TB Clinical Trial
Official title:
A Study of the Immunogenicity of M. Bovis BCG (SSI Strain), Delivered Intradermally in Healthy Volunteers
To assess the immunogenicity of M. bovis BCG (SSI strain), given intrademally in the standard dose used in clinical practice and to measure the development of the immune response in the first six months after administration. M. bovis BCG is a fully licensed vaccine that has been in routine clinical use for the last 50 years. It is the most widely administered vaccine in the world today and has an excellent safety record.
Volunteers for the study will be recruited through advertisements. Each volunteer will have
received an information sheet concerning the study and will have agreed to participate in
writing.
Volunteers will be given at least 48 hours between reading the information leaflet and
agreeing to participate. Female volunteers will have a pregnancy test prior to enrollment.
Volunteers will give signed consent for their GP’s to be notified about their participation
in the trial. The GP will be faxed a letter on the day of screening and asked to reply if
they know of a reason why the volunteer should not take part. The signed consent form will
also be faxed with the letter.
A week after the screening visit and after a negative Heaf test, subjects will receive a
single intradermal injection of 106 cfu M. bovis BCG in 0.1ml just inferior to the insertion
of the deltoid muscle. Blood tests will be taken at the screening visit and day of
immunisation, 1 and 2 weeks, and 1, 2, 3 and 6 months after the immunisation. 75mls will be
taken on the screening visit, and 60mls will be taken on all subsequent visits. Screening
samples will be tested for full blood count, biochemical screen and immunological assays to
determine vaccine immunogenicity. Peripheral blood mononuclear cells will be prepared for
cellular immunological assays to be performed without or following cryopreservation. Other
serological measures of immune response, i.e.
antibody titres, will be assayed on frozen plasma samples. All blood tests will be taken
within 1-3 days of the due date as described in the schedule above.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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