title: Effectiveness of Monovalent Rotavirus Vaccine After Programmatic Implementation in Botswana: A Multisite Prospective Case-Control Study.
abstract: BACKGROUND
  Botswana introduced monovalent G1P rotavirus vaccine (RV1) in July 2012, providing one of the first opportunities to assess the effectiveness of routine RV1 vaccination in a high-burden setting in Africa. We sought to determine the effectiveness of RV1 against rotavirus diarrhea hospitalization using a case-control evaluation.
  
  
  METHODS
  Vaccine age-eligible children <5 years of age admitted with diarrhea at 4 hospitals in Botswana were enrolled from June 2013 to April 2015. Card-confirmed vaccine history was compared between case patients (children with laboratory-confirmed rotavirus diarrhea) and nonrotavirus "test-negative" diarrhea controls. Vaccine effectiveness (VE) was computed using unconditional logistic regression models adjusting for age, birth month/year, and hospital. Sequence-based genotyping was performed on antigen-positive samples.
  
  
  RESULTS
  Among 242 case patients and 368 controls, 82% (199/242) and 92% (339/368), respectively, had received ≥1 doses of RV1. Effectiveness of a full series (2 doses) of RV1 against rotavirus diarrhea requiring hospitalization was 54% (95% confidence interval [CI], 23%-73%); 1 dose of RV1 was 48% (95% CI, 1%-72%) effective. Effectiveness was 59% (95% CI, 4%-83%) against rotavirus caused by G2P, the most common (37%) circulating genotype. However, the effectiveness of 2 RV1 doses was significantly higher in children with no undernutrition (VE, 75% [95% CI, 41%-89%]), compared to those with moderate or severe undernutrition (VE, -28% [95% CI, -309% to 60%]) (P= .02).
  
  
  CONCLUSIONS
  Routine RV1 vaccination in Botswana showed effectiveness similar to that in clinical trials in Africa, including against a serotype fully heterotypic to the vaccine. Undernutrition may in part explain the lower rotavirus VE in low-income settings.
authors.affiliation: Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Gastañaduy
authors.affiliation: Department of Paediatrics and Adolescent Health, University of Botswana Botswana-UPenn Partnership, Gaborone Children's Hospital of Philadelphia and University of Pennsylvania Perelman School of Medicine.
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Steenhoff
authors.affiliation: Department of Medical Laboratory Sciences, University of Botswana and National Health Laboratory.
authors.forename: Margaret
authors.initials: M
authors.lastname: Mokomane
authors.affiliation: Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Mathew D
authors.initials: MD
authors.lastname: Esona
authors.affiliation: Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Bowen
authors.affiliation: Botswana Ministry of Health, Gaborone.
authors.forename: Haruna
authors.initials: H
authors.lastname: Jibril
authors.affiliation: Division of Infectious Disease, Department of Pediatrics, McMaster University, Hamilton, Canada.
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Pernica
authors.affiliation: Department of Paediatrics and Adolescent Health, University of Botswana Department of Pediatrics, Princess Marina Hospital, Gaborone, Botswana.
authors.forename: Loeto
authors.initials: L
authors.lastname: Mazhani
authors.affiliation: Department of Pathology and Molecular Medicine, McMaster University, Hamilton.
authors.forename: Marek
authors.initials: M
authors.lastname: Smieja
authors.affiliation: Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Jacqueline E
authors.initials: JE
authors.lastname: Tate
authors.affiliation: Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Umesh D
authors.initials: UD
authors.lastname: Parashar
authors.affiliation: Department of Paediatrics and Adolescent Health, University of Botswana Botswana-UPenn Partnership, Gaborone University of British Columbia, Vancouver, Canada.
authors.forename: David M
authors.initials: DM
authors.lastname: Goldfarb
mesh_terms: D001902:Botswana / Q000453:epidemiology; D016022:Case-Control Studies; D002675:Child, Preschool; D003967:Diarrhea / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology*; D005243:Feces / Q000821:virology; D005260:Female; D005838:Genotype; D006760:Hospitalization; D006801:Humans; D007223:Infant; D016015:Logistic Models; D008297:Male; D044342:Malnutrition / Q000453:epidemiology; D011446:Prospective Studies; D012401:Rotavirus / Q000276:immunology; D012400:Rotavirus Infections / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000276:immunology*; D064166:Vaccine Potency; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000276:immunology
chemical_list: C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated
keywords: Africa; diarrhea; rotavirus; rotavirus vaccine; vaccine effectiveness