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Diarrheal etiology and impact of co-infections on rotavirus vaccine efficacy estimates in a clinical trial of a monovalent human-bovine (116E) oral rotavirus vaccine, Rotavac, India.

Background: Rotavirus vaccine (RV) efficacy estimates in low-resource settings are lower than in developed countries. We detected co-infections in cases of severe rotavirus diarrhea in a RV efficacy trial to determine whether these negatively impacted RV efficacy estimates.

Methods: We performed TaqMan Array Card assays for enteropathogens on stools from rotavirus EIA positive diarrhea episodes and all severe episodes (Vesikari score >= 11), from a phase III vaccine efficacy trial of Rotavac®, a monovalent human-bovine (116E) rotavirus vaccine, carried out across three sites in India. We estimated pathogen-specific etiologies of diarrhea, described associated clinical characteristics, and estimated the impact of co-infections on RV efficacy using the test-negative design.

Results: 1507 specimens from 1169 infants were tested for the presence of co-infections. Rotavirus was the leading cause of severe diarrhea even among vaccinated children, followed by adenovirus 40/41, Shigella/EIEC, norovirus GII, sapovirus, and Cryptosporidium spp. Bacterial co-infections in rotavirus positive diarrhea were associated with a longer duration of diarrhea and protozoal co-infections with increased odds of hospitalization. Using the test-negative design, RV efficacy against severe rotavirus gastroenteritis increased from 49.3% to 60.6% in the absence of co-infections (difference 11.3%; 95% CI: -10.3, 30.2).

Conclusion: While rotavirus was the dominant etiology of severe diarrhea, even in vaccinated children, a broad range of other etiologies was identified. Accounting for co-infections led to an 11.3% increase in the vaccine efficacy estimate. Although not statistically significant, an 11.3% decrease in vaccine efficacy due to presence of co-infections would explain an important fraction of the low RV efficacy in this setting.

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