Key result
Rotavirus vaccine demonstrated 84% effectiveness against acute gastroenteritis in EIA-positive children, but offered no significant protection in EIA-negative children with virus detected by qRT-PCR alone.
Why the study?
Does rotavirus vaccination prevent acute gastroenteritis in children under 5 years of age when evaluated using different diagnostic assays?
Case-Control (n=1,148)
Yes
Does rotavirus vaccination prevent acute gastroenteritis in children under 5 years of age when evaluated using different diagnostic assays?
Effect estimate: VE 84% (95% CI 71%-91%)
Enzyme immunoassay (EIA) remains the most appropriate diagnostic tool for evaluating rotavirus vaccine effectiveness, as qRT-PCR detects low-level viral shedding that may not be causally associated with acute gastroenteritis.
Rotavirus vaccine efficacy may vary by diagnostic method; leaves open clinical relevance of qRT-PCR-only detections in case-control data.
We compared rotavirus detection rates in children with acute gastroenteritis (AGE) and in healthy controls using enzyme immunoassays (EIAs) and semiquantitative real-time reverse transcription PCR (qRT-PCR). We calculated rotavirus vaccine effectiveness using different laboratory-based case definitions to determine which best identified the proportion of disease that was vaccine preventable. Of 648 AGE patients, 158 (24%) were EIA positive, and 157 were also qRT-PCR positive. An additional 65 (10%) were qRT-PCR positive but EIA negative. Of 500 healthy controls, 1 was EIA positive and 24 (5%) were qRT-PCR positive. Rotavirus vaccine was highly effective (84% [95% CI 71%-91%]) in EIA-positive children but offered no significant protection (14% [95% CI -105% to 64%]) in EIA-negative children for whom virus was detected by qRT-PCR alone. Children with rotavirus detected by qRT-PCR but not by EIA were not protected by vaccination, suggesting that rotavirus detected by qRT-PCR alone might not be causally associated with AGE in all patients.
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Tate et al. (2013) conducted a case-control in Acute gastroenteritis (n=1,148). Rotavirus vaccine vs. Unvaccinated was evaluated on Vaccine effectiveness against rotavirus-associated acute gastroenteritis in EIA-positive children (VE 84%, 95% CI 71%-91%). Rotavirus vaccine demonstrated 84% effectiveness against acute gastroenteritis in EIA-positive children, but offered no significant protection in EIA-negative children with virus detected by qRT-PCR alone.
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