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Effectiveness of a live oral human rotavirus vaccine after programmatic introduction in Bangladesh: A cluster-randomized trial.

Abstract Rotavirus vaccines are now globally recommended by the World Health Organization (WHO), but in early 2009 WHO's Strategic Advisory Group of Experts on Immunization reviewed available data and concluded that there was no evidence for the efficacy or effectiveness of a two-dose schedule of the human rotavirus vaccine (HRV; Rotarix) given early at 6 and 10 wk of age. Additionally, the effectiveness of programmatic rotavirus vaccination, including possible indirect effects, has not been assessed in low-resource populations in Asia.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title plos medicine
Publication Year Start




PMID- 28419095
OWN - NLM
STAT- In-Process
DA  - 20170418
LR  - 20170418
IS  - 1549-1676 (Electronic)
IS  - 1549-1277 (Linking)
VI  - 14
IP  - 4
DP  - 2017 Apr
TI  - Effectiveness of a live oral human rotavirus vaccine after programmatic
      introduction in Bangladesh: A cluster-randomized trial.
PG  - e1002282
LID - 10.1371/journal.pmed.1002282 [doi]
AB  - BACKGROUND: Rotavirus vaccines are now globally recommended by the World Health
      Organization (WHO), but in early 2009 WHO's Strategic Advisory Group of Experts
      on Immunization reviewed available data and concluded that there was no evidence 
      for the efficacy or effectiveness of a two-dose schedule of the human rotavirus
      vaccine (HRV; Rotarix) given early at 6 and 10 wk of age. Additionally, the
      effectiveness of programmatic rotavirus vaccination, including possible indirect 
      effects, has not been assessed in low-resource populations in Asia. METHODS AND
      FINDINGS: In Bangladesh, we cluster-randomized (1:1) 142 villages of the Matlab
      Health and Demographic Surveillance System to include two doses of HRV with the
      standard infant vaccines at 6 and 10 wk of age or to provide standard infant
      vaccines without HRV. The study was initiated November 1, 2008, and surveillance 
      was conducted concurrently at Matlab Diarrhoea Hospital and two community
      treatment centers to identify children less than 2 y of age presenting with acute
      rotavirus diarrhea (ARD) through March 31, 2011. Laboratory confirmation was made
      by enzyme immunoassay detection of rotavirus antigen in stool specimens. Overall 
      effectiveness of the HRV vaccination program (primary objective) was measured by 
      comparing the incidence rate of ARD among all children age-eligible for
      vaccination in villages where HRV was introduced to that among such children in
      villages where HRV was not introduced. Total effectiveness among vaccinees and
      indirect effectiveness were also evaluated. In all, 6,527 infants were
      age-eligible for vaccination in 71 HRV villages, and 5,791 in 71 non-HRV
      villages. In HRV villages, 4,808 (73.7%) infants received at least one dose of
      HRV. The incidence rate of ARD was 4.10 cases per 100 person-years in non-HRV
      villages compared to 2.8 per 100 person-years in HRV villages, indicating an
      overall effectiveness of 29.0% (95% CI, 11.3% to 43.1%). The total effectiveness 
      of HRV against ARD among vaccinees was 41.4% (95% CI, 23.2% to 55.2%). The point 
      estimate for total effectiveness was higher against ARD during the first year of 
      life than during the second (45.2% versus 28.9%), but estimates for the second
      year of life lacked precision and did not reach statistical significance.
      Indirect effects were not detected. To check for bias in presentation to
      treatment facilities, we evaluated the effectiveness of HRV against acute
      diarrhea associated with enterotoxigenic Escherichia coli; it was 4.0% (95% CI,
      -46.5% to 37.1%), indicating that bias likely was not introduced. Thirteen
      serious adverse events were identified among recipients of HRV, but none were
      considered related to receipt of study vaccine. The main limitation of this study
      is that it was an open-label study with an observed-only control group (no
      placebo). CONCLUSIONS: The two-dose HRV rotavirus vaccination program
      significantly reduced medically attended ARD in this low-resource population in
      Asia. Protection among vaccinees was similar to that in other low-resource
      settings. In low-resource populations with high rotavirus incidence, large-scale 
      vaccination across a wide population may be required to obtain the full benefit
      of rotavirus vaccination, including indirect effects. TRIAL REGISTRATION:
      ClinicalTrials.gov NCT00737503.
FAU - Zaman, K
AU  - Zaman K
AD  - International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka,
      Bangladesh.
FAU - Sack, David A
AU  - Sack DA
AUID- ORCID: http://orcid.org/0000-0002-9338-5119
AD  - Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United
      States of America.
FAU - Neuzil, Kathleen M
AU  - Neuzil KM
AUID- ORCID: http://orcid.org/0000-0001-9480-2714
AD  - PATH, Seattle, Washington, United States of America.
FAU - Yunus, Mohammad
AU  - Yunus M
AD  - International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka,
      Bangladesh.
FAU - Moulton, Lawrence H
AU  - Moulton LH
AUID- ORCID: http://orcid.org/0000-0001-7041-7387
AD  - Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United
      States of America.
FAU - Sugimoto, Jonathan D
AU  - Sugimoto JD
AUID- ORCID: http://orcid.org/0000-0002-1761-328X
AD  - Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 
      Seattle, Washington, United States of America.
FAU - Fleming, Jessica A
AU  - Fleming JA
AUID- ORCID: http://orcid.org/0000-0002-8187-5209
AD  - PATH, Seattle, Washington, United States of America.
FAU - Hossain, Ilias
AU  - Hossain I
AD  - International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka,
      Bangladesh.
FAU - Arifeen, Shams El
AU  - Arifeen SE
AUID- ORCID: http://orcid.org/0000-0002-5372-5932
AD  - International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka,
      Bangladesh.
FAU - Azim, Tasnim
AU  - Azim T
AD  - International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka,
      Bangladesh.
FAU - Rahman, Mustafizur
AU  - Rahman M
AD  - International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka,
      Bangladesh.
FAU - Lewis, Kristen D C
AU  - Lewis KDC
AD  - PATH, Seattle, Washington, United States of America.
FAU - Feller, Andrea J
AU  - Feller AJ
AD  - Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United
      States of America.
FAU - Qadri, Firdausi
AU  - Qadri F
AD  - International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka,
      Bangladesh.
FAU - Halloran, M Elizabeth
AU  - Halloran ME
AD  - Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 
      Seattle, Washington, United States of America.
AD  - Biostatistics Department, University of Washington, Seattle, Washington, United
      States of America.
FAU - Cravioto, Alejandro
AU  - Cravioto A
AD  - International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka,
      Bangladesh.
FAU - Victor, John C
AU  - Victor JC
AUID- ORCID: http://orcid.org/0000-0002-7970-6588
AD  - PATH, Seattle, Washington, United States of America.
LA  - eng
PT  - Journal Article
DEP - 20170418
PL  - United States
TA  - PLoS Med
JT  - PLoS medicine
JID - 101231360
EDAT- 2017/04/19 06:00
MHDA- 2017/04/19 06:00
CRDT- 2017/04/19 06:00
PHST- 2016/11/10 [received]
PHST- 2017/03/10 [accepted]
AID - 10.1371/journal.pmed.1002282 [doi]
AID - PMEDICINE-D-16-03639 [pii]
PST - epublish
SO  - PLoS Med. 2017 Apr 18;14(4):e1002282. doi: 10.1371/journal.pmed.1002282.
      eCollection 2017 Apr.

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