Sustained impact of rotavirus vaccine on rotavirus hospitalisations in Lusaka, Zambia, 2009-2016.

BACKGROUND: Monovalent rotavirus vaccine (RV1) was introduced in Lusaka in February 2012 and rolled out countrywide in November 2013 in the routine Expanded Programme on Immunisation and administered at 6 and 10 weeks with no catch up dose. Reported here is the monitoring of rotavirus acute gastroenteritis hospitalisations at the University Teaching Hospital, Lusaka, Zambia as part of efforts to document the impact of rotavirus vaccine. METHODS: Children <5 years hospitalised for acute gastroenteritis (AGE) from January 2009 to December 2016 were recruited into the rotavirus disease burden active surveillance and had their stools tested for rotavirus by enzyme immunoassay. We compared rotavirus-associated AGE hospitalisations of the pre-vaccine era (2009-2011) with the post-rotavirus vaccine introduction period (2013-2016). RESULTS: With the increase in RV1 coverage in Lusaka, rotavirus AGE declined significantly from 40% of diarrhoea hospitalisation in the pre-vaccine era to 29% of diarrhoea hospitalisation in the post-vaccine era (p < 0.001) in children <5 years. After a decreasing trend in rotavirus positivity from 2013 to 2015, positivity increased to 37% in 2016. However, the post-vaccine years (2012-2016) saw substantial decline in the number tested (median decline: 34% (range: 20-43%)) and the number of positive results (median decline: 52% (range: 30-65%). CONCLUSION: A sustained and significant decline in rotavirus AGE hospitalisations was observed in children <5 years since the introduction of RV1 in Lusaka, Zambia. Despite an increase in rotavirus positivity in 2016, the total number of children enrolled and the number of rotavirus positive children remained below baseline. The reason for the increase in rotavirus positivity in 2016 is unknown but could be due to an accumulation of susceptible children and the shifting of disease to children of older age groups. This finding underscores the need for continued monitoring of rotavirus vaccine impact.

Diversity of rotavirus strains circulating in children under five years of age who presented with acute gastroenteritis before and after rotavirus vaccine introduction, University Teaching Hospital, Lusaka, Zambia, 2008-2015.

BACKGROUND: Following the introduction of rotavirus vaccine into the routine immunization schedule, the burden of rotavirus disease has significantly reduced in Zambia. Although rotavirus vaccines appear to confer good cross-protection against both vaccine and non-vaccine strains, concerns about strain replacement following vaccine implementation remain. We describe the diversity of the circulating rotavirus strains before and after the Rotarix® vaccine was introduced in Lusaka from January 2012. METHODS: Under five children were enrolled through active surveillance at University Teaching Hospital using a standardized WHO case investigation form. Stool samples were collected from children who presented with ≥3 loose stool in 24 h and were admitted to the hospital for acute gastroenteritis as a primary illness. Samples were tested for group A rotavirus antigen enzyme-linked immunosorbent assay. Randomly selected rotavirus positive samples were analysed by reverse transcription polymerase chain reaction for G and P genotyping and and Nucleotide sequencing was used to confirm some mixed infections. RESULTS: A total of 4150 cases were enrolled and stool samples were collected from 4066 (98%) children between 2008 and 2011, before the vaccine was introduced. Rotavirus antigen was detected in 1561/4066 (38%). After vaccine introduction (2012 to 2015), 3168 cases were enrolled, 3092 (98%) samples were collected, and 977/3092 (32%) were positive for rotavirus. The most common G and P genotype combinations before vaccine introduction were G1P[8] (49%) in 2008; G12P[6] (24%) and G9P[8] (22%) in 2009; mixed rotavirus infections (32%) and G9P[8] (20%) in 2010, and G1P[6] (46%), G9P[6] (16%) and mixed infections (20%) in 2011. The predominant strains after vaccine introduction were G1P[8] (25%), G2P[4] (28%) and G2P[6] (23%) in 2012; G2P[4] (36%) and G2P[6] (44%) in 2013; G1P[8] (43%), G2P[4] (9%), and G2P[6] (24%) in 2014, while G2P[4] (54%) and G2P[6] (20%) continued to circulate in 2015. CONCLUSION: These continual changes in the predominant strains suggest natural secular variation in circulating rotavirus strains post-vaccine introduction. These findings highlight the need for ongoing surveillance to continue monitoring how vaccine use affects strain evolution over a longer period of time and assess any normal seasonal fluctuations of the rotavirus strains.