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Effect of Non-Rotavirus Enteric Infections on Vaccine Efficacy in a ROTASIIL Clinical Trial
Dilip Abraham1, Prasanna Samuel Premkumar1, James A Platts-Mills2
1The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India.
The American Journal of Tropical Medicine and Hygiene
|April 16, 2024
Summary
Rotavirus remains a primary cause of severe gastroenteritis in young Indian children. The ROTASIIL® vaccine showed moderate efficacy, with co-infections not significantly impacting performance in this study.
Area of Science:
- Pediatric infectious diseases
- Vaccinology
- Microbiology
Background:
- Severe gastroenteritis (GE) poses a significant health burden in children under two years old, particularly in low- and middle-income countries.
- Understanding the causative enteric pathogens and their impact on vaccine efficacy is crucial for public health interventions.
Purpose of the Study:
- To determine the proportion of enteric pathogens causing severe GE in Indian children under two years.
- To assess the influence of co-infections on the efficacy of the ROTASIIL® vaccine.
- To characterize the clinical presentation of severe GE associated with specific pathogens.
Main Methods:
- Quantitative polymerase chain reaction (qPCR) on stool samples from a phase III ROTASIIL® vaccine trial.
- Calculation of adjusted attributable fraction (AF) to determine pathogen contribution to disease.
- Test-negative design employed to estimate vaccine efficacy (VE) with and without co-infection adjustment.
Main Results:
- Rotavirus (23.5%) and adenovirus 40/41 (17.0%) were the most frequent pathogens identified.
- Shigella spp./enteroinvasive E. coli, norovirus GII, enterotoxigenic E. coli, and Cryptosporidium spp. were also significant contributors.
- Severe GE cases linked to rotavirus and Shigella spp. showed prolonged vomiting and diarrhea, respectively; Cryptosporidium spp. infections were more severe, requiring hospitalization.
- Adjusted VE for ROTASIIL® was 46.5% (ITT) and 49.1% (per-protocol).
Conclusions:
- Rotavirus remains the leading cause of severe GE in this pediatric population.
- Co-infections did not substantially reduce ROTASIIL® vaccine efficacy, suggesting other factors may influence vaccine performance in resource-limited settings.
- Further research is needed to identify the causes of severe GE not explained by the tested pathogens.
