Hepatitis B vaccine stored outside the cold chain setting: a pilot study in rural Lao PDR

Background: 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 degrees 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. Methods: 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). Findings: 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. Interpretation: 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. Published by Elsevier Ltd.