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Identification
- Summary
Tuberculin purified protein derivative is a purified protein used in the Mantoux test for Mycobacterium tuberculosis testing.
- Brand Names
- Aplisol, Tubersol
- Generic Name
- Tuberculin purified protein derivative
- DrugBank Accession Number
- DB11601
- Background
Tuberculin Purified Protein Derivative (PPD) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The diagnostic test is commonly referred to as the Mantoux test which serves to minimize the risk of transmission of infection with Mycobacterium tuberculosis through early diagnosis and appropriate therapeutic intervention. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis. It is included in the World Health Organization's List of Essential Medicines.
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Protein Based Therapies
Other protein based therapies - Protein Chemical Formula
- Not Available
- Protein Average Weight
- Not Available
- Sequences
- Not Available
- Synonyms
- Mycobacterium tuberculosis purified protein derivative
- Purified protein derivative of tuberculin
- Tuberculin PPD
- Tuberculin, purified protein derivative
- Tuberculin,purified protein derivative
- Tuberculina PPD
- Tuberculinum
- External IDs
- DRG-0133
Pharmacology
- Indication
Indicated as a diagnostic agent in Mantoux Test used to detect infection with Mycobacterium tuberculosis.
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Diagnostic agent Tuberculosis •••••••••••• - Contraindications & Blackbox Warnings
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It is intradermally administered to facilitate detection of active tuberculosis caused by Mycobacterium tuberculosis. Tuberculin PPD is an inactivated purified protein fraction obtained from human strain of Mycobacterium tuberculosisand antigen that induces a delayed hypersensitivity response after few hours following administration. When the person has already acquired the tuberculin antigen, the immune response is stimulated to produce antigen-specific T cells that circulate in the bloodstream for up to several months and years. Clinically, a delayed hypersensitivity reaction to tuberculin is a manifestation of previous infection with M tuberculosis or a variety of non-tuberculosis bacteria. In most cases sensitization is induced by natural mycobacterial infection or by vaccination with BCG Vaccine. The antigen causes, pain, edema and infiltration of immune cells in the injection area.
- Mechanism of action
When exposed to M. tuberculosis antigen, the sensitization initiates in the regional lymph nodes where T lymphocytes proliferate in response to the antigenic stimulus to give rise to specifically sensitized lymphocytes which may exist in the circulation up to many years. Antigen is presented to T cells by being ingested by antigen presenting cells (APC), which then present it on their surface to lymphocytes in combination with various MHC molecules once they reach local lymph nodes 4. Tuberculin PPD most likely interacts with toll-like receptor 2 expressed on APCs that initiates an inflammatory response. Subsequent restimulation of these sensitized lymphocytes with the same or a similar antigen, such as the intradermal injection of tuberculin PPD, evokes a local reaction mediated by these cells. This reaction is referred to as a delayed-type hypersensitivity response that includes vasodilation, edema, and the infiltration of lymphocytes, basophils, monocytes, and neutrophils into the site of antigen injection. The sensitized antigen-specific T lymphocytes proliferate and release lymphokines, which mediate the accumulation of other cells at the site 5. In vitro studies show that Tuberculin PPD promotes the upregulation of vascular endothelial growth factor (VEGF) expression in T lymphocytes through major histocompatibility (MHC) class II interaction with CD4+ T lymphocyte interaction 3. The reactions are evident after 5-6 hours following administration.
Target Actions Organism AToll-like receptor 2 ligandHumans - Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
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Some adverse effects at the injection site include pain, discomfort, pyrexia, and erythema, rash, hemorrhage, hematoma and rarely ulcer and necrosis. Other unwanted effects include severe hypersensitivity reactions, dyspnea, generalized rash and syncope.
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.Not Available
- Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Aplisol Injection 5 [iU]/0.1mL Intradermal ENDO USA, Inc. 2008-04-25 Not applicable US 
Aplisol Injection 5 [iU]/0.1mL Intradermal A-S Medication Solutions 2008-04-25 Not applicable US Aplisol Injection 5 [iU]/0.1mL Intradermal TYA Pharmaceuticals 2014-04-25 Not applicable US Aplisol Injection 5 [iU]/0.1mL Intradermal REMEDYREPACK INC. 2013-11-26 2017-11-29 US Tuberculin Ppd (mantoux) Liquid 250 tub / 0.1 mL Intradermal Aventis Pasteur Limited 1975-12-31 2001-07-19 Canada 
Categories
- Drug Categories
- Amino Acids, Peptides, and Proteins
- Antigens
- Antigens, Bacterial
- Antihistamine Drugs
- Bacterial Proteins
- Biological Factors
- Cell-mediated Immunity
- Compounds used in a research, industrial, or household setting
- Indicators and Reagents
- Laboratory Chemicals
- Proteins
- Skin Test Antigen
- Tuberculin
- Tuberculosis
- Tuberculosis Skin Test
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- I7L8FKN87J
- CAS number
- 92129-86-7
References
- General References
- Yang H, Kruh-Garcia NA, Dobos KM: Purified protein derivatives of tuberculin--past, present, and future. FEMS Immunol Med Microbiol. 2012 Dec;66(3):273-80. doi: 10.1111/j.1574-695X.2012.01002.x. Epub 2012 Aug 1. [Article]
- Prasad TS, Verma R, Kumar S, Nirujogi RS, Sathe GJ, Madugundu AK, Sharma J, Puttamallesh VN, Ganjiwale A, Myneedu VP, Chatterjee A, Pandey A, Harsha H, Narayana J: Proteomic analysis of purified protein derivative of Mycobacterium tuberculosis. Clin Proteomics. 2013 Jul 19;10(1):8. doi: 10.1186/1559-0275-10-8. [Article]
- Matsuyama W, Kubota R, Hashiguchi T, Momi H, Kawabata M, Nakagawa M, Arimura K, Osame M: Purified protein derivative of tuberculin upregulates the expression of vascular endothelial growth factor in T lymphocytes in vitro. Immunology. 2002 May;106(1):96-101. [Article]
- 6. (2012). In Rang and Dale's Pharmacology (7th ed., pp. 82-84). Edinburgh: Elsevier/Churchill Livingstone. [ISBN:978-0-7020-3471-8]
- Tubersol (Tuberculin Purified Protein Derivative) product information [Link]
- World Health Organization Model List of Essential Medicines (19th List) [Link]
- External Links
- PubChem Substance
- 347911212
- 8948
- Wikipedia
- Tuberculin
- FDA label
- Download (138 KB)
- MSDS
- Download (59 KB)
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample dataNot Available Completed Screening Human Immunodeficiency Virus (HIV) Infections / Tuberculosis (TB) 1 somestatus stop reason just information to hide Not Available Withdrawn Basic Science Atopic Dermatitis 1 somestatus stop reason just information to hide 3 Completed Diagnostic Tuberculosis (TB) 2 somestatus stop reason just information to hide 3 Recruiting Diagnostic Latent Tuberculosis Infection (LTI) 1 somestatus stop reason just information to hide 3 Unknown Status Treatment Verruca Vulgaris 1 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection Intradermal 5 [iU]/0.1mL Injection, powder, for suspension 5 UI/0.1ML Injection, powder, lyophilized, for solution Parenteral 5 IU Injection, solution Intradermal 100 U/2mL Injection, solution Intradermal Injection, powder, lyophilized, for solution Parenteral 10 IU Liquid Intradermal 1 tub / 0.1 mL Liquid Intradermal 250 tub / 0.1 mL Injection Intradermal 0.4 mcg Injection Subcutaneous 0.4 mcg Injection, solution Intradermal 2 TU/0.1mL Solution Intradermal 50 UT Injection, solution Intradermal 5 [iU]/0.1mL Solution Intradermal 5 tub / 0.1 mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Targets
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Ligand
- General Function
- Cooperates with LY96 to mediate the innate immune response to bacterial lipoproteins and other microbial cell wall components. Cooperates with TLR1 or TLR6 to mediate the innate immune response to bacterial lipoproteins or lipopeptides (PubMed:17889651, PubMed:21078852). Acts via MYD88 and TRAF6, leading to NF-kappa-B activation, cytokine secretion and the inflammatory response. May also activate immune cells and promote apoptosis in response to the lipid moiety of lipoproteins (PubMed:10426995, PubMed:10426996). Recognizes mycoplasmal macrophage-activating lipopeptide-2kD (MALP-2), soluble tuberculosis factor (STF), phenol-soluble modulin (PSM) and B.burgdorferi outer surface protein A lipoprotein (OspA-L) cooperatively with TLR6 (PubMed:11441107). Stimulation of monocytes in vitro with M.tuberculosis PstS1 induces p38 MAPK and ERK1/2 activation primarily via this receptor, but also partially via TLR4 (PubMed:16622205). MAPK activation in response to bacterial peptidoglycan also occurs via this receptor (PubMed:16622205). Acts as a receptor for M.tuberculosis lipoproteins LprA, LprG, LpqH and PstS1, some lipoproteins are dependent on other coreceptors (TLR1, CD14 and/or CD36); the lipoproteins act as agonists to modulate antigen presenting cell functions in response to the pathogen (PubMed:19362712). M.tuberculosis HSP70 (dnaK) but not HSP65 (groEL-2) acts via this protein to stimulate NF-kappa-B expression (PubMed:15809303). Recognizes M.tuberculosis major T-antigen EsxA (ESAT-6) which inhibits downstream MYD88-dependent signaling (shown in mouse) (By similarity). Forms activation clusters composed of several receptors depending on the ligand, these clusters trigger signaling from the cell surface and subsequently are targeted to the Golgi in a lipid-raft dependent pathway. Forms the cluster TLR2:TLR6:CD14:CD36 in response to diacylated lipopeptides and TLR2:TLR1:CD14 in response to triacylated lipopeptides (PubMed:16880211). Required for normal uptake of M.tuberculosis, a process that is inhibited by M.tuberculosis LppM (By similarity)
- Specific Function
- amyloid-beta binding
- Gene Name
- TLR2
- Uniprot ID
- O60603
- Uniprot Name
- Toll-like receptor 2
- Molecular Weight
- 89836.575 Da
References
- Biyikli OO, Baysak A, Ece G, Oz AT, Ozhan MH, Berdeli A: Role of Toll-Like Receptors in Tuberculosis Infection. Jundishapur J Microbiol. 2016 Sep 14;9(10):e20224. eCollection 2016 Oct. [Article]
- Strapagiel D, Kasztalska K, Druszczynska M, Kowalewicz-Kulbat M, Vrba A, Matusiak A, Chmiela M, Rudnicka W: Monocyte response receptors in BCG driven delayed type hypersensitivity to tuberculin. Folia Histochem Cytobiol. 2008;46(3):353-9. doi: 10.2478/v10042-008-0044-1. [Article]
Drug created at May 24, 2016 22:49 / Updated at October 13, 2024 00:21