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Intervention Review

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Booster dose vaccination for preventing hepatitis B

  1. Jalal Poorolajal1,*,
  2. Mahmood Mahmoodi2,
  3. AliAkbar Haghdoost3,
  4. Reza Majdzadeh2,
  5. Siavosh Nasseri-Moghaddam4,
  6. Leila Ghalichi2,
  7. Akbar Fotouhi2

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 10 NOV 2010

DOI: 10.1002/14651858.CD008256.pub2


How to Cite

Poorolajal J, Mahmoodi M, Haghdoost A, Majdzadeh R, Nasseri-Moghaddam S, Ghalichi L, Fotouhi A. Booster dose vaccination for preventing hepatitis B. Cochrane Database of Systematic Reviews 2010, Issue 11. Art. No.: CD008256. DOI: 10.1002/14651858.CD008256.pub2.

Author Information

  1. 1

    Faculty of Health, Hamadan University of Medical Sciences (UMSHA), Department of Epidemiology and Biostatistics, Research Centre for Health Sciences, Hamadan, Hamadan, Iran

  2. 2

    Tehran University of Medical Science (TUMS), Department of Epidemiology and Biostatistics, Tehran, Iran

  3. 3

    Kerman University of Medical Sciences, Community Medicine Department and Physiology Research Center, Kerman, Kerman, Iran

  4. 4

    Shariati Hospital, Tehran University of Medical Sciences, Digestive Disease Research Centre, Tehran, Tehran, Iran

*Jalal Poorolajal, Department of Epidemiology and Biostatistics, Research Centre for Health Sciences, Faculty of Health, Hamadan University of Medical Sciences (UMSHA), Shahid Fahmideh Avenue, Hamadan, Hamadan, 6517838695, Iran. poorolajal@umsha.ac.ir. poorolajal@yahoo.com.

Publication History

  1. Publication Status: New
  2. Published Online: 10 NOV 2010

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This is not the most recent version of the article. View current version (07 JUN 2016)

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Ayerbe 2001A non-randomised clinical trial in which anamnestic response to a booster dose of hepatitis B vaccine was explored in a group of protected and non-protected vaccinees.

Belloni 2000A non-randomised clinical trial which explored anamnestic immune response to a booster dose in a single intervention group five years post primary vaccination without considering a control group.

Boxall 2004A non-randomised clinical trial investigating anamnestic immune response to a booster dose of vaccine in those individuals who were born to hepatitis B virus carrier mothers, who had received vaccine plus immunoglobulin during infancy.

Bryan 1997A non-randomised clinical trial exploring anamnestic immune response to a booster dose in two different intervention groups during the period less than five years post primary vaccination.

Bucher 1994A non-randomised clinical trial with two parallel intervention groups to investigate anamnestic immune response to two different regiments of booster doses five years after the initial immunisation, without considering a control group.

Chadha 2000A non-randomised clinical trial which was conducted to explore anamnestic immune response to a booster dose in two groups with different vaccination history ten years after the primary immunisation without considering a control group.

Chan 1991A randomised clinical trial which was conducted to explore anamnestic immune response to a booster dose during the first five years post primary vaccination in which two different booster doses were administered without considering any control group.

Coursaget 1986A non-randomised clinical trial in which individuals received booster doses one year after initial vaccination and were followed for the next six years in order to assess incidence of hepatitis B infection in comparison with non vaccinated individuals.

Da Villa 1996A non-randomised clinical trial which investigated anamnestic immune response to a booster dose in two groups of vaccinees after five and ten years from the last vaccination, without considering a control group.

Dahifar 2007A non-randomised clinical trial which was conducted to investigate anamnestic immune response to a booster dose in children, one or two years post primary immunisation.

Dahifar 2008A non-randomised clinical trial which explored anamnestic immune response to booster dose in a single intervention group five years post primary vaccination without considering a control group.

Davidson 1986A non-randomised clinical trial which assessed anamnestic immune response to booster dose in a single intervention group six to seven years after initial vaccination, without considering a control group.

Dentico 2002A non-randomised clinical trial with four parallel intervention groups enrolled in order to investigate anamnestic immune response to four different booster doses after the initial immunisation without considering a control group.

Durlach 2003A non-randomised clinical trial which was conducted to explore anamnestic immune response to a booster dose in a single intervention group 10 years post primary vaccination, without considering a control group.

Duval 2005A non-randomised clinical trial which investigated anamnestic immune response to two different regiments of booster doses in two parallel intervention groups five years after the initial immunisation, without considering a control group.

Floreani 2004A non-randomised clinical trial which was conducted to explore anamnestic immune response to a booster dose in a single intervention group six years after the initial vaccination, without considering a control group.

Gabbuti 2007A non-randomised clinical trial which explored anamnestic immune response to a booster dose in a single intervention group 11 years post primary vaccination, without considering a control group.

Gilca 2008A non-randomised clinical trial which was conducted to investigate anamnestic immune response to a booster dose in two groups of vaccinees after five and ten years from the last vaccination, without considering a control group.

Hammitt 2007A non-randomised clinical trial which was conducted to explore anamnestic immune response to a booster dose in a single intervention group 15 years after the primary immunisation, without considering a control group.

Laplanche 1987A randomised clinical trial, in which individuals received booster doses shortly (less than five years) after initial vaccination and were followed for the next five years to assess incidence of hepatitis B infection.

Li 1996A non-randomised clinical trial which investigated anamnestic immune response to a booster dose in a single intervention group seven years post primary vaccination, without considering a control group.

Li 1998A non-randomised clinical trial which explored anamnestic immune response to booster dose in a single intervention group six and half years after the initial immunisation, without considering a control group.

Lu 2004A non-randomised clinical trial which was conducted to explore anamnestic immune response to a booster dose in a single intervention group 15 years after the primary immunisation, without considering a control group.

Lu 2008aA non-randomised clinical trial which was conducted to investigate anamnestic immune response to a booster dose in a single intervention group 13 years after the primary immunisation, without considering a control group.

Lu 2008bA non-randomised clinical trial which was conducted to investigate anamnestic immune response to a booster dose in a single intervention group 15 years after the primary immunisation, without considering a control group.

Milne 1992aA non-randomised clinical trial which explored anamnestic immune response to a booster dose in a single intervention group five years after the initial vaccination, without considering a control group.

Milne 1992bA non-randomised clinical trial which assessed anamnestic immune response to a booster dose in a single intervention group five and half years post primary vaccination, without considering a control group.

Milne 1994A non-randomised clinical trial which investigated anamnestic immune response to booster dose in a single intervention group nine years after the initial immunisation, without considering a control group.

Peces 2001A non-randomised clinical trial which was conducted to explore anamnestic immune response to a booster dose in a single intervention group six years post primary vaccination, without considering a control group.

Petersen 2004A non-randomised clinical trial which enrolled seven parallel intervention groups to investigate anamnestic immune response to different doses and different types of a booster of hepatitis B vaccine during 5, 7, 8, 9, 10, and 12.5 years after the initial immunisation, without considering a control group.

Saffar 2004A non-randomised clinical trial which enrolled three parallel intervention groups to explore anamnestic immune response to three different booster doses 10 years post primary vaccination, without considering a control group.

Samandari 2007A non-randomised clinical trial which enrolled three parallel intervention groups to investigate anamnestic immune response to booster doses 6, 12, and 14 years after primary vaccination without considering a control group.

Saygun 2002A non-randomised clinical trial which was conducted to explore T cell proliferation in response to HBsAg stimulation in vaccinees, considering non immunised and uninfected individuals as control group.

Seto 2002A non-randomised clinical trial which was conducted to investigate anamnestic immune response to booster dose in a single intervention group six years post primary vaccination, without considering a control group.

Shih 1999A non-randomised community-based clinical trial which was conducted to evaluate long-term universal hepatitis B vaccination program during infancy and the effects of a booster dose on non-protected school age children, some of whom were born to hepatitis B virus carrier mothers.

Su 2007A non-randomised clinical trial which explored anamnestic immune response to a booster dose in a single intervention group 20 years post primary vaccination, without considering a control group.

Trivello 1992A non-randomised clinical trial which was conducted to explore anamnestic immune response to a booster dose in a single intervention group five years post primary vaccination, without considering a control group.

Trivello 1995A non-randomised clinical trial which was conducted to investigate anamnestic immune response to a booster dose in two parallel intervention groups with different vaccination history six years post primary vaccination, without considering a control group.

van der Sande 2007A randomised clinical trial which explored anamnestic immune response to a booster dose in both protected and non-protected vaccinees 15 years post primary vaccination, without simultaneously assessing the immune response in the control group.

Wang 2007A non-randomised clinical trial which was conducted to explore anamnestic immune response to a booster dose in a single intervention group 16 years after the initial immunisation, without considering a control group.

Watson 2001A non-randomised clinical trial which was conducted to assess anamnestic immune response to two different booster doses in two parallel intervention groups 13 years post primary vaccination, without considering a control group.

Williams 2001A randomised clinical trial which was conducted to investigate anamnestic immune response to two different booster doses in two parallel intervention groups nine years post primary vaccination, without considering a control group.

Williams 2003A non-randomised clinical trial which was conducted to explore anamnestic immune response to booster doses in two groups of vaccinees five and nine years after the primary vaccination, without considering a control group.

Wismans 1989A non-randomised clinical trial exploring anamnestic immune response to booster before five years from the initial vaccination.

Xueliang 2000A non-randomised clinical trial which was conducted to assess anamnestic immune response to a booster dose in a single intervention group 11 years after the initial immunisation, without considering a control group.

Zanetti 2005A randomised clinical trial which was conducted to explore anamnestic immune response to two different booster doses in two parallel intervention groups 10 years post primary vaccination, without considering a control group.

Zhang 1993A non-randomised clinical trial whose participants were children, born to hepatitis B virus carrier mothers.

Zhuang 1998A randomised placebo-controlled clinical trial with school age children to assess anamnestic immune response to a booster dose only three years after the primary vaccination.

 
Characteristics of studies awaiting assessment [ordered by study ID]
Aspinall 1995

MethodsDesign: unknown.
Follow-up: unknown.

ParticipantsUnknown.

InterventionsBooster dose of hepatitis B vaccine.

OutcomesAnamnestic immune response to a booster dose.

NotesNeither full text nor abstract was accessible.

Patel 2004

MethodsDesign: randomised clinical trial.
Follow-up: 10 years.

ParticipantsHealthy participants.

InterventionsBooster dose of hepatitis B vaccine versus nothing.

OutcomesAnamnestic immune response to a booster dose.

NotesA poster presentation, but full text was not accessible.

Petersen 1995

MethodsDesign: unknown.
Follow-up: 9 years.

ParticipantsHealthy participants.

InterventionsBooster dose of hepatitis B vaccine.

OutcomesAnamnestic immune response to a booster dose.

NotesNeither full text nor abstract was accessible.

Watson 1998

MethodsDesign: unknown.
Follow-up: unknown.

ParticipantsHealthy participants.

InterventionsBooster dose of hepatitis B vaccine.

OutcomesAnamnestic immune response to a booster dose.

NotesNeither full text nor abstract was accessible.

Yang 1995

MethodsDesign: unknown.
Follow-up: 7 years.

ParticipantsHealthy participants.

InterventionsBooster dose of hepatitis B vaccine.

OutcomesAnamnestic immune response to a booster dose.

NotesNeither full text nor abstract was accessible.

 
Summary of findings for the main comparison. Summary findings of non-RCTs

StratumStudyFollow-up (yr)EndemicityParticipantsAge group (yr)VaccineBoosterSample size*PRRIVPAIRGMTpreGMTpostFold rise

1Belloni 20005HypoHealthy5RV-51100%1.00---

Bucher 19945HypoHCWs40.4PDVRV47Unknown0.89---

Bucher 19945HypoHCWs40.9PDVPDV49Unknown0.80---

Da Villa 19965HyperHealthy5MixedRV27Unknown0.96---

Dahifar 20085IntermediateHealthy6.5RVRV4100%1.00---

Duval 20055HypoHealthy15.1RVRV38100%0.92---

Duval 20055HypoHealthy15.1RVRV50100%0.96---

Gilca 20085HypoHealthy15.5RVRV36100%0.94---

Milne 1992a5HypoHealthy6.1PDVRV55Unknown0.82---

Milne 1992b5HyperHealthy18RVRV8100%1.00---

Petersen 20045HyperHealthy5.2RVRV71Unknown0.850.071572243

Trivello 19925HypoHCWsadultsRVRV21100%0.192.44844.93346

Trivello 19925HypoHCWsadultsRVRV78100%0.171458.47458

Williams 20035HyperHealthy5.3RVRV4490%0.93---

Total-5-----579-0.78**--1190**

2Floreani 20046IntermediateHCWs31.4RVRV11Unknown0.45---

Floreani 20046IntermediateHCWs28.8PDVRV7Unknown1.00---

Li 19986HyperHealthy6-7PDVPDV65Unknown0.77---

Peces 20016IntermediateHCWsRVRV1Unknown1.00---

Samandari 20076HyperHealthy5.9RVRV116Unknown0.97---

Seto 20026HypoHealthy6.1RVRV34100%1.00---

Trivello 19956HypoHCWs29.8PDVRV40100%0.88---

Trivello 19956HypoHCWs30.8PDVRV99100%0.92---

Davidson 19867HypoHCWs43PDVRV16Unknown0.81---

Li 19967HyperHealthy8-11PDVPDV2694%1.000.127.8278

Petersen 20047HyperHealthy7.4RVRV21100%0.860.24126525

Petersen 20047HyperHealthy7.5RVRV14100%1.000.2463263

Petersen 20048HyperHealthy8.1RVRV63Unknown0.950.071572243

Milne 19949HyperHealthy11-12RVRV17Unknown0.942158.479

Petersen 20049HyperHealthy9.1PDVRV25Unknown0.520.0734486

Williams 20019HyperHCWs46.7RVRV13100%1.000.96633658

Williams 20019HyperHCWs46.7RVRV15100%1.006.831920281

Williams 20039HyperHealthy9.25PDVRV25Unknown0.88---

Chadha 200010IntermediateHCWs37.3RVRV1080%0.80---

Da Villa 199610HyperHealthy10PDVRV147Unknown0.96---

Durlach 200310HypoHCWs44.3RVRV15100%0.80---

Gilca 200810HypoHealthy20.3RVRV42100%1.00---

Petersen 200410HyperHealthy10.4PDVRV29Unknown0.690.0734486

Saffar 200410IntermediateHealthy10.7RVRV57Unknown0.953.84166.7643

Saffar 200410IntermediateHealthy10.7RVRV52Unknown0.883.84130.934

Saffar 200410IntermediateHealthy10.7RVRV56Unknown0.793.84103.227

Zanetti 200510HypoHealthy10.9RVRV342Unknown0.9732.1885.628

Zanetti 200510HypoHealthy21.8RVRV48Unknown0.96234.81715.17

Total-------1406-0.92**--277**

3Gabbuti 200711HypoHealthy23RVRV12100%0.92124.12790.422

Xueliang 200011HyperHealthy16-20PDVRV27Unknown0.782.122612

Petersen 200412HyperHealthy12.6PDVRV12100%0.670.241146

Samandari 200712HyperHealthy11.8RVRV118Unknown0.81---

Lu 2008a13HyperHealthy13.14RV-522Unknown0.74---

Watson 200113HypoHealthy14-23RVRV3Unknown1.00---

Watson 200113HypoHealthy43-67RVRV2Unknown1.00---

Samandari 200714HyperHealthy14PDVRV58Unknown0.60---

Hammitt 200715HyperHealthy14.6RVRV37100%0.621.422.716

Lu 200415HyperHealthy15PDVRV49Unknown0.96---

Lu 2008b15HyperHealthy15-17PDVRV872Unknown0.71---

van der Sande 200715HyperHealthy14.9PDVRV143Unknown0.95---

Total-------1855-0.75**--20**

4Wang 200716HyperHealthy15.9PDVRV386Unknown0.771.2662.750

Su 200720HyperHealthy18.7PDVRV139Unknown0.500.055.15103

Su 200720HyperHealthy18.7PDVRV58Unknown0.910.32167.79524

Su 200720HyperHealthy18.7PDVRV119Unknown0.973.54443.95125

Total-------702-0.76**--112**

 - No data
PRRIV: protective response rate to Initial vaccination.
PAIR: proportion of anamnestic immune response to booster dose in non-protected vaccinees.
GMTpre: geometric mean titre pre-booster dose.
GMTpost: geometric mean titre post-booster dose.
* the sample size of some studies are very small because most of the participants in these studies were protected vaccinees and were excluded from the analysis.
** Frequency weighted average.
 
Summary of findings 2. AIR to booster dose in non-protected vaccinees

StratumNo. of studiesNo. of groupsNo. of participantsWeighted PAIR [95% CI]

111145790.78 [0.75, 0.80]

2182814060.92 [0.91, 0.92]

3101218550.75 [0.74, 0.75]

4227020.76 [0.75, 0.77]

 PAIR: proportion of anamnestic immune response in non-protected vaccinees.
 
Summary of findings 3. GMT fold rise post booster

StratumNo. of studiesNo. of groupsNo. of participantsWeighted GMT fold-rise

1231701189.9 [1055.3, 1324.6]

2614763276.9 [233.5, 320.3]

3448819.7 [17.4, 22.0]

424702112.4 [102.9, 121.8]

 GMT: geometric mean titre.
 
Summary of findings 4. Sequential GMT comparison

TrialNo. of participantsGMT at 1st weekGMT at 2nd weekGMT at 4th week

Dentico 2002168.918.222.8

Samandari 2007743.22829.8

Dentico 20021616.63329.5

Samandari 20071384.6148145

Dentico 20021626.8260.9262.2

Samandari 2007166221070653

Dentico 200216162.91321.21358.7

Weighted average [95% CI]44218.02 [15.27, 20.78]511.88 [465.97, 557.79]356.07 [325.11, 387.03]

 GMT: geometric mean titre.
 
Summary of findings 5. Adverse events

Local eventsFrequency

Pain19

Tenderness0

Redness3

Swelling2

Other1

Systemic eventsFrequency

Fever2

Headache1

Malaise0

Irritability0

Rash0

Nausea2

Myalgia1

Arthralgia0

Other0

 Total sample size for assessing adverse events was 1525.