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BCG Vaccination of Children Against Leprosy Preliminary Findings of the WHO-Controlled Trial in Burma

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BCG Vaccination of Children Against Leprosy Preliminary Findings of the WHO-Controlled Trial in Burma Bull. Org. mond. Sante 11970, 42, 235-281 Bull. Wid Hlth Org. BCG Vaccination of Children against Leprosy Preliminary Findings of the WHO-controlled Trial in Burma L. M. BECHELLI,1 GALLEGO GARBAJOSA,2 K. UEMURA,3 V. ENGLER,4 V. MARTINEZ DOMINGUEZ,5 L. PAREDES,6 T. SUNDARESAN,7 G. KOCH 8 & M. MATEJKA9 The use ofBCG vaccine in the prevention ofleprosy has been one of the most important subjects of investigation in the field of leprology in the last 25 years. The action of the vaccine was for many years investigated by determining its effect on the lepromin reaction. Field studies were later considered essential to determine whether BCG vaccination would be useful to leprosy contacts, to the child population probably exposed to infection, or to persons persistently lepromin-negative. The interest of the World Health Organization in this matter began in 1952 and, following the recommendations of certain advisory committees, it was decided to institute a field trial in Singu township in Burma. The main purpose of the investigation was to observe, in a highly endemic area, the protective effect, if any, of BCG vaccine against leprosy in the child population not exposed to Mycobacterium leprae at home but possibly exposed to the infection elsewhere. Field operations began at the end of August 1964 and the preliminary findings obtained up to the end of June 1968 relate to 3 annual re-examinations. So far, from the material studied, it appears that, under the conditions prevailing in Singu township, no significant effect of BCG vaccine can be seen within a period of 3 years. When children in both trial groups are followed-up for much longer periods, mainly children aged 0-4 years at intake, it is possible that a significant difference may emerge. However, to be operationally desir- able, a merely significant difference is not enough; the protective effect ofBCG should be substantial to warrant its large-scale use as an immunization procedure against leprosy. The use of BCG in the prevention of leprosy has The possibility of using BCG as a preventive agent been one of the most important subjects of inves- in leprosy, first suggested by Fernandez (1939), was tigation in leprology in the last 25 years. If field for many years investigated by determining the effect epidemiological trials indicate a preventive effect of of the vaccine on the lepromin reaction.'0 From the BCG vaccination against leprosy, the methodology studies carried out in healthy individuals it would of control would be substantially changed and better appear that: (1) BCG vaccination may accelerate results would be achieved in the protection of the the conversion to positive of the lepromin test in healthy population, especially children, at risk. children, especially those under 4 years of age; (2) there is a group of poor or slow responders in 1 Chief Medical Officer, Leprosy, World Health Organiza- whom lepromin reactivity could not be achieved, tion, Geneva, Switzerland. even with repeated BCG vaccination; (3) in some 2Team Leader, WHO Leprosy BCG Trial, Burma. of the investigations (mainly on children aged 7 years 3Chief Statistician, Health Statistical Methodology, World Health Organization, Geneva, Switzerland. 4Statistician, WHO Leprosy BCG Trial, Burma. 10 It is generally agreed among leprologists that " A posi- 6 Medical tive reaction to lepromin is regarded as an expression of a Officer, Leprosy, World Health Organization, certain amount of resistance to M. leprae, directly propor- Geneva, Switzerland. tionate to the degree of positivity. ' Former Team Leader, WHO Leprosy BCG Trial, A negative reaction is interpreted as follows: Burma. (a) In patients with leprosy, and contacts living with open I Statistician, Health Statistical Methodology, World cases, it is generally regarded as a sign of deficient resistance. Health Organization, Geneva, Switzerland. (b) In healthy individuals not contaminated with leprosy, it Former Scientist, WHO Leprosy BCG Trial, Burma. is not a sign of deficient resistance unless negativity persists Scientist, WHO Leprosy BCG Trial, Burma. on repeated testing" (Committee on Immunology. 1959). 2467 - 235- 236 L. M. BECHELLI AND OTHERS or more) the lepromin conversion in the BCG-vac- every means to obtain scientific information on the cinated subjects has not been significantly higher protective value of BCG vaccination against leprosy than that observed in the control group. (World Health Organization, 1969) and the subject Thus it may be asked whether BCG vaccination was again considered by the WHO Expert Commit- is useful to contacts, to children who are probably tee on Leprosy (1960, 1966). These committees exposed, or to those persons who are persistently stressed the importance of, and need for, such inves- lepromin-negative. Only field studies will provide tigations and strongly recommended that the World answers to these questions. Health Organization should carry out a field trial, Epidemiological investigations were started later in view of the controversy concerning the use of and, even without controlled trials, vaccination with BCG in control projects. BCG was recommended by the Sixth International A draft document, initially prepared in June 1962, Congress of Leprology in 1953 for the protection was revised and copies were sent to the British of contacts and as a part of leprosy-control cam- Medical Research Council (MRC) for discussions paigns. At the same time, further studies were to be held in December 1963. It was agreed that advocated to determine the value of such vaccina- even if the MRC trial in Uganda were successful, tion. At the Seventh International Congress of it would be necessary to undertake a trial in a Leprology in 1958 the Committee on Epidemiology country with different characteristics and a higher and Control (1959) stated: " Although such studies proportion of lepromatous cases. are under way in several countries and although On the basis of the above-mentioned document, some preliminary reports have been published, evi- and of data collected in Burma, the Technical Out- dence regarding the value of BCG in the prevention line for the trial was prepared (for details, see Annex) of leprosy is still insufficient to warrant its general and at the end of August 1964 the field operations use. The recommendation of the Sixth International started. Congress of Leprology is therefore modified in this document ". At the Eighth International Congress REVIEW OF THE LITERATURE CONCERNING of Leprology in 1963, the Panel on Epidemiology EPIDEMIOLOGICAL STUDIES AND FIELD and Control (1963) emphasized that " field studies CONTROLLED TRIALS are necessary to determine whether that anticipation (of the conversion to positivity of the lepromin test According to the experience of many specialists in children) is useful to individuals not yet exposed and as stated by the WHO Expert Committee on to M. leprae and whether it may prevent leprosy Leprosy (1966) " Reactivity to lepromin increases in contacts and in those who are persistently lepro- rapidly with age, from negativity at infancy to min-negative. This study is difficult because of the almost universal positivity after adolescence in relatively low incidence of leprosy and of the need endemic areas and is associated with relative resis- to follow the studied group for some years". The tance". In the light of this and of the studies con- WHO Expert Committee on Leprosy (1966) made cerning the conversion of lepromin reaction in BCG- the following recommendation concerning BCG: vaccinated subjects (summarized briefly above) we " BCG vaccination may accelerate the conversion of may make the following assumptions. the lepromin test in children. It appears, however, (1) It is doubtful whether BCG vaccination is use- that there is a group of poor or slow responders ful to the small proportion of the population whose lepromin conversion cannot be elicited by (perhaps about 5 %-10%), either children or adults, BCG or other agents. The value of BCG vaccina- unable to develop a positive lepromin reaction and tion in the control of leprosy should be determined therefore more prone to acquire leprosy and to in field trials ". develop the lepromatous type ofleprosy. The limited, The World Health Organization became interested or doubtful, value of BCG vaccination in the pre- in this matter as early as 1952. In that year, the vention of leprosy was initially suggested by Bechelli, WHO Expert Committee on Leprosy (1953) strongly Paula Souza and their associates from studies in recommended that field trials to test the value of which it appeared that BCG had not increased sig- BCG should be undertaken with suitable controls nificantly the proportion of lepromin reactors in and a statistical evaluation. In 1954, the Executive certain groups of subjects, that in spite of vaccina- Board of the World Health Organization in Resolu- tion there was always a certain proportion of non- tion EB 14.R3 emphasized the importance of using lepromin reactors and that cross-sensitivity with BCG VACCINATION OF CHILDREN AGAINST LEPROSY: WHO FIELD TRIAL IN BURMA 237 tuberculosis infection would occur irregularly and field trials) attention has been drawn to the fact within a limited range (Paula Souza, Ferraz & that the majority of published papers relate to Bechelli, 1953; Paula Souza et al., 1953, 1956; experiments with only small numbers of persons or Paula Souza & Bechelli, 1958; Bechelli et al., 1953, short periods of observation, or else the group 1956; Bechelli, Quagliato & Nassif, 1953;
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