BCG VACCINE SUMMARY
BCG VACCINE for percutaneous use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis.1 The TICE® strain used in this BCG VACCINE preparation was developed at the University of Illinois from a strain originated at the Pasteur Institute.
BCG VACCINE (TICE® strain) is indicated for the prevention of tuberculosis in persons not previously infected with M. tuberculosis who are at high risk for exposure. As with any vaccine, immunization with BCG VACCINE may not protect 100% of susceptible individuals.
The Advisory Committee on Immunization Practices (ACIP) and the Advisory Committee for the Elimination of Tuberculosis has recommended that BCG vaccination be considered in the following circumstances.3
TB Exposed Tuberculin Skin Test-Negative Infants and Children
BCG vaccination is recommended for infants and children with negative tuberculin skin tests who are (a) at high risk of intimate and prolonged exposure to persistently untreated or ineffectively treated patients with infectious pulmonary tuberculosis and who cannot be removed from the source of exposure and cannot be placed on long-term primary preventive therapy, or (b) continuously exposed to persons with infectious pulmonary tuberculosis who have bacilli resistant to isoniazid and rifampin, and the child cannot be separated from the presence of the infectious patient.3
TB Exposed Health Care Workers (HCW) in High Risk Settings
BCG vaccination of HCWs should be considered on an individual basis in settings where (a) a high percentage of TB patients are infected with M. tuberculosis strains resistant to both isoniazid and rifampin, (b) transmission of such drug resistant M. tuberculosis strains to HCWs and subsequent infection are likely, and (c) comprehensive TB infection control precautions have been implemented and have not been successful. Vaccination should not be required for employment or for assignment of HCWs in specific work areas. HCWs considered for BCG vaccination should be counseled regarding the risks and benefits associated with both BCG vaccinations and TB preventive therapy.3
Exposed Health Care Workers in Low Risk Settings
BCG vaccination is not recommended for HCWs in settings in which the risk for M. tuberculosis transmission is low.3
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NEWS HIGHLIGHTS
Published Studies Related to BCG Vaccine (Bacillus Calmette-Guerin)
Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period? [2011.07.15]
BACKGROUND: Observational studies have suggested that BCG may have nonspecific beneficial effects on survival. Low-birth-weight (LBW) children are not given BCG at birth in Guinea-Bissau; we conducted a randomized trial of BCG at birth (early BCG) vs delayed BCG... CONCLUSIONS: Though early BCG did not reduce infant mortality significantly, it may have a beneficial effect in the neonatal period. This could be important for public health because BCG is often delayed in low-income countries.
Evidence of an effect of BCG revaccination on incidence of tuberculosis in school-aged children in Brazil: second report of the BCG-REVAC cluster-randomised trial. [2011.07.12]
BCG revaccination is still used in some tuberculosis endemic countries. Until now, the little evidence available suggested that BCG revaccination confers very limited additional protection, although there was no information on whether protection depends on the setting and age of revaccination, or if protection increases with time since vaccination...
Maintenance therapy with bacillus Calmette-Guerin Connaught strain clearly prolongs recurrence-free survival following transurethral resection of bladder tumour for non-muscle-invasive bladder cancer. [2011.07]
OBJECTIVE: * To confirm the recurrence-preventing efficacy and safety of 18-month bacillus Calmette-Guerin (BCG) maintenance therapy for non-muscle-invasive bladder cancer... CONCLUSION: * BCG maintenance therapy significantly prolonged the post-TURBT RFS compared with BCG induction therapy alone or epirubicin intravesical therapy. (c) 2010 THE AUTHORS. BJU INTERNATIONAL (c) 2010 BJU INTERNATIONAL.
NRAMP1 and hGPX1 gene polymorphism and response to bacillus Calmette-Guerin therapy for bladder cancer. [2011.03]
BACKGROUND: The natural resistance-associated macrophage protein 1 (NRAMP1) gene is associated with susceptibility to Mycobacterium tuberculosis in humans and to bacillus Calmette-Guerin (BCG) in mice. The detoxification enzyme, human glutathione peroxidase 1 (hGPX1), is associated with recurrence of bladder cancer (BCa). OBJECTIVE: To determine whether NRAMP1 and hGPX1 gene polymorphisms correlate with response to BCG immunotherapy for non-muscle-invasive BCa (NMIBC)... CONCLUSIONS: Polymorphisms of the NRAMP1 and hGPX1 genes may be associated with recurrence of BCa after BCG immunotherapy. Copyright (c) 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Sequential intravesical chemoimmunotherapy with mitomycin C and bacillus Calmette-Guerin and with bacillus Calmette-Guerin alone in patients with carcinoma in situ of the urinary bladder: results of an EORTC genito-urinary group randomized phase 2 trial (30993). [2011.03]
BACKGROUND: Bacillus Calmette-Guerin (BCG) is the intravesical treatment of choice for carcinoma in situ (CIS). OBJECTIVE: Our aim was to assess if sequential mitomycin C (MMC) plus BCG after transurethral resection (TUR) is worthy of further study in non-muscle-invasive bladder cancer patients with CIS... CONCLUSIONS: In the treatment of patients with CIS, sequential chemoimmunotherapy with MMC plus BCG had acceptable toxicity. CR and disease-free rates were similar to those on BCG alone and to previous publications on sequential chemoimmunotherapy. TRIAL REGISTRATION: This study was registered with the US National Cancer Institute clinical trials database (protocol ID: EORTC-30993). http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=68869&version=HealthProfessional&protocolsearchid=7920643. Copyright (c) 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Clinical Trials Related to BCG Vaccine (Bacillus Calmette-Guerin)
Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients [Recruiting]
The purpose of this study is to compare the bladder cancer treatments, Mitomycin C (MMC) and
Bacillus Calmette Guerin (BCG), to find out which is better. In this study, the patient will
get either the Mitomycin C (MMC) or the Bacillus Calmette Guerin (BCG). They will not get
both.
The patient had a Transurethral Resection (TUR) or an in office cystoscopy to make the
diagnosis of bladder cancer. A biopsy was done and removed any tumors the doctor saw. Even
after the doctor removes the tumors, the cancer can return. In this case, the doctor will
put medicine into the bladder to destroy cancer cell. This is called intravesical therapy.
The two most commonly used drugs for this purpose are MMC and BCG.
Both drugs have been studied for many years. They both show good results when compared to
other treatments. They have not been studied using the schedule that will be used in the
study. The doctor does not know if these two drugs are equally effective in treating the
cancer and preventing recurrence.
BCG has been studied more often than MMC. The studies have shown that a long schedule of BCG
is better than a short schedule of MMC. They have also shown that the side effects of BCG
are more intense than with MMC. A recent study showed that a new dose of MMC is better than
the old standard dose. Since the side effects of MMC occur less often, it is important to
learn whether the two drugs are equally effective. That could help us decide between the
treatments. In this study, the doctor will compare MMC and BCG when given for the same
amount of time. The doctor hopes the study will tell us which drug is more effective in
preventing the return of the cancer.
Bacille Calmette Gu�rin Immunisation at Birth and Childhood Morbidity in Danish Children. [Recruiting]
In high-income societies the use of health care and medication is steadily increasing.
Children have high morbidity, many visits at the general practitioner, an increasing number
of hospitalisations, and an increasing use of medication. And, when children are ill,
someone has to stay home to care for them. An un-explained global increase in the incidence
of the allergic diseases eczema, wheezing, asthma and allergies means that 25% of
high-income populations are affected. Cheap preventive measures are highly warranted. Recent
studies have shown a positive, non-specific effect of early Bacille Calmette Guérin (BCG)
immunisation on neonatal mortality in low-income countries and suggested a positive,
non-specific effect on allergic disease in high-income countries. "Non-specific" means that
the vaccine effect goes beyond prevention of the targeted disease, i. e. the BCG vaccine
benefits the health status of the immunised individual in ways unrelated to protection
against tuberculosis (TB). For instance, in a recent randomised trial in West Africa the
investigators showed that the BCG vaccine at birth was safe in low birth weight (LBW)
infants and significantly reduced neonatal mortality in these children, with a significant
long-lasting effect on infant mortality in the smallest newborns with a birth weight <1. 5
kg. There is an urgent need to explore the huge potential of the BCG's beneficial
immune-stimulatory effects among children in high-income populations.
Therefore, the investigators will carry out a large prospective randomised clinical trial in
Denmark primarily designed to test the hypothesis that infants who get the BCG vaccine at
birth experience 20% fewer hospitalisations during early childhood.
Secondary outcomes
1. To test the hypothesis that infants who get the BCG vaccine at birth are prescribed
less antibiotics during early childhood than non-BCG-immunised infants.
2. To test the hypothesis that Danish infants who get the BCG vaccine at birth develop
less eczema, asthmatic bronchitis/wheeze and food allergy at 3 and 12 months of age:
self-reported, diagnosed by a physician, or found at clinical examination; and are
prescribed less anti-eczema/asthma/allergy medication during early childhood than
non-BCG-immunised infants.
3. To test the hypothesis that infants who receive the BCG at birth respond in
paraclinical measures: Specific IgE, thymic gland size, leucocyte count and
differentiation, monocyte memory, cytokine profiles, and antibody titres following
immunisation against diphtheria, tetanus, pertussis, pneumococcus, hemophilus.
4. To test the hypothesis that infants who get the BCG vaccine at birth respond in growth
measures: weight, length and head circumference.
5. To test the hypothesis that infants who get the BCG vaccine at birth respond with
decreased morbidity: common cold, pneumonia, febrile episodes, diarrhoea and vomiting,
acute otitis media, febrile convulsions.
6. To test the hypothesis that premature infants with gestational age less than 37 weeks
who get the BCG vaccine at birth have unaffected psychomotor development measures: Ages
and Stages scores.
7. To test the hypothesis that infants who get the BCG vaccine at birth has unaffected
coverage with the subsequent vaccinations in the Child Vaccination Programme.
8. To test the above mentioned hypotheses specifically in the strata of premature and
low-birth-weight Danish infants.
Study of AERAS 422 in Healthy Adults [Recruiting]
BCG Vaccination Delivered Intradermally, Orally and by Combined Routes [Recruiting]
This study will assess the safety of a Bacillus Calmette-Guérin (BCG) vaccine against
tuberculosis (TB) and will evaluate if giving the vaccine by mouth, injection, or by both
methods produces greater results. BCG vaccine and/or placebo (substance containing no
medication) will be given by mouth and/or by injection into the skin. This study, conducted
at Saint Louis University, will enroll 60 (up to 80) healthy volunteers, 18-40 years old,
who are negative for a TB test (QuantiFERON®-Gold) and human immunodeficiency virus (HIV).
Study procedures will include a physical exam; review of TB exposure history and medical
history; collection of multiple samples of blood, urine, stool, tears, and nose fluid; and
skin and blood tests for TB. Volunteers may participate for about 24 months.
Hyperthermia and Mitomycin C, Bacillus Calmette-Guerin, or Standard Therapy as Second-Line Therapy in Treating Patients With Recurrent Bladder Cancer [Recruiting]
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above
normal body temperature. Drugs used in chemotherapy, such as mitomycin C and epirubicin
hydrochloride, work in different ways to stop the growth of tumor cells, either by killing
the cells or by stopping them from dividing. Biological therapies, such as bacillus
calmette-guerin (BCG) and interferon alfa, may stimulate the immune system in different ways
and stop tumor cells from growing. It is not yet known whether giving hyperthermia together
with mitomycin C is more effective than giving BCG or standard therapy as second-line
therapy in treating patients with recurrent bladder cancer.
PURPOSE: This randomized phase III trial is studying how well hyperthermia given together
with mitomycin C works compared with BCG or standard therapy as second-line therapy in
treating patients with recurrent bladder cancer.
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