How useful is a history of rubella vaccination for determination of disease susceptibility? A cross-sectional study at a public funded health clinic in Malaysia.

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by  Cheong, Ai Theng

Cheongetal.BMCFamilyPractice2013,14:19
http://www.biomedcentral.com/1471-2296/14/19
RESEARCH ARTICLE Open Access
How useful is a history of rubella vaccination for
determination of disease susceptibility? A
cross-sectional study at a public funded health
clinic in Malaysia
Ai Theng Cheong1*, Seng Fah Tong2 and Ee Ming Khoo3
Abstract
Background: Identification of pregnant women susceptible to rubella is importantas vaccinationcan be given
postpartum to prevent future risksof congenital rubella syndrome. However,in Malaysia, rubella antibody screening
is not offered routinely to pregnant women in public funded health clinics due to cost constraint. Instead, a history
ofrubella vaccination is asked to be provided to establish the women’srisk for rubella infection. The usefulness of
this history, however, is not established. Thus, this paper aimed to determine theusefulness of a history of rubella
vaccination indetermining rubella susceptibility inpregnant women.
Methods: A cross-sectional study was conducted on500 pregnant women attending a public funded health clinic.
Face-to-face interviews were conducted, and demographic data and history of rubella vaccination were obtained.
Anti-rubella IgG test was performed.
Results: A majority ofthe women (66.6%)had a positive vaccination history. Of these, 92.2%womenwere immune.
A third (33.4%) of the women had a negative or unknown vaccinationhistory, but 81.4% of them were immuneto
rubella. The sensitivity and specificityof a history ofrubella vaccination inidentifying disease susceptibility was
54.4% (95%CI: 40.7, 67.4%)and 69.3% (95%CI: 64.7, 73.5%)respectively; the positive predictivevalue was 18.6%
(95%CI:13.1, 25.5%)and thenegativepredictivevalue was 92.2% (95% CI:88.6, 94.7%).
Conclusions: A vaccination history ofrubella had a poor diagnostic value in predicting rubella susceptibility.
However, obtaining a vaccinationhistory is inexpensive compared with performing a serological test. A cost-utility
analysis would be useful indetermining which test (history versus serological test)is more cost-effective in a
country with resource constraint.
Keywords: Rubella susceptibility,History, Vaccination, Sensitivity, Specificity
Background Although some women may acquire natural immunity
Rubella infection is a mild disease when it affects against rubella by virtue of being infected in childhood,
children. However, when it affects pregnant women in which is often asymptomatic [3], it is still important to
the early trimester, it can cause serious complications vaccinate susceptible women as CRS carries serious
such asmiscarriage tothe motherandcongenital rubella consequences.
syndrome (CRS) to the fetus [1,2]. CRS is an important Cutts et al. (1999) estimated a total of 110,000 CRS
cause of severe birth defects with ophthalmic, auditory, cases in the developing countries [4]. The incidence rate
cardiacandneurologicalabnormalities. ofCRSindevelopingcountriesrangedfrom0.4to4.3per
1000 live births [5]. In Malaysia, a retrospective review of
rubella serology from 1993–1998 at University Hospital,
*Correspondence:[email protected]
1DepartmentofFamilyMedicine,FacultyofMedicineandHealthSciences, Kuala Lumpur had reported an incidence rate of 0.5 per
UniversitiPutraMalaysia,Serdang,Selangor43400,Malaysia 1000 live births for CRS [5,6]. In recent years, sporadic
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Cheongetal.BMCFamilyPractice2013,14:19 Page2of5
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cases of CRS have been reported in literature [7,8], to45yearsattendingtheclinicforantenatalbookingwere
althoughtheexactnumberisunknown. invitedtoparticipateinthestudy.Womenwithsymptoms
One of the ways to reduce CRS is to vaccinate all ofpossibleacuterubellainfectionassignifiedbyfeverand
women before they reach reproductive age. The World rashwereexcludedfrom thestudy.Pregnantwomenwho
Health Organization (WHO) has reported that 131 out consented to the study were recruited. For women aged
of 193 WHO member countries (68%) have included ru- lessthan18years,writtenconsentsweretakenfromboth
bella vaccination in their national immunization sched- the women and their guardians. The study was approved
ule [9]. Malaysia started the rubella vaccination program by the Medical Ethics Committee of University Malaya
in 1988 targeting school girls aged 12 to 15 years, and MedicalCentreandtheMinistryofHealth,Malaysia.
women in the reproductive age group (15 – 44 years)
[10]. Since 2002, the program has replaced rubella Setting
vaccine with the 2-dose measles-mumps-rubella (MMR) Malaysia is a multiracial country with a population of
vaccination for all children aged 1 and 7 years [11]. In 28.3 million according to the population census of 2010.
2011, the uptake of the MMR vaccination for children The ethnic distribution consists of 67.4% Malay, 24.6%
aged 1 to 2 years was about 95% [12]. Despite the Chinese, 7.3% Indian and 0.7% others [25]. Selangor is
vaccination program, outbreak of rubella has been the most densely populated among the fourteen states of
reported among 16-year old students in a military voca- the country. It has a population of 5.46 million and is
tional training school in 2006 [13] and the prevalence of highly urbanized. The health clinic in this study served a
rubella susceptibility in pregnant women has been population of 67,578 [25]. It has a maternal and child
reported to range between 8% and 11% in Malaysia health clinic that provides free service to Malaysian citi-
[14,15]. This prevalence is relatively high compared with zens. The ethnic distribution of this study-population of
some countries in the Asia-pacific region such as female aged 15–45 years was similar to the Selangor and
Australia (2.7%) [16] and Japan (6.7%) [17], but is lower Malaysiancensus[25,26].
than Singapore (15.8%), Thailand (18.0%), Taiwan
(16.7%) and Sri Lanka (24%) [18-21]. Therefore, efforts Datacollection
are still needed to reduce rubella susceptibility among Face-to-face interviews were conducted using structured
pregnantwomen. data collection forms to obtain socio-demographic data,
To achieve a reduction in rubella susceptibility in history of rubella vaccination and past history of rubella
women, apart from implementing rubella vaccination as infection. (Additional file 1). For history of rubella vacci-
part of the childhood immunization schedule, supple- nation, the following question was asked: “Have you ever
mentary vaccination can be employed as an additional been vaccinated for rubella?” There were three options
strategy [22]. In some countries, screening for rubella for response: “yes”, “no” or “don’t know”. Those who
antibodies is carried out duringantenatal period to iden- answered “no” or “don’t know” were considered suscep-
tify susceptible women who are then vaccinated post tible to rubella infection. The history of rubella vaccin-
partum [22-24]. In Malaysia, rubella antibody is not rou- ation was self reported as there was no documentation of
tinely screened for in pregnant women in public funded vaccination available for verification. The women were
health clinics due to cost constraint. Instead, these alsoaskedforpasthistoryofrubellainfection.Thosewho
women are routinely asked for a history of rubella vac- answeredyeswereaskediftheyhadthediagnosisverified
cination to identify their risk for rubella infection as eitherbyadoctororbyabloodtest.
some studies have shown that rubella vaccination status All recruited women then had their serum IgG rubella
is significantly associated with susceptibility to rubella antibodylevelmeasured,andthislevelwasusedasthegold
infection [20,21]. Women who have no history of rubella standardforrubellasusceptibility.TheIgGrubellaantibody
vaccination are then offered the vaccination post par- was measured using the AxSYM Rubella IgG assay based
tum. The aim of this study was thus to determine the on the Microparticle Enzyme Immunoassay (MEIA) tech-
usefulness of a history of rubella vaccination as a scree- nology.ArubellaIgGantibodylevelof10IU/mLorgreater
ning tool for rubella susceptibility in countries such as indicates immunity to rubella infection either through
Malaysia that do not offer routine antenatal rubella anti- previous rubella infection or induced by previous vaccine.
body screening. ArubellaIgGantibodyleveloflessthan10IU/mLisconsi-
deredsusceptibletorubellainfection.
Methods
Studydesignandparticipants Samplesize
A cross-sectional study was carried out at a public Using epi-info version 6.0, the sample size was calcu-
funded health clinic from June to October 2005 in the lated based on the expected prevalence of rubella
state of Selangor, Malaysia. All pregnant women aged 15 susceptibility of 8% and the worst acceptable prevalence
Cheongetal.BMCFamilyPractice2013,14:19 Page3of5
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of 11% with a confidence level of 95%. The estimated Table2Sensitivity,specificity,positiveandnegative
samplesizewas314. predictivevalueofrubellavaccinationhistoryagainst
rubellasusceptibility
Statisticalanalysis Rubellavaccination Rubellasusceptibility Total
Data were analyzed using SPSS version 15. Sensitivity history (anti-rubellaIgGtest) (%)
and specificity, the positive and negative predictive Susceptible Immune
values of a history of rubella vaccination in identifying (IgG<10IU/mL) (IgG≥10IU/mL)
N(%) N(%)
rubella susceptibility were determined using anti-rubella
IgG level as the gold standard. In this study, the “test” Nohistoryofvaccinationor 31(18.6%) 136(81.4%) 167
unknownvaccinationstatus (100%)
was a “history of rubella vaccination”. The aim of the
(rubellasusceptible)
“test” was to correctly identify women who were suscep-
Historyofvaccination 26(7.8%) 307(92.2%) 333
tible to rubella. The gold standard for rubella suscep- (rubellaimmuned) (100%)
tibility was those with anti-rubella IgG<10 IU/mL.
Total 57 443 500
Sensitivity of the test is defined as the percentage of all
Sensitivityofrubellavaccinationhistoryforrubellasusceptibility=31/(31+26)
susceptible women who indeed reported to be not vacci- x100=54.4%(95%CI:40.7,67.4%).
nated or to be unknown whether vaccinated. Specificity Specificityofrubellavaccinationhistoryforrubellasusceptibility=307/(307
+136)x100=69.3%(95%CI:64.7,73.5%).
is defined as the percentage of all protected women that
Positivepredictivevalueofrubellavaccinationhistory=31/(31+136)x100=
indeed reported to be vaccinated. Positive predictive 18.6%(95%CI:13.1,25.5%).
value of the test is the chance that a woman who Negativepredictivevalueofrubellavaccinationhistory=307/(307+26)x100
=92.2%(95%CI:88.6,94.7%).
reportedtobenot vaccinated wassusceptible torubella.
our previous analysis have shown that a negative vacci-
Results nation history was a significant predictor for rubella
Five hundred and two (502) patients who satisfied the susceptibility (odd ratio=2.7, 95% CI: 1.5, 4.7) after con-
inclusion criteria were approached. Two patients refused trolling for age, ethnicity, parity, education level and
to participate. The response rate was 99.6%. A majority of occupation[15].
women were Malay (55.2%), followed by Chinese (23.0%), Thesensitivityofahistoryofrubellavaccinationiniden-
Indian (8.6%) andothers (13.2%). The age ranged from 16 tifying rubella susceptibility using serological test as gold
to 42 years, the mean age being 27.2 (SD 4.8) years; the standardwas54.4%(95%CI:40.7,67.4%)andthespecificity
medianagewas27.0years(IQR6.0).Halfthewomenwere was 69.3% (95% CI: 64.7, 73.5%). The positive predictive
primigravida(49.2%).Noneofthemreportedapasthistory value was 18.6% (95% CI: 13.1, 25.5%) and the negative
ofrubellainfectionthatwasconfirmedbyclinicaldiagnosis predictivevaluewas92.2%(95%CI:88.6,94.7%)(Table2).
of a physician or by blood test. The prevalence of rubella
susceptibilityinthisstudywas11.4%[95%CI:8.6,14.2%]. Discussion
Most of the women (66.6%) had a positive vaccination The aim of the test (vaccination history) was to identify
history. Of these, 92.2% were immune. (Table 1) A third women susceptible to rubella in order to offer them
(33.4%) of the women had a negative vaccination history vaccination to prevent rubella in future pregnancies. For
(no history of previous vaccination or unknown vaccin- this purpose, sensitivity is the most important element
ation status); nevertheless, 81.4% of them were immune of the test. The sensitivity of the test was 54%. Hence,
to rubella. (Table 2) A history of rubella vaccination on the basis of just a history of rubella vaccination,
was significantly associated with rubella susceptibility almost half the susceptible women would be overlooked
(χ2 = 12.737, P ≤0.001). Logistic regression results from and remain unprotected against rubella. On the other
hand,comparedwithnoserologicaltestingatall,anega-
tive vaccination history would at least identify half of the
Table1Selfreportedrubellavaccinationhistoryand
rubellasusceptibility susceptible women. The specificity of the test was 69%;
however, it is not a clinical problem that 31% of the
Selfreported Rubellasusceptibility TotalN=500
rubella (anti-rubellaIgGtest) N(%) women were protected while they reported to be not
vaccination Susceptible Non-susceptible vaccinated. This could be due to natural immunity they
history (IgG<10IU/mL) (IgG≥10IU/mL) acquired during childhood subclinical infection that
N=57N(%) N=443N(%)
often goes unnoticed. The positive predictive value of
Nohistoryof 22(33.3) 44(66.7) 66(100.0) the test is only 19%, which means that there is a one in
vaccination
five chance that a woman who reported to be not vacci-
Unknown 9(8.9) 92(91.1) 101(100.0)
nated was susceptible to rubella, the majority being pro-
vaccinationstatus
tected. The negative predictive value was 92%, which
Vaccinated 26(7.8) 307(92.2) 333(100.0)
meansthatthemajority ofwomen whoreportedpositive
Cheongetal.BMCFamilyPractice2013,14:19 Page4of5
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vaccination history were protected. The relatively low design and thesocio-economicstatus ofthe participants,
sensitivity and positive predictive value of the rubella who were mainly from the middle and lower socio-
vaccination history might not be useful in screening for economic groups that may differ from patients seen in
rubella-susceptible women. Serological testing, the gold other settings. Therefore, caution is necessary in genera-
standard test, is superior in correctly identifying women lizing the findings. Nevertheless, this study that has pro-
who are susceptible to rubella. Nonetheless, serological vided us the preliminary evidence of an inexpensive test,
test is expensive compared with an enquiry of vacci- namely, a history of rubella vaccination, is not a useful
nation history. A cost-utility analysis is needed to deter- screening tool for rubella susceptibility. Further study is
mine which test is preferable from a public health point needed to confirm this as it may have implications on
of view: a history of vaccination “test” or a serological the healthcare policy regarding rubella antibody testing
test,especiallyfor aresource constrainedcountry. inpregnant women.
7.8% of the women who reported having had vacci-
nation were found to have low antibody titer level and Conclusions
were considered to be not protected based on the cut-off A test based on the history of rubella vaccination has
level of anti-rubella IgG of 10 IU/mL. This proportion is low sensitivity, specificity and predictive values in deter-
substantial given the serious complications resulting from mining rubella susceptibility. Serological testing needs to
congenital rubella syndrome. Therefore, screening for be considered in all women of childbearing age to effec-
rubella susceptibilityusingahistoryofrubellavaccination tively prevent the occurrence of congenital rubella syn-
would have overlooked this group of women and denied drome. However, as serology test is more expensive than
them the benefit of rubella booster dose to prevent con- taking a vaccination history, a cost-utility analysis is
genital rubella syndrome. Some studies have reported the recommendedincaseofresource constraint.
possibilityofagradualdeclineintherubellaantibodytiter
from a protective level to a non-protective level in some
Additional file
individuals who had the vaccination [27-29]. Therefore, it
is possible for rubella to occur during pregnancy even in
Addistionalfile1:Structureddatacollectionform.
womenwhohavehadthevaccination.
About two-third of the women who reported negative
Competinginterests
rubella vaccination history had protective antibody titers. Theauthorsdeclarenocompetinginterests.
Some of these women may have acquired the immunity
through subclinical infections they were not aware of Authors’contributions
Allauthorscontributedtothedesign,analysisandwriteupofthisstudy.
when they were young [3]. Some women may have expe-
ATCproducedthefirstdraftofthemanuscript.Allauthorscontributedto
rienced fever and rash and did not relate it to rubella therevisionofthedraft.Thefinalmanuscripthasbeenreadandapproved
infection as these symptoms mimic other common viral byallauthors.
infections. Locally, rubella antibody test is not performed
Acknowledgements
inwomenforconfirmationofthediseaseasthediseaseis TheauthorswishtothanktheDirectorGeneralofHealth,Malaysia,for
mildandself-limiting,anddoesnotrequirenotification. permissiontopublishthiswork.Wewouldalsoliketothankthestaffsatthe
clinicfortheirsupportandthepatientswhotookpartinthisstudy.
Inthisstudy,weusedanti-rubellaIgGlevelof10IU/mL
asthecut-offpointforprotectionagainstrubellainfection. Authordetails
This was the recommended level based on earlier epi- 1DepartmentofFamilyMedicine,FacultyofMedicineandHealthSciences,
UniversitiPutraMalaysia,Serdang,Selangor43400,Malaysia.2Departmentof
demiological studies when rubella infection was prevalent
FamilyMedicine,FacultyofMedicine,UniversitiKebangsaanMalaysia,Jalan
[30]. Although a recent study on the sero-prevalence of YaacobLatifCheras,KualaLumpur56000,Malaysia.3DepartmentofPrimary
rubella antibody over time has suggested that the cut-off CareMedicine,FacultyofMedicine,UniversityofMalaya,KualaLumpur
50603,Malaysia.
level of anti-rubella IgG for protection against infection
should be adjusted according to an immunized antenatal Received:6June2012Accepted:25January2013
population rather than following the older recommenda- Published:31January2013
tion[30],welackedlocalserologicaldataregardingrubella
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