Last updated: 10/06/2025 04:40:24
Characterisation of the T Cell Response to Tuberculin Purified Protein Derivative (PPD) in Previously Vaccinated, Healthy Participants Aged 18-55 Inclusive
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official 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)
Trial description: The purpose of this study is to investigate the timing and composition of the cellular response in skin to an immune challenge with PPD in healthy participants previously vaccinated with BCG. The study will also evaluate the robustness of the model and validation of biological methods to be used to assess the impact of future novel therapeutic interventions on immune response.
Primary purpose:
Diagnostic
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Percentage of antigen specific cluster of differentiation 4+ (CD4+) T cells from blisters in response to ex vivo PPD stimulation, harvested on Day 16
Timeframe: Day 16
Secondary outcomes:
Standard Deviation (SD) of the logged data for the percentage of antigen specific CD4+ T cells from blisters in response to ex vivo PPD stimulation, harvested on Day 16
Timeframe: Day 16
Number of participants with adverse events (AEs) and Serious AEs related to study procedures
Timeframe: Up to 9 Weeks
Percentage of antigen specific CD4+ T cells from blisters in response to ex vivo PPD stimulation, harvested on Days 4, 9 and 23
Timeframe: Days 4, 9 and 23
Percentage of antigen specific CD4+ T cells from blood in response to ex vivo PPD stimulation, collected over time and relative to Baseline
Timeframe: Baseline and up to 9 weeks
Interventions:
Enrollment:
35
Primary completion date:
2022-03-05
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
healthy volunteers
Product
Not applicable
Collaborators
Not applicable
Study date(s)
August 2021 to May 2022
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Male
Age
18 - 55 Years
Accepts healthy volunteers
Yes
- Participant must be 18 to 55 years of age inclusive.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Prior medical history of anaphylaxis.
- A medical history of severe adverse reaction to vaccines.
Inclusion and exclusion criteria
Inclusion criteria:
- Participant must be 18 to 55 years of age inclusive.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Participants with a history of BCG vaccination.
- Alanine amino transferase (ALT), alkaline phosphatase and bilirubin =<1.5 times (x) upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Coagulation screening parameters (prothrombin Time [PT], activated partial thromboplastin time [aPTT] and fibrinogen) within the normal range.
- Electrocardiogram (ECG) with no clinically significant abnormality at the discretion of the investigator/designee. QT interval corrected for heart rate according to Fridericia’s formula (QTcF) =<480 milliseconds (msec). Based on averaged QTc values of triplicate ECGs obtained over a brief recording period.
- COVID-19 screening (Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] test) negative. Two consecutive approved molecular tests (polymerase chain reaction [PCR] or antigen test) separated by >24 hours.
- Body weight >= 50 kilogram (kg) and body mass index (BMI) within the range 19.5 –32 kilogram per meter square (kg/m^2, inclusive).
- Male participants.
- Capable of giving signed informed consent.
Exclusion criteria:
- Prior medical history of anaphylaxis.
- A medical history of severe adverse reaction to vaccines.
- Individuals known to be hypersensitive (Type I) to the active substance or any of the excipients of Tuberculin PPD RT23 SSI.
- Individuals who have experienced a severe local reaction to tuberculin products.
- A medical history of asthma (excluding childhood asthma, as defined by the investigator), allergic rhinitis or atopic dermatitis defined by the need for intermittent or continuous therapy or any other significant allergies that, in the opinion of the investigator or GlaxoSmithKline medical monitor, contraindicates their participation.
- A medical history of severe adverse reaction to local anesthetic.
- A medical history indicating previous tuberculosis infection.
- Presence of keloids or history of keloids.
- Immunodeficiency or autoimmunity assessed by medical history.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
- A positive COVID-19 test result within the last 90 days.
- Participants with known COVID-19 positive contacts in the past 14 days.
- Having received PPD test or BCG or other vaccination within 30 days prior to antigen challenge with PPD (Day 1) of study.
- Antibiotics or antiviral therapy after a serious illness within 30 days of study entry.
- Use of prescription drugs or non-prescription drugs, including non-steroidal anti-inflammatory drugs (NSAIDs), within 7 days prior to the Baseline saline injections, if in the opinion of the investigator the medication will interfere with the study procedures or compromise participant safety. Participants must not currently take any of the following: topical steroid cream on the arms, oral or systemic steroids or any other immune modulators.
- Use of nicotine patches on the arm at screening that would interfere with the injection sites.
- The participant has participated in a clinical trial and has received an investigational product within the following time period prior to antigen challenge with PPD (Day 1) in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- A positive pre-study Mycobacterium Tuberculosis (MTB) result – using QuantiFERON Gold within 3 months prior to antigen challenge with PPD (Day 1).
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months prior to antigen challenge with PPD (Day 1).
- Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to antigen challenge with PPD (Day 1).
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody within 3 months prior to antigen challenge with PPD (Day 1).
- The participant is at high-risk of mycobacterium tuberculosis (MTB) infection in the opinion of the investigator.
- Presence of tattoos, naevi or other skin abnormalities on the volar forearm that may, in the opinion of the investigator, interfere with study assessments.
- Fitzpatrick skin color grades V and above on the volar forearm that may, in the opinion of the investigator, interfere with study assessments.
- Participants participating, within 7 days of screening, in recreational sun-bathing, or use of sun-bed, on the area of the skin from wrist to shoulder inclusive.
- The participant has a phobia to needles or minor surgical procedures.
- An average weekly intake of >14 units of alcohol.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56-day period.
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2022-03-05
Actual study completion date
2022-11-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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