• Product Name: BCG Live
• Tradename: TICE BCG
• Manufacturer: Organon Teknika Corp
• Vaccine Ontology ID: VO_0000103
• CDC CVX code: 19
• Type: Live, attenuated vaccine
• Status: Licensed
• Location Licensed: USA (License #0956)
• Host Species for Licensed Use: Human
• ag85A gene engineering:
  • Type: Recombinant protein preparation
  • Detailed Gene Information: Click Here.
• Preservative: No preservative in TICE BCG.
• Preparation: TICE BCG is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis. The TICE® strain was developed at the University of Illinois from a strain originated at the Pasteur Institute. The medium in which the BCG organism is grown for preparation of the freeze-dried cake is composed of the following ingredients: glycerin, asparagine, citric acid, potassium phosphate, magnesium sulfate, and iron ammonium citrate. The final preparation prior to freeze drying also contains lactose. The freeze-dried BCG preparation is delivered in glass vials, each containing 1 to 8 x 10^8 colony forming units (CFU) of TICE® BCG which is equivalent to approximately 50 mg wet weight. Determination of in-vitro potency is achieved through colony counts derived from a serial dilution assay. A single dose consists of 1 reconstituted vial.
• Immunization Route: intravesicular infusion
• Storage: This vaccine should be kept refrigerated.
• Description: TICE® BCG induces a granulomatous reaction at the local site of administration. Intravesical TICE® BCG has been used as a therapy for, and prophylaxis against, recurrent tumors in patients with carcinoma in situ (CIS) of the urinary bladder, and to prevent recurrence of Stage TaT1 papillary tumors of the bladder at high risk of recurrence. It works against cancer as a biologic response modifier. Specifically, TICE BCG has no direct antitumor effect but is able to stimulate inflammatory immune response in the bladder wall that, in turn, destroys cancer cells within the bladder. TICE BCG vaccination may cause a false-positive reaction to the TST (Tuberculin Skin Test), which may complicate decisions about prescribing treatment.

Human Response

• Vaccination Protocol: A large scale trial evaluating the efficacy of BCG was conducted from 1956 to 1963 and involved almost 60,000 school children who received BCG at the age of 14 or 15 (FDA: TICE BCG).
• Side Effects: Side effects of vaccination include: headache, fever, hardening of skin at injection site, and swelling of the lymph nodes near the injection site. The most common side effect is large scars that remain on the skin at the injection site (FDA: TICE BCG).
• Efficacy: The efficacy of this vaccine has been shown to vary between clinical studies. For example, in this study, the efficacy was found to be 84% up to 6 years after immunization but in another study, a US Public Health Service trial, of BCG in Georgia and Alabama published in 1966 showed an efficacy of only 14% (FDA: TICE BCG).