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Bacillus Calmette-Guerin (BCG, TheraCys, TICE, Pacis)

Indications: 1) intravesical use for carcinoma in situ of the bladder (bladder cancer) [6] 2) 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] 3) 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 4) diabetes mellitus type 1 ? [8] - two doses of BCG vaccine may improve glycemic control - HgbA1c 6.2% vs 7.1% after 3 years [8] 5) lowers risk of lung cancer in American Indian & native Alaskans - RR= 0.4 [9] Contraindications: 1) tuberculin-positive individual 2) hypersensitivity to BCG or any component 3) immunocompromised patients (live vaccine) [7] 4) burn patients 5) fever 6) urinary tract infection 7) 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): 1) Connaught strain (TheraCys): 3.4 x 10E8 CFU (27 mg) 2) 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: 1) most common (1-10%) - bladder infection, flu-like syndrome, prostatitis, dysuria, urinary frequency, mycotic aneurysm 2) uncommon (< 1%) - skin ulceration, abscess, hematuria, anaphylactic shock (infants), lymphadenitis Drug interactions: 1) immunosupressive agents 2) bone marrow suppressants 3) anti-tuberculosis drugs Test interactions: causes positive PPD tuberculin skin test Mechanism of action: 1) live vaccine using an attenuated strain of Mycobacterium bovis [5] - inherently resistant to pyrazinamide [10] 2) BCG vaccination 52% effective against pulmonary tuberculosis [2] 3) protect children against [4] a) latent tuberculosis infection b) 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]

Related

Mycobacterium tuberculosis (MTB)

General

vaccine antineoplastic agent (chemotherapeutic agent)

References

  1. Kaiser Permanente Northern California Regional Drug Formulary, 1998
  2. Journal Watch 24(12):99, 2004
    1. 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: 15126436
    2. Dye C. A booster for tuberculosis vaccines. JAMA. 2004 May 5;291(17):2127-8. No abstract available. PMID: 15126443
  3. Department of Veterans Affairs, VA National Formulary
  4. 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: 16243089
  5. Medical Knowledge Self Assessment Program (MKSAP) 16, 17. American College of Physicians, Philadelphia 2012, 2015
  6. Deprecated Reference
  7. 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. 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. 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: 31553471 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2751896
  10. 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. Harris E BCG Vaccine Not Effective Against COVID-19. JAMA. Published online May 3, 2023. PMID: 37133901 https://jamanetwork.com/journals/jama/fullarticle/2804705