title: Hepatitis B vaccine stored outside the cold chain setting: a pilot study in rural Lao PDR.
abstract: Hepatitis B vaccine birth dose (HepB-BD) was introduced in Lao People's Democratic Republic (Lao-PDR) to prevent perinatal hepatitis B virus transmission. HepB-BD, which is labeled for storage between 2 and 8°C, is not available at all health facilities, because of some lack of functional cold chain; however, previous studies show that HepB-BD is stable if stored outside the cold chain (OCC). A pilot study was conducted in Lao-PDR to evaluate impact of OCC policy on HepB-BD coverage.
  
  
  
  During the six month pilot, HepB-BD was stored OCC for up to 28 days in two intervention districts and stored in cold chain in two comparison districts. In the intervention districts, healthcare workers were educated about HepB-BD and OCC storage. A post-pilot survey compared HepB-BD coverage among children born during the pilot (aged 2-8 months) and children born 1 year before (aged 14-20 months).
  
  
  
  In the intervention districts, 388 children aged 2-8 months and 371 children aged 14-20 months were enrolled in the survey; in the comparison districts, 190 children aged 2-8 months and 184 children aged 14-20 months were enrolled. Compared with the pre-pilot cohort, a 27% median increase in HepB-BD (interquartile range [IQR] 58%, p<0.0001) occurred in the pilot cohort in the intervention districts, compared with a 0% median change (IQR 25%, p=0.03) in comparison districts. No adverse reactions were reported.
  
  
  
  OCC storage improved HepB-BD coverage with no increase in adverse reactions. Findings can guide Lao-PDR on implementation and scale-up options of OCC policy.
authors.affiliation: Division of Viral Hepatitis, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, 30329, GA, USA. Electronic address: akolwaite@cdc.gov.
authors.forename: Amy R
authors.initials: AR
authors.lastname: Kolwaite
authors.affiliation: National Immunization Program, Mother and Child Health Center, Ministry of Health, Simuang Road, Vientiane, Lao People's Democratic Republic.
authors.forename: Anonh
authors.initials: A
authors.lastname: Xeuatvongsa
authors.affiliation: WHO Representative Office in the Lao People's Democratic Republic, That Luang Road, Vientiane, Lao People's Democratic Republic.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Ramirez-Gonzalez
authors.affiliation: Global Immunization Division, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, 30329, GA, USA.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Wannemuehler
authors.affiliation: Faculty of Postgraduate Studies, University of Health Sciences, Ministry of Health, Samsenthai Road, Vientiane, Lao People's Democratic Republic.
authors.forename: Viengnakhone
authors.initials: V
authors.lastname: Vongxay
authors.affiliation: Faculty of Postgraduate Studies, University of Health Sciences, Ministry of Health, Samsenthai Road, Vientiane, Lao People's Democratic Republic.
authors.forename: Vansy
authors.initials: V
authors.lastname: Vilayvone
authors.affiliation: WHO Regional Office for the Western Pacific, Corner of United Nations Avenue and Taft Avenue, Ermita, 1000 Manila, Philippines.
authors.forename: Karen
authors.initials: K
authors.lastname: Hennessey
authors.affiliation: Global Immunization Division, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, 30329, GA, USA.
authors.forename: Minal K
authors.initials: MK
authors.lastname: Patel
mesh_terms: D004356:Drug Storage; D005260:Female; D017325:Hepatitis B Vaccines / Q000032:analysis*; D006801:Humans; D007223:Infant; D007812:Laos; D008297:Male; D010865:Pilot Projects; D012034:Refrigeration; D012424:Rural Population; D014611:Vaccination / Q000706:statistics & numerical data*
chemical_list: D017325:Hepatitis B Vaccines
keywords: Hepatitis B vaccine; Hepatitis B vaccine birth dose; Hepatitis B virus; Lao People's Democratic Republic; Outside the cold chain