Rotarix (rotavirus vaccine) / GSK - LARVOL DELTA

Pathogen-Focused Metagenomic Analysis of Pediatric Diarrheal Cases among Children under Five in Zambia Reveals Predominance of Human Rotavirus Genotypes G3 and G12 (ASTMH 2025) - "VP7 analysis revealed the presence of genotypes G1, G2, G3, G8, G9, and G12, which mostly clustered with global reference strains, while VP4 analysis identified P[4], P[6], P[8], and P[11] genotypes that form clades with vaccine strains (Rotarix & Rotavac) and wild-type lineages. Importantly, fully vaccinated children experienced milder disease compared to partially vaccinated or unvaccinated children (p = 0.002).This study demonstrates the significant value of VCS in genomic surveillance of vaccine-preventable diseases. It enables high-resolution detection of viral genotypes, reassortants, and antigenic variants, thereby facilitating real-time monitoring of viral evolution and guiding adaptive immunization programs and public health responses."

Clinical • Genomic analysis • Omic analysis • Pediatrics • Rotavirus Infections

Rotavirus A genotype diversity and antigenic profile in Central Ethiopia: implications for rotarix® vaccine efficacy. (PubMed, Front Microbiol) - "The dominance of the G9P[4] genotype, together with substantial amino acid substitutions in the current circulating RVA strains that diverge from the G1P[8] Rotarix® strain, may compromise vaccine performance. These findings underscore the need to evaluate vaccine efficacy, maintain molecular surveillance, and incorporate broader genotype coverage in future vaccine design."

Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Australian Rotavirus Surveillance Program: Annual Report, 2024. (PubMed, Commun Dis Intell (2018)) - "Of the 1,880 samples confirmed rotavirus positive, 1,610 (85.6%) were identified as wildtype rotavirus; 268 (14.3%) were identified as the Rotarix vaccine-like strain; and two G1P[8] samples could not be confirmed as wildtype or vaccine-like due to inadequate sequence quality...Understanding the diversity of genotypes in circulation, and the emergence of variants, provides important context for any changes observed in disease epidemiology in the community. The Australian Rotavirus Surveillance Program provides diagnostic laboratories with valuable feedback on laboratory data quality, by reporting incidences of wildtype, vaccine-like, and/or false positive rotavirus results."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Rotavirus Infections

Genomic Analysis of Rotavirus G8P[8] Strains Detected in the United States Through Active Surveillance, 2016-2017. (PubMed, Viruses) - "During the 2016-2017 rotavirus surveillance season, the New Vaccine Surveillance Network (NVSN) identified 36 G8P[8] rotavirus strains across four sites in the U.S. This study presents the whole-genome characterization of these G8P[8] strains, along with comparative sequence analyses against the current vaccine strains, Rotarix and RotaTeq. Clinical analysis revealed no significant differences in hospitalization rates, length of stay, or severity scores between G8P[8] RVA-positive and non-G8P[8] RVA-positive subjects. Additionally, phylodynamic analysis determined the evolutionary rates and the most recent common ancestor for these strains, highlighting the importance of ongoing monitoring of rotavirus genotypes to assess the spread of these emerging G8P[8] strains."

Journal • Infectious Disease • Rotavirus Infections

Rotavirus Genotype Dynamics and the Emergence of G3P[8] in Thailand Following Nationwide Vaccine Implementation. (PubMed, Int J Mol Sci) - "The introduction of two live-attenuated oral vaccines, Rotarix and RotaTeq, has significantly decreased illness and death associated with rotavirus in countries where they are included in childhood immunization schedules. This study demonstrated a significant decline in the prevalence of rotavirus A infection in pediatric patients in Chiang Mai, Thailand, during the post-vaccination period. The findings from this study contribute to a better understanding of rotavirus epidemiology in Thailand following the implementation of the rotavirus vaccines."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Pediatrics • Rotavirus Infections

Two decades of GSK rotavirus vaccine (RV1): a global analysis to estimate vaccination completion and deaths averted in children under 5 years. (PubMed, Expert Rev Vaccines) - "By December 2025, 0.5 billion babies will be protected with RV1, resulting in 259,000 RVGE-related deaths avoided since 2004. RV1 has contributed to reducing the number of RVGE cases and related deaths and is anticipated to continue reducing this disease burden."

Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Intussusception risk after rotavirus vaccination in Korean infants. (PubMed, Vaccine) - "The risk of intussusception increased within 7 days after the first dose of Rotarix vaccination, while no significant evidence of an increased risk was observed after RotaTeq vaccination."

Journal • Rotavirus Infections

Maternal-infant rotavirus-specific antibody kinetics to inform timing of vaccine boosting in Malawi: An observational study. (PubMed, PLoS Med) - "These findings suggest that administering a booster dose between 6 and 8 months of age, when maternal antibody titer is low and severe rotavirus gastroenteritis risk is high, may enhance the immunogenicity and effectiveness of the rotavirus vaccine in LMICs."

Journal • Observational data • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Whole genome characterisation of DS-1-like G8P[4] rotavirus A strains circulating in South Africa between 2009 and 2021 reveals endemic sub-lineages and evidence of radical epitope changes. (PubMed, Infect Genet Evol) - "Radical amino acid substitutions were identified in neutralising epitopes of VP4 (11 variations) and VP7 (18 variations) relative to the Rotarix® vaccine strain...These findings within the key antigenic sites of G8P[4] strains may reflect ongoing viral adaptation with potential implications for infectivity and sustained circulation in African regions. Taken together, the findings underscore the significance of continued genomic surveillance to monitor evolution and guide the reassessment, optimisation of current vaccines and the development of future vaccines with broader protective efficacy."

Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Unveiling a Shift in the Rotavirus Strains in Benin: Emergence of Reassortment Intergenogroup and Equine-like G3P[8] Strains in the Post-Vaccination Era. (PubMed, Viruses) - "In the P[8] gene, three conservative (N195G, N195D, N113D) and one radical (D133N) substitutions were observed when compared with vaccine strains Rotarix and RotaTeq. These findings suggest continuous viral evolution, potentially driven by vaccine pressure. Ongoing genomic surveillance is essential to monitor genotype shifts as part of the efforts to evaluate the impact of emerging strains and to assess vaccine effectiveness in Sub-Saharan Africa."

Journal • Rotavirus Infections

Unveiling the Genomic Landscape of G2P[6] Rotavirus a Strains in Brazil: Evolutionary and Epidemiological Perspectives. (PubMed, Viruses) - "In Brazil, molecular surveillance expanded after Rotarix™ vaccine introduction, alongside G2P[4] dominance...Phylogenetic data indicate multiple reassortment events and international viral exchange, highlighting Brazil's role in RVA diversity. Ongoing full-genome surveillance is crucial to track rare variants and assess their public health relevance."

Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

High-Throughput Flow Cytometry-Based Titration of a Live Attenuated Rotavirus Vaccine. (PubMed, J Biotechnol) - "Here, we report a flow cytometry-based method for potency assessment of the Rotarix rotavirus vaccine...The coefficient of variation for inter- and intra-assay for both formulations is ≈2%. Moreover, the flow cytometry method reduced the hands-on and analysis time by at least 4 days, offering a rapid high-throughput alternative tool to streamline the challenges associated with potency testing for viral-based vaccines, impacting therapeutics time to market."

Journal • Infectious Disease • Rotavirus Infections

Cost-effectiveness and benefit-risk of rotavirus vaccination in Afghanistan: a modelling analysis informed by post-licensure surveillance. (PubMed, BMC Health Serv Res) - "Our study supports the sustained use of rotavirus vaccination in Afghanistan. The health benefits of the vaccine greatly exceed the potential risks."

Benefit-risk assessment • HEOR • Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Rotavirus alphagastroenteritidis: Circulating Strains After the Introduction of the Rotavirus Vaccine (Rotarix®) in Luanda Province of Angola. (PubMed, Viruses) - "The genotype combinations G3P[6], G8P[6], and G12P[8] were detected for the first time in Luanda Province. In conclusion, the emergence of new genotype combinations supports the need for continuous surveillance to identify the trend in R. alphagastroenteritidis infection and the emergence of new strains circulating in Luanda Province in the post-vaccination period."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Pediatrics • Rotavirus Infections

Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=580 | Recruiting | Sponsor: Sanofi | Trial completion date: May 2027 ➔ Aug 2027 | Trial primary completion date: May 2027 ➔ Aug 2027

Trial completion date • Trial primary completion date • Infectious Disease • Pneumococcal Infections

Australian Rotavirus Surveillance Program Annual Report, 2023. (PubMed, Commun Dis Intell (2018)) - "Of these confirmed rotavirus positive samples, 1,554 of 1,781 (87.3%) were identified as wildtype rotavirus, and 226 of 1,781 (12.7%) were identified as the Rotarix vaccine-like strain...The ability to monitor the genotypes of rotavirus strains causing disease across ages and across jurisdictions provides important data on assessing the performance of the national rotavirus vaccine program and to inform public health interventions during outbreaks. This Australian Rotavirus Surveillance Program also provides important data to monitor annual variations in genotypic patterns and to provide diagnostic laboratories with quality assurance by reporting incidences of wildtype, vaccine-like, or false positive rotavirus results."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Rotavirus Infections

Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa (clinicaltrials.gov) - P2 | N=720 | Completed | Sponsor: Centre for Infectious Disease Research in Zambia | Active, not recruiting ➔ Completed

Trial completion • Rotavirus Infections

Genetic and Antigenic Variability in VP4 and VP7 of Group A Human Rotavirus in Yunnan, China from 2015-2020. (PubMed, Intervirology) - "Our study shows that G9P [8] is the most dominant rotavirus genotype in Yunnan China. Consistent with the recent epidemic trend of RV strains in China, this study could provide new perspectives on vaccine research."

Journal • Rotavirus Infections

Early-life gut microbiome associates with positive vaccine take and shedding in neonatal schedule of the human neonatal rotavirus vaccine RV3-BB. (PubMed, Nat Commun) - P2 | "High abundance of Streptococcus and Staphylococcus is associated with no shedding in the neonatal schedule group. RV3-BB vaccine administered in a neonatal schedule modulates the early microbiome environment and presents a window of opportunity to optimise protection from rotavirus disease."

Clinical • Journal • Infectious Disease • Rotavirus Infections

Cost-effectiveness analysis of alternative infant and neonatal rotavirus vaccination schedules in Malawi. (PubMed, PLOS Glob Public Health) - "Considering the neonatal vaccine is not yet available, adding a third dose of Rotarix at 14 weeks of age is cost-effective at WTP thresholds above $138 per DALY averted. The neonatal vaccine offers a more cost-effective alternative to Malawi's current rotavirus vaccine, while adding a third dose to the current strategy also provides substantial benefits."

HEOR • Journal • Rotavirus Infections

Whole-Genome Analysis of G2P[4] Rotavirus Strains in China in 2022 and Comparison of Their Antigenic Epitopes with Vaccine Strains. (PubMed, Viruses) - "High genetic variability among the newly characterized G2P[4] RVA strains suggest the strains evolve fast. Finally, our data suggest that the multivalent RotaTeq vaccine could have provided better protection than the monovalent Rotarix and LLR."

Clinical • Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Diverse processes in rotavirus vaccine development. (PubMed, Hum Vaccin Immunother) - "While two widely used vaccines, Rotarix and RotaTeq, have shown good efficacy in high-income countries, their effectiveness is lower in low- and middle-income countries due to factors such as malnutrition and poor sanitation.4-6 These challenges include complex vaccination schedules and high production costs. Researchers are working on novel vaccines, including inactivated virus and viral protein-based options, as well as virus-like particles and recombinant proteins.7-9 Improving vaccine stability and applicability is crucial for resource-limited settings, and global vaccination strategies are expected to significantly reduce infection burdens, improve child health, and contribute to the achievement of global health goals.10-14."

Journal • Review • Infectious Disease • Rotavirus Infections

Regional difference on rotavirus vaccine coverage in children with diarrhea in Mozambique, before and during COVID-19 pandemic: a cross-sectional analysis. (PubMed, BMC Infect Dis) - "Despite national level increase of the rotavirus vaccine coverage, during the COVID-19 pandemic, there was a significant reduction in the sentinel site in the center region of the country. Future rotavirus interventions should target areas with lowest rotavirus vaccine coverage, also, rotavirus diarrheal cases and severity should be monitored in those settings to evaluate the interventions impact."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Rotavirus Infections

Challenges and lessons learned during the switching of rotavirus vaccine from Rotarix to Rotavac in Zambia. (PubMed, Vaccine) - "The impact of the Rotarix vaccine era was reversed due to the global supply chain disruptions, leading to missed vaccinations, increased diarrhea-related hospitalizations, and higher infant mortality in Zambia. The COVID-19 pandemic may also have further disrupted the vaccination sessions, further impacting rotavirus vaccination. Rotarix shortages likely contributed to rising rotavirus cases. There is an urgent need to completely replace the old under-5 vaccination card with a revised one to improve documentation for new rotavirus vaccines."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Novel Coronavirus Disease • Rotavirus Infections

ROTA-biotic: Measuring the Impact of Rotavirus Vaccines on Paediatric Antibiotic Usage (clinicaltrials.gov) - P=N/A | N=1600 | Completed | Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

New trial • Gastroenterology • Gastrointestinal Disorder • Pediatrics • Rotavirus Infections