Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Children and Infants After BCG Vaccination at Birth
Brief Summary: This study is designed to evaluate the safety of the TB vaccine MVA85A in healthy children and infants in South Africa. A single vaccination with MVA85A has been shown to be safe and highly immunogenic in a wide range of subjects in previous clinical trials. In this trial,we will vaccinate 24 children with 5 x 10\^7pfu of MVA85A and three groups of 36 infants with 2.5 x 10\^7, 5 x 10\^7 or 1 x 10\^8 pfu.

Participants will be identified from the general population living in Worcester, Western Cape, South Africa


Options:
A: Inclusion Criteria:

* Eligible subjects will be children or infants aged 6 months - 11 years.
* Subject's parent/guardian is willing and able to give written informed consent for participation in the study.
* Subject is BCG vaccinated within the first 4 weeks of life
* In addition, informed assent will be obtained from all children aged 7 years or older unless they are adjudged incapable of understanding the basic concepts covered in the informed assent form, and an attempt will be made to obtain informed assent from children aged younger than 7 years if they are judged capable of understanding the basic concepts covered in the informed assent form
* Subject is in good health
* Subject has clinically acceptable laboratory results from screening visit
* CXR normal with no evidence of active or past TB
* Subject's parent/legal guardian is willing to allow child to undergo an HIV test
* Parent/guardian and subject able (in the Investigators opinion) and willing to comply with all study requirements.

Exclusion Criteria:

* Subject is Mantoux (\>10 mm) and/or ELISPOT (\> 50 spots/million PBMC) positive for M tb (PPD, ESAT 6 and/or CFP10)
* Subject is HIV antibody positive
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient/subject at risk because of participation in the study, or may influence the result of the study, or the patient/subject's ability to participate in the study.
* Patient/subjects/healthy volunteers who have participated in another research study involving an investigational product in the past 12 weeks
* Patient/subjects previously enrolled into this study.
* Received a live vaccine (e.g. measles) in the previous 4 weeks or due to receive a live vaccine in the 4 weeks following enrolment
B: Inclusion Criteria:

* HIV infected mother receiving either cART, or started on PMTCT prophylaxis
* Maternal antenatal and post-natal written informed consent;
* Maternal age 18 years or older at the time of informed consent;
* Infant age \< 96 hours;
* Infant birth and residence in the study area;
* Mother contactable and able to attend follow-up visits.

Exclusion Criteria:

* Neonatal Apgar score \< 7 at 5 minutes;
* Infant birth weight \< 2,000g or \> 4,500g;
* Estimated infant gestational age \< 32 weeks;
* Neonatal respiratory distress;
* History or evidence of infant congenital abnormality, or immunosuppressive condition, other than HIV infection;
* Any maternal or infant condition or systemic illness that in the opinion of the investigator is likely to affect safety or immunogenicity of study vaccine;
* Infant BCG vaccination prior to enrollment;
* Residence in a household, or frequent close contact, with an adult diagnosed with active TB who has not yet completed TB treatment;
* Mother with active TB who has not yet completed TB treatment;
* Unknown or negative maternal HIV status;
* Intention to leave the study area and/or unable to attend follow-up visits.
C: Inclusion Criteria

* Healthy adults aged 18 to 50 years
* Resident in or near Oxford for the duration of the vaccination study
* Willingness to allow the investigators to discuss the volunteer's medical history with the volunteer's GP
* Screening Elispot positive (more than 50 spots/million PBMC) for at least any 1 of the 3 ESAT6 peptide pools or any one of the 3 CFP10 pools ; and screening Elispot positive for PPD.
* Heaf test grade II-IV or positive Mantoux test.
* CXR normal; or abnormal but not clinically significant CXR findings with no evidence of past/present TB infection or disease on the CXR.
* For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day of vaccination
* Agreement to refrain from blood donation during the course of the study
* Written informed consent
* Willingness to undergo an HIV

Exclusion Criteria

* Any deviation from the normal range in biochemistry or haematology blood tests or in urine analysis
* Heaf grade IV
* 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, ε 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection and asplenia
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
* 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
* Chronic or active neurological disease requiring ongoing specialist supervision
D: Inclusion Criteria:

* Healthy adult aged 18 to 50 years
* Resident in or near Oxford for the duration of the vaccination study
* Immunization with BCG greater than 12 months prior to enrolment in the study
* Able and willing (in the Investigators' opinions) to comply with all study requirements
* Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
* Agreement to practice barrier contraception from the start of the study until 3 months after the final vaccination
* For females, a negative pregnancy test on the day of vaccination and agreement to practice effective contraception for the entire duration of the study
* Agreement to refrain from blood donation during the course of the study
* Written informed consent

Exclusion Criteria:

* Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
* Prior receipt of a recombinant MVA or fowlpox vaccine
* Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
* Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (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
* Any history of anaphylaxis in reaction to vaccination
* Close contact with fowl during the study period (e.g. chicken farming)
* History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
* History of serious psychiatric condition
* Any other chronic illness requiring hospital specialist supervision
* Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol intake of greater than 42 units every week)
* Seropositive for hepatitis B surface antigen (HBsAg)
* Seropositive for hepatitis C virus (antibodies to HCV)
* For females, pregnancy, lactation or willingness/intention to become pregnant during the study
* Any other significant disease, disorder or finding, which, in the opinion of the Investigators, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate in the study.
* Mantoux skin test equal to or greater than 15 millimetres
* Screening Elispot positive (greater than 17 sfc/million PBMC) in any ESAT6 peptide or CFP10 peptide pool
* Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis

Answer: A