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PubMed1995

Prevention and early detection of leprosy in children.

India with its 4 million cases of leprosy, accounts for one-third of the world's population of leprosy patients. One-fourth of them are below 15 years of age. We report a 5-year follow-up study of healthy children who were close contacts of leprosy patients, in order to: 1. detect subclinical infection and observe the development of overt disease by using the Fluorescent Leprosy Antibody Absorption Technique (FLA-ABS) and the lepromin test which assess the humoral and cell-mediated immunity (CMI), respectively; 2. evaluate the efficacy of dapsone as a chemoprophylactic agent in the 'at risk' contacts. Four-hundred-and-fifty-five healthy contacts were studied. Majority of the contacts of multibacillary patients (303) were FLA-ABS positive (75 percent) and lepromin negative (55 percent) showing that although most of them had been infected, the lepromin status was negative (P < 0.01). On the other hand, the majority of the contacts of paucibacillary patients (152) were lepromin positive (57 percent) (P < 0.05). Furthermore, only 61 percent of contacts of paucibacillary patients were FLA-ABS positive as compared to 75 percent of contacts of multibacillary patients demonstrating that the former had been exposed to a lesser quantum of infection (P < 0.05). On the basis of results of FLA-ABS and lepromin tests, these 455 contacts were classified into four groups, viz. Group I comprising children who were FLA-ABS positive and lepromin positive; Group II, who were FLA-ABS positive and lepromin negative; Group III, who were FLA-ABS negative and lepromin positive; and Group IV who were FLA-ABS negative and lepromin negative.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

PubMed1994

An eight-year field trial on antileprosy vaccines among high-risk household contacts in the Calcutta metropolis.

One-hundred-seventy-nine lepromin-negative household contacts were vaccinated with heat-killed Mycobacterium leprae, BCG, or a combination of the two. Vaccination induced lepromin positivity in 131 of these contacts. Over an 8-year follow-up period, 12 lepromin-positive contacts developed leprosy, all tuberculoid; while 2 lepromin-negative vaccinated contacts developed leprosy, both lepromatous. Overall, 7.8% of the vaccinated contacts developed the disease. Seven-hundred-fourteen household contacts were not vaccinated, and served as controls. Among the 504 who were lepromin positive, leprosy developed in 35, all tuberculoid, over the 8-year follow up. Among the 210 lepromin-negative unvaccinated contacts, 61 developed leprosy: tuberculoid in 29, borderline in 4, lepromatous in 8, and indeterminate in 20. Overall, 13.5% of the 714 unvaccinated contacts and 29.0% of the 210 unvaccinated, lepromin-negative contacts developed leprosy. Vaccination could not induce lepromin positivity in all contacts. The three vaccines were equally effective in inducing lepromin positivity. Vaccination reduced the overall incidence of leprosy from 13.5% to 7.8% among household contacts but did not reduce the incidence of lepromatous leprosy (1.2% of all the vaccinated and 1.1% of all the unvaccinated contacts).

BCG Vaccine↗

PubMed1975

[The diangostic value of skin tests with tissue-extracts, especially in lepra and sarcoidosis (author's transl)].

The immunological aspects of lepra (India, Germany) and Sarcoidosis are presented under consideration of cutaneous reaction to lepromin and Kveim-extracts. Patients with lepra, erythema nodosum, sarcoidosis and different dermatoses have been tested with lepromin, Kveim-Antigen and tuberculin. The specifity of the results has been discussed. Patients with tuberculoid lepra did not react on Kveim-test, but patients with sarcoidosis can give positive reaction on lepromin. Patients with erythema nodosum without clinical signs of sarcoidosis are Kveim negativ and a positive lepromin-test is an exception. The positive Kveim-test is bound to a histological examination. The positive lepromin-test in non lepraendemic countries should be interpreted also by histological examination. Granulomatous dermatoses can show positive lepromin-tests, but the histological picture is different from the lepromin reaction in tuberculoid lepra. The positive reactions on tissue extracts are not combined with positive immunfluorescence results. Intracutaneous injection of lepra-bacilli in lepromin extract can be presented days to weeks after intracutaneous application in biopsies.

Antigens↗

PubMed1993

T-cell stimulation with purified mycobacterial antigens in patients and healthy subjects infected with Mycobacterium leprae: secreted antigen 85 is another immunodominant antigen.

Peripheral blood leucocytes from 9 paucibacillary and 12 multibacillary leprosy patients, from 18 healthy controls and from 34 healthy leprosy contacts were stimulated with three mycobacterial heat shock proteins with respective molecular weights of 70, 65 and 18 kDa and with the secreted 30-32 kDa protein, also called antigen 85. Antigen 85 was found to be the most powerful T-cell antigen (as measured by lymphoproliferation and IFN-gamma secretion), eliciting a positive response in all (100%) paucibacillary patients and in all lepromin-positive controls and contacts. The three heat shock proteins (hsp) were less active T-cell stimuli. Reactivity to the 70 kDa hsp was found in only 44% of the paucibacillary patients, in 80% of the lepromin-positive controls and in 60% of the lepromin-positive leprosy contacts. The 65 kDa hsp stimulated T cells in 89% of the paucibacillary patients and in 80% of the lepromin-positive controls and contacts. Responsiveness to the 18 kDa hsp, finally, was clearly more frequent in tuberculoid leprosy patients (78%) than in lepromin-positive controls (40%) or lepromin-positive leprosy contacts (4%). T-cell reactivity of 8 lepromin-negative controls, of 9 lepromin-negative contacts and of 12 multibacillary leprosy patients was low to all the antigens tested. Although proliferative and IFN-gamma responses were generally closely related, some subjects demonstrated a dissociation of these two immune parameters. Our data confirm previous findings on the powerful T-cell stimulatory properties of antigen 85 during M. leprae infection and suggest that this antigen is indeed a potentially protective T-cell immunogen.

Antigens, Bacterial↗

PubMed2001

Response of Mycobacterium habana vaccine in patients with lepromatous leprosy and their household contacts. A pilot clinical study.

Single dose vaccination was carried out with Mycobacterium habana vaccine, 31 lepromatous leprosy cases receiving 1.5 mg (1.5 mg = 6.27 x 10(8) bacilli) and 36 household contacts randomly receiving 1.5, 2.0, 2.5 mg vaccine intradermally. Duration of study was 18 weeks. Vaccination induced lepromin conversion in 100% of lepromatous leprosy cases and lepromin negative household contacts and augmentation of lepromin reactivity in 100% of lepromin positive household contacts, which was stable for the 15 weeks duration of follow-up. The maximum augmentation in lepromin reactivity was obtained with 1.5 mg of vaccine, which is probably the supramaximal dose. Overall, post-vaccination, those without prior BCG vaccination scars showed higher mean values of lepromin augmentation. Local vaccination site changes included induration, ulceration, itching, pain and uncomplicated regional lymphadenopathy, all of which remitted spontaneously by 15 weeks. Systemic side-effects noted were pyrexia, ENL and jaundice, and were seen with no greater frequency than that reported in other vaccine trials. Overall, systemic side-effects were easily controlled and were not accompanied by clinically detectable nerve or ocular damage. The safety profile investigations revealed an increase in the mean values of Hb%, RBC count and PCV in household contacts and of PCV in lepromatous patients, post-vaccination. Alterations in the liver function tests were also observed in patients of lepromatous leprosy. Thus, M. habana vaccine appears to be useful in stimulating specific CMI against M. leprae as evidenced by increased lepromin reactivity.

Adult↗

PubMed1996

Immunotherapy of far-advanced lepromatous leprosy patients with low-dose convit vaccine along with multidrug therapy (Calcutta trial).

This report describes a promising mode of treatment of lepromin-unresponsive, far-advanced, lepromatous (LL) leprosy patients with antileprosy vaccines as an adjunct to multidrug therapy (MDT). The Trial Groups included 50 highly bacilliferous, lepromin-negative, untreated LL patients. They were given MDT for 2 years. Of them, 30 patients were administered a mixed antileprosy vaccine containing killed Mycobacterium leprae of human origin plus M. bovis BCG. The remaining 20 patients were given M. bovis BCG. Depending on the severity of lepromin unresponsiveness, they were given one to six inoculations at 3-month intervals. Another 20 similar LL patients were taken in the Control Group. They were given only MDT for 2 years. From the start of the study, all patients belonging to the Trial and Control Groups were followed every 3 months for clinical, bacteriological and immunological outcomes. Within 2 years all 50 patients of the Trial Groups and 19 of the 20 patients of the Control Group became clinically inactive and bacteriologically negative. However, the clinical cure and the falls of the bacterial and morphological indexes were much faster in those patients receiving the mixed vaccine therapy than in those patients who were given BCG plus MDT or only MDT. The immunological improvements in the patients of the Trial and Control Groups were assessed by: a) lepromin testing at the beginning of the study and at 3-month intervals and also by b) the in vitro leukocyte migration inhibition (LMI) test at both the beginning and end of the study. As the patients were given more and more vaccinations, the incidence of lepromin conversion increased, more so in the patients receiving the mixed vaccine. Thus, 63%, 15% and 5% of the patients became lepromin positive in those patients receiving the mixed vaccine, BCG, and MDT only, respectively. Lamentably, the vaccine-induced lepromin positivity was temporary and faded away within several months. At the beginning of the study, the LMI test against specific M. leprae antigen was negative in all patients of both the Trial and Control Groups. After the end of the chemo-immunotherapy schedule, the LMI test became positive in 50% and 20% of LL patients receiving the mixed vaccine and BCG, respectively. None of the Control Group could show LMI positivity after completion of the MDT schedule. These results show that treatment of LL patients with the mixed vaccine and MDT could quickly reverse the clinical course of the disease, remove immunologic anergy in some patients, and induce a rapid decrease in the bacterial load in them.

Adult↗

PubMedDate not supplied

Comparison in leprosy patients of Fernandex and Mitsuda reactions using human and armadillo antigens. A double-blind study.

The Mitsuda and Fernandez reactions to bacilli prepared from lesions of human patients and bacilli from infected armadillos were studied in 112 leprosy patients. It was observed that there is no substantial difference when armadillo lepromin is used instead of human lepromin except that a larger induration occurs with the use of the armadillo lepromin in a majority of cases. The number of those reporting a burning sensation at the armadillo lepromin injection site was slightly higher in lepromatous patients; whereas the burning sensation was observed at the human lepromin injection site by the tuberculoid cases. With the significant information compiled in this study, it is concluded that lepromin prepared from bacilli obtained from infected armadillos is as effective as that prepared from bacilli obtained from the lesions of leprosy patients.

Adult↗

PubMed1981

Histology of the Fernandez reaction. An appraisal.

The early lepromin reaction was studied clinically and histologically in 38 leprosy patients. There was a quantitative and a qualitative difference in the character of the early inflammatory response to lepromin in the different groups of leprosy patients. In tuberculoid patients, the extent and degree of inflammation and the density of lymphocytic infiltration were maximal. In the polar lepromatous group, the inflammatory reaction was far less intense, and lymphocytes were scarce or absent. An intermediate histology was noted in the borderline and indeterminate groups of patients. In 11 patients with negative clinical reactions, the histology showed moderately dense lymphocytic infiltrations. The paucity of the clinical reaction could be due to the injection and localization of the antigen in the mid- and deep dermis. The correlation between early and late lepromin reactivity, both clinically and histologically, in the polar tuberculoid group and the polar lepromatous group was good. In the borderline and indeterminate groups, only the correlation between the early and late histological reactions to lepromin was good. The relationships between the early and late clinical reactions to lepromin showed marked variation. It is suggested that the early reaction is as good an indicator of lepromin reactivity as the late reaction in all forms of leprosy but only if it is assessed histologically.

Adolescent↗

PubMed1996

Evaluation of cell mediated immunity in healthy contacts of leprosy.

The cell mediated immunity (CMI) was studied in 50 healthy contacts of leprosy patients and 50 age & sex matched non-contact controls by lepromin test and leucocyte migration inhibition (LMI) test using phytohaemagglutinin (PHA) and lepromin and its association with other risk factors in contacts was assessed. The lepromin positivity correlated well with LMI results. There was no difference in CMI in I, II and III degree of contacts. Amongst direct contacts lepromin test was positive in 67 per cent as compared to 92 per cent in indirect contacts while in LMIT migration index (MI) was significantly increased (0.66 +/- 0.20) in direct contacts. MI was also significantly increased (0.73 +/- 0.20) contacts of less than two years duration which decreased to 0.51 +/- 0.18 in contacts of more than five years duration. Lepromin positivity also increased from 60 per cent to 100 per cent in these contacts. The specific CMI was significantly suppressed in contacts of LL patients (MI:0.74 +/- 0.21) and BL patients (MI: 0.61 +/- 0.01) as compared to healthy controls. B.C.G. vaccinated individuals showed better CMI response. The findings in the study showed specific unresponsiveness to lepromin in LMI in leprosy contacts of less than two years duration, direct contacts, contacts of lepromatous spectrum of index patients and contacts not vaccinated with B.C.G. emphasizing that CMI status is an important parameter in identifying the contact population at the greater risk of acquiring leprosy.

Chemotaxis, Leukocyte↗

PubMedDate not supplied

Immuno-epidemiological studies on subclinical infection in leprosy. I. Clinical and immunological findings in schoolchildren and adults in Okinawa.

For the purpose of understanding subclinical infection with Mycobacterium leprae among the inhabitants in an endemic area, 3,547 schoolchildren and 1,487 adults in several regions of Okinawa were surveyed by using clinical examinations and immunological tests, i.e. the fluorescent leprosy antibody absorption (FLA-ABS) test and the lepromin test using Dharmendra's antigen, during a period from 1978 to 1984. The enlargement of peripheral nerves, especially that of lateral or bilateral auricular and/or ulnar nerves, without loss of sensation was found in 8.4% of the schoolchildren and in 9% of the adults. A frequency of these signs and symptoms was significantly higher in male than in female and tended to increase with age. The percentage of positive reactions in FLA-ABS tests for schoolchildren and adults was 21.8 and 22.5, respectively, the values suggesting a minimum frequency of subclinical infection with M. leprae among these inhabitants. The percentage of positive FLA-ABS tests was significantly higher in those with neural signs and symptoms than in those without. Such a correlation was not found in the lepromin test. Ill-defined depigmentation of the skin without loss of sensation was found in a few percentage of both schoolchildren and adults. However, this sings and symptoms did not correlate with the FLA-ABS test nor with the lepromin test. A history of tuberculin test and BCG vaccination in the schoolchildren seemed to influence the lepromin-reactivity. Among 770 schoolchildren tested with both FLA-ABS and lepromin, 70 (9.1%) were the FLA-ABS positive but lepromin non-positive responders. Neural signs and symptoms were found in 31 of these children.

Adolescent↗

PubMed1991

Early detection of leprosy in children.

Healthy children contacts of leprosy patients had their humoral and cell-mediated immunological status assessed using the Fluorescent Leprosy Antibody Absorption Technique (FLA-ABS) and the Lepromin test, respectively. Subsequently, they were followed up for 2 1/2 years to study the development of overt disease. Two-hundred children were studied and classified into four groups, viz. Group I comprised of children who were FLA-ABS positive and Lepromin positive; Group II = FLA-ABS positive and Lepromin negative; Group III = FLA-ABS negative and Lepromin positive; Group IV = FLA-ABS negative and Lepromin negative. The good cell-mediated immune (CMI) response in the 107 children in Group I prevented them from developing the disease though they had been infected. Out of the 37 children in Group II, 15 developed the disease. There were no children in Group III. None of the 56 children in Group IV developed the disease, possibly because they had not been significantly infected. All these findings were statistically significant (P less than 0.01). This study highlights the protective role of cell-mediated immunity in leprosy. It also suggests the need to carry out surveillance surveys in the endemic population to identify and follow up those at risk.

Adolescent↗

PubMed1991

Flow cytometric analysis of CD2 modulation on human peripheral blood T lymphocytes by Dharmendra preparation of Mycobacterium leprae.

It has been reported previously that Mycobacterium leprae modulated CD2 on human peripheral blood T lymphocytes and that this modulation was accompanied by a marked reduction in the proliferative response of these cells to mitogens and antigens. In this study, we report that treatment of peripheral blood mononuclear cells from healthy individuals with Dharmendra preparation of M. leprae inhibited their ability to form rosettes with sheep red blood cells. Flow cytometric analysis of Dharmendra lepromin-treated cells showed that, in addition to CD2, CD4 and CD8 were modulated while the surface expression of CD3 was not affected. The specificity of CD2 modulation was confirmed by similar effects of Dharmendra lepromin on thymocytes and lymph node cells from human CD2 transgenic mice. The modulatory effect of Dharmendra lepromin was not observed at lower temperatures. Dharmendra lepromin treatment of activated T cells resulted in reduced binding of monoclonal antibodies to IL-2R and D66 epitope of CD2. The modulatory effects were not observed with Dharmendra preparation of BCG or other preparations of M. leprae. Our results indicate that certain M. leprae factor(s) specifically modulate(s) CD2, CD4, CD8 and IL-2R but not CD3 on T lymphocytes. The suppressive effect of Dharmendra lepromin on the T-cell proliferative response reported earlier may be explained by its modulatory effect on a number of T-cell surface molecules.

Animals↗

PubMed1995

Fibronectin-binding antigen 85 and the 10-kilodalton GroES-related heat shock protein are the predominant TH-1 response inducers in leprosy contacts.

Peripheral blood mononuclear cells from 27 healthy leprosy contacts were analyzed for lymphoproliferation and TH-1 cytokine secretion (interleukin-2 and gamma interferon) in response to heat shock proteins with molecular masses of 65, 18, and 10 kDa from Mycobacterium leprae and the 30-32-kDa antigen 85 (Ag 85) from Mycobacterium bovis BCG. Cells from 18 and 19 of 19 lepromin-positive contacts proliferated or produced TH-1 cytokines in response to the M. leprae 10-kDa protein and to Ag 85, respectively. Limiting-dilution analysis for two lepromin-positive contacts indicated that about one-third of M. leprae-reactive T cells displayed specificity to the M. leprae 10-kDa protein and Ag 85. The M. leprae 65- and 18-kDa proteins were less potent TH-1 response inducers: gamma interferon and interleukin-2 could be measured in 14 and 19 lepromin-positive contacts, respectively. In contrast, very low or undetectable proliferative and cytokine responses were found for 8 lepromin-negative contacts. Our data demonstrate that the fibronectin-binding Ag 85 and the 10-kDa GroES homolog are powerful mycobacterial TH-1 response inducers in the vast majority of lepromin-positive contacts and suggest that they might be valuable candidates for a future subunit vaccine.

Adolescent↗

PubMed1992

Filter paper blood spot test for detection of anti-ND-BSA antibodies in school children.

For identifying individuals at 'high risk' for developing leprosy, a simplified technique of collection of blood samples on filter paper for detection of anti -ND-BSA antibodies, was optimised. Anti-ND-BSA antibody reactivity on the filter paper was lost on storage at room temperature, but was stable at least for a period of 8 wk at lower temperature. Among the 1495 children screened, 166 (11.1%) were lepromin negative and 122 (8.2%) positive for anti-ND-BSA antibody. In the first phase, 7 of 871 children followed up for 2 yr developed leprosy, while in the second phase 2 of 624 children followed-up for 9 yr developed leprosy. The positivity and negativity of anti-ND-BSA antibodies and lepromin in these I children indicate that the positive status for anti-ND-BSA antibodies has a better predictive value than negative lepromin reactivity. Measurement of anti-ND-BSA antibodies was also of value for monitoring the efficacy of therapy and course of the disease. Extrapolation of the two tests to the total population of children evaluated showed that an individual with negative lepromin reactivity along with presence of anti-ND-BSA antibodies is at a higher risk for developing leprosy than those who have both the tests normal. Lepromin reactivity alone was not of much value for the prediction for development of the disease. However, the presence of anti-ND-BSA antibody was a better indicator for the development of the disease. The probability of developing leprosy in a child with any one of the tests abnormal was higher as compared to a child having all the tests normal.

Adolescent↗

PubMedDate not supplied

Post-vaccination sensitization with ICRC vaccine.

ICRC vaccine is one of the candidate anti-leprosy vaccines under test in a large scale comparative vaccine in trial. The objectives of the present study was to study the sensitization potential, as measured by Rees' MLSA and lepromin, and reactogenicity of this vaccine preparation in the local population. The study included 368 'healthy' individuals aged 1-70 years. Each individual received either ICRC vaccine or normal saline (control) by random allocation. They were also tested with Rees' MLSA and lepromin-A, 12 weeks after vaccination. Reactions to Rees' MLSA were measured after 48 hours and those to lepromin-A after 48 hours and three weeks. Character and size of local response, at the vaccination site, were recorded at 3rd, 8th and 15th week after vaccination. The results of the study showed that healing of vaccination lesion was uneventful, the mean size of the lesion being 10.3 mm. The mean sizes of post-vaccination reactions, to Rees' MLSA and lepromin (both early and late reactions), were significantly higher in the vaccine group compared to that in the normal saline group; the sensitizing effect attributable to the vaccine was of the order of 3.5 mm, 1.7 mm and 2.2 mm respectively. In conclusion, the study has demonstrated that ICRC vaccine was 'safe' and produced significant sensitizing effect as measured by post-vaccination sensitization to Rees' MLSA and lepromin, in the local population.

Adolescent↗

PubMed1994

IgG response to purified 65- and 70-kDa mycobacterial heat shock proteins and to antigen 85 in leprosy.

IgG antibody response to mycobacterial heat-shock proteins (hsp) (the 70-kDa antigen from Mycobacterium tuberculosis and M. bovis BCG; the 65-kDa antigen from M. leprae and M. bovis BCG) and to the fibronectin-binding antigen 85 from M. bovis BCG was analyzed in a dot-blot assay in plasma from leprosy patients and their contacts. Most plasma--whatever the status of the subjects--reacted to the hsp 70; 8 of 9 (89%) of paucibacillary patients recognized the 65 mycobacterial hsp but only 2 of 9 (22%) recognized the antigen 85. In contrast, 12 of 12 (100%) of multibacillary patients reacted with the antigen 85 and only 4 of 12 (33%) reacted to the hsp 65 from M. leprae. On the one hand, 7 of 25 (28%) of the lepromin-positive contacts and 2 of 9 (22%) of the lepromin-negative contacts recognized the antigen 85. On the other hand, 11 of 25 (44%) of the lepromin-positive contacts but only 1 of 9 (11%) of the lepromin-negative contacts reacted to the hsp65 from M. leprae. Finally, very few (10%) of the lepromin-positive controls showed a positive reaction to the M. leprae 65-kDa antigen, the BCG 65-kDa antigen, and the 85-kDa antigen of BCG. Thus, differences in binding to the hsp65 from M. leprae and to antigen 85 could be helpful in distinguishing different forms of the disease.

Antibodies, Bacterial↗

PubMedDate not supplied

The Kveim test in leprosy.

The response to lepromin and Kveim antigens was compared and studied in 15 leprosy patients who were tuberculin negative. Of the 11 lepromin positive tuberculoid patients, 4 were Kveim positive, 1 was equivocal, and the rest were negative. Of the four lepromin negative lepromatous patients, one gave a positive Kveim test while the other three were negative. It has been shown that false-positive Kveim reactions are found in a higher percentage of South Indian leprosy patients than in those of other backgrounds, such as Japanese and Malaysian Chinese patients. It is also suggested that no definite relationship exists between the reaction of leprosy patients to lepromin and Kveim antigens. We further suggest that the anergy exhibited by lepromatous patients to the antigen of M. leprae is specific, as evidenced by the positive Kveim response in one lepromatous patient.

China↗

PubMed1992

Sensitization potential and reactogenicity of BCG with and without various doses of killed Mycobacterium leprae.

A study was conducted in 997 individuals in two villages in south India to find the acceptability and sensitizing effect of the antileprosy combination vaccine of BCG plus killed Mycobacterium leprae (KML). Three preparations of the combination, BCG 0.1 mg + 6 x 10(8) KML (I), BCG 0.1 mg + 5 x 10(7) KML (II), and BCG 0.1 mg + 5 x 10(6) KML (III), along with BCG 0.1 mg (IV), and normal saline (V), were used in the study. Each individual received one of the above five preparations by random allocation. They were also tested with Rees' M. leprae soluble skin-test antigen (MLSA) and lepromin-A, both at intake and 12 weeks after vaccination. Reactions to Rees' MLSA were measured after 48 hr; those to lepromin-A after 48 hr and 3 weeks. The character and size of the local response at the vaccination site were recorded at 3, 8, 12, 15, and 27 weeks after vaccination. The mean sizes of postvaccination sensitization to both Rees' MLSA and lepromin-A in the vaccine groups were significantly larger than those in the normal saline group, clearly demonstrating the ability of the vaccines to induce sensitization as measured by responses to the two skin tests. The sensitizing effect was the highest following vaccination with vaccine I. It was not significantly different for vaccines II, III, and IV, although, generally, a dose-response effect was observed. The sensitizing effect attributable to the vaccine was more clearly seen in children than in adults. The above conclusions were the same irrespective of which results were considered, reactions to Rees' MLSA or Fernandez or Mitsuda reactions to lepromin-A. A significant finding of the study was that at intake the Mitsuda reactions provided a measure of sensitizing effect due to vaccine. The healing of vaccination lesions was uneventful. In more than 90% of vaccinated individuals, the lesions had healed by the 12th week in vaccine groups II, III, and IV, and by the 15th week in vaccine group I. The results showed that vaccination with BCG or combination vaccines was equally safe in individuals with or without previous BCG scars. Thirteen persons, aged 10 years or older, developed suppurative lymphadenitis around the 8th week (7 in vaccine group I, 3 each in vaccine groups II and III). However, healing was prompt after drainage in these individuals.

Adolescent↗