A sham case-control study of effectiveness of DTP-Hib-hepatitis B vaccine against rotavirus acute gastroenteritis in Kenya

Details

• Alternative Title:
  BMC Infect Dis
• Personal Author:
  Khagayi, Sammy ; Tate, Jacqueline E ; Onkoba, Reuben ; Parashar, Umesh ; Odhiambo, Frank ; Burton, Deron ; Laserson, Kayla ; Feikin, Daniel R
• Description:
  Background
  
  In many GAVI-eligible countries, effectiveness of new vaccines will be evaluated by case-control methodology. To inform the design and assess selection bias of a future case-control study of rotavirus vaccine effectiveness (VE) in western Kenya, we performed a sham case-control study evaluating VE of pentavalent vaccine (DTP-Hib-HepB) against rotavirus acute gastroenteritis (AGE).
  
  Methods
  
  From ongoing rotavirus surveillance, we defined cases as children 12 weeks to 23 months old with EIA-confirmed rotavirus AGE. We enrolled one community-based and two hospital-based control groups. We collected vaccination status from cards at enrollment, or later in homes, and evaluated VE by logistic regression.
  
  Results
  
  We enrolled 91 cases (64 inpatient, 27 outpatient), 252 non-rotavirus AGE facility-based controls (unmatched), 203 non-AGE facility-based controls (age-matched) and 271 community controls (age-matched). Documented receipt of 3 pentavalent doses was 77% among cases and ranged from 81-86% among controls. One percent of cases and 0-2% of controls had no pentavalent doses. The adjusted odds ratio of three versus zero doses for being a case was 3.27 (95% CI 0.01-1010) for community controls and 0.69 (95% CI 0.06-7.75) for non-rotavirus hospital-based AGE controls, translating to VE of -227% and 31%, respectively, with wide confidence intervals. (No facility-based non-AGE controls were unvaccinated.) Similar results were found for ≥2 pentavalent doses and for severe rotavirus AGE.
  
  Conclusions
  
  The study showed that it is feasible to carry out a real case control in the study area, but this needs to be done as soon as the vaccine is introduced to capture the real impact. Sham case-control or pilot studies before vaccine introduction can be useful in designing case-control VE studies.
  
  
• Subjects:
  Case-Control Studies Diphtheria-Tetanus-Pertussis Vaccine Female Gastroenteritis Haemophilus Vaccines Hepatitis B Vaccines Humans Infant Inpatients Logistic Models Male Outpatients Prevalence Research Design Rotavirus Infections Vaccines, Attenuated

  More +
• Source:
  BMC Infect Dis. 2014; 14:77.
• Document Type:
  Journal Article
• Place as Subject:
  Kenya
• Volume:
  14
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:6bf610b4d48eb2da6719867cd90b54a3cdf66167f145f47a56063bbc607dffa3
• Download URL:
  https://stacks.cdc.gov/view/cdc/22370/cdc_22370_DS1.pdf
• File Type:
  [PDF - 543.00 KB ]