Rotavirus Vaccine Research Articles

Human cytomegalovirus seropositivity and its influence on oral rotavirus vaccine immunogenicity: a specific concern for HIV-exposed-uninfected infants.

Oral rotavirus vaccines demonstrate diminished immunogenicity in low-income settings where human cytomegalovirus infection is acquired early in childhood and modulates immunity. We hypothesized that human cytomegalovirus infection around the time of vaccination may influence immunogenicity. We measured plasma human cytomegalovirus-specific immunoglobulin M antibodies in rotavirus vaccinated infants from 6 weeks to 12 months old and compared rotavirus immunoglobulin A antibody titers between human cytomegalovirus seropositive and seronegative infants. There was no evidence of an association between human cytomegalovirus serostatus at 9 months and rotavirus-specific antibody titers at 12 months (geometric mean ratio 1.01, 95% CI: 0.70, 1.45; P = 0.976) or fold-increase in RV-IgA titer between 9 and 12 months (risk ratio 0.999, 95%CI: 0.66, 1.52; P = 0.995) overall. However, HIV-exposed-uninfected infants who were seropositive for human cytomegalovirus at 9 months old had a 63% reduction in rotavirus antibody geometric mean titers at 12 months compared to HIV-exposed-uninfected infants who were seronegative for human cytomegalovirus (geometric mean ratio 0.37, 95% CI: 0.17, 0.77; P = 0.008). While the broader implications of human cytomegalovirus infections on oral rotavirus vaccine response might be limited in the general infant population, the potential impact in the HIV-exposed-uninfected infants cannot be overlooked. This study highlights the complexity of immunological responses and the need for targeted interventions to ensure oral rotavirus vaccine efficacy, especially in vulnerable subpopulations.

Effect of the COVID-19 Pandemic on Rotavirus Infection Frequency in Children

Aims: During the COVID-19 pandemic, measures such as the wearing of masks, social distancing, enhanced hygiene practices, closures of workplaces and schools, and lockdowns influenced the spread of various infectious diseases. This study aimed to compare the frequency of rotavirus infections during the pandemic to that of the pre-pandemic period.
 Methods: This retrospective study included 2912 patients diagnosed with acute gastroenteritis who were admitted to the Pediatric Health and Diseases Department of Hisar Intercontinental Hospital between January 2018 and August 2022. For the diagnosis of rotavirus infection, the Rota-Adeno Ag Rapid Test-Cassette was applied to stool samples as an immunochromatographic method. Patients were divided into two groups based on their hospital admission dates: before the COVID-19 pandemic (1 January 2018 to 10 March 2020) and during the COVID-19 pandemic (11 March 2020 to 30 August 2022).
 Results: The prevalence of rotavirus infection in the entire population was 9.5% (n=277). The rate of cases of rotavirus infection was higher among patients during the COVID-19 pandemic compared to the group of patients before the COVID-19 pandemic (10.9% vs. 8.7%, p=0.050). A sharp decline in the frequency of rotavirus infection was observed at the beginning of the COVID-19 pandemic compared to the pre-COVID-19 pandemic period, followed by a sharp increase. In 2022, the frequency of rotavirus infections exceeded the pre-COVID-19 pandemic levels.
 Conclusion: The provision of the rotavirus vaccine for free by health authorities, especially for at-risk infants, together with adherence to hand washing, hygiene, and sanitation rules can significantly reduce the frequency of rotavirus infections during both pandemic and non-pandemic periods.

Characteristics of acute diarrhea under the sentinel surveillance system at the Vietnam National Children’s Hospital from 2018 to 2022

The study describes a sentinel diarrhea surveillance system at the Vietnam National Children’s Hospital from 2018 - 2022, characterizing the epidemiology of acute diarrhea (AD) due to rotavirus (RV) and identifying circulating RV strains. Of 4,765 AD cases, 861 were positive for RV, accounting for 18.07%. The disease appeared in all months, peaking in the winter-spring months (from October to March of the following year). The groups of children aged 6 - 11 months, 12 - 23 months, and 6 weeks-6 months had the highest number of cases, but the highest positive rate is 24 - 47 months old. About 24% of RV patients under 2 years of age have already been vaccinated, while this proportion among 3 - 5 years of age patients is 41%. Dehydration and no dehydration account for 96,7%, while severe dehydration only accounts for 3.3%, the prevalent RV types identified were G3P[8], G8P[8], G1P[8], G9P[8], which account for 50.7%, 20.6%, 11.4%, and 9%, respectively and changed annually. It is necessary to implement RV vaccines in the Expanded Program on Immunization. Meanwhile maintaining an RV sentinel surveillance system and continuing research on the effectiveness of RV vaccines in Viet Nam are also critical for controlling RV in Vietnam.

Efficacy of Rotavirus Vaccines.

Efficacy of Rotavirus Vaccines.

A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China

ABSTRACT This open-label, randomized, phase 3 study in China (V260-074; NCT04481191) evaluated the immunogenicity and safety of concomitant and staggered administration of three doses of an oral, live, pentavalent rotavirus vaccine (RV5) and three doses of an intramuscular, inactivated poliomyelitis vaccine (IPV) in 400 healthy infants. The primary objective was the non-inferiority of neutralizing antibody (nAb) responses in the concomitant- versus the staggered-use groups. Antibody responses were measured at baseline and 1-month post-dose 3 (PD3). Parents/legal guardians recorded adverse events for 30 or 15 d after study vaccinations in the concomitant-use or staggered-use groups, respectively. At PD3, >98% of participants seroconverted to all three poliovirus types, and the primary objective was met as lower bounds of the two-sided 95% CI for between-group difference in nAb seroconversion percentages ranged from − 4.3% to − 1.6%, for all poliovirus types, p < .001. At PD3, geometric mean titers (GMTs) of nAb responses to poliovirus types 1, 2, and 3 in the concomitant-use group and the staggered-use group were comparable; 100% of participants had nAb titers ≥1:8 and ≥1:64 for all poliovirus types. Anti-rotavirus serotype-specific IgA GMTs and participants with ≥3-fold rise in postvaccination titers from baseline were comparable between groups. Administration of RV5 and IPV was well tolerated with comparable safety profiles in both groups. The immunogenicity of IPV in the concomitant-use group was non-inferior to the staggered-use group and RV5 was immunogenic in both groups. No safety concerns were identified. These data support the concomitant use of RV5 and IPV in healthy Chinese infants.

Enablers and barriers to rotavirus vaccine coverage in Assam, India- A qualitative study

BackgroundEstimates suggest that 78,000 children died due to rotavirus gastroenteritis annually between 2011 and 2013 in India. The north eastern state of Assam reported 38.4% pediatric diarrheal admissions testing positive for rotavirus. Rotavirus vaccine (RVV) was introduced in Assam in 2017 following which the National Family Health Survey-5 (NFHS-5) (2019) revealed low RVV coverage in Assam with wide variation between the districts. the current study was conceptualized and undertaken to capture the enablers and barriers to RVV coverage in Assam. MethodsQualitative study conducted in 5 randomly selected districts in Assam. Participants (key informants) were recruited by purposive sampling at each level of the health system including healthcare officials, service providers and caregivers based on availability. Thirty-five in-depth interviews (IDIs) and five focus group discussions (FGDs) were conducted. Interviews were tape recorded and transcribed. Data was coded and analyzed using the thematic framework approach. ResultsFindings from the qualitative data collection were collated and analyzed under 7 identified themes. Difficult terrain, limited service provider availability and no catch-up training for new recruits were some of the barriers to RVV coverage. In contrast, Information, Education & Communication (IEC) in vernacular language, RVV safety profile, development partner support and adequate RVV supply were identified as some of the enablers of RVV coverage. ConclusionFew broad recommendations to overcome identified barriers include comprehensive inter-sectoral coordination, regular monitoring and frequent refresher training sessions. There is a need for a future study utilizing existing coverage data and larger sample size to triangulate the findings of this study.

Duration of Breastfeeding and the Risk of Diarrheal Illness in Children Below Age of 2 Years in South Africa, 2016: A CrossSectional Study

Background: Childhood diarrheal illness is a threat to public health in relation to child health. The prevalence is high in regions like South Asia and Sub-Saharan regions. These regions contribute to over three-quarters of the diarrheal illness cases in the world. However, there has been evidence on how the duration of breastfeeding reduces the risk of childhood diarrheal illness in infants. Aim: To explore the impact of the duration of breastfeeding on the occurrence of childhood diarrheal illness in a sample of children below the age of 2 years in South Africa, 2016. Methods: A cross-sectional study was employed that used secondary data for analysis from the South Africa Demography and Health Surveys, 2016. Six Hundred and Sixty-one participants that were mother-child pairs were used in the final study. Frequency and distribution were used to describe the study population baseline characteristic. Bivariate and multivariate were used to find the relationship between diarrheal illness and other factors (vaccination, rotavirus vaccine etc.). Poisson regression was used to find the predictors of diarrheal illness. Results: The prevalence of childhood diarrheal illness was 13.2% (n=87) for breastfeeding infants. Multivariate analysis showed that the duration of breastfeeding is associated with childhood diarrheal illness (RR:2.34: 95% CL: 1.11-4.94 p=0.03). Chi-square was employed, and it showed a significant interaction between the duration of breastfeeding and diarrheal illness ((X2 (2) = 8.06, p&lt;.05) and therefore null hypothesis was rejected. The age of a child and the duration of breastfeeding were the only significant variables in the study, and the rest were not significant. Conclusion: The longer the duration of breastfeeding, the more the child suffers from a diarrheal illness. Breastfeeding alone does not prevent diarrheal illness among infants, so more exploration in future is required to verify factors that are associated with breastfeeding in the prevention of diarrheal such as the biological nature of the child and the mother’s milk content. More emphasis on health education concerning breastfeeding and diarrheal illness with mainly targeting the rural areas.

Rates and determinants of Rotavirus vaccine uptake among children in Italy: a cross-sectional study within the 2022 OBVIOUS* project

IntroductionThe World Health Organization defines rotavirus as among the most severe causes of viral gastroenteritis affecting children under 5 year old. Italy and other European countries do not release disaggregated data on rotavirus vaccination coverage. This study aimed to assess the uptake and drivers of rotavirus vaccination in Italy.MethodsWe administered a survey to 10,000 Italian citizens recruited via an online panel and proportionate to key demographic strata. We examined rotavirus vaccine uptake among parents whose youngest child was aged 6 weeks to 4 years, their sociodemographic characteristics, their beliefs about vaccine administration, and who recommended the rotavirus vaccination.ResultsA total of 711 respondents met the inclusion criteria for the rotavirus vaccine questionnaire. The uptake was estimated at 60.3% nationwide (66.4% among mothers and 50.2% among fathers). Being a mother and living in cities/suburbs was significantly associated with a higher likelihood of vaccine uptake, while fathers were more likely to be uncertain of their children’s vaccine status. Living in Central Italy and having friends/relatives opposed to vaccination were found to be significantly associated with a lower likelihood of vaccine uptake, while parents’ education level and children’s demographics were not found to correlate with any outcomes. In 90.3% of cases, the rotavirus vaccination was recalled as being recommended by a paediatrician.ConclusionsConsistent collection of behavioural preferences and socioeconomic characteristics of recipients of rotavirus vaccine campaigns, their epidemiological information, cost-benefit, and national policy data are crucial for designing effective vaccination strategies in Italy and other European countries with similar social profiles to reach the target uptake.

Novel Universal Recombinant Rotavirus A Vaccine Candidate: Evaluation of Immunological Properties.

Rotavirus infection is a leading cause of severe dehydrating gastroenteritis in children under 5 years of age. Although rotavirus-associated mortality has decreased considerably because of the introduction of the worldwide rotavirus vaccination, the global burden of rotavirus-associated gastroenteritis remains high. Current vaccines have a number of disadvantages; therefore, there is a need for innovative approaches in rotavirus vaccine development. In the current study, a universal recombinant rotavirus antigen (URRA) for a novel recombinant vaccine candidate against rotavirus A was obtained and characterised. This antigen included sequences of the VP8* subunit of rotavirus spike protein VP4. For the URRA, for the first time, two approaches were implemented simultaneously-the application of a highly conserved neutralising epitope and the use of the consensus of the extended protein's fragment. The recognition of URRA by antisera to patient-derived field rotavirus isolates was proven. Plant virus-based spherical particles (SPs), a novel, effective and safe adjuvant, considerably enhanced the immunogenicity of the URRA in a mouse model. Given these facts, a URRA + SPs vaccine candidate is regarded as a prospective basis for a universal vaccine against rotavirus.

Using big data to analyze the vaccination status of children with congenital heart disease in Yinzhou District, China

ABSTRACT Congenital heart disease (CHD) represents a significant population warranting particular attention concerning vaccination coverage. To comprehend the vaccination status of CHD within Yinzhou District, Ningbo City, China, and to facilitate the formulation of preventive, control, and immunization strategies against vaccine-preventable diseases in children with congenital heart conditions. Using the China Yinzhou Electronic Health Record Study (CHERRY) database, we analyzed the vaccination coverage of children with CHD born between January 1, 2016 and September 20, 2021, and analyzed the influencing factors associated with the level of vaccination coverage. This study involved 762 children diagnosed with CHD at the age of 12 months, revealing that 86.74% of these children had received at least one dose of the National Immunization Program (NIP) vaccines. The coverage for non-NIP vaccines, such as the rotavirus vaccine, influenza vaccine, Influenza Haemophilus influenzae Type b (Hib) Conjugate Vaccine, 13-valent pneumococcal conjugate vaccine (PCV13), and inactivated enterovirus type 71 vaccine (EV71), stood at 27.30%, 7.74%, 63.25%, 33.76%, and 34.51%, respectively. The completion coverage for the entire vaccination schedule were 27.30%, 5.51%, 55.77%, 34.25%, and 25.59%, respectively. There was a statistically significant correlation between vaccination coverage in classification of diagnostic medical institutions and the types of diagnosed diseases. Compared to their typically developing counterparts, 12-month-old children afflicted with CHD exhibit a slightly diminished vaccination coverage, alongside a discernible inclination toward delayed vaccination. Notably, the determination to undergo vaccinations seems predominantly influenced by the classification of diagnostic medical institutions. In practical terms, proactive measures involving early diagnosis, comprehensive health assessments, and timely interventions ought to be implemented to enhance vaccination rates while prioritizing safety.

Production of OSU G5P[7] Porcine Rotavirus Expressing a Fluorescent Reporter via Reverse Genetics.

Rotaviruses are a significant cause of severe, potentially life-threatening gastroenteritis in infants and the young of many economically important animals. Although vaccines against porcine rotavirus exist, both live oral and inactivated, their effectiveness in preventing gastroenteritis is less than ideal. Thus, there is a need for the development of new generations of porcine rotavirus vaccines. The Ohio State University (OSU) rotavirus strain represents a Rotavirus A species with a G5P[7] genotype, the genotype most frequently associated with rotavirus disease in piglets. Using complete genome sequences that were determined via Nanopore sequencing, we developed a robust reverse genetics system enabling the recovery of recombinant (r)OSU rotavirus. Although rOSU grew to high titers (~107 plaque-forming units/mL), its growth kinetics were modestly decreased in comparison to the laboratory-adapted OSU virus. The reverse genetics system was used to generate the rOSU rotavirus, which served as an expression vector for a foreign protein. Specifically, by engineering a fused NSP3-2A-UnaG open reading frame into the segment 7 RNA, we produced a genetically stable rOSU virus that expressed the fluorescent UnaG protein as a functional separate product. Together, these findings raise the possibility of producing improved live oral porcine rotavirus vaccines through reverse-genetics-based modification or combination porcine rotavirus vaccines that can express neutralizing antigens for other porcine enteric diseases.

Abundance of Selected Lipopolysaccharide-Rich Bacteria and Levels of Toll-like Receptor 4 and Interleukin 8 Expression Are Significantly Associated with Live Attenuated Rotavirus Vaccine Shedding among South African Infants.

Bacterial lipopolysaccharides (LPSs) have been shown to promote enteric viral infections. This study tested the hypothesis that elevated levels of bacterial LPS improve oral rotavirus vaccine replication in South African infants. Stool samples were collected from infants a week after rotavirus vaccination to identify vaccine virus shedders (n = 43) and non-shedders (n = 35). Quantitative real-time PCR was used to assay for selected LPS-rich bacteria, including Serratia marcescens, Pseudomonas aeruguinosa and Klebsiella pneumonia, and to measure the gene expression of bacterial LPS, host Toll-like Receptor 4 (TLR4) and Interleukin-8 (IL-8). The abundance of selected LPS-rich bacteria was significantly higher in vaccine shedders (median log 4.89 CFU/g, IQR 2.84) compared to non-shedders (median log 3.13 CFU/g, IQR 2.74), p = 0.006. The TLR4 and IL-8 gene expressions were increased four- and two-fold, respectively, in vaccine shedders versus non-shedders, but no difference was observed in the bacterial LPS expression, p = 0.09. A regression analysis indicated a significant association between the abundance of selected LPS-rich bacteria and vaccine virus shedding (Odds ratio 1.5, 95% CI = 1.10-1.89), p = 0.002. The findings suggest that harbouring higher counts of LPS-rich bacteria can increase the oral rotavirus vaccine take in infants.

Correlates of immune protection against human rotaviruses: natural infection and vaccination.

Species A rotaviruses are the leading viral cause of acute gastroenteritis in children under 5 years of age worldwide. Despite progress in the characterization of the pathogenesis and immunology of rotavirus-induced gastroenteritis, correlates of protection (CoPs) in the course of either natural infection or vaccine-induced immunity are not fully understood. There are numerous factors such as serological responses (IgA and IgG), the presence of maternal antibodies (Abs) in breast milk, changes in the intestinal microbiome, and rotavirus structural and non-structural proteins that contribute to the outcome of the CoP. Indeed, while an intestinal IgA response and its surrogate, the serum IgA level, are suggested as the principal CoPs for oral rotavirus vaccines, the IgG level is more likely to be a CoP for parenteral non-replicating rotavirus vaccines. Integrating clinical and immunological data will be instrumental in improving rotavirus vaccine efficacy, especially in low- and middle-income countries, where vaccine efficacy is significantly lower than in high-income countries. Further knowledge on CoPs against rotavirus disease will be helpful for next-generation vaccine development. Herein, available data and literature on interacting components and proposed CoPs against human rotavirus disease are reviewed, and limitations and gaps in our knowledge in this area are discussed.

Prevalence of Rotavirus antigen in children with gastroenteritis in Auchi Etsako West Local Government Area, Edo State, Nigeria.

This study aimed to determine the prevalence of rotavirus infection among children in Auchi, Edo State, Nigeria, and its association with selected demographic factors. Rotavirus infections are a major cause of viral gastroenteritis in children globally, and despite the availability of vaccines, they continue to pose a significant health burden. The study population consisted of 200 children aged 2-15 years, with data collected through a questionnaire and stool samples analysed using Enzyme Linked Immunosorbent Assay (ELISA) kits (Abbexa, UK) following the manufacturer's instructions. The overall prevalence of rotavirus infection was found to be 6%, which was relatively low compared to previous studies in Nigeria and other countries. The study revealed that children in the age group of 6-10 years had the highest prevalence of rotavirus infection, while the prevalence was lower among nursery and secondary school children. There was no significant association between any of the participant's demographic factors and rotavirus infection. However, living in rural areas was associated with a higher risk of rotavirus infection compared to semi-urban and urban areas. The study emphasizes the importance of rotavirus vaccination, promoting good hygiene practices, and raising awareness among parents, caregivers, and healthcare professionals. Further investigation is needed to explore additional risk factors and improve understanding of rotavirus infection in this population.

Vedolizumab and Ustekinumab Levels in Pregnant Women With Inflammatory Bowel Disease and Infants Exposed In Utero

Vedolizumab and ustekinumab pharmacokinetics in pregnancy and the infant after in utero exposure remain incompletely defined. We aim to define the antenatal stability of ustekinumab and vedolizumab levels and the time at which infant drug levels become undetectable. This multicenter prospective observational cohort study recruited pregnant or preconception women with inflammatory bowel disease receiving vedolizumab or ustekinumab. Trough drug levels, clinical data, and biochemical data were documented preconception, during each trimester of pregnancy, and postpartum. Maternal and cord blood drug levels were measured at delivery and in infants until undetectable. Infant outcomes were assessed until 2 years of age. A total of 102 participants (vedolizumab, n= 58) were included. The majority of mothers were, and remained, in clinical and biochemical remission. Maternal vedolizumab levels decreased over the course of pregnancy in association with increasing weight, rather than increasing gestation. Maternal ustekinumab levels remained stable. The median time to drug becoming undetectable in the infant was shorter for vedolizumab (11 wk; range, 5-19 wk; n= 32) than ustekinumab (14 wk; range, 9-36 wk; n= 17) and correlated positively with infant delivery level. Thirty-two of 41 (88%) and 17 of 30 (67%) vedolizumab- and ustekinumab-exposed infants had undetectable drug levels by 15 weeks of age, respectively. Pregnancy and infant outcomes were favorable. Twenty infants with undetectable drug levels received the rotavirus vaccine, with no adverse reactions reported. Maternal vedolizumab levels decreased, whereas ustekinumab levels remained stable over the course of pregnancy. Most vedolizumab- and approximately half of ustekinumab-exposed infants had undetectable drug levels by 15 weeks of age. No concerning maternal or infant safety signals were identified.

MRNA-Based Vaccines Are Highly Immunogenic and Confer Protection in the Gnotobiotic Pig Model of Human Rotavirus Diarrhea.

Human rotavirus (HRV) is still a leading cause of severe dehydrating gastroenteritis globally, particularly in infants and children. Previously, we demonstrated the immunogenicity of mRNA-based HRV vaccine candidates expressing the viral spike protein VP8* in rodent models. In the present study, we assessed the immunogenicity and protective efficacy of two mRNA-based HRV trivalent vaccine candidates, encoding VP8* of the genotypes P[8], P[6], or P[4], in the gnotobiotic (Gn) pig model of Wa (G1P[8]) HRV infection and diarrhea. Vaccines either encoded VP8* alone fused to the universal T-cell epitope P2 (P2-VP8*) or expressed P2-VP8* as a fusion protein with lumazine synthase (LS-P2-VP8*) to allow the formation and secretion of protein particles that present VP8* on their surface. Gn pigs were randomly assigned into groups and immunized three times with either P2-VP8* (30 µg) or LS-P2-VP8* (30 µg or 12 µg). A trivalent alum-adjuvanted P2-VP8* protein vaccine or an LNP-formulated irrelevant mRNA vaccine served as the positive and negative control, respectively. Upon challenge with virulent Wa HRV, a significantly shortened duration and decreased severity of diarrhea and significant protection from virus shedding was induced by both mRNA vaccine candidates compared to the negative control. Both LS-P2-VP8* doses induced significantly higher VP8*-specific IgG antibody titers in the serum after immunizations than the negative as well as the protein control. The P[8] VP8*-specific IgG antibody-secreting cells in the ileum, spleen, and blood seven days post-challenge, as well as VP8*-specific IFN-γ-producing T-cell numbers increased in all three mRNA-vaccinated pig groups compared to the negative control. Overall, there was a clear tendency towards improved responses in LS-P2-VP8* compared to the P2-VP8*mRNA vaccine. The demonstrated strong humoral immune responses, priming for effector T cells, and the significant reduction of viral shedding and duration of diarrhea in Gn pigs provide a promising proof of concept and may provide guidance for the further development of mRNA-based rotavirus vaccines.

Effectiveness and Safety of Bovine Human Pentavalent Rotavirus Vaccine (BRV-PV) in Preventing Severe Acute Rotavirus Gastroenteritis (SRVGE): A systematic review of the experience in developing countries

Background: Severe acute rotavirus gastroenteritis (SRVGE) is the world's highest cause of children mortality, with symptoms of severe dehydrating diarrhea due to rotavirus (RV) infection. SRVGE provides a high economic burden, mostly in developing countries. Currently, three RV vaccines (Rotarix, RotaTeq, Rotavac) are licensed internationally by the World Health Organization (WHO) and are not yet applicable in developing countries. Hence, research shows the potential of BRV-PV in preventing RV infection in pediatrics, especially in developing countries. Objective: This review aims to analyze the effectiveness and safety of BRV-PV in developing countries. Methods: This systematic review includes studies from the ScienceDirect, PubMed, Elsevier, and Cochrane databases that met the inclusion and exclusion criteria. The search method uses the Boolean operator with the articles from the last ten years. Eight articles with a total of 9088 children were reviewed to analyze the effectiveness and safety of BRV-PV. Results and Discussion: Of all the studies involved, BRV-PV has effectively reduced the incidence of hospitalization and emergency cases due to SRVGE. Furthermore, BRV-PV is also safe for children in developing countries, proven by increased anti-RV IgA concentrations and minimal side effects. Conclusion: BRV-PV is more effective, safe, heat-stable, and affordable than the previous three RV vaccines in developing countries Keyword: BRV-PV, Gastroenteritis, Rotavirus, Rotavirus Vaccine Latar Belakang: Severe acute rotavirus gastroenteritis (SRVGE) merupakan penyebab kematian anak tertinggi di dunia dengan gejala diare dehidrasi parah akibat infeksi rotavirus (RV). SRVGE memberikan beban ekonomi yang tinggi, terutama di negara-negara berkembang. Saat ini, tiga vaksin RV (Rotarix, RotaTeq, Rotavac) dilisensikan secara internasional oleh World Health Organization (WHO) dan belum dapat diterapkan di negara-negara berkembang. Oleh karena itu, penelitian menunjukkan potensi BRV-PV dalam mencegah infeksi RV pada anak-anak, khususnya di negara berkembang. Tujuan: Ulasan ini bertujuan untuk menganalisis efektivitas dan keamanan BRV-PV dalam mencegah SRVGE. Metode: Tinjauan sistematis ini mencakup studi dari database ScienceDirect, PubMed, Elsevier, dan Cochrane yang memenuhi kriteria inklusi dan eksklusi. Metode pencariannya menggunakan operator boolean dengan artikel sepuluh tahun terakhir. Delapan artikel dengan total 9088 pediatri ditinjau untuk menganalisis efektivitas dan keamanan BRV-PV. Hasil dan Pembahasan: Dari semua penelitian yang terlibat, BRV-PV telah secara efektif mengurangi kejadian rawat inap dan kasus darurat akibat SRVGE. Selain itu, BRV-PV juga aman untuk anak-anak di negara berkembang, terbukti dengan peningkatan konsentrasi IgA anti-RV dan efek samping yang minimal. Kesimpulan: BRV-PV lebih efektif, aman, tahan panas, dan terjangkau dibandingkan tiga vaksin RV sebelumnya di negara berkembang.. Kata Kunci: BRV-PV, Gastroenteritis, Rotavirus, Vaksin Rotavirus

Understanding rapid implementation from discovery to scale: Rwanda’s implementation of rotavirus vaccines and PMTCT in the quest to reduce under-5 mortality

BackgroundOver the last eight decades, many evidence-based interventions (EBIs) have been developed to reduce amenable under-5 mortality (U5M). Implementation research can help reduce the lag between discovery and delivery, including as new EBIs emerge, or as existing ones are adapted based on new research. Rwanda was the first low-income African country to implement the rotavirus vaccine (RTV) and also adopted Option B+ for effective prevention of mother-to-child transmission (PMTCT) before the World Health Organization’s (WHO) recommendation. We use implementation research to identify contextual factors and strategies associated with Rwanda’s rapid uptake of these two EBIs developed or adapted during the study period.MethodsWe conducted a mixed methods case study informed by a hybrid implementation research framework to understand how Rwanda outperformed regional and economic peers in reducing U5M, focusing on the implementation of health system-delivered EBIs. The research included review of existing literature and data, and key informant interviews to identify implementation strategies and contextual factors that influenced implementation outcomes. We extracted relevant results from the broader case study and used convergent methods to understand successes and challenges of implementation of RTV, a newly introduced EBI, and PMTCT, an adapted EBI reflecting new research.ResultsWe found several cross-cutting strategies that supported the rapid uptake and implementation of PMTCT, RTV, and leveraging facilitating contextual factors and identifying and addressing challenging ones. Key implementation strategies included community and stakeholder involvement and education, leveraging of in-country research capacity to drive adoption and adaptation, coordination of donors and implementing partners, data audit and feedback of coverage, a focus on equity, and integration into pre-existing systems, including community health workers and primary care. The availability of donor funding, culture of evidence-based decision-making, preexisting accountability systems, and rapid adoption of innovation were facilitating contextual factors.ConclusionImplementation strategies which are generalizable to other settings were key to success in rapidly achieving high acceptability and coverage of both a new and an evolving EBI. Choosing strategies which leverage their facilitating factors and address barriers are important for other countries working to accelerate uptake of new EBIs and implement needed adaptations based on emerging evidence.

Post-marketing surveillance of intussusception after Rotarix administration in Afghanistan, 2018–2022

BackgroundIn January 2018, Afghanistan introduced the monovalent oral rotavirus vaccine (Rotarix) nationwide, administered as a 2-dose series at six and ten weeks of age. We describe characteristics of intussusception cases and assess potential intussusception risk associated with Rotarix vaccination in Afghan infants. MethodsMulti-center prospective active hospital-based surveillance for intussusception was conducted from May 2018 to March 2022 in four sentinel sites in Afghanistan. We applied the Brighton Level 1 criteria for intussusception and verified vaccination status by reviewing vaccine cards. We used the self-controlled case series (SCCS) methodology to compare intussusception incidence in the 1 to 21 days after each dose of Rotarix vaccination against non-risk periods. ResultsA total of 468 intussusception cases were identified in infants under 12 months, with 264 cases aged between 28 and 245 days having confirmed vaccination status contributing to the SCCS analysis. Most case-patients (98 %) required surgery for treatment, and over half (59 %) of those who underwent surgery required intestinal resection. Nineteen (7 %) case-patients died. Eighty-six percent of case-patients received the first dose of Rotarix, and 69 % received the second dose before intussusception symptom onset. There was no increased risk of intussusception in the 1–7 days (relative incidence: 0.9, 95 % CI: 0.1, 7.5), 8–21 days (1.3, 95 % CI: 0.4, 4.2), or 1–21 days (1.1, 95 % CI: 0.4, 3.4) following receipt of the first dose or in the 1–7 days (0.2, 95 % CI: 0.3, 1.8), 8–21 days (0.7, 95 % CI: 0.3, 1.5), or 1–21 days (0.6, 95 % CI: 0.3, 1.2) following the second dose. ConclusionRotarix vaccination was not associated with an increased intussusception risk, supporting its continued use in Afghanistan's immunization program. However, there was a high level of death and resection due to intussusception among Afghan infants.

Expert consensus on immunoprophylaxis of childhood rotavirus gastroenteritis (2024 version)

Rotavirus gastroenteritis (RVGE) is a global public health challenge that seriously threatens the health of children under 5 years of age. In China, the burden associated with RVGE is substantial and its prevention and control are difficult. On the basis of Expert Consensus on Immunoprophylaxis of Childhood Rotavirus Gastroenteritis (2020 Version) and Rotavirus Vaccines: WHO Position Paper-July 2021, in this updated consensus we systematically review advances in RVGE epidemiological research; safety, effectiveness/efficacy, and immune persistence of post-marketing rotavirus (RV) vaccines; and RV immunization strategies. We also provide guidance for RVGE diagnosis and treatment. Following the principles of prioritizing prevention and integrating medical and preventive approaches, we aim to facilitate the implementation of comprehensive prevention and control measures focusing on RV vaccination to reduce the childhood RVGE disease burden and provide reference for professionals working for disease control and prevention, vaccination, clinical diagnosis and treatment, and related fields.