Woman and Man
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Extract
Background and study aims MVA85A is a new vaccine being developed against tuberculosis which is designed to act as a boosting immunisation in people who have already received BCG. In clinical trials so far it has been given intradermally, which means an injection just under the skin, like BCG. However, the majority of licensed vaccines are injected intramuscularly. In this study we wished to assess the safety of MVA85A delivered intramuscularly compared to the intradermal route. We also wished to study the immune response generated by the vaccine by these two routes. Who can participate? Healthy BCG-vaccinated adult volunteers aged 18 to 55 were recruited in Oxford, UK. What does the study involve? Volunteers were randomly allocated into either the first group which received MVA85A intramuscularly or the second group which received MVA85A intradermally. The dose was the same for both groups. Volunteers were followed-up for six months and underwent blood tests at several time-points. What are the possible benefits and risks of participating? There are some known side effects of MVA85A. In healthy adults, a standard dose of intradermal MVA85A causes a mild local reaction when injected into the skin. This is visible as redness and swelling of the skin at the injection site, which lasts a week or two before healing completely without a scar. Occasionally the site of injection is also tender for a few days. About half of volunteers also get mild flu-like symptoms (headache, tiredness, aches) following vaccination with MVA85A but these are mild. It is not known whether intramuscular MVA85A will cause the same side effects. Severe allergic reactions are rare but could potentially occur with any vaccine. Blood tests are performed throughout the trial but are not usually harmful. Having blood taken may cause slight pain and occasionally bruising at the site where the needle enters. Rarely, people feel light-headed or even faint.There are no known benefits of participating in this research. Where is the study run from? University of Oxford (UK) When is the study starting and how long is it expected to run for? January to October 2010 Who is funding the study? The Wellcome Trust (UK) Who is the main contact? Prof. Helen McShane
Inclusion criteria
- Tuberculosis