willingness to allow the investigators to discuss the volunteer's medical history with the volunteer's HIV lead physician
  • Willing to use effective contraception throughout duration of study (if female)
  • HIV antibody positive; diagnosed at least 6 months previously
  • CD4 count >300
  • Arm 1: HIV viral load not >100,000 copies per millilitre
  • Arm 2: Undetectable HIV viral load
  • Written informed consent

Exclusion Criteria:

  • Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or on urinalysis
  • Group 1 only: Any ARV therapy within the past 6 months
  • Previous history of TB disease and/or treatment
  • Any AIDS defining illness
  • Group 1: CD4 count nadir <300
  • Group 2: CD4 count nadir <100
  • 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
  • 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
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, other than HIV infection, such as asplenia
  • Evidence of hepatomegaly
  • 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): NCT00731471

Centre Hospitalier Le Dantec
Dakar, Senegal, BP 7325
Sponsors and Collaborators
University of Oxford
Centre Hospitalier Universitaire Le Dantec, Dakar, Senegal
Principal Investigator: Helen McShane University of Oxford
Principal Investigator: Souleymane Mboup Centre Hospitalier Universitaire Le Dantec

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Helen McShane, University of Oxford Identifier: NCT00731471     History of Changes
Other Study ID Numbers: TB019
First Posted: August 11, 2008    Key Record Dates
Last Update Posted: March 28, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections