TBNCT00480714
A Study of the Immunogenicity of BCG, Delivered Intradermally in Healthy Volunteers
A study testing BCG (SSI Strain) in people with TB, run by University of Oxford at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- TB
- What is being tested?
- BCG (SSI Strain)
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2003to Sep 2003
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult aged 18-65 years.
- Normal medical history and physical examination.
- Normal urine dipstick, blood count, liver enzymes, and creatinine.
Who cannot join
- Exposure to TB/BCG vaccination at any point. Previous residence in a TB endemic area.
- Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, psychiatric disorder, drug or alcohol abuse.
- Oral or systemic steroid medication or the use of immunosuppressive agents.
- Positive HIV or core HBV antibody test.
- Positive Heaf test
- Positive ANA or serum anti-DNA antibody.
- Confirmed pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Oxford, CCVTM, Churchill Hospital
Oxford, Oxfordshire, OX3 7LJ
About this study
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.
Read the detailed description
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.
- Conditions
- TB
- Being tested
- BCG (SSI Strain)
- Keywords
- TB, Vaccine, BCG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG (SSI Strain)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
The induction of T-cell responses
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startMar 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TBStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Investigators
- Helen I McShane, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480714
- Sponsor's protocol ID
- TB003
- Status last verified
- May 2007
- First submitted
- 30 May 2007
- Last updated
- 31 May 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McShane H, Pathan AA, Sander CR, Keating SM, Gilbert SC, Huygen K, Fletcher HA, Hill AV. Recombinant modified vaccinia virus Ankara expressing antigen 85A boosts BCG-primed and naturally acquired antimycobacterial immunity in humans. Nat Med. 2004 Nov;10(11):1240-4. doi: 10.1038/nm1128. Epub 2004 Oct 24.
PubMed 15502839Pathan AA, Sander CR, Fletcher HA, Poulton I, Alder NC, Beveridge NE, Whelan KT, Hill AV, McShane H. Boosting BCG with recombinant modified vaccinia ankara expressing antigen 85A: different boosting intervals and implications for efficacy trials. PLoS One. 2007 Oct 24;2(10):e1052. doi: 10.1371/journal.pone.0001052.
PubMed 17957238