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Effectiveness of Pentavalent Rotavirus Vaccine in Shanghai, China: A Test-Negative Design Study
Wenjie Ma1, Zhongqiu Wei1, Jiayin Guo2
1Department of Infectious Disease, Children's Hospital of Fudan University, National Children's Medical Center, Shanghai, China.
Insights
A 3-dose RotaTeq (RV5) vaccine provides high protection against rotavirus gastroenteritis in young children in Shanghai. The study found 85% vaccine effectiveness, with the G8P8 genotype being most prevalent.
Area of Science:
- Pediatric infectious diseases
- Vaccinology
- Public health
Background:
- Rotavirus gastroenteritis remains a significant cause of childhood illness globally.
- The live oral pentavalent rotavirus vaccine (RotaTeq, RV5) is widely used, but its effectiveness in diverse populations requires ongoing evaluation.
- Understanding vaccine effectiveness (VE) is crucial for optimizing vaccination strategies and disease control.
Purpose of the Study:
- To assess the vaccine effectiveness (VE) of the live oral pentavalent rotavirus vaccine (RotaTeq, RV5) in young children in Shanghai, China.
- To determine the VE of RV5 against rotavirus gastroenteritis using a test-negative design.
- To identify prevalent rotavirus genotypes circulating in the study population.
Main Methods:
- A test-negative design study was conducted, recruiting children with acute diarrhea at a tertiary children's hospital in Shanghai.
- Clinical data and vaccination history were collected, and fecal samples were analyzed for rotavirus detection and genotyping.
- Unconditional logistic regression models were used to compare vaccination odds ratios between rotavirus-positive cases and test-negative controls, adjusting for confounders.
Main Results:
- The study enrolled 390 children, with 45 rotavirus-positive cases and 345 test-negative controls. After exclusions, 41 cases and 290 controls were analyzed for RV5 VE.
- The 3-dose RV5 vaccination demonstrated 85% VE (95% CI, 50%-95%) against mild to moderate rotavirus gastroenteritis in children aged 14 weeks to 4 years.
- Higher VE (97%, 95% CI, 83%-100%) was observed in children aged 14 weeks to 2 years. The predominant circulating rotavirus genotypes were G8P8 (78.95%), G9P8 (18.42%), and G2P4 (2.63%).
Conclusions:
- A 3-dose vaccination regimen of RotaTeq (RV5) offers high protection against rotavirus gastroenteritis in young children in Shanghai.
- The study highlights the significant impact of RV5 on reducing rotavirus disease burden in this population.
- The G8P8 genotype emerged as the most prevalent strain in Shanghai following the introduction of the RV5 vaccine.
Objective:
To evaluate vaccine effectiveness (VE) of a live oral pentavalent rotavirus vaccine (RotaTeq, RV5) among young children in Shanghai, China, via a test-negative design study.
Study Design:
We consecutively recruited children visiting a tertiary children's hospital for acute diarrhea from November 2021 to February 2022. Information on clinical data and rotavirus vaccination was collected. Fresh fecal samples were obtained for rotavirus detection and genotyping. To evaluate VE of RV5 against rotavirus gastroenteritis among young children, unconditional logistic regression models were conducted to compare ORs for vaccination between rotavirus-positive cases and test-negative controls.
Results:
A total of 390 eligible children with acute diarrhea were enrolled, including 45 (11.54%) rotavirus-positive cases and 345 (88.46%) test-negative controls. After excluding 4 cases (8.89%) and 55 controls (15.94%) who had received the Lanzhou lamb rotavirus vaccine, 41 cases (12.39%) and 290 controls (87.61%) were included for the evaluation of RV5 VE. After adjustment for potential confounders, the 3-dose RV5 vaccination showed 85% (95% CI, 50%-95%) VE against mild to moderate rotavirus gastroenteritis among children aged 14 weeks to ≤4 years and 97% (95% CI, 83%-100%) VE among children aged 14 weeks to ≤2 years with genotypes G8P8, G9P8, and G2P4 represented 78.95%, 18.42%, and 2.63% of circulation strains, respectively.
Conclusions:
A 3-dose vaccination of RV5 is highly protective against rotavirus gastroenteritis among young children in Shanghai. The G8P8 genotype prevailled in Shanghai after RV5 introduction.
