TY - JOUR
T1 - Effectiveness of a monovalent rotavirus vaccine in infants in Malawi after programmatic roll-out
T2 - An observational and case-control study
AU - VACSURV Consortium
AU - Bar-Zeev, Naor
AU - Kapanda, Lester
AU - Tate, Jacqueline E.
AU - Jere, Khuzwayo C.
AU - Iturriza-Gomara, Miren
AU - Nakagomi, Osamu
AU - Mwansambo, Charles
AU - Costello, Anthony
AU - Parashar, Umesh D.
AU - Heyderman, Robert S.
AU - French, Neil
AU - Cunliffe, Nigel A.
AU - Beard, James
AU - Crampin, Amelia C.
AU - King, Carina
AU - Lewycka, Sonia
AU - Mvula, Hazzie
AU - Phiri, Tambosi
AU - Verani, Jennifer R.
AU - Whitney, Cynthia G.
N1 - Funding Information:
We thank the collaborating members of the VacSurv Consortium. This work was supported by a Wellcome Trust Programme Grant ( number 091909/Z/10/Z ) and the MLW Programme Core Award from the Wellcome Trust. Rotavirus genotyping in this paper was partially supported by a research grant from GlaxoSmithKline Biologicals. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the US Centers for Disease Control and Prevention.
Funding Information:
NB-Z and NF have received research grant support from GlaxoSmithKline Biologicals. MI-G has received research grant support from GlaxoSmithKline Biologicals and Sanofi Pasteur MSD. ON has received research grant support and honoraria from Japan Vaccine and Merck Sharp & Dohme for lectures on rotavirus vaccines. NAC has received research grant support and honoraria for participation in rotavirus vaccine advisory board meetings from GlaxoSmithKline Biologicals. All other authors declare no competing interests.
Publisher Copyright:
© 2015 Bar-Zeev, et al.
Copyright:
Copyright 2015 Elsevier B.V., All rights reserved.
PY - 2015/4/1
Y1 - 2015/4/1
N2 - Background: Rotavirus is the main cause of severe acute gastroenteritis in children in Africa. Monovalent human rotavirus vaccine (RV1) was added into Malawi's infant immunisation schedule on Oct 29, 2012. We aimed to assess the impact and effectiveness of RV1 on rotavirus gastroenteritis in the 2 years after introduction. Methods: From Jan 1, 2012, to June 30, 2014, we recruited children younger than 5 years who were admitted into Queen Elizabeth Central Hospital, Blantyre, Malawi, with acute gastroenteritis. We assessed stool samples from these children for presence of rotavirus with use of ELISA and we genotyped rotaviruses with use of RT-PCR. We compared rotavirus detection rates in stool samples and incidence of hospital admittance for rotavirus in children from Jan 1 to June 30, in the year before vaccination (2012) with the same months in the 2 years after vaccination was introduced (2013 and 2014). In the case-control portion of our study, we recruited eligible rotavirus-positive children from the surveillance platform and calculated vaccine effectiveness (one minus the odds ratio of vaccination) by comparing infants with rotavirus gastroenteritis with infants who tested negative for rotavirus, and with community age-matched and neighbourhood-matched controls. Findings: We enrolled 1431 children, from whom we obtained 1417 stool samples (99%). We detected rotavirus in 79 of 157 infants (50%) before the vaccine, compared with 57 of 219 (40%) and 52 of 170 (31%) in successive calendar years after vaccine introduction (p=0·0002). In the first half of 2012, incidence of rotavirus hospital admission was 269 per 100 000 infants compared with 284 in the same months of 2013 (rise of 5·8%, 95% CI -23·1 to 45·4; p=0·73) and 153 in these months in 2014 (a reduction from the prevaccine period of 43·2%, 18·0-60·7; p=0·003). We recruited 118 vaccine-eligible rotavirus cases (median age 8·9 months; IQR 6·6-11·1), 317 rotavirus-test-negative controls (9·4 months; 6·9-11·9), and 380 community controls (8·8 months; 6·5-11·1). Vaccine effectiveness for two doses of RV1 in rotavirus-negative individuals was 64% (95% CI 24-83) and community controls was 63% (23-83). The point estimate of effectiveness was higher against genotype G1 than against G2 and G12. Interpretation: Routine use of RV1 reduced hospital admissions for several genotypes of rotavirus in children younger than 5 years, especially in infants younger than 1 year. Our data support introduction of rotavirus vaccination at the WHO recommended schedule, with continuing surveillance in high-mortality countries. Funding: Wellcome Trust, GlaxoSmithKline Biologicals.
AB - Background: Rotavirus is the main cause of severe acute gastroenteritis in children in Africa. Monovalent human rotavirus vaccine (RV1) was added into Malawi's infant immunisation schedule on Oct 29, 2012. We aimed to assess the impact and effectiveness of RV1 on rotavirus gastroenteritis in the 2 years after introduction. Methods: From Jan 1, 2012, to June 30, 2014, we recruited children younger than 5 years who were admitted into Queen Elizabeth Central Hospital, Blantyre, Malawi, with acute gastroenteritis. We assessed stool samples from these children for presence of rotavirus with use of ELISA and we genotyped rotaviruses with use of RT-PCR. We compared rotavirus detection rates in stool samples and incidence of hospital admittance for rotavirus in children from Jan 1 to June 30, in the year before vaccination (2012) with the same months in the 2 years after vaccination was introduced (2013 and 2014). In the case-control portion of our study, we recruited eligible rotavirus-positive children from the surveillance platform and calculated vaccine effectiveness (one minus the odds ratio of vaccination) by comparing infants with rotavirus gastroenteritis with infants who tested negative for rotavirus, and with community age-matched and neighbourhood-matched controls. Findings: We enrolled 1431 children, from whom we obtained 1417 stool samples (99%). We detected rotavirus in 79 of 157 infants (50%) before the vaccine, compared with 57 of 219 (40%) and 52 of 170 (31%) in successive calendar years after vaccine introduction (p=0·0002). In the first half of 2012, incidence of rotavirus hospital admission was 269 per 100 000 infants compared with 284 in the same months of 2013 (rise of 5·8%, 95% CI -23·1 to 45·4; p=0·73) and 153 in these months in 2014 (a reduction from the prevaccine period of 43·2%, 18·0-60·7; p=0·003). We recruited 118 vaccine-eligible rotavirus cases (median age 8·9 months; IQR 6·6-11·1), 317 rotavirus-test-negative controls (9·4 months; 6·9-11·9), and 380 community controls (8·8 months; 6·5-11·1). Vaccine effectiveness for two doses of RV1 in rotavirus-negative individuals was 64% (95% CI 24-83) and community controls was 63% (23-83). The point estimate of effectiveness was higher against genotype G1 than against G2 and G12. Interpretation: Routine use of RV1 reduced hospital admissions for several genotypes of rotavirus in children younger than 5 years, especially in infants younger than 1 year. Our data support introduction of rotavirus vaccination at the WHO recommended schedule, with continuing surveillance in high-mortality countries. Funding: Wellcome Trust, GlaxoSmithKline Biologicals.
UR - http://www.scopus.com/inward/record.url?scp=84925351380&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84925351380&partnerID=8YFLogxK
U2 - 10.1016/S1473-3099(14)71060-6
DO - 10.1016/S1473-3099(14)71060-6
M3 - Article
C2 - 25638521
AN - SCOPUS:84925351380
VL - 15
SP - 422
EP - 428
JO - The Lancet Infectious Diseases
JF - The Lancet Infectious Diseases
SN - 1473-3099
IS - 4
ER -