A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Are Infected With HIV
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Tuberculosis
- Sponsor
- University of Oxford
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Safety of MVA85A
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
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.)
Outcomes
Primary Outcomes
Safety of MVA85A
Time Frame: Six months
Secondary Outcomes
- Immunogenicity of MVA85A(Six months)