Hepatitis B vaccination of newborns in rural China ......• Among providers who had used the...
Transcript of Hepatitis B vaccination of newborns in rural China ......• Among providers who had used the...
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Hepatitis B vaccination of newborns in rural China: evaluation of an out-of-cold-chain delivery strategy
Istanbul, Turkey
March 15-17, 2006
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Contents
• Introduction
• Objective
• Methods and Implementation
• Results
• Conclusions
• Next steps
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Hepatitis B in China
• Hepatitis B (HB) is one of the four major infectious diseases in China
• 120 million people are chronically infected with hepatitis B virus (HBV)—10% of the population
• An estimated 280,000 deaths annually>33% of global deaths attributed to HB
Sources:State of the World’s Vaccines and Immunization. WHO, UNICEF, The World Bank. 2002.The Global Alliance for Vaccines and Immunization. Progress Report. 2002.1992 National Serosurvey. China.
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HBV surface antigen rate among children
7.12%
2.10%
11.40%
8.25%
0%
2%
4%
6%
8%
10%
12%
HB
sAg
Rat
e
Urban2002
Rural2002Urban
1992
Rural1992
Urban: 71%
Rural: 28%
Source: Serosurvey adopting the samples from 2002 national nutrition survey (unpublished)
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Increase in on-time administration of HB vaccine birth dose
0102030405060708090
100
National Eastern Middle Western
Cov
erag
e(%
)
1997200120022003
Project Focus
Source: National EPI Coverage Survey. China. 1999 and 2004
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Proportion of children receiving the HB vaccine birth dose on 1st or 2nd day of life
0 10 20 30 40 50 60 70 80 90
Place of Birth
Geography
Overall
Percent (Weighted)
PlainsHillsMountains
County Hospital or AboveTownship HospitalHome
Source: National EPI Coverage Survey. China. 1999
Project Focus
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Objective
To evaluate strategies for improving on-time delivery (within 24 hours) of the HB vaccine birth dose in remote areas of China, especially among children born at home.
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Study design
• Townships situated at least 20 km from the county capital in three counties in Hunan Province were randomly divided into three groups: – Group 1: Ampoule inside the cold chain– Group 2: Ampoule outside the cold chain– Group 3: HB vaccine in Uniject™* (HB-Uniject) outside the cold
chain
• All ampoules of HB vaccine and HB-Uniject packages were marked with vaccine vial monitors (VVMs)
*Uniject is a registered trademark of BD.
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Hospital vaccination in the cold chain;home vaccination out of the cold chain
Group 1:– HB vaccine delivered in
township hospitals. Vaccine stored in the cold chain
Group 2 and Group 3:– Village-based doctors and
midwives trained as vaccine providers. Vaccine stored and delivered out of the cold chain
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Preparations
• Held trainings with vaccine providers at township and village levels
• Conducted social mobilization to emphasize the importance of hepatitis B immunization and on-time delivery of the birth dose
• Monitored vaccine storage temperatures with data loggers
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Evaluation methods
Baseline and final coverage survey– Review of children’s immunization cards– Review of village/township immunization
records
Immunologic response survey– Radioimmunoassay for HBsAg, anti-HBs
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Results: Significant improvements in on-time vaccination
11.3 6.8
57.9
77.3
8.78.0
67.667.8
0
20
40
60
80
100
Group 1: AmpouleInside Cold Chain
Group 2: AmpouleOutside Cold Chain
Group 3: HB-UnijectOutside Cold Chain
Total
Perc
ent o
f inf
ants
who
rece
ived
the
first
dos
e of
va
ccin
e w
ithin
24
hour
s of
birt
h
BaselineFinal
Raising awareness
helps
Out-of-cold-chain storage helps more
Unijecthelps even
more
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Results: Significant improvements in on-time vaccination
Hospital births—improved Home births—improved by by raising awareness out-of-cold-chain strategy
2.4 2.5 0.6
77.9 80.3
25.2
51.8
66.7
10.711.018.4
87.6
0
20
40
60
80
100
Group 1Ampoule
Inside ColdChain
Group 2Ampoule
Outside ColdChain
Group 3 HB-Uniject
Outside ColdChain
Group 1Ampoule
Inside ColdChain
Group 2Ampoule
Outside ColdChain
Group 3 HB-Uniject
Outside ColdChain
Perc
ent o
f inf
ants
who
rece
ived
the
first
dose
of v
acci
ne
with
in 2
4 ho
urs o
f birt
h
BaselineFinal
Born in the hospital Born at home
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Results: Home-born infants better served when vaccinated at home
73.5
32.8
0
20
40
60
80
100
Home-born and immunized athome
Home-born and immunized intownship hospitalPe
rcen
t of i
nfan
ts w
ho re
ceiv
ed th
e fi
rst
dose
of v
acci
ne w
ithin
24
hour
s of
bir
th
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Serology results: No difference between in-the-cold-chain and out-of-cold-chain groups
Anti-HBs positive HBsAg positive
Children % 95%CI Children % 95%CI
Group 1 203 194 95.6 91.5-97.8 1 0.5 0.03-3.1
Group 2 203 195 96.1 92.1-98.2 1 0.5 0.03-3.1
Group 3 200 191 95.5 91.4-97.8 3 1.5 0.4-4.7
Total 606 580 96.0 93.7-97.1 5 0.8 0.3-2.0
Groups Children observed
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Serology results: No difference between in-the-cold-chain and out-of-cold-chain groups
Anti-HBs>=10 mIU/ml Groups Children
observed
Children with Anti-
HBs +Among Anti-
HBs positive (%)Among children
observed (%)GMT
Group 1 203 194 180(92.8 %)
180(88.7 %) 95.5
Group 2 203 195 184(94.4 %)
184(90.6 %) 93.3
Group 3 200 191 178(93.2 %)
178(89.0 %) 102.3
Inside cold chain 203 194 180
(92.8 %) 180
(88.7 %) 95.5
Outside cold chain 403 386 362
(93.8 %) 362
(89.8 %) 97.7
Total 606 580 542(93.5 %)
542(89.4 %) 97.7
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Storage temperatures: freeze and heat exposure
• In the cold chain: 2/3 township refrigerators below 0 °C
• Out of the cold chain: temperatures 2°C–30°C – 0.2% vaccine was discarded due to heat exposure
– VVMs effective in identifying heat exposure
• No serious adverse events following immunization were reported during the study
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Acceptability of Uniject• Among providers who had used the Uniject device:
– 98% thought Uniject was easy to carry, transport, and use
– 95% thought Uniject could administer a full dose of HB vaccine
– 88% thought Uniject could save immunization time compared with standard syringes
• Almost all immunization providers thought that the village-based out-of-cold-chain strategy could improve the on-time delivery of the HB vaccine birth dose among children born at home
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Conclusion 1
• In remote areas in China and other countries where many children are born at home, on-time administration of HB vaccine has been difficult to achieve through routine immunization service
• Village health workers using an out-of-cold chain immunization strategy can improve the on-time administration of the HB vaccine birth dose among infants born at home
• Training and monitoring of hospital health workers can improve on-time administration of the HB vaccine birth dose to children born in hospitals
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Conclusion 2
• Simple tools such as VVMs and Uniject can ensure vaccine quality and injection safety when vaccines are administered by village health workers
• HB vaccine is sufficiently heat stable to withstand routine out-of-cold-chain storage in tropical conditions without loss of immunogenicity
• Taking vaccine out of the cold chain could potentially decrease the risk of vaccine damage due to inadvertent freezing
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Next steps
• Improve awareness and coordination of the birth dose in hospital settings through increased supervision
• HB vaccine manufacturer will start application of licensure for use of HB-Uniject stored out of the cold chain
• Introduce VVMs on EPI vaccines, in accordance with UNICEF and WHO recommendations
• Adopt national policy of HB vaccine storage out of the cold chain, initially in warm areas among children born at home
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Increase in coverage of HB3
0102030405060708090
100
National Beijing Hubei Guizhou
Cov
erag
e(%
)
2001 2002 2003
Integration into EPI since 2002
Source: National Coverage Survey, 2004
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Progress in Hepatitis B Immunization Western Provinces 1999-2004 *
0
500
1000
1500
2000
2500
3000
3500
4000
1999 2000 2001 2002 2003 2004
Dos
es A
dmin
iste
red
(100
0s)
BCGDTP1DTP3HBV1HBV3HBV1 Ontime
* Adjusted for corrected data Qinghai (2004), Xinjiang (2003-4)