Related Experiment Video
Updated: May 18, 2026
Assays for the Specific Growth Rate and Cell-binding Ability of Rotavirus
Published on: January 28, 2019
Human rotavirus vaccine Rotarix™ provides protection against diverse circulating rotavirus strains in African
Andrew Duncan Steele1, Kathleen M Neuzil, Nigel A Cunliffe
1Rotavirus Vaccine Program, PATH, 2201 Westlake Ave, Seattle, WA 98121, USA. duncan.steele@gatesfoundation.org
Insights
The Rotarix™ rotavirus vaccine effectively prevents severe gastroenteritis in infants, even when caused by various circulating rotavirus types. This provides evidence for the vaccine's broad protective capabilities against different rotavirus strains.
Area of Science:
- Pediatrics
- Infectious Diseases
- Vaccinology
Background:
- Rotaviruses are a leading cause of severe acute gastroenteritis in children globally.
- The Rotarix™ vaccine (human G1P[8]) showed significant reduction in severe rotavirus gastroenteritis in a Phase III trial.
- This study evaluated Rotarix™ efficacy against diverse rotavirus G and P types in infants.
Purpose of the Study:
- To assess the efficacy of the Rotarix™ vaccine in preventing severe rotavirus gastroenteritis in infants.
- To determine vaccine effectiveness against various circulating rotavirus G and P genotypes.
- To provide evidence for the heterotypic protection offered by the Rotarix™ vaccine.
Main Methods:
- Infants aged 5-10 weeks were randomized to receive two or three doses of Rotarix™ or placebo.
- Weekly home visits monitored for gastroenteritis episodes.
- Rotaviruses were detected by ELISA and genotyped using RT-PCR and sequencing to calculate vaccine efficacy against specific G and P types.
Main Results:
- Vaccine efficacy against G1 wild-type was 64.1%, against G12 was 51.5%, and against G8 was 64.4%.
- Efficacy against the predominant P[8] type was 59.1%, against P[4] was 70.9%, and against P[6] was 55.2%.
- Rotarix™ demonstrated effectiveness against multiple circulating rotavirus G and P types.
Conclusions:
- The Rotarix™ vaccine is effective in preventing severe rotavirus gastroenteritis caused by diverse circulating strains.
- These findings support the heterotypic protection conferred by the Rotarix™ vaccine.
- The study adds to the evidence base for Rotarix™'s broad-spectrum efficacy.
Background:
Rotaviruses are the most important cause of severe acute gastroenteritis worldwide in children <5 years of age. The human, G1P[8] rotavirus vaccine Rotarix™ significantly reduced severe rotavirus gastroenteritis episodes in a Phase III clinical trial conducted in infants in South Africa and Malawi. This paper examines rotavirus vaccine efficacy in preventing severe rotavirus gastroenteritis, during infancy, caused by the various G and P rotavirus types encountered during the first rotavirus-season.
Methods:
Healthy infants aged 5-10 weeks were enrolled and randomized into three groups to receive either two (10 and 14 weeks) or three doses of Rotarix™ (together forming the pooled Rotarix™ group) or three doses of placebo at a 6,10,14-week schedule. Weekly home visits were conducted to identify gastroenteritis episodes. Rotaviruses were detected by ELISA and genotyped by RT-PCR and nucleotide sequencing. The percentage of infants with severe rotavirus gastroenteritis caused by the circulating G and P types from 2 weeks post-last dose until one year of age and the corresponding vaccine efficacy was calculated with 95% CI.
Results:
Overall, 4939 infants were vaccinated and 4417 (pooled Rotarix™ = 2974; placebo = 1443) were included in the per protocol efficacy cohort. G1 wild-type was detected in 23 (1.6%) severe rotavirus gastroenteritis episodes from the placebo group. This was followed in order of detection by G12 (15 [1%] in placebo) and G8 types (15 [1%] in placebo). Vaccine efficacy against G1 wild-type, G12 and G8 types were 64.1% (95% CI: 29.9%; 82%), 51.5% (95% CI:-6.5%; 77.9%) and 64.4% (95% CI: 17.1%; 85.2%), respectively. Genotype P[8] was the predominant circulating P type and was detected in 38 (2.6%) severe rotavirus gastroenteritis cases in placebo group. The remaining circulating P types comprised of P[4] (20 [1.4%] in placebo) and P[6] (13 [0.9%] in placebo). Vaccine efficacy against P[8] was 59.1% (95% CI: 32.8%; 75.3%), P[4] was 70.9% (95% CI: 37.5%; 87.0%) and P[6] was 55.2% (95% CI: -6.5%; 81.3%)
Conclusions:
Rotarix™ vaccine demonstrated efficacy against severe gastroenteritis caused by diverse circulating rotavirus types. These data add to a growing body of evidence supporting heterotypic protection provided by Rotarix™.
Trial Registration Number:
NCT00241644.
