Bacillus Calmette-Guerin (BCG, TheraCys, TICE, Pacis)
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Indications
- intravesical use for carcinoma in situ of the bladder (bladder cancer)[6]
- chemoprophylaxis for tuberculosis[6]
- BCG vaccine is no longer recommended for adults at high risk for tuberculosis in the USA
- given to children in countries where tuberculosis is endemic to prevent disseminated tuberculosis & tuberculous meningitis[5]
- may be considered for infants & children who are skin test- negative & who cannot be given isoniazid prophylaxis who have been exposed or are at high risk for exposure to tuberculosis
- diabetes mellitus type 1 ?[8]
- two doses of BCG vaccine may improve glycemic control
- lowers risk of lung cancer in American Indian & native Alaskans
Contraindications
- tuberculin-positive individual
- hypersensitivity to BCG or any component
- immunocompromised patients (live vaccine)[7]
- burn patients
- fever
- urinary tract infection
- not effective for prevention of Covid-19[11] Warning:
- instillation of BCG into a bleeding mucosa may promote systemic infection
Dosage
Powder for injection (lyophilized):
- Connaught strain (TheraCys): 3.4 x 10E8 CFU (27 mg)
- Tice strain (TICE): 1-8 x 10E8 CFU (50 mg, 2 mL)
Pharmacokinetics
- in men, benefits of BCG vaccination lost after 35-40 years
- no loss in benefit of BCG vaccination in women
Adverse effects
- most common (1-10%)
- bladder infection, flu-like syndrome, prostatitis, dysuria, urinary frequency, mycotic aneurysm
- uncommon (< 1%)
- skin ulceration, abscess, hematuria, anaphylactic shock (infants), lymphadenitis
Drug interactions
- immunosupressive agents
- bone marrow suppressants
- anti-tuberculosis drugs
Test interactions
causes positive PPD tuberculin skin test
Mechanism of action
- live vaccine using an attenuated strain of Mycobacterium bovis[5]
- inherently resistant to pyrazinamide[10]
- BCG vaccination 52% effective against pulmonary tuberculosis[2]
- protect children against[4]
- latent tuberculosis infection
- severe tuberculosis
Notes
- tuberculin-induced IFN-gamma release is the preferred method of tuberculosis screening for patients who have received BCG either as vaccine or as chemotherapy[5]
More general terms
Additional terms
References
- ↑ Kaiser Permanente Northern California Regional Drug Formulary, 1998
- ↑ 2.0 2.1 Journal Watch 24(12):99, 2004 a) Aronson NE, Santosham M, Comstock GW, Howard RS, Moulton LH, Rhoades ER, Harrison LH. Long-term efficacy of BCG vaccine in American Indians and Alaska Natives: A 60-year follow-up study. JAMA. 2004 May 5;291(17):2086-91. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15126436 b) Dye C. A booster for tuberculosis vaccines. JAMA. 2004 May 5;291(17):2127-8. No abstract available. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15126443
- ↑ Department of Veterans Affairs, VA National Formulary
- ↑ 4.0 4.1 Soyasal A et al, Effect of BCG vaccination on risk of Mycobacteriam tuberculosis infection in children with a household tuberculosis contact. A prospective community-based study. Lancet 366:1443, 2005 PMID: https://www.ncbi.nlm.nih.gov/pubmed/16243089
- ↑ 5.0 5.1 5.2 5.3 Medical Knowledge Self Assessment Program (MKSAP) 16, 17. American College of Physicians, Philadelphia 2012, 2015
- ↑ 6.0 6.1 6.2 Deprecated Reference
- ↑ 7.0 7.1 Trimble R et al Vaccine-Associated Paralytic Poliomyelitis and BCG-osis in an Immigrant Child with Severe Combined Immunodeficiency Syndrome
Texas, 2013 MMWR Weekly, August 22, 2014 / 63(33);721-724 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6333a1.htm - ↑ 8.0 8.1 8.2 Phend C, TB Vaccine for T1D Study Stirs Controversy. Long-term data suggest BCG vaccine may alter immune attack. MedPage Today. June 25, 2018 https://www.medpagetoday.com/meetingcoverage/ada/73696
Kuhtreiber W, et al Repeat BCG vaccination creates lasting reductions of HbA1c in subjects with long-term type 1 diabetes - long-term clinical trial follow-up. American Diabetes Association (ADA) 2018; Abstract 109-LB - ↑ 9.0 9.1 Usher NT; Chang S, Howard RS et al Association of BCG Vaccination in Childhood With Subsequent Cancer Diagnoses. A 60-Year Follow-up of a Clinical Trial. JAMA Netw Open. 2019;2(9):e1912014 Sept 25, 2019 PMID: https://www.ncbi.nlm.nih.gov/pubmed/31553471 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2751896
- ↑ 10.0 10.1 Rothaus C A Man with Delirium and Renal Insufficiency. NEJM Resident 360. Feb 17, 2021 https://resident360.nejm.org/clinical-pearls/a-man-with-delirium-and-renal-insufficiency
- ↑ 11.0 11.1 Harris E BCG Vaccine Not Effective Against COVID-19. JAMA. Published online May 3, 2023. PMID: https://www.ncbi.nlm.nih.gov/pubmed/37133901 https://jamanetwork.com/journals/jama/fullarticle/2804705