Exploring T Cell response to Tuberculin Purified Protein Derivative
Research type
Research Study
Full title
A single group, open-label, enabling study to characterise the T cell response in the skin to an immune challenge with tuberculin purified protein derivative (PPD) in healthy participants aged 18-55 inclusive, previously vaccinated with Bacillus Calmette Guérin (BCG)
IRAS ID
299473
Contact name
Ugochukwu Stephanie Igwe
Contact email
Sponsor organisation
GSK
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
• The main objective of this study is to understand how T cells (an important component of the immune system) respond when challenged by an intradermal (into the skin) injection of Tuberculin Purified Protein Derivative (PPD) to the inner forearms of participants.
• This study will have no direct medical benefit to participants, but the results collected may help future development of medicines targeting the immune system.
• The study will include approximately 24 healthy male volunteers, who have previously received Bacillus Calmette Guérin (BCG) vaccination to protect against tuberculosis. PPD injections are used clinically to assess response to this vaccination and in this study are used to challenge the immune system. All participants will receive the same intervention, and neither study doctors nor participants are blinded.
• Each participant will be enrolled into the study for approximately 9 weeks during which they will undergo:
o A screening period of up to 28 days.
o 2 baseline visits, to collect samples pre-PPD injections.
o Up to 23 days for study related procedures and assessments – the PPD challenge will be administered on Day 1, and the following visits up to Day 23 will be used to collect samples of blood, blister fluid and biopsies of the skin.
o A follow-up visit 7-14 days following Day 23 to ensure healing of sample sites.
o The maximum number of procedures are as follows: 3 saline injections (at baseline visit 1), 6 PPD injections (on day 1), 3 biopsies and 6 blisters.
o There are no overnight visits.
• The samples collected will be used to understand the response, number and type of immune cells produced after the PPD challenge, as well as to perform some genetic analyses on ribonucleic acid (RNA) samples, to characterise gene expression associated with the PPD challenge.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
21/WM/0160
Date of REC Opinion
16 Jul 2021
REC opinion
Further Information Favourable Opinion