Rotarix (rotavirus vaccine) / GSK - LARVOL DELTA

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

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 | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal Infections

Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=2320 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal Infections

Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=2320 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Infectious Disease • Pneumococcal 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 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Infectious Disease • Pneumococcal Infections

Significant abundance of bacterial flagellin and expression of its surface localized receptor toll-like receptor 5 and cytokine interleukin-22 in South African infants with poor oral rotavirus vaccine take. (PubMed, Gut Pathog) - "Fecal samples were collected from infants a week after first dose of Rotarix vaccination to establish vaccine shedders (n = 50) and non-shedders (n = 44)...The expression of IL-22 (p = 0.054), and not IL-18 dependent NLRC4 (p = 0.650), was increased 3.4-fold in non-shedders versus shedders. Collectively, our observations suggest a possible negative impact of the abundance of viable flagellated bacteria at the time of vaccination on the replication and therefore the performance of RV vaccines."

IO biomarker • Journal • Infectious Disease • Rotavirus Infections • IL18 • IL22 • TLR5

Effectiveness of monovalent rotavirus vaccine against hospital-attended rotavirus gastroenteritis among children in Uganda. (PubMed, Vaccine) - "Routine Rotarix vaccination was effective in preventing hospital visits for rotavirus diarrhea among Ugandan infants, although protection was not sustained after the first year of life. Protection was demonstrated against partially heterotypic rotavirus strains. These results support the continued use of rotavirus vaccines in Uganda. Additional studies are needed to understand the lower rotavirus VE seen in Uganda and other high-mortality settings."

Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants (clinicaltrials.gov) - P3 | N=1196 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed | Trial completion date: May 2025 ➔ Dec 2024

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

Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants (clinicaltrials.gov) - P3 | N=1200 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Oct 2024 ➔ May 2025

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

Epidemiological, molecular, and evolutionary characteristics of G1P[8] rotavirus in China on the eve of RotaTeq application. (PubMed, Front Cell Infect Microbiol) - "Phylogenetic and neutralizing epitope analysis showed that Rotavin-M1 might have better protection on G1P[8] prevalent in China than Rotarix and RotaTeq. Identity and phylogeny analysis showed that Chinese G1P[8] from before 2018 was generally stable with possible genetic recombination among local strains. These findings not only are of great significance for predicting the prevalence of G1P [8] in China, but also provide data reference for evaluating rotavirus vaccine efficacy."

Journal • Rotavirus Infections

Impact of dosing schedules on performance of rotavirus vaccines in Ghana. (PubMed, Sci Adv) - "We quantified the impact of the previously implemented 6/10-week Rotarix vaccine (RV1) in Ghana to the model-predicted impact for other vaccine dosing schedules across three hospitals and the entire country...A third dose could prevent an additional 9 to 14% of deaths. An additional dose of RV1 might be an effective strategy to improve rotavirus vaccine impact, particularly in settings with low vaccine effectiveness."

Journal • Rotavirus Infections

Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (clinicaltrials.gov) - P1/2 | N=750 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Meningococcal Infections • Pediatrics

The Apparent Lack of the Risk of Intussusception Immediately After Rotavirus Vaccination Among Japanese Infants. (PubMed, Viruses) - "The incidence rate ratio of vaccinated to unvaccinated infants between 42 and 245 days of life was estimated at 0.96 (95%CI: 0.43-2.1; p = 0.92). Given that over 95% of infants received the first dose before 15 weeks of age, the risk of intussusception associated with the rotavirus vaccines in high-incidence-rate countries can be reduced to a minimum by adhering to the recommended schedule at 2, 3, and 4 months of age."

Journal • Retrospective data • Rotavirus Infections

Impact of rotavirus vaccination in Malawi from 2012 to 2022 compared to model predictions. (PubMed, NPJ Vaccines) - "Rotarix® vaccine was introduced into the Malawi national immunization program in October 2012...Comparing observed RVGE cases to the model-predicted incidence without vaccination, overall effectiveness was estimated to be modest at 36.0% (95% prediction interval: 33.6%, 39.9%), peaking in 2014, and was highest in infants (52.5%; 95% prediction interval: 50.1%, 54.9%). Our mathematical models provide a validated platform for assessing strategies to improve rotavirus vaccine impact in low-income settings."

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

A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants (clinicaltrials.gov) - P3 | N=400 | Completed | Sponsor: GlaxoSmithKline | Recruiting ➔ Completed

Trial completion • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks (clinicaltrials.gov) - P3 | N=2000 | Completed | Sponsor: GlaxoSmithKline | Recruiting ➔ Completed

Trial completion • Gastroenterology • Gastrointestinal Disorder