Journal of Epidemiology and Public Health (2020), 05(02): 245-257 Research

Masters Program in Public Health, Universitas Sebelas Maret

The Effects of Bacille Calmette-Guerin Immunization

and Contact History on the Risk of Leprosy:
Meta Analysis of Case Control Study

Priscilla Jessica Pihahey1,2), Bhisma Murti2), Yulia Lanti Retno Dewi3)

1)Health Polytechnics Ministry of Health Sorong, West Papua
2)Masters Program in Public Health, Universitas Sebelas Maret
3)Faculty of Medicine, Universitas Sebelas Maret

ABSTRACT

Background: Leprosy or Hansen's is an are analyzed using the Revman 5.4

infectious disease caused by Mycobacterium application.
leprosy. The incubation period is 3 to 20 Results: Fifteen articles were reviewed in
years and affects the skin, peripheral nerves, this study with a total of 2,435 case subjects
mucosa of the upper respiratory tract, and and 4,212 controls. The results of the meta-
eyes. Based on research in leprosy endemic analysis showed that getting BCG immu-
areas, BCG immunization provides protection nization reduced the risk of leprosy by 0.77
against the risk of developing disease. Contact times compared to not getting BCG immu-
with untreated sufferers can lead to leprosy. nization (aOR= 0.77; 95% CI= 0.40 to 1.49;
This study aims to see how much influence p= 0.43), having a history of contact with
BCG immunization and contact history have lepers increased the risk of leprosy by 3.55
on the risk of leprosy by meta-analysis. times compared to do not have a history of
Subjects and Method: This was a contact with leprosy patients (aOR = 3.55
systematic review and meta-analysis. The 95% CI = 1.86 to 6.76; p<0.001).
study was carried out by collecting articles Conclusion: The risk of leprosy decreases
from PubMed, ProQuest, Science Direct, by getting BCG immunization, having a
Scopus, Spinger Link, EBSCO, Google history of contact with lepers increases the
Scholar, Embase, LILACS, Embase, Emerald, risk of leprosy.
PLOS, and Perpusnas databases. The key
words are "leprosy OR" hansen desease Keywords: leprosy, BCG immunization,
"AND" risk factor "AND" immunization BCG contact history, meta-analysis
"OR" vaccine BCG "AND" household contacts
"AND" odds ratio". The inclusion criterion Correspondence:
was a full text study. Article searches from Priscilla Jessica Pihahey. Masters Program in
1949 to 2020 used English and Indonesian. Public Health, Universitas Sebelas Maret,
The study design was case control and the Jl.Ir. Sutami 36A, Surakarta 57126, Central
results are reported in Adjusted Odd Ratio Java. Email: [email protected].
(aOR). Articles that meet the requirements Mobile: 08114852336

Cite this as:

Pihahey PJ, Murti B, Dewi YLR (2020). The Effects of Bacille Calmette-Guerin Immunization and Contact
History on the Risk of Leprosy: Meta Analysis of Case Control Study. J Epidemiol Public Health. 05(02):245-
257. https://doi.org/10.26911/jepublichealth.2020.05.02.12.
Journal of Epidemiology and Public Healthis licensed under a Creative Commons
Attribution-NonCommercial-ShareAlike 4.0 International License.

BACKGROUND will first attack the peripheral nervous

Leprosy is a chronic granulo-matrix infec- system, skin, mucosa, respiratory tract,
tion caused by the obligate intracellular reticuloendothelial system, muscles, eyes,
organism Mycobacterium leprosy. Leprosy bones and testes. Leprosy is also known as

e-ISSN: 2549-0273 245

Pihahey et al./ The Effects of Bacille Calmette-Guerin Immunization

Leprosy, Morbus Hansen, Lepra, Hansenia- the time provided a protective effect with a
sis, Mal de San Lazaro, Judham, Aussatz, risk 0.42 times lower than that. didn't
Mafung, Kustha, LepraArabum (Amirud- receive the vaccine.
din, 2019). A study by Ratnawati (2016) con-
Leprosy is unique because in the cluded that people who live with leprosy
explanation of the characteristics, modes of sufferers with unsanitary home sanitation
transmission, prevention and quarantine of conditions have a risk of contracting 7.85
lepers, it has also been recorded around times than healthy home sanitation. Diffe-
1512 BC by the prophet Moses in the holy rent research results reported by Aprizal et
book of Leviticus 13: 1-45. After more than al., (2017) state that individual charac-
3000 years have passed, the spread of teristic factors, household contact, neighbor
leprosy has not been eliminated (Bible, contact, home physical environment and
2019; Sehgal., Et al 2006). occupant density are statistically proven to
WHO has been doing treatment since have no effect on the incidence of leprosy.
1981 by providing 3 types of drug therapy The purpose of this study is to draw
or Multi Drug Therapy (MDT), namely conclusions by conducting systematic
dapsone, rifampin, and clofazimine. This studies and meta-analyzes. By collecting
therapy is successful for healing but leprosy and combining all relevant and pre-existing
has not been eliminated from all over the research results regarding BCG immuniza-
world, especially in developing countries tion and contact history with leprosy
and tropical climates (WHO, 2016, 2019a). sufferers against the risk of leprosy.
Report of leprosy cases from 152
countries to WHO in 2018 from Africa SUBJECTS AND METHOD
Region 42, American Region 32, Southeast 1. Study Design
Asia Region 11, Eastern Mediterranean This research is a systematc review and
Region 18, European Region 32 and West- meta-analysis conducted by following the
ern Pacific Region 26. New cases detected PRISMA flow diagram. The article search
were 208,613 and the prevalence of leprosy databases are presented as follows: Pub-
registered was 184,194 cases . The countries Med, ProQuest, Science Direct, Scopus,
with the highest leprosy burden in 2018 Spinger Link, EBSCO, Google Scholar,
were India with 120,334 cases, Brazil with Embase, LILACS, Embase, Emerald, PLOS,
28,660 cases, Indonesia with 17,017 cases, Perpusnas. The key words are "leprosy OR"
Bangladesh 3,729 cases (WHO, 2019b). hansen desease "OR" leprosy "OR" leprosy
Turankar et al., (2016) found that ", AND" risk factor "AND" immunization
active M. leprosy from environmental soil BCG "OR" vaccine BCG "AND" household
samples specifically came from public contacts "AND" odds ratio, AND "leprosy
bathing places, washing places used by and odds ratio ".
patients, around the patient's house, ward 2. Inclusion Criteria
or hospital where patients were receiving The inclusion criteria in this research are
patients. full text articles, in English and Indonesian.
A retrospective cohort study for 16 The articles were published from 1949 to
years and a follow-up of 7 years evaluating 2020. The study design was an observatio-
the presence or absence of BCG immuni- nal with case-control study. The article
zation scars against leprosy by Gomes et al., discusses the history of BCG immunization
(2019) concluded that BCG vaccination at against leprosy risk and contact history

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Pihahey et al./ The Effects of Bacille Calmette-Guerin Immunization

against leprosy risk. The sample in the case RESULTS

study is an individual diagnosed positive for The process of searching for articles on an
leprosy, while the control is an individual electronic data base according to PRISMA
without symptoms of leprosy with negative flow diagrams can be seen in Figure 1.
results. Study articles were those that were Fifteen articles out of 9,878 were
conducted by multivariate analysis and reviewed in this study with a total of 2,435
reported results in adjusted odds ratio case subjects and 4,212 controls. Five of the
(aOR). articles were research conducted on the
3. Exclusion Criteria South American continent and eleven
The exclusion criteria in this study were research articles were conducted in the
research articles on quasi experimental Asian continent. Next, the researchers
trials, RCT, study protocol, pilot study, conducted an assessment of the quality of
animal studies. Research articles were the articles (Table 1).
those that were performed by univariate, 1. The effect of BCG immunization on
bivariate or non-adjusted odds ratio (aOR) the risk of leprosy.
analysis. Table 2 provides information on 6 articles
4. Operational Definition with a case-control study design as a meta-
Leprosy sufferers are all people who analysis source of the effect of BCG
experience symptoms of leprosy and are immunization on leprosy risk.
diagnosed by health personnel. a. Forest plot
BCG Immunization History is all Figure 2. Forest plot shows that getting
people who have received BCG vaccine BCG immunization reduces the risk of
immunization with scars or without scars leprosy by 0.77 times compared to not
who have been checked for correctness. getting BCG immunization, but this is not
Contact History is a track record of an statistically significant. The distribution of
individual in the form of a statement of data is stated to be heterogeneous (random
having had physical contact with a person effect model), I2= 91%.
with leprosy. b. Funnel Plot
5. Instruments Figure 3 funnel plot of the effect of BCG
The study was conducted by following the immunization on the risk of leprosy, there
PRISMA flow diagram and assessing the is no publication bias, it is shown by the
quality of research articles, using the Cri- symmetrical plot right and left. The number
tical Appraisal Check List For Study from of left-sided plots is 3 with a graph showing
the Center for Evidence Based Manage- a standard error between 0.4 and 0. The
ment, (2014) for a case control study. right-sided plot is 3 with the graph showing
6. Data Analysis that the SE is between 0.6 and 0.2.
The data analysis process in this study was 2. Effect of contact history on leprosy
carried out using the Review Manager Table 2 provides information on 12 articles
application (RevMan 5.3), to determine the with a case-control study design as a source
effect size and heterogeneity of the study. of meta-analysis of contact history on
The results of meta-analysis data process- leprosy risk.
ing are presented in the form of a forest a. Forest plot
plot and a funnel plot. Figure 4. The forest plot shows that a
history of contact with leprosy patients
increase the risk of leprosy by 3.55 times

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Pihahey et al./ The Effects of Bacille Calmette-Guerin Immunization

compared to no contact with leprosy <0.001).

patients and it is statistically significant (p

Articles identified through

databases search (n =9.878)

Initial identification (n= 9,878) Delete the duplication (n= 2,678)

Articles issued (n = 6,217)

- Title is not relevant (n = 6,055)
Selected articles (n=7,200) - Not an observational study (n = 106)
- Animal Studies (n = 12)
- Not in English, Indonesian (n = 24)
- Not full Text (n= 20)

Eligible full text articles

Full-text articles were issued with reasons (n = 960)
(n = 983)
- Outcome is not risk of leprosy (n = 885)
- OR resulted from bivariate analysis (n = 75)

Articles included in Full-text articles issued on the grounds that they do

qualitative synthesis (n = 23) not meet the quantitative requirements (n = 8)
- Not a case control study (n = 4)
- Not BCG immunization, contact history (4)

Articles included in
quantitative synthesis
(meta-analysis) (n=15)

Figure 1. PRISMA flow chart

The heterogeneity value of I2 is 91%, number of plots on the left is 3, the plots in
meaning that the distribution of data in this the middle are 2 and 7 plots on the right
study is heterogeneous (random effect side. The left side plot on the graph appears
model). to have a standard error between 0.5 and 0
b. Funnel Plot while the right side plot of the graph shows
Figure 5. The funnel plot shows publication a standard error between 0 and 1. The
bias, from the imbalance of the distance publication bias in this study also occurs
between the studies on the left and the right from an imbalance in the distance between
side of the funnel plot. the studies on the left and the right side of
Asymmetrical shape of the funnel plot the funnel plot.
with the plot tendency to the right side. The

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 Pihahey et al./ The Effects of Bacille Calmette-Guerin Immunization

Table 1. Assessment of Research Quality

Publication (Author, Year)
Scoring Item Muliyil Zodpey Kerr-Pontes Jariwala Efrizal et Sari Harlim Lima Awaluddin Feenstra Norlatifah Schmitt Murto Rodrigues Masrizal et
et al., et al., et al., et al., al., et al., et al., et al., (2004) et al., et al., et al., et al., et al., al., (2020)
(1991) (1998) (2006) (2013) (2016) (2019) (2019) (2015) (2013) (2010) (2010) (2013) (2019)
Relevance of goal 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
and problem
Relevance of 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
methods and
problems
Sample adequacy 1 1 1 1 1 1 0 1 1 1 0 1 1 0 0
Validity 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
sample 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
Cases and con- 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
trols were compa-
rable
Criteria 1 1 1 1 1 1 1 1 0 1 0 1 1 1 1
objective / 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
unbiased
Data search 1 1 1 1 1 1 1 1 0 1 1 1 1 1 1
information 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
Revan and valid 0 1 1 1 1 1 0 1 0 1 1 0 1 0 0
data analysis
The relevance of 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
the effect size
Total 11 12 12 12 12 12 11 12 10 12 10 11 12 10 10

Note:
Yes = 1
No = 0

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Pihahey et al./ The Effects of Bacille Calmette-Guerin Immunization

Table 2. Summary of sources of the effect of BCG immunization and contact history on leprosy risk
Sample size Intervention (I) and Effect
Author and Year Country Comparator (C) Outcome
Case Control OR (95 % CI)
Muliyil et al., (1991) India 397 669 I: BCG, No, contact Leprosy Risk 0.85 (0.59 to 1.10)
C: Not BCG, Contact
Zodpey et al., (1998) India 76 172 I: BCG Leprosy Risk 0.29 (0.21 to 0.41)
C: No BCG
Kerr-Pontes et et al., Brazil 226 875 I: BCG Leprosy Risk 0.48 (0.33 to 0.70)
(2006) C: No BCG
Jariwala et al., (2013) India 76 152 I: BCG, No Contact Leprosy Risk 0.30 (0.15 to 0.57)
C: No BCG, Contact
Efrisal et al., (2016) Indonesia 56 56 I: BCG Leprosy Risk 4.13 (1.35 to 12.64)
C: No BCG
Sari et al. (2019) Indonesia 85 85 I: BCG, No Contact Leprosy Risk 2.56 (1.24 to 5.29)
C: No BCG, Contact
Harlim et al. (2019) Indonesia 42 42 I: No Contact Leprosy Risk 9.19 (1.82 to 46.55)
C: Contact
Lima et al. (2015) Brazil 185 136 I: No Contact Leprosy Risk 3.86 ( 2.21 to 6.75)
C: Contact
Awaluddin (2004) Indonesia 80 80 I: No Contact Leprosy Risk 30.3 ( 3.90 to 233.90)
C: Contact
Feenstra et al. (2013) Bangladesh 90 199 I : No Contact Leprosy Risk 1.09 (1.00 to 1.19)
C: Contact
Norlatifah et al. Indonesia 31 62 I : No Contact Leprosy Risk 5.45 (1.89 to 15.69)
(2010) C: Contact
Schmitt et al. (2010) Brazil 121 242 I : No Contact Leprosy Risk 8.33 ( 4.05 to 17.14)
C: Contact
Murto et al. (2013) Brazil 340 340 I : No Contact Leprosy Risk 1.51 (1.0 to 2.28)
C: Contact
Rodrigues et al. Brazil 40 164 I : No Contact Leprosy Risk 8.76 (3.41 to 22.50)
(2019) C: Contact
Masrizal et al. (2020) Indonesia 32 32 I : No Contact Leprosy Risk 3.90 ( 0.9 to 16.7)
C: Contact

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Pihahey et al./ The Effects of Bacille Calmette-Guerin Immunization

Figure 2. Forest plot of the effect of BCG immunization on leprosy risk

Figure 3. Funnel plot of the effect of BCG immunization on leprosy risk

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Pihahey et al./ The Effects of Bacille Calmette-Guerin Immunization

Figure 4. Forest plot of the effect of contact history on leprosy risk

Figure 5. Funnel plot of the effect of contact history on leprosy risk

DISCUSSION history of contact with patients.

This research is a systematic study and Most of the primary studies only
meta-analysis of the risk factors for leprosy. report the results of statistical analysis in
The independent variables in this study the crude odds ratio (cOR), this shows that
were history of BCG immunization and the results of these studies have not

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Pihahey et al./ The Effects of Bacille Calmette-Guerin Immunization

controlled for confounding factors. Sales et al., (2011) concluded that

Confounding factor according to having a BCG scar showed a highly statis-
Murti (2018) is a mixture of estimated tically significant protective effect for co-
relationships between exposure and the prevalent cases (OR = 0.28; 95% CI: 0.21 to
disease under study, by other factors that 0.37) and incidence (OR = 0.45; 95% CI :
are related, both to disease and exposure. 0.30 to 0.68). Contacts who received the
According to the inclusion criteria, this BCG vaccine also showed significant pro-
study uses the results of primary studies tection against disease (OR = 0.44: 95% CI:
that have controlled for confounding 0.29 to 0.64).
factors as shown by multivariate data According to Murti (2019), when
analysis and the size of the relationship someone pays for immunization, the costs
reported is in the form of Adjusted Odds incurred are marginal personal costs. The
Ratio (aOR). benefit of immunization is immunity to
Estimates of the combined relation- disease which is a marginal benefit. The
ship of the association of each risk factor positive impact of immunization is that the
with the incidence of leprosy were pro- people around you indirectly benefit even
cessed using the RevMan 5.3 application though they do not pay.
using the generic inverse-variance method. BCG immunization does not provide a
This method is used to analyze data in the guarantee that a person can avoid leprosy
form of: rate, time-to-event, hazard ratio, infection. The results of this meta-analysis
ordinal scale, adjusted estimate, difference study provide evidence that there is an
of mean ratio of mean (Anulus, 2019). The influence between BCG immunization and
results of the systematic review and meta- the risk of leprosy, namely as a protective
analysis of this study are presented in the factor against leprosy. BCG immunization
form of a forest plot and a funnel plot. reduces the risk of leprosy. Reducing the
A forest plot is a diagram that pro- risk of leprosy can have an impact on
vides an overview of the information from reducing morbidity, disability, social stigma
each study examined in the meta-analysis, and mortality due to leprosy.
estimates of the overall results and the 2. History of Contact with Leprosy
heterogeneity between study results. A The effect of contact history with leprosy
funnel plot is a diagram in meta-analysis risk can be seen from the meta-analysis
used to demonstrate possible publication results. Forest plot shows that contact
bias. The funnel plot also shows the rela- history with leprosy patients can increase
tionship between the Effect Size of the the risk of leprosy by 3.55 times compared
study and the sample size or Standard to not having contact with leprosy patients
Error of the Effect Size of the various and it is statistically significant.
studies studied (Murti 2018). Bakker et al., (2004) concluded that
1. The effect of BCG immunization on household contacts of patients with multi-
leprosy. bacillary leprosy (MB) had an adjusted
The results of the forest plot show that hazard ratio (aHR) of 4.6 (95% CI: 1.6 to
getting BCG immunization can reduce the 12.9) and household contacts were positive
risk of leprosy, namely 0.77 times com- based on the results of the polymerase
pared to not getting BCG immunization, chain react-ion ( PCR) had an aHR of 9.36
although it is statistically significant. (95% CI: 2.5 to 34.9) compared to no
contact.

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Pihahey et al./ The Effects of Bacille Calmette-Guerin Immunization

A history of household contact with a risk of leprosy increased with worse per-
patient with leprosy increased leprosy sonal hygiene (b= -1.20; 95% CI= -1.92 to -
(aOR= 1.48; 95% CI= 1.17 to 1.88), the risk 0.49; p= 0.001). Contact with sufferers can-
increased for contacts aged ≥50 years not be avoided, but the risk of leprosy can
(aOR= 3.11; 95% CI= 2.03 to 4.76) and boys be reduced through health education about
have a higher risk than girls (aOR= 1.70; leprosy, evidence-based health care, good
95% CI= 1.20 to 2.42) (Teixeira et al., personal hygiene and getting BCG
2020). immunization.
Household contacts are the group
with the highest risk, because of their AUTHOR CONTRIBUTION
closeness to persons affected by leprosy. Priscilla Jessica Pihahey is the principal
The risk increases if the patient has a high researcher who chooses topics, collects
bacillus content. However, these risk fac- research data, formulates articles, and
tors are often uncertain, even not well processes data. Bhisma Murti formulated
recorded in the leprosy monitoring pro- the background, research data analysis.
gram. This results in the maintenance of Yulia Lanti Retno Dewi helped formulate
disease transmission chains and delays in the framework and document review.
diagnosis of leprosy reactions (Bakker et al.
2006; Goulart et al. 2008; Sales et al. CONFLICT OF INTEREST
2011b). There is no conflict of interest in this study.
According to Murti (2019), one of the
reasons that health services for infectious FUNDING AND SPONSORSHIP
diseases is important is because it has a This study uses funds from the Ministry of
positive externality of consumption. If cases Health of the Republic of Indonesia.
of infectious diseases increase and are not
treated, a large part of the population will ACKNOWLEDGEMENT
become vulnerable to contracting the Researchers thank and give appreciation to
disease. the Ministry of Health of the Republic of
The importance of primary health Indonesia, Poltekkes Kemenkes Sorong,
services in controlling leprosy. The diffi- Universitas Sebelas Maret Library. Elec-
culty of primary health workers in recog- tronic databases: PubMed, Science Direct,
nizing community needs is a consequence Scopus, Google Scholar, PLOS, EBESCO,
of the weakness of the integrated health LILACS, Embase, Emerald, ProQuest,
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