A Study of MVA85A, in Asymptomatic Volunteers Infected With TB, HIV or Both

Inclusion Criteria:

For all groups:

• Asymptomatic adults aged 21 to 50 years
• Chest x-ray normal with no evidence of past/present TB infection or disease or any other clinically significant finding
• Resident in or near Worcester for the duration of the vaccination study
• Willingness to allow the investigators to discuss the volunteer's medical history with the
• volunteer's usual doctor or HIV physician
• Agreement to refrain from blood donation during the course of the study
• Willing and able to provide written informed consent
• Willingness to undergo an HIV test

For the M.Tb infected- and M.Tb/HIV coinfected- groups:

• Screening Elispot positive (more than 50 spots/million PBMC): for either the pool of ESAT6 peptides and/or the pool of CFP10 peptides and screening Elispot positive for PPD.

• Positive Mantoux test. (>10mm induration)

For the HIV infected and M.Tb/HIV coinfected groups:

• HIV antibody positive; diagnosed at least 3 months previously
• CD4 count >300; nadir CD4 not < 300

Exclusion Criteria:

For all groups:

• Any deviation from the normal range in biochemistry or haematology blood tests or in urine analysis that is considered to be clinically significant
• Any previous ARV therapy
• 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.)
• Pregnant/lactating female and any female who is willing or intends to become pregnant during the study
• Any AIDS defining illness
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
• Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
• Seropositive for hepatitis B surface antigen (HBsAg) and or hepatitis C (antibodies to HCV)
• 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)
• Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
• Any history of anaphylaxis in reaction to vaccination
• PI assessment of lack of willingness to participate and comply with all requirements of the protocol
• Any other finding which in the opinion of the investigator would significantly increase the risk of having an adverse outcome from participating in this protocol

For the M.Tb infected group (but not the HIV infected and M.Tb/HIV coinfected groups):

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection and asplenia

For the HIV infected and M.Tb/HIV coinfected groups (but not the M.Tb infected/HIV uninfected group)

• CD4 count now more than 300 and CD4 nadir not less than 300