Rotavirus serotype surveillance: Results and experiences in Tanzania. Adolfine Hokororo. KPA Vaccinology Symposium- 29 th April

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Rotavirus serotype surveillance: Results and experiences in Tanzania Adolfine Hokororo KPA Vaccinology Symposium- 29 th April 2016 1

outline 1. Introduction-burden of RVGE 2. goals of RVGE sentinel surveillance 3. Surveillance in Tanzania 4. Results, lessons learnent, way forward KPA Vaccinology Symposium- 2016 29th April 2

Burden of Rotavirus Gastroenteritis Rotavirus (RV) is the most common cause of severe gastroenteritis (GE) in children worldwide 1 In children <5 years, RVGE is responsible for: 25 million outpatient visits per year (1986 2000 estimate)3 >2 million hospitalisations per year (1986 2000 estimate)3 453,000 deaths (2008 estimate)2 >WHO Strategic Advisory Group of Experts (SAGE) recommended the inclusion of RV vaccination in all national immunisation programmes to reduce the burden of disease 4 1. Parashar UD, et al. J Infect Dis 2009;200:S9 15; 2. Tate JE, et al. Lancet Infect Dis 2012;2:136 41; 3. Parashar UD, et al. Emerg Infect Dis 2003;9:565 72; 4. WHO. Wkly Epidemiol Rec 2009;84:213 36 KPA Vaccinology Symposium- 29th April 2016 3

Situation in Tanzania Diarrhea remains an important cause of morbidity and mortality among children under five (U5) in Tanzania.(1,2) Prevalence of 15%, about 23 900 annual deaths,11% of child mortality (1) Rotavirus infection accounts for significant proportion of these statistics. Local Studies reported prevalence of 8.4-43%(3-9) 1. WHO 2. 2. TDHS 3. 3-9. Brookfield e al 1976, Mhalu et a 1992, Sam et al 1992, Temu M et al 2002,, Gascon et al 2000, Moyo et al 2007, Temu A et al 2009 ) KPA Vaccinology Symposium- 29th April 2016 4

Sentinel surveillance for rotavirus Key objectives 1. Contribute data to estimate the burden of disease due to rotavirus AGE in children < 5 2. Monitor circulating rotavirus strains in the AFR region 3. Support awareness and regional advocacy efforts for the introduction of rotavirus vaccines 4. Post marketing surveillance for AEFI (baseline data on IS) 5. Evaluate impact following the introduction of these new vaccines KPA Vaccinology Symposium- 2016 29th April 5

Surveillance IN tanzania The surveillance was initiated in Tanga (Bombo Hospital) 2007. Zanzibar (Mnazi mmoja) and Mwanza (Bugando Medical Centre)- 2010. 2007-2013 KPA Vaccinology Symposium- 2016 29th April 6

Surveillance in TZ Rotavirus surveillance was initiated in Tanzania for the following purpose; To estimate the incidence of hospitalizations associated with rotavirus among under -fives; To determine the age and seasonal distribution of hospitalizations associated with rotavirus among under-fives; To estimate the proportion of diarrhoea hospitalizations attributable to rotavirus among children under-fives and To identify and characterize the prevalent strains of rotavirus in preparation for the introduction of vaccine. KPA Vaccinology Symposium- 29th April 2016 7

Inclusion criteria methods : Child under five years of age Admitted for treatment of acute gastroenteritis as a primary illness Gastroenteritis of 7 days Admitted to hospital ward (hospitalized), not out patient cases Exclusion Criteria Presence of any of the following Child aged equal or more than 5 years Child with bloody diarrhoea Child with symptoms > 7 days Patient acquired gastroenteritis during hospitalization for treatment of other diseases (hospital acquired gastroenteritis) A child who met the inclusion criteria = eligible to be enrolled (eligible case) into the surveillance A child was considered to be enrolled when a case report/ investigation Form (CIF) is completed and a stool specimen taken stool samples were taken within 48 hrs after admission and not more than 7 days after on set of acute diarrhea presence of rotavirus In stool samples was detected by Enzyme Linked Immunoassay (ELISA) 50 ELISA + samples from each site- randomly selected each year for Genotyping

methods Using WHO SOPs Children under 5 years of age who were hospitalized with acute diarrhea were enrolled, and their stool specimens were collected. Enzyme immunoassay- DAKO kits were used to detect rotavirus. Rotavirus positive samples were sent to Regional reference laboratory (RRL) in Medunsa for quality control and genotyping. Rotavirus strains were characterized for G and P types with use of a reverse-transcriptase polymerase chain reaction (RT-PCR). KPA Vaccinology Symposium- 29th April 2016 9

results From Nov 2007-June 2012; 2022 children were enrolled into the surveillance. Of 2022 children, 1998 (98%) stool samples were collected. Of 1998 collected samples 796(40%) were positive for rotavirus. Seasonal peaks, varied from year to year Jan-Feb in the first 2 years and Apr-June in the last two years. 88% of all rotavirus infections occurred among children below one year of age. Of 796 positive specimens, 308 (38.6%) specimens were sent to Regional Reference laboratory (RRL) for genotyping. Rotavirus infection was associated with a prolonged hospital stay and dehydration. KPA Vaccinology Symposium- 29th April 2016 10

2007_04 2008_01 2008_02 2008_03 2008_04 2009_01 2009_02 2009_03 2009_04 2010_01 2010_02 2010_03 2010_04 2011_01 2011_02 2011_03 2011_04 2012_01 2012_02 rotavirus cases per quarter 300 200 100 0 total diarrhea cases rota positive cases KPA Vaccinology Symposium- 2016 29th April 11

No of positive cases Total number of cases tested positive by age group from Nov 2007 to June 2012 500 450 400 350 300 250 200 150 100 50 0 Positive cases <1year 12-23mths 24-59 mths Positive cases 446 178 72 Age groups KPA Vaccinology Symposium- 2016 29th April 12

circulating genotypes 2008-2011 G9P8 3% G8P6 3% mixed GP 22% GIP8 34% G1P6 4% G2P4 15% G8P4 19% KPA Vaccinology Symposium- 2016 29th April 13

Vaccine introduction Tanzania introduced the rotavirus vaccine into the routine immunization programme in Jan 2013. Vaccine introduced - Rotarix - human monovalent vaccine G1 with a potential for cross protection. KPA Vaccinology Symposium- 2016 29th April 14

conclusions Rotavirus infection is responsible for 40% of severe gastroenteritis in Tanzania. G1P8, G8P4, G2P4 are responsible for 68% of infections There is diversity of genotypes of rotavirus infection causing gastroenteritis. These results were used by MOH and WHO to lobby for Rotavirus vaccine introduction in TZ KPA Vaccinology Symposium- 29th April 2016 15

Next steps : Surveillance is continuing with new objectives- from May 2013 1. Monitoring the vaccine impact on burden of rotavirus disease. 2. Assessing vaccine effectiveness. 3. Monitoring strain types. 4. Follow up on AEFI- Intussusception

WHO AFRO. WHO Country Office acknowledgements MOHSW/IVD - Tanzania Mainland and Zanzibar RGS Teams- Mwanza, Tanga and Zanzibar RRL-Medunsa- University of Limpopo Other partners, donors and stake holders in NVI KPA Vaccinology Symposium- 29th April 2016 17

Ahsanteni sana!!!