Indications for: BCG VACCINE

Prevention of tuberculosis in persons not previously infected with M. tuberculosis who are at high risk for exposure. 

Clinical Trials:

Prospective Trial

  • A prospective trial evaluated the TICE strain of BCG Vaccine in 1716 vaccinated and 1665 non-vaccinated infants who were all born at the Cook County Hospital in Chicago and followed for 12-23 years.

  • The vaccinated arm had 17 cases of tuberculosis (0.43/1000/yr) vs 65 cases in the nonvaccinated arm (1.7/1000/yr), which corresponds to a 75% reduction in cases of tuberculosis (P <.001).

  • 8 of the 790 vaccinated patients developed tuberculosis compared with 30 of the 945 patients (P <.001).

1995 Study

  • A 1995 study evaluated the vaccine potency of BCG Vaccine (TICE strain) in 26 tuberculin negative patients and subsequent tuberculin conversion was monitored.

  • 24 patients returned for follow-up testing with PPD 10 TU 8 weeks after vaccination. 22 of the 24 patients converted to positive and 2 remained negative.

  • The conversion rate was 92% and the average positive skin test reading was 15.5mm in induration.

Second Study

  • 22 volunteers who were 18 to 40 years of age received a standard dose of BCG Vaccine (TICE strain). Volunteers were not health care worker, were not foreign born, were HIV negative, and were negative responders to a 10 TU PPD skin test. Volunteers returned for a 10 TU skin test 8 weeks after vaccination.

  • The conversion rate of 95%.

Adults and Children:

Reserve for persons with a reaction of <5mm induration after skin testing with 5 tuberculin units (TU) of PPD tuberculin (preferred method is the Mantoux skin-test). Give by percutaneous route using a multiple puncture device into the deltoid. Clean the inj site area using an alcohol swab(s) and allow skin to dry thoroughly. Drop the immunizing BCG vaccine dose of 0.2–0.3mL onto the vaccination site and spread using the multiple puncture device; may add additional 1–2 drops to ensure a very wet vaccination site. Cover the site with loose gauze and keep dry for 24hrs. Document tuberculin reactivity resulting from BCG vaccination. Perform tuberculin skin test 2–3 months after vaccination; if tuberculin negative, repeat vaccination after 2–3 months. Infants <1mo: reduce vaccine dose by ½; if tuberculin negative after vaccination, give full dose after 1yr of age. TB exposed tuberculin skin test-negative infants and children: give BCG vaccine. TB exposed health care workers in high risk settings: consider BCG vaccination on an individual basis. Health care workers in low risk settings: BCG vaccine is not recommended.

BCG VACCINE Contraindications:

Immunocompromised due to HIV infections, congenital immunodeficiency (eg, chronic granulomatous disease or interferon gamma receptor deficiency, leukemia, lymphoma, or generalized malignancy). Immunosuppressed due to steroids, alkylating agents, antimetabolites, or radiation. Active TB. Severe immune deficiency syndromes. Children with family history of immune deficiency disease.

BCG VACCINE Warnings/Precautions:

Do not inject by IV, SC, IM or intradermal route. Do not administer to individuals previously infected with M. tuberculosis. Have epinephrine (1:1000) available. Vaccinate only if tuberculin negative to a recent skin test with 5 TU. Persons in groups at high risk for HIV infection or attributing a positive skin test to BCG vaccination: use caution. Acute, localized irritative toxicities; evaluate and consult expert for serious infectious complications if symptoms (eg, fever ≥103°F) or acute localized inflammation longer than 2–3 days occur. Initiate anti-TB therapy if systemic BCG infection occurs and consult expert. Pregnancy, nursing mothers: not recommended.

BCG VACCINE Classification:

BCG Live.

BCG VACCINE Interactions:

Do not prepare parenteral drugs in areas where BCG vaccine has been in use to avoid cross-contamination. BCG vaccination results in tuberculin skin test reactivity; do not vaccinate in individuals with a positive tuberculin skin test. Concomitant use with antimicrobials or immunosuppressive agents may interfere with immune response; only use under medical supervision. Separate live vaccines by at least 30 days if possible.

Adverse Reactions:

Localized irritative toxicities (eg, “flu-like” syndrome, fever, anorexia, myalgia, neuralgia), BCG osteomyelitis; disseminated BCG infection.

Generic Drug Availability:


How Supplied:

Single-dose vial—1