[Complications following intradermal tuberculosis vaccination with BCG vaccine].
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(1) Local and regional adverse effects (ulceration, abscesses and adenitis are generally mild, although they can persist for more than three months. Systemic effects are rare but potentially life-threatening (osteitis, disseminated BCG infection, anaphylaxis, etc.). (2) Some risk factors are related to the vaccine itself or to its administration (intradermal route, certain strains of vaccine, high doses, etc.). There are very few data on the adverse effects of multipuncture BCG administration. (3) The frequency of adverse effects is inversely related to age at vaccination. The vaccine can cause severe disseminated BCG infection, especially in subjects with congenital or acquired immunodeficiency (notably HIV infection and immunosuppressive therapy). (4) The risk of adverse effects can be minimised by avoiding patients with contraindications and by careful administration.
The actual incidence of tuberculosis in Switzerland is below 50 per 100,000 people and if contracted tuberculous disease can be treated readily. These were the main reasons why routine BCG vaccination in neonates was discontinued in 1987. However, the epidemiological and sociodemographic situation may change and it may be necessary to reintroduce BCG vaccination on a large scale. In view of this possibility 70 neonates who had received BCG vaccine after birth were reviewed at the time of MMR vaccination or DT booster vaccination in the second year of life. 34 (44.3%) had a positive response to tuberculin testing (Monotest). Nine had no scar, and more than half of the children with a scar had a negative Monotest. There was no correlation at all between the existence or absence of a BCG scar and a positive or negative tuberculin test. The results support the present immunization policy for tuberculosis in Switzerland, but raise questions on the timing of BCG vaccination at birth.
BACKGROUND: To explore Bacillus Calmette-Guérin vaccine (BCG) as a protective factor against tuberculosis (TB) and how human immunodeficiency virus (HIV) infection modifies the effect of BCG on TB. METHODS: Two matched case-control studies were conducted. One study compared TB cases and controls who were HIV positive. The second compared TB cases and controls who were HIV negative. The study population consisted of 88 TB cases and 88 controls among HIV-positive individuals and 314 TB cases and 310 controls among HIV-negative individuals. Cases were new TB diagnoses, confirmed by either bacteriology, pathology, radiology or clinical response to treatment; controls were selected from people without TB symptoms and who sought medical attention in the same institution where a case was enrolled. BCG was assessed by the presence of a typical scar. RESULTS: The level of protection against all clinical forms of TB was 22% among HIV positive individuals (odds ratio [OR] = 0.78, 95% CI : 0.48-1.26) and 26% among HIV negatives (OR = 0.74, 95% CI : 0.52-1.05). There was a significant difference (P = 0.002) in the level of protection against extrapulmonary TB (ETB) between HIV-negative (OR = 0.54, 95% CI : 0.32-0.93) and HIV-positive individuals (OR = 1.36, 95% CI : 0.72-2.57). CONCLUSION: BCG has a modest protective effect against all forms of TB independent of HIV status, and BCG confers protection against extrapulmonary TB among HIV-negative individuals. However, HIV infection seems to abrogate the protective effect of BCG against extrapulmonary TB. Our data support the public health importance of BCG vaccine in the prevention of extrapulmonary TB among immunocompetent individuals.
The study included 1015 children vaccinated BCG at birth in the "Gh. Marinescu" Maternity Hospital of Bucharest during the 1972-1975 period. The Romanian lyophilized BCG vaccine prepared in sodium glutamate in doses of 0.10 mg/0.1 ml was used. Of these children 543 were vaccinated in the Maternity Hospital and 472 by the vaccination teams of the Institute of Phthisiology, Bucharest. During the first two years 660 of these children were controlled at various intervals. Sensitivity to 2 U PPD was moderate during the first year, the mean diameter being of 4-5.3 mm in the children vaccinated before discharged from hospital and of 3.5-6.7 mm in diameter in the children vaccinated after discharge. At the age of 1 and 2 years the mean diameter did not exceed 3 mm. The vaccinal scar was present in more than 95% of the children in the first year, the mean diameter ranging between 3.6 and 4.8 mm. No postvaccinal complications were recorded. The authors consider that the results obtained can be taken as criteria for assessing the operational and technical effectiveness of BCG in neonates.
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BCG test reactions were studied in 1095 non-tuberculous children from 6 months to 5 years of age, who had received BCG vaccination in the newborn period, in order to find out the diagnostic value of the BCG test in previously BCG vaccinated children. Previous BCG vaccination has an effect on the BCG test reaction in the form of an accelerated BCG reaction. Although the degree of reaction decreases with time, 51.4% of children still showed a strongly accelerated BCG reaction 4 1/2-5 years after BCG vaccination. It is concluded that the BCG test cannot be used as a diagnostic test for tuberculosis in children under 5 years of age who have had previous BCG vaccination.
In 1986 the compulsory mass BCG vaccination of infants born in a selected area of the Czech Republic was abolished. The observed annual risk of tuberculous infection in children aged 0-6 years was below 0.1% and the annual risk of tuberculous disease 7/100,000. The increase of tuberculous cases among nonvaccinated children indicated a protective efficacy of BCG vaccine of 80%. A benefit analysis proved that the advantages and disadvantages of BCG vaccination were in balance. The number of nonvaccinated children developing tuberculosis was so small that mass application of BCG has been found to be redundant. The important advantage of not using the vaccination is the maintenance of the epidemiological and diagnostic value of tuberculin tests. The tests in connection with preventive chemotherapy remain an important tool, enabling control of infected individuals.
PURPOSE: BCG vaccination using the multipuncture percutaneous method has long been employed in Japan. The purpose of this study is to clarify whether the number of needle scars achieved the BCG vaccination differs with the vaccinating physician. METHODS: A total of 218 babies who were vaccinated at the age of 4 months by different physicians at the Public Health Centres of Katsushika-Ward, Tokyo, were examined at the age of 3 years, in the three-year-old health check-up programme. The BCG vaccination with the multipuncture method generates 18 needle scars at a maximum. We examined each child for how many needle scars after BCG vaccination were visible, with reference to the vaccinating physician. RESULTS: The mean number of the visible scars was 9.23 (SD 6.11), and significantly smaller (P < 0.01) than that for all 22 Wards (12.18 +/- 5.64) investigated with the same method. The mean number of needle scars of the babies in Katsushika Ward was the third smallest among the 22 Wards and significantly smaller (P < 0.05) than the national average as determined in the nationwide survey conducted in 2000. Significant differences were evident among the 7 physicians performing the vaccination, the best and second best means being 15.26 (SD3.62) and 14.59 (SD3.58) respectively, and significantly larger (P < 0.01) than the means for the 7 physicians. The worst mean was 3.43 (SD4.46), significantly smaller (P < 0.01) than the mean for the 7 physicians. CONCLUSION: The mean number of needle scars after BCG vaccination of babies significantly differed with the 7 physicians in the present study. Poor technique was presumed responsible for small numbers of scars and technical training is therefore necessary in order to improve the BCG vaccination outcome.
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BCG-vaccinated schoolchildren, 8-9 yrs of age, were simultaneously tested on separate arms with tuberculin and a sensitin. Using the 6 mm cut-off they reacted in 49% to two tuberculin units purified protein derivative (PPD RT23), in 67% to 0.1 micrograms Mycobacterium avium sensitin RS10, and in 58% to 0.1 micrograms M. scrofulaceum sensitin RS95. The corresponding figures for non-BCG-vaccinated schoolchildren of the same age tested at the same time were 3, 25 and 32%, respectively. The results indicate a stimulating influence of BCG-vaccination on tuberculin and sensitin reactivity. Since the sensitin reactions were the larger ones, these reactions were not only due to the vaccination. The BCG-vaccinated schoolchildren seem to have acquired infections by atypical mycobacteria despite vaccination.