Safety and immunogenicity of a new tuberculosis (TB) vaccine (MVA85A) in healthy volunteers in Cape Tow

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 36

Inclusion Criteria

1. Healthy adults aged 18 to 50 years (for the first 2 arms), either sex
2. Healthy adolescents (aged 12 - 14) for the third arm of the study, either sex
3. Screening Elispot negative (less than 17 spots/million PBMC) in all three ESAT6 pools and all three CFP10 pools
4. Mantoux test less than 15 mm (less than 10 mm if BCG negative)
5. Chest x-ray (CXR) normal with no evidence of active or past TB
6. For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day of vaccination
7. Agreement to refrain from blood donation during the course of the study
8. Written informed consent
9. Willingness to undergo a human immunodeficiency virus (HIV) test

Exclusion Criteria

1. Any deviation from the normal range in biochemistry or haematology blood tests or in urine analysis
2. Mantoux greater than 15 mm
3. Prior receipt of a recombinant MVA or Fowlpox vaccine
4. 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
5. 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).
6. Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection and asplenia
7. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
8. Evidence of cardiovascular disease
9. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
10. History of diabetes mellitus
11. Chronic or active neurological disease requiring ongoing specialist or medical supervision
12. Chronic gastrointestinal disease requiring ongoing specialist or medical supervision
13. History of greater than two hospitalisations for invasive bacterial infections (pneumonia, meningitis)
14. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
15. Seropositive for hepatitis B surface antigen (HBsAg)
16. Seropositive for hepatitis C virus (antibodies to HCV)
17. Evidence of serious psychiatric condition
18. Any other ongoing chronic illness requiring hospital specialist or medical supervision
19. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
20. Pregnant or lactating female
21. Female who is willing or intends to become pregnant during the study
22. Any history of anaphylaxis in reaction to vaccination
23. Inability to give informed consent
24. PI assessment of lack of willingness to participate and comply with all requirements of the protocol
25. 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events (AEs) at follow up visits up to a year post-vaccination.

Secondary Outcome Measures

Name	Time	Method
The specific endpoints for immunogenicity will be markers of cell-mediated immunity (e.g. gamma interferon [IFN-g], tumour necrotising facto alpha [TNF-a], etc) at follow up visits up to a year post-vaccination.