BCG Vaccine

Introduction

BCG, or bacille Calmette-Guerin, is a vaccine for tuberculosis (TB) disease. Many foreign-born persons have been BCG-vaccinated. BCG is used in many countries with a high prevalence of TB to prevent childhood tuberculous meningitis and miliary disease. However, BCG is not generally recommended for use in the United States because of the low risk of infection with Mycobacterium tuberculosis, the variable effectiveness of the vaccine against adult pulmonary TB, and the vaccine's potential interference with tuberculin skin test reactivity. The BCG vaccine should be considered only for very select persons who meet specific criteria and in consultation with a TB expert.

Recommendations

Children. BCG vaccination should only be considered for children who have a negative tuberculin skin test and who are continually exposed, and cannot be separated from, adults who

Are untreated or ineffectively treated for TB disease (if the child cannot be given long-term treatment for infection); or
Have TB caused by strains resistant to isoniazid and rifampin.

Health Care Workers. BCG vaccination of health care workers should be considered on an individual basis in settings in which

A high percentage of TB patients are infected with M. tuberculosis strains resistant to both isoniazid and rifampin;
There is ongoing transmission of such drug-resistant M. tuberculosis strains to health care workers and subsequent infection is likely; or
Comprehensive TB infection-control precautions have been implemented, but have not been successful.

Health care workers considered for BCG vaccination should be counseled regarding the risks and benefits associated with both BCG vaccination and treatment of Latent TB Infection (LTBI).

Contraindications

Immunosuppression. BCG vaccination should not be given to persons who are immunosuppressed (e.g., persons who are HIV infected) or who are likely to become immunocompromised (e.g., persons who are candidates for organ transplant).

Pregnancy. BCG vaccination should not be given during pregnancy. Even though no harmful effects of BCG vaccination on the fetus have been observed, further studies are needed to prove its safety.

Testing for TB in BCG-Vaccinated Persons

The tuberculin skin test (TST) and blood tests to detect TB infection are not contraindicated for persons who have been vaccinated with BCG.

Tuberculin Skin Test (TST). BCG vaccination may cause a false-positive reaction to the TST, which may complicate decisions about prescribing treatment. The presence or size of a TST reaction in persons who have been vaccinated with BCG does not predict whether BCG will provide any protection against TB disease. Furthermore, the size of a TST reaction in a BCG-vaccinated person is not a factor in determining whether the reaction is caused by LTBI or the prior BCG vaccination. (See below for specific guidance on skin test results.)

TB Blood Tests. Blood tests to detect TB infection, unlike the TST, are not affected by prior BCG vaccination and are less likely to give a false-positive result.

Treatment for LTBI in BCG-Vaccinated Persons

Treatment of LTBI substantially reduces the risk that TB infection will progress to disease. Careful assessment to rule out the possibility of TB disease is necessary before treatment for LTBI is started. Evaluation of TST reactions in persons vaccinated with BCG should be interpreted using the same criteria for those not BCG-vaccinated. Persons in the following high-risk groups should be given treatment for LTBI if their reaction to the TST is at least 5 mm of induration or they have a positive result using a TB blood test:

HIV-infected persons
Recent contacts to a TB case
Persons with fibrotic changes on chest radiograph consistent with old TB
Patients with organ transplants
Persons who are immunosuppressed for other reasons (e.g., taking the equivalent of >15 mg/day of prednisone for 1 month or longer, taking TNF-a antagonists)

In addition, persons in the following high-risk groups should be considered for treatment of LTBI if their reaction to the TST is at least 10 mm of induration or they have a positive result using a TB blood test:

Recent arrivals (less than 5 years) from high-prevalence countries
Injection drug users
Residents and employees of high-risk congregate settings (e.g., correctional facilities, nursing homes, homeless shelters, hospitals, and other health care facilities)
Mycobacteriology laboratory personnel
Persons with clinical conditions that place them at high-risk for developing TB disease (e.g., diabetes)
Children less than 4 years of age, or children and adolescents exposed to adults in high-risk categories

Persons with no known risk factors for TB may be considered for treatment of LTBI if their reaction to the tuberculin test is at least 15 mm of induration or they have a positive result using a TB blood test. Targeted skin testing programs should only be conducted among high-risk groups. All testing activities should be accompanied by a plan for follow-up care for persons with TB infection or disease.

Additional Information

Bacillus Calmette-Guerin (BCG) for Bladder Cancer

Examples

Generic Name	Brand Name
Bacillus Calmette-Guerin (BCG)	TheraCys BCG, TICE BCG

How It Works

Bacillus Calmette-Guerin (BCG) is used to treat bladder cancerbecause it stimulates immune responses that can destroy cancer cells within the bladder. BCG may be used to treat early-stage cancer, but it is used most commonly to prevent the return (recurrence) of noninvasive bladder cancer. It is most often used after cancer has been removed from the bladder using transurethral resection (TUR) surgery.

BCG is also used in some countries as a vaccine to provide protection against tuberculosis (TB).

When it is used to treat bladder cancer, BCG is given through a urinary catheter (intravesically) into the bladder.

Limit your fluid intake for 4 hours before the procedure, so you will be able to hold the medicine in your bladder during the treatment.
BCG is given through a urinary catheter. You will be asked not to urinate for 2 hours and to change position every 15 to 20 minutes so the medicine washes the entire bladder wall.
For 6 hours after treatment, wash your genital area after every urination to avoid skin irritation.
Treatment is usually given once a week for 6 weeks. After this, you may be treated again every month for 6 to 12 months or every 3 to 6 months over the next 2 years.

Why It Is Used

BCG is used following TUR surgery for noninvasive bladder cancer in people who are at medium or high risk for recurrence of cancer. It can also be used following TUR surgery in people who cannot have acystectomy procedure for bladder cancer. But its usefulness in these cases is limited.

How Well It Works

Studies show that treatment with BCG delays the recurrence of cancer, slows cancer growth, and possibly helps people with bladder cancerlive longer.1

Side Effects

All medicines have side effects. But many people don't feel the side effects, or they are able to deal with them. Ask your pharmacist about the side effects of each medicine you take. Side effects are also listed in the information that comes with your medicine.

Here are some important things to think about:

Usually the benefits of the medicine are more important than any minor side effects.
Side effects may go away after you take the medicine for a while.
If side effects still bother you and you wonder if you should keep taking the medicine, call your doctor. He or she may be able to lower your dose or change your medicine. Do not suddenly quit taking your medicine unless your doctor tells you to.

Call911or other emergency services right away if you have:

Trouble breathing.
Swelling of your face, lips, tongue, or throat.

Call your doctor right away if you have:

Hives.
Hepatitis or abscess.
Inflammation of the lung tissue (pneumonitis).
For men, inflammation and infection of the prostate, testicles, orepididymis.
Contraction of the bladder or obstruction of the ureters.
Allergic reaction to BCG or disseminated tuberculosis.

Common side effects of this medicine include:

Burning or pain with urination, a sense of needing to urinate often, or urinating small amounts often.
Fatigue, joint aches, skin rash, or fever of less than 101°F (38°C).
Nausea, vomiting, or loss of appetite.

See Drug Reference for a full list of side effects. (Drug Reference is not available in all systems.)

What To Think About

If you have major side effects from BCG treatment, you may need treatment with antibiotics and corticosteroids.

Taking medicine

Medicine is one of the many tools your doctor has to treat a health problem. Taking medicine as your doctor suggests will improve your health and may prevent future problems. If you don't take your medicines properly, you may be putting your health (and perhaps your life) at risk.

There are many reasons why people have trouble taking their medicine. But in most cases, there is something you can do. For suggestions on how to work around common problems, see the topicTaking Medicines as Prescribed.

Advice for women

Do not use this medicine if you are pregnant or planning to get pregnant. If you need to use this medicine, talk to your doctor about how you can prevent pregnancy.

Checkups

Follow-up care is a key part of your treatment and safety. Be sure to make and go to all appointments, and call your doctor if you are having problems. It's also a good idea to know your test results and keep a list of the medicines you take.

Complete the new medication information form (PDF) to help you understand this medication.

Citations

National Cancer Institute (2012). Bladder Cancer Treatment (PDQ)—Health Professional Version. Available online: http://www.cancer.gov/cancertopics/pdq/treatment/bladder/healthprofessional.

By	Healthwise Staff
Primary Medical Reviewer	E. Gregory Thompson, MD - Internal Medicine
Specialist Medical Reviewer	Christopher G. Wood, MD, FACS - Urology, Oncology
Current as of	April 30, 2013

WHY is this medicine prescribed?

BCG vaccine provides immunity or protection against tuberculosis (TB). The vaccine may be given to persons at high risk of developing TB. It is also used to treat bladder tumors or bladder cancer.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Your doctor or a health care provider will administer this medicine. When used to protect against TB, it is injected into the skin. Keep the vaccination area dry for 24 hours after receiving the vaccine, and keep the area clean until you cannot tell the vaccination area from the skin around it.

When used for bladder cancer, the medicine flows into your bladder through a tube or catheter. Avoid drinking fluids for 4 hours before your treatment. You should empty your bladder before treatment. During the first hour after the medication is infused, you will lie on your stomach, back, and sides for 15 minutes each. Then you will stand, but you should keep the medication in your bladder for another hour. If you cannot keep the medication in your bladder for the entire 2 hours, tell your health care provider. At the end of 2 hours you will empty your bladder in a seated manner for safety reasons. Your urine should be disinfected for 6 hours after the medication is administered. Pour a similar amount of undiluted bleach in the toilet after you urinate. Let it stand for 15 minutes before flushing.

Various dosing schedules may be used. Your doctor will schedule your treatment. Ask your doctor to explain any directions you do not understand.

When the vaccine is given to protect against TB, it usually is given only one time but may be repeated if there is not a good response in 2-3 months. Response is measured by a TB skin test.

What SPECIAL PRECAUTIONS should I follow?

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Before receiving BCG vaccine,

tell your doctor and pharmacist if you are allergic to BCG vaccine or any other drugs.
tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially antibiotics, cancer chemotherapy agents, steroids, tuberculosis medications, and vitamins.
tell your doctor if you have had a recent smallpox vaccination or if you have had a positive TB test.
tell your doctor if you have an immune disorder, cancer, fever, an infection, or an area of severe burns on your body.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking BCG vaccine, call your doctor immediately.

What SIDE EFFECTS can this medicine cause?

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BCG vaccine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

swollen lymph nodes
small red areas at the site of injection. (These usually appear 10-14 days after injection and slowly decrease in size. They should disappear after about 6 months.)
fever
blood in the urine
frequent or painful urination
upset stomach
vomiting

If you experience any of the following symptoms, call your doctor immediately:

severe skin rash
difficulty breathing or swallowing
wheezing

What should I do in case of OVERDOSE?

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In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

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Keep all appointments with your doctor and the laboratory

Who should have the BCG (TB) vaccine?

BCG vaccination is recommended for babies and adults at risk of catching tuberculosis (TB).

Babies who should have the BCG vaccine

The BCG vaccination is recommended for all babies up to one year old who:

are born in areas where the rates of TB are high
have one or more parents or grandparents who were born in countries with a high incidence of TB

Older children and adults who should have the BCG vaccine

The BCG vaccination is recommended for all older children and adults at risk of TB including:

older children with an increased risk of TB who were not vaccinated against TB when they were babies
anyone under 16 who has come from an area where TB is widespread
anyone under 16 who has been in close contact with someone who has pulmonary TB (TB infection of the lung)

Workers who should have the BCG vaccine

BCG vaccination is recommended for people under the age of 35 who are at risk of TB through their jobs including:

laboratory staff who are in contact with blood, urine and tissue samples
veterinary staff and other animal workers, such as abattoir workers, who work with animals, such as cattle or monkeys, that are susceptible to TB
prison staff who work directly with prisoners
staff of care homes for the elderly
staff of hostels for homeless people
staff who work in facilities for refugees and asylum seekers
healthcare workers with an increased risk of exposure to TB

Travellers who should have the BCG vaccine

The BCG vaccine is also recommended for people under 16 years of age who are going to live and work with local people for more than three months in an area with high rates of TB.

Parts of the world that have high rates of TB include:

Africa – particularly sub-Saharan Africa (all the African countries south of the Sahara desert) and west Africa, including Nigeria and South Africa
southeast Asia – including India, Pakistan, Indonesia and Bangladesh
Russia
China
South America
the western Pacific region (to the west of the Pacific Ocean) – including Vietnam and Cambodia

How is the BCG injection given?

BCG vaccination is given as an injection into the upper arm. If it's advised that your baby has the BCG vaccine, the jab is usually offered soon after birth or while your baby is still in hospital.

How to tell if you're already immune to TB

Before you have the BCG vaccination, you should be tested to see if you've been exposed to TB before. A test, called the tuberculin skin test, or Mantoux test, should be carried out before BCG vaccination if someone is:

six years or over
a baby or child under six with a history of residence or a prolonged stay (more than three months) in a country with an annual TB incidence of 40 per 100,000 or more
those who have had close contact with a person with known TB
those who have a family history of TB within the last five years

The Mantoux test assesses your sensitivity to a substance called tuberculin purified protein derivative (PPD) when it's injected into your skin.

If your skin is sensitive to PPD tuberculin a hard red bump will develop at the site of the injection, usually within 48 to 72 hours of having the test.

If you develop this reaction (a positive test result) it shows that your immune system recognises TB because of previous exposure and you should not be vaccinated as you already have some immunity to TB. In this case, the BCG vaccine would have no clinical benefit and may cause unpleasant side effects.

If the test is negative, you can go ahead and have the BCG vaccine.

If you have a strongly positive Mantoux result, you should be referred to a TB specialist team for further assessment.

Who should not have the BCG vaccination?

The BCG vaccine is not recommended for:

people who have already had a BCG vaccination
people with a past history of TB
people with a positive tuberculin skin test (Mantoux)
people who have had a previous anaphylactic reaction (severe allergic reaction) to any of the substances used in the vaccine
newborn babies in a household where a case of TB is suspected or confirmed
people who have a septic skin condition at the site where the injection will be given
people who have received another live vaccine less than three weeks earlier
people with a weakened immune system, either as a result of a health condition such asHIV, treatments such as chemotherapy or medicines that suppress the immune system such as steroid tablets
people who have cancer of the white blood cells, bone marrow or lymph nodes, such asleukaemia or lymphoma
people who are seriously unwell (vaccination should be delayed until they recover)
pregnant women

BCG vaccinations are not usually offered to people over the age of 16 because the vaccine doesn't work well in those over 16 and there's virtually no evidence showing that it is effective in those aged over 35.

However, some people over 16 and under 35 whose work puts them at occupational risk of TB may still be offered the vaccine.