30 Khartoum Medical Journal (2008) Vol. 1, No. 1, pp.

30-33

Coverage and efficacy of BCG vaccination in

displaced populations: a measure of effectiveness of
an Expanded Programme of Immunization
Wigdan MA Ismaiela, Eltahir AG Khalil1b1, Ib C Bygbjergb, Faiza M Osmana,
Ahmed M Musaa & Ahmed M El-Hassan.a
a
Institute of Endemic Diseases, University of Khartoum, Sudan.
b
Department of International Health, Faculty of Health Sciences, Copenhagen University, Denmark

.) BCG( .
.)Mantoux 828
. %33 %83
.
Abstract: Growing numbers of refugees and internally displaced populations (IDPs) and their health problems are creating a
need to continuously assess and modify preventive interventions, including immunization programmes, to suit evolving needs.
Infants and young children are the most commonly affected by nutritional and infectious diseases leading to about 15 million
annual deaths. Mycobacterial infections, particularly tuberculosis, are important causes of morbidity and mortality among
refugees and internally displaced people. BCG vaccination protects against disseminated childhood tuberculosis and may
reduce child mortality in Africa. Assessment of BCG efficacy is difficult and gives widely variable results. This study aimed at
assessing BCG coverage and efficacy among internally displaced children in Sudan, so as to modify BCG vaccination schedules
to suit this population, if needed. Following parent/guardian informed consent, eight hundred and twenty eight healthy
children 5 years were enrolled in the study. BCG coverage was assessed using vaccination card checking and scar rate, while
BCG efficacy was assessed by injecting 5 TU PPD intradermally and reactivity was measured after 48-72 hours. Card checking
put BCG coverage at 83%, while BCG scar rate was 92%. Thirty-three per percent had Mantoux reading of 5 mm with a mean
Mantoux induration of 4.2 mm (5.32SD). Skin non-reactivity was higher in the older age groups. Non-reactive Mantoux was
higher among Nuba tribes of Kordofan as compared to other ethnic groups. There was no correlation between this high non-
reactivity rate and the nutritional status. Increased skin non-reactivity in infants could be explained by immaturity of the
immune system; but no explanation could be found for this phenomenon in other age groups. The high skin non-reactivity
may indicate a need for re-vaccination as practiced elsewhere. In conclusion, the current BCG vaccine schedule in Sudan
has adequate coverage, but may need to be modified to include revaccination so as to obtain better protection and reduce
infant mortality especially in IDPs. The probable explanation for high negative Mantoux reactivity may be due to differences
in ethnicity. There is also a need to introduce alternative techniques to assess BCG efficacy under field conditions.

Keywords: Internally Displaced Population (IDPs), BCG vaccination, Mantoux Test

Introduction Tuberculosis (Tb) is an important public health problem

Sudan has a long history of civil unrest resulting in massive
population displacement and settlements which lead
to destruction of primary health care services including
preventive programmes (1). Children are the most vulnerable
groups in developing countries especially among internally
displaced people (IDP) (2). Approximately 15 million children
die each year mostly from common communicable diseases
and malnutrition and 150 million children suffer from ill
health and poor growth (3).
*Corresponding author: Institute of Endemic Diseases,
University of Khartoum, Khartoum, Sudan. P.O. Box 45235.
Email eltahirk@iend.org, eltahir@postmanster.co.uk
among internally displaced people where overcrowding,
malnutrition and poor hygiene pose as risk factors for
transmission and outbreaks (4). Globally, Tb is currently
responsible for an estimated 8 million new cases and 3 million
deaths each year (5). Neonatal BCG vaccination has been
shown to offer protection in children against some forms
of tuberculosis, leprosy (6,7) and possibly reduce even non-
tuberculosis mortality (8). The efficacy of BCG vaccination
varies from 0 - 80% (6,9,10,11,12,13,14,15)
Community-based evaluation of vaccines efficacy against
communicable diseases is important to evaluate vaccination
programmes as well as the vaccines potency in the post-
application periods. Most vaccines evaluation, in phase
I/II or for efficacy (phase III) need blood sampling and
Coverage and efficacy of BCG vaccination in displaced populations
complicated immunological techniques or expensive and
time consuming field studies. However, BCG vaccination
coverage and efficacy is relatively easy to measure by scar
rate and Mantoux test, respectively.
Mantoux test measures delayed hypersensitivity reaction
(DTHR). Vaccination card checking, BCG scar rate and
percentage of Mantoux conversion can indicate the
degree of coverage, vaccine efficacy as well as exposure
to mycobacterium in the community. A positive test may
indicate (i) previous BCG vaccination, (ii) previous or present
Mycobacteria tuberculosis exposure/ infection, or (iii) cross-
reactivity to other mycobacteria in an exposed individual.
The value of monitoring of BCG vaccine effectiveness by
Mantoux testing alone has been disputed (16). Still, BCG vaccine
scarring is often used as a surrogate marker of vaccination or
of effective vaccination (17). Recently, the BCG scar has been
extended to evaluate protection against tuberculosis in HIV
sero-positive versus sero-negative individuals (18).
In this study, the BCG scar rate and the rate of Mantoux
positivity were evaluated as surrogate markers of coverage
and vaccine efficacy. These measures were acceptable,
affordable and available for the group of children at high
risk of tuberculosis in an IDP camp, Omdurman, Sudan.
Patients and methods
Following informed consent, a clinical sheet was designed to
collect the following information: child age and sex, tribe,
clinical examination of the child, past and family history of
TB, in addition Mantoux test result and presence or absence
of BCG scar was recorded. Checking and recording of the
findings in the vaccination card was also undertaken (date/
yr o study).
The study population was mainly of Nuba (Kordofanian)
and Dinka (Nilotic) tribes. The study area (Elsalam camp,
Omdurman) was geographically divided into 16 quarters.
Four quarters were randomly selected and all healthy
children in the age group 9-60 months were enrolled in
the study. Mantoux test was performed by injecting 0.1 ml
containing five TU PPD (Statens Serum Institut, Denmark)
intradermally in the volar aspect of the left forearm (9).
The induration was measured after 48-72 hours using the
ballpoint pen technique (19). The test was considered positive
if the induration was 5 mm in diameter (20). One hundred
and forty four of these children were nutritionally assessed
by measuring weight, height and haemoglobin level as a
measure of micronutrients. Haemoglobin was measured
using cyanmethemoglobin method.
Epi Info version 6.00 was used for data entry, frequencies
calculation and cross tabulation. Linear regression was used
for correlations.
Results
Eight hundred and twenty eight healthy children were
enrolled in this study. Eleven per cent of the children
(97/828) was lost to follow up. Seven hundred and thirty
one children were grouped according to age, BCG scar rate
and Mantoux test induration (Table 1). Male: female ratio
was 1.1:1.0 Ninety two percent of the study group had BCG
scars, while 33% had a Mantoux reading 5 mm with a mean
31
Mantoux induration of 4.2 mm (5.32). The skin non-reactivity
was higher in the older age groups with an overall rate of
48%, with no statistically significant difference between
induration values in different age groups. The Mantoux non-
reactivity was higher among Nuba tribe compared to the
Dinka (p<0.05) (Table 2).
Table 3 shows that when stunting and wasting were assessed,
84/123 (68%) and 92/114 (81%) were adequately nourished,
respectively.
The Pearson correlation coefficient for stunting (height vs
age; Z-score) and Mantoux size was r=-0.029 (r^2=0.00)
and between underweight (weight vs height; z-score) and
Mantoux size is r=-0047 (r^2=0.00). There was no correlation
between Mantoux induration size and haemoglobin level {r=
-0.135 (r^2=0.00)}.
Forty-three per cent had low haemoglobin levels with
no correlation between Mantoux induration size and
haemoglobin level {r=-0.135 (r^2=0.00)}.
Discussion
The majority of the target group were BCG scar positive,
which was close to the results obtained by vaccination card
checking. This most probably indicates adequate coverage,
viable vaccination and efficient cold chain. The high negative
Mantoux reactivity makes vaccine efficacy questionable;
but it could probably be explained by ethnic difference,
highlighting the need for more research for efficacy of BCG
vaccination in multi-ethnic countries like Sudan. Black et
al, (21) in Malawi reported no protection offered by BCG
against Tb. Sinha & Bang (22) in West Bengal, proved that the
tuberculin-test response was grossly impaired in severely
protein deficient children. The nutritional status of our
target group was good and no correlation between Mantoux
non-reactivity and their nutritional status was found.
Mantoux test is affected by many factors, such as BCG
vaccine type used, dosage of vaccine, application method,
the dosage and quality of Mantoux reagent, the age of the
child, the immunity and nutritional status, experience of
the person performing the BCG vaccination and the Mantoux
test (23) .
Increased skin non-reactivity in infants tested could be
explained by the immaturity of the immune system (24). This
is in disagreement with the finding of Marchant et al (25) who
found that BCG vaccination induced Th1-type of response in
newborns. This in vivo effect should be reflected by positive
Mantoux skin test. However, no explanation could be found
for low Mantoux reactivity in the other age groups. Some
studies showed that the effect of BCG vaccination that is
probably measured by Mantoux skin test induration disappears
3-5 years after vaccination (26). Another study showed that
the effectiveness of BCG against tuberculous meningitis was
of limited duration (27). The disappearance of the Mantoux
induration with age could be due to non-skin reactivity either
(DTHR) or absence of cytokines immune response developed
in response to the vaccine. Our results also agree with the
recommendations made by Fourie (28) in South Africa, who
showed the importance of repeated vaccination strategy at
3 months after birth, at school entry and on school leaving.
Revaccination is recommended especially in countries where
leprosy is a public health problem, as it is in Sudan. A single
32 Wigdan MA Ismaiel et al.

dose of BCG conferred 50% protection against leprosy and

repeated doses will raise the protection to 100% (29).
In conclusion, the current BCG vaccine schedule for IDP
population in Sudan has adequate coverage; but may need
to be modified to include revaccination to obtain better
protection and reduce infant mortality. The only explanation
for high negative Mantoux reactivity may be ethnic
difference. Mantoux test is not ideal for testing BCG vaccine
efficacy. There is a need to introduce alternative techniques
to assess BCG efficacy under field condition.

Table 1. Mean Mantoux size and BCG scar rate in different age groups of children in Elsalam camp
Age Group/months 0 - 4* 5 - 10 >10 Mean Mantoux size** BCG scar rate%
9-12 (n=72) 33 (46%) 31 (43%) 8 (11%) 5.3 85.5%
13-24 (n=175) 113 (64%) 48 (27%) 10 (6%) 3.8 93.0%
25-36 (n=187) 119 (64%) 45 (24%) 17 (9%) 4.2 91.7%
37-48 (n=148) 90 (60%) 35 (24%) 17 (12%) 4.5 94.9%
49-60 (n=149) 100 (67%) 31 (21%) 11 (7%) 3.9 93.3%
Total (n=731) 455 (62%) 190 (26%) 86 (12%)
p value*= 0.09 p value** = 0.07

Table 2. Mantoux non-reactivity among different tribes in Elsalam camp

Mantoux size Nuba Dinka Others Total
0-4 60(78%) 12(16%) 5(6%) 77(100%)
5-10 25(53%) 13(28%) 9(19%) 47(100%)
>10 7(54%) 4(31%) 2(15%) 13(100%)

Table 3. Nutritional status of children assessed for Mantoux reactivity in Elsalam camp
Z-score* Severe Moderate Adequate Total
Stunting (height for age) 19(15%) 20(16%) 123(100%) 84(68%)
Underweight (weight for height) 4(3%) 18(16) 114(100%) 92(81%)
* Z-score classification: Severe-3.0; Moderate-2 and >-2.9; Adequate=>-1.9

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