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1.
J Med Virol ; 96(5): e29650, 2024 May.
Article in English | MEDLINE | ID: mdl-38727133

ABSTRACT

To analyze the epidemiological characteristics of group A rotavirus (RVA) diarrhea in Beijing between 2019 and 2022 and evaluate the effectiveness of the RV5 vaccine. Stool specimens were collected from patients with acute diarrhea, and RVA was detected and genotyped. The whole genome of RVA was sequenced by fragment amplification and Sanger sequencing. Phylogenetic trees were constructed using Bayesian and maximum likelihood methods. Descriptive epidemiological methods were used to analyze the characteristics of RVA diarrhea. Test-negative design was used to evaluate the vaccine effectiveness (VE) of the RV5. Compared with 2011-2018, RVA-positive rates in patients with acute diarrhea under 5 years of age and adults decreased significantly between 2019 and 2022, to 9.45% (249/634) and 3.66% (220/6016), respectively. The predominant genotype of RVA had changed from G9-VIP[8]-III between 2019 and 2021 to G8-VP[8]-III in 2022, and P[8] sequences from G8-VP[8]-III strains formed a new branch called P[8]-IIIb. The complete genotype of G8-VP[8]-III was G8-P[8]-I2-R2-C2-M2-A2-N2-T2-E2-H2. The VE of 3 doses of RV5 was 90.4% (95% CI: 28.8%-98.7%) against RVA diarrhea. The prevalence of RVA decreased in Beijing between 2019 and 2022, and the predominant genotype changed to G8P[8], which may be related to RV5 vaccination. Continuous surveillance is necessary to evaluate vaccine effectiveness and improve vaccine design.


Subject(s)
Diarrhea , Feces , Genotype , Phylogeny , Rotavirus Infections , Rotavirus Vaccines , Rotavirus , Humans , Rotavirus/genetics , Rotavirus/classification , Rotavirus/immunology , Rotavirus/isolation & purification , Rotavirus Infections/epidemiology , Rotavirus Infections/virology , Rotavirus Infections/prevention & control , Diarrhea/virology , Diarrhea/epidemiology , Rotavirus Vaccines/administration & dosage , Rotavirus Vaccines/immunology , Child, Preschool , Prevalence , Beijing/epidemiology , Male , Infant , Female , Adult , Feces/virology , Middle Aged , Child , Young Adult , Adolescent , Vaccine Efficacy , Aged , Genome, Viral , Infant, Newborn
2.
BMC Pediatr ; 24(1): 358, 2024 May 23.
Article in English | MEDLINE | ID: mdl-38778329

ABSTRACT

BACKGROUND: Rotavirus has a significant morbidity and mortality in children under two years. The burden of rotavirus diarrhea 4 years post introduction of rotavirus vaccine in Uganda is not well established. This study aimed to determine the prevalence, severity of dehydration and factors associated with rotavirus diarrhea among children aged 3 to 24 months after the introduction of the vaccine at Fort Portal Regional Referral hospital. METHODS: This was a cross-sectional hospital-based study in which children with acute watery diarrhea were included. A rectal tube was used to collect a stool sample for those unable to provide samples. Stool was tested for rotavirus using rapid immunochromatographic assay. Data was analysed using SPSS version 22 with logistic regression done to determine the factors. RESULTS: Out of 268 children with acute watery diarrhea, 133 (49.6%) were females. Rotavirus test was positive in 42 (15.7%), majority of whom had some dehydration 28(66.7%). The factors that were independently associated with rotavirus diarrhea were; age < 12 months (AOR = 8.87, P = 0.014), male gender (AOR = 0.08, P = 0.001), coming from a home with another person with diarrhea (AOR = 17.82, P = 0.001) or a home where the water source was a well (AOR = 50.17, P = 0.002). CONCLUSION: The prevalence of rotavirus diarrhea was three times less in the post rotavirus vaccination period compared to pre-rota vaccination period. Majority of the participants with rotavirus diarrhea had some dehydration. There is need for provision of safe water sources to all homes. Surveillance to determine the cause of the non rota diarrhea should be done.


Subject(s)
Rotavirus Infections , Rotavirus Vaccines , Humans , Uganda/epidemiology , Cross-Sectional Studies , Male , Female , Infant , Rotavirus Vaccines/administration & dosage , Prevalence , Rotavirus Infections/epidemiology , Rotavirus Infections/prevention & control , Risk Factors , Child, Preschool , Dehydration/epidemiology , Dehydration/etiology , Diarrhea/epidemiology , Diarrhea/virology , Feces/virology , Logistic Models , Diarrhea, Infantile/epidemiology , Diarrhea, Infantile/virology , Diarrhea, Infantile/prevention & control
3.
Hum Vaccin Immunother ; 20(1): 2353480, 2024 Dec 31.
Article in English | MEDLINE | ID: mdl-38757507

ABSTRACT

Following the introduction of rotavirus vaccination into the Moroccan National Immunization Program, the prevalence of the disease has decreased by nearly 50%. However, evidence on the economic value of rotavirus vaccinations in Morocco is limited. This health economic analysis evaluated, from both country payer and societal perspectives, the costs and the cost-effectiveness of three rotavirus vaccines using a static, deterministic, population model in children aged < 5 years in Morocco. Included vaccines were HRV (2-dose schedule), HBRV (3-dose schedule) and BRV-PV 1-dose vial (3-dose schedule). One-way and probabilistic sensitivity analyses were conducted to assess the impact of uncertainty in model inputs. The model predicted that vaccination with HRV was estimated to result in fewer rotavirus gastroenteritis events (-194 homecare events, -57 medical visits, -8 hospitalizations) versus the 3-dose vaccines, translating into 7 discounted quality-adjusted life years gained over the model time horizon. HRV was associated with lower costs versus HBRV from both the country payer (-$1.8 M) and societal (-$4.1 M) perspectives, and versus BRV-PV 1-dose vial from the societal perspective (-$187,000), dominating those options in the cost-effectiveness analysis. However, costs of BRV-PV 1-dose vial were lower than HRV from the payer perspective, resulting in an ICER of approximately $328,376 per QALY, above the assumed cost effectiveness threshold of $3,500. Vaccination with a 2-dose schedule of HRV may be a cost-saving option and could lead to better health outcomes for children in Morocco versus 3-dose schedule rotavirus vaccines.


Subject(s)
Cost-Benefit Analysis , Rotavirus Infections , Rotavirus Vaccines , Humans , Rotavirus Vaccines/economics , Rotavirus Vaccines/administration & dosage , Rotavirus Vaccines/immunology , Child, Preschool , Rotavirus Infections/prevention & control , Rotavirus Infections/economics , Infant , Morocco , Female , Male , Infant, Newborn , Vaccination/economics , Gastroenteritis/prevention & control , Gastroenteritis/economics , Gastroenteritis/virology
4.
Front Immunol ; 15: 1364429, 2024.
Article in English | MEDLINE | ID: mdl-38690265

ABSTRACT

Background: This meta-analysis was performed to assess the prevalence and circulating strains of rotavirus (RV) among Chinese children under 5 years of age after the implantation of the RV vaccine. Material and methods: Studies published between 2019 and 2023, focused on RV-based diarrhea among children less than 5 years were systematically reviewed using PubMed, Embase, Web of Science, CNKI, Wanfang and SinoMed Data. We synthesized their findings to examine prevalence and genetic diversity of RV after the RV vaccine implementation using a fixed-effects or random-effects model. Results: Seventeen studies met the inclusion criteria for this meta-analysis. The overall prevalence of RV was found to be 19.00%. The highest infection rate was noted in children aged 12-23months (25.79%), followed by those aged 24-35 months (23.91%), and 6-11 months (22.08%). The serotype G9 emerged as the most predominant RV genotype, accounting for 85.48% of infections, followed by G2 (7.70%), G8 (5.74%), G1 (4.86%), and G3 (3.21%). The most common P type was P[8], representing 64.02% of RV cases. Among G-P combinations, G9P[8] was the most frequent, responsible for 78.46% of RV infections, succeeded by G8P[8] (31.22%) and G3P[8] (8.11%). Conclusion: Despite the variation of serotypes observed in China, the G1, G2, G3, G8 and G9 serotypes accounted for most RV strains. The genetic diversity analysis highlights the dynamic nature of RV genotypes, necessitating ongoing surveillance to monitor changes in strain distribution and inform future vaccine strategies.


Subject(s)
Genetic Variation , Rotavirus Infections , Rotavirus , Humans , Rotavirus Infections/epidemiology , Rotavirus Infections/virology , Rotavirus/genetics , China/epidemiology , Prevalence , Infant , Child, Preschool , Genotype , Rotavirus Vaccines/immunology , Male
5.
Expert Rev Vaccines ; 23(1): 606-618, 2024.
Article in English | MEDLINE | ID: mdl-38813689

ABSTRACT

INTRODUCTION: Rotavirus is a leading cause of severe diarrheal disease and death in children under five years of age worldwide. Vaccination is one of the most important public health interventions to reduce this significant burden. AREAS COVERED: This literature review examined vaccination coverage, hospitalization rate, mortality, genotypic distribution, immunogenicity, cost-effectiveness, and risk versus benefit of rotavirus vaccination in children in South America. Nine out of twelve countries in South America currently include a rotavirus vaccine in their national immunization program with coverage rates in 2022 above 90%. EXPERT OPINION: Introduction of the rotavirus vaccination has led to a marked reduction in hospitalizations and deaths from diarrheal diseases in children under 5 years, particularly infants under 1 year, in several South American countries. In Brazil, hospitalizations decreased by 59% and deaths by 21% (30-38% in infants). In Peru, hospitalizations in infants fell by 46% and deaths by 37% (56% in infants). Overall, data suggest that rotavirus vaccination has reduced rotavirus deaths by 15-50% in various South American countries. There is some evidence that immunity wanes after the age of 1-year old. Ongoing surveillance of vaccine coverage and changes in morbidity and mortality is important to maximize protection against this disease.


Subject(s)
Diarrhea , Hospitalization , Immunization Programs , Rotavirus Infections , Rotavirus Vaccines , Humans , Rotavirus Vaccines/administration & dosage , Rotavirus Vaccines/immunology , Rotavirus Infections/prevention & control , Rotavirus Infections/epidemiology , Diarrhea/prevention & control , Diarrhea/epidemiology , Diarrhea/virology , Infant , Hospitalization/statistics & numerical data , South America/epidemiology , Child, Preschool , Vaccination/statistics & numerical data , Cost-Benefit Analysis , Rotavirus/immunology , Vaccination Coverage/statistics & numerical data , Cost of Illness
6.
BMC Infect Dis ; 24(1): 547, 2024 May 31.
Article in English | MEDLINE | ID: mdl-38822241

ABSTRACT

Noroviruses are the second leading cause of death in children under the age of 5 years old. They are responsible for 200 million cases of diarrhoea and 50,000 deaths in children through the word, mainly in low-income countries. The objective of this review was to assess how the prevalence and genetic diversity of noroviruses have been affected by the introduction of rotavirus vaccines in Africa. PubMed, Web of Science and Science Direct databases were searched for articles. All included studies were conducted in Africa in children aged 0 to 5 years old with gastroenteritis. STATA version 16.0 software was used to perform the meta-analysis. The method of Dersimonian and Laird, based on the random effects model, was used for the statistical analyses in order to estimate the pooled prevalence's at a 95% confidence interval (CI). Heterogeneity was assessed by Cochran's Q test using the I2 index. The funnel plot was used to assess study publication bias. A total of 521 studies were retrieved from the databases, and 19 were included in the meta-analysis. The pooled norovirus prevalence's for pre- and post-vaccination rotavirus studies were 15% (95 CI, 15-18) and 13% (95 CI, 09-17) respectively. GII was the predominant genogroup, with prevalence of 87.64% and 91.20% respectively for the pre- and post-vaccination studies. GII.4 was the most frequently detected genotype, with rates of 66.84% and 51.24% respectively for the pre- and post-vaccination studies. This meta-analysis indicates that rotavirus vaccination has not resulted in a decrease in norovirus infections in Africa.


Subject(s)
Caliciviridae Infections , Gastroenteritis , Genetic Variation , Norovirus , Rotavirus Infections , Rotavirus Vaccines , Humans , Rotavirus Vaccines/immunology , Rotavirus Vaccines/administration & dosage , Infant , Africa/epidemiology , Child, Preschool , Caliciviridae Infections/epidemiology , Caliciviridae Infections/prevention & control , Caliciviridae Infections/virology , Norovirus/genetics , Norovirus/classification , Norovirus/immunology , Rotavirus Infections/prevention & control , Rotavirus Infections/epidemiology , Rotavirus Infections/virology , Gastroenteritis/virology , Gastroenteritis/epidemiology , Gastroenteritis/prevention & control , Infant, Newborn , Prevalence , Rotavirus/genetics , Rotavirus/immunology , Rotavirus/classification , Vaccination/statistics & numerical data
7.
Hum Vaccin Immunother ; 20(1): 2333106, 2024 Dec 31.
Article in English | MEDLINE | ID: mdl-38566502

ABSTRACT

Vaccine co-administration is a useful strategy for improving vaccine coverage and adherence. In Italy, an update to the national immunization program (NIP) in 2023 included recommendations for co-administration of pediatric vaccines, including the four-component vaccine for meningococcus B (4CMenB), pneumococcal conjugate vaccine (PCV), hexavalent vaccines, and oral rotavirus vaccines. Safety is a major concern when considering vaccine co-administration; therefore, a literature review of the available evidence on 4CMenB co-administration with PCV, hexavalent/pentavalent, and rotavirus vaccines was performed. Of 763 publications screened, two studies were reviewed that reported safety data on 4CMenB co-administration with PCV, hexavalent/pentavalent, and rotavirus vaccines in infants aged 0-24 months. Overall, these studies supported that there were no significant safety signals when co-administering 4CMenB with PCV, hexavalent/pentavalent, and rotavirus vaccines, compared with individual vaccination. This review provides key insights for healthcare professionals on the tolerability of co-administering 4CMenB with routine vaccines.


Subject(s)
Meningococcal Infections , Meningococcal Vaccines , Humans , Infant , Meningococcal Infections/prevention & control , Meningococcal Vaccines/administration & dosage , Neisseria meningitidis, Serogroup B , Rotavirus Vaccines/administration & dosage , Vaccination , Vaccines, Conjugate/administration & dosage , Infant, Newborn , Pneumococcal Vaccines/administration & dosage
8.
Hum Vaccin Immunother ; 20(1): 2335730, 2024 Dec 31.
Article in English | MEDLINE | ID: mdl-38575525

ABSTRACT

Rotavirus is the most common cause of diarrhea in children worldwide. In 2016, rotavirus infection resulted in 258 173 300 episodes of diarrhea and 128 500 child deaths in the globe. The study aimed to assess the magnitude of Rotavirus vaccine dose-two dropout and associated factors among children who received rotavirus vaccine dose-one in sub-Saharan African countries. The appended and most recent demographic and health survey (DHS) dataset of 17 sub-Saharan African countries was used for data analysis. A total of 73,396 weighted samples were used. Factors associated with the outcome variable were considered significant if their p-values were ≤ .05 in the multilevel mixed-effect logistic regression model. The overall Rotavirus vaccine dose-two dropouts was 10.77% (95% CI 10.55%, 11.00%), which ranged from 2.77% in Rwanda to 37.67% in Uganda. Being younger, late birth order, having difficulty accessing health facilities, having no media exposure, having no work, having home delivery, having no antenatal follow-up, and having no postnatal checkup were factors significantly associated with the outcome variable. The overall Rotavirus vaccine dose-two dropout was higher in sub-Saharan African countries which implies that vaccine dropout is still a great issue in the region. Special attention should be given to those mothers who are young, who have no work, who give birth at home, who experienced difficulty in accessing health facilities, and late birth orders. Furthermore, targeted interventions should be considered for improving access and utilization of media, antenatal care, and postnatal care services.


Subject(s)
Rotavirus Vaccines , Child , Humans , Female , Pregnancy , Multilevel Analysis , Diarrhea/prevention & control , Africa South of the Sahara/epidemiology , Demography
9.
Vaccine ; 42(15): 3514-3521, 2024 May 31.
Article in English | MEDLINE | ID: mdl-38670845

ABSTRACT

Group A rotavirus (RVA) is the primary etiological agent of acute gastroenteritis (AGE) in children under 5 years of age. Despite the global implementation of vaccines, rotavirus infections continue to cause over 120,000 deaths annually, with a majority occurring in developing nations. Among infants, the P[8] rotavirus strain is the most prevalent and can be categorized into four distinct lineages. In this investigation, we expressed five VP4(aa26-476) proteins from different P[8] lineages of human rotavirus in E. coli and assessed their immunogenicity in rabbits. Among the different P[8] strains, the Wa-VP4 protein, derived from the MT025868.1 strain of the P[8]-1 lineage, exhibited successful purification in a highly homogeneous form and significantly elicited higher levels of neutralizing antibodies (nAbs) against both homologous and heterologous rotaviruses compared to other VP4 proteins derived from different P[8] lineages in rabbits. Furthermore, we assessed the immunogenicity of the Wa-VP4 protein in mice, pigs, and cynomolgus monkeys, observing that it induced robust production of nAbs in all animals. Interestingly, there was no significant difference between in nAb titers against homologous and heterologous rotaviruses in pigs and mankeys. Collectively, these findings suggest that the Wa-VP4* protein may serve as a potential candidate for a rotavirus vaccine.


Subject(s)
Antibodies, Neutralizing , Antibodies, Viral , Capsid Proteins , Macaca fascicularis , Rotavirus Infections , Rotavirus Vaccines , Rotavirus , Animals , Antibodies, Neutralizing/immunology , Antibodies, Neutralizing/blood , Rotavirus Vaccines/immunology , Rotavirus Vaccines/administration & dosage , Antibodies, Viral/immunology , Antibodies, Viral/blood , Swine , Rabbits , Mice , Rotavirus/immunology , Rotavirus/genetics , Capsid Proteins/immunology , Capsid Proteins/genetics , Rotavirus Infections/prevention & control , Rotavirus Infections/immunology , Female , Mice, Inbred BALB C , Humans , Immunogenicity, Vaccine , Viral Nonstructural Proteins/immunology , Viral Nonstructural Proteins/genetics
10.
Am J Trop Med Hyg ; 110(6): 1201-1209, 2024 Jun 05.
Article in English | MEDLINE | ID: mdl-38626750

ABSTRACT

This study examined the relative proportion of enteric pathogens associated with severe gastroenteritis (GE) among children younger than 2 years in a phase III efficacy trial of the ROTASIIL® vaccine in India, evaluated the impact of co-infections on vaccine efficacy (VE), and characterized the association between specific pathogens and the clinical profile of severe GE. Stored stool samples collected from cases of severe GE in the phase III trial were tested by quantitative polymerase chain reaction using TaqMan™ Array Cards. Etiology was attributed by calculating the adjusted attributable fraction (AF) for each pathogen. A test-negative design was used to estimate VE. The pathogens with the highest AFs for severe diarrhea were rotavirus (23.5%), adenovirus 40/41 (17.0%), Shigella spp./enteroinvasive Escherichia coli, norovirus GII, enterotoxigenic E. coli, and Cryptosporidium spp. A considerable proportion of the disease in these children could not be explained by the pathogens tested. Severe GE cases associated with rotavirus and Shigella spp. were more likely to have a longer duration of vomiting and diarrhea, respectively. Cases attributed to Cryptosporidium spp. were more severe and required hospitalization. In the intention-to-treat population, VE was estimated to be 43.9% before and 46.5% after adjustment for co-infections; in the per-protocol population, VE was 46.7% before and 49.1% after adjustments. Rotavirus continued to be the leading cause of severe GE in this age group. The adjusted VE estimates obtained did not support co-infections as a major cause of lower vaccine performance in low- and middle-income countries.


Subject(s)
Coinfection , Diarrhea , Gastroenteritis , Rotavirus Infections , Rotavirus Vaccines , Rotavirus , Humans , Rotavirus Vaccines/therapeutic use , Rotavirus Vaccines/immunology , Rotavirus Vaccines/administration & dosage , Infant , Gastroenteritis/virology , Gastroenteritis/microbiology , Gastroenteritis/prevention & control , Rotavirus Infections/prevention & control , Rotavirus Infections/epidemiology , Diarrhea/virology , Diarrhea/microbiology , Diarrhea/prevention & control , Diarrhea/epidemiology , Coinfection/microbiology , Coinfection/virology , Rotavirus/immunology , Female , Vaccine Efficacy , Shigella/immunology , Male , India/epidemiology , Feces/virology , Feces/microbiology , Vaccines, Attenuated , Norovirus/immunology , Enterotoxigenic Escherichia coli/immunology
11.
J Virol ; 98(5): e0021224, 2024 May 14.
Article in English | MEDLINE | ID: mdl-38591886

ABSTRACT

Porcine rotaviruses (PoRVs) cause severe economic losses in the swine industry. P[7] and P[23] are the predominant genotypes circulating on farms, but no vaccine is yet available. Here, we developed a bivalent subunit PoRV vaccine using truncated versions (VP4*) of the VP4 proteins from P[7] and P[23]. The vaccination of mice with the bivalent subunit vaccine elicited more robust neutralizing antibodies (NAbs) and cellular immune responses than its components, even at high doses. The bivalent subunit vaccine and inactivated bivalent vaccine prepared from strains PoRVs G9P[7] and G9P[23] were used to examine their protective efficacy in sows and suckling piglets after passive immunization. The immunized sows showed significantly elevated NAbs in the serum and colostrum, and the suckling piglets acquired high levels of sIgA antibodies from the colostrum. Challenging subunit-vaccinated or inactivated-vaccinated piglets with homologous virulent strains did not induce diarrhea, except in one or two piglets, which had mild diarrhea. Immunization with the bivalent subunit vaccine and inactivated vaccine also alleviated the microscopic lesions in the intestinal tissues caused by the challenge with the corresponding homologous virulent strain. However, all the piglets in the challenged group displayed mild to watery diarrhea and high levels of viral shedding, whereas the feces and intestines of the piglets in the bivalent subunit vaccine and inactivated vaccine groups had lower viral loads. In summary, our data show for the first time that a bivalent subunit vaccine combining VP4*P[7] and VP4*P[23] effectively protects piglets against the diarrhea caused by homologous virulent strains.IMPORTANCEPoRVs are the main causes of diarrhea in piglets worldwide. The multisegmented genome of PoRVs allows the reassortment of VP4 and VP7 genes from different RV species and strains. The P[7] and P[23] are the predominant genotypes circulating in pig farms, but no vaccine is available at present in China. Subunit vaccines, as nonreplicating vaccines, are an option to cope with variable genotypes. Here, we have developed a bivalent subunit candidate vaccine based on a truncated VP4 protein, which induced robust humoral and cellular immune responses and protected piglets against challenge with homologous PoRV. It also appears to be safe. These data show that the truncated VP4-protein-based subunit vaccine is a promising candidate for the prevention of PoRV diarrhea.


Subject(s)
Rotavirus Vaccines , Vaccines, Subunit , Animals , Female , Mice , Antibodies, Neutralizing/blood , Antibodies, Neutralizing/immunology , Antibodies, Viral/blood , Antibodies, Viral/immunology , Capsid Proteins/immunology , Capsid Proteins/genetics , Diarrhea/prevention & control , Diarrhea/virology , Diarrhea/veterinary , Diarrhea/immunology , Genotype , Immunity, Cellular , Mice, Inbred BALB C , Rotavirus/immunology , Rotavirus Infections/prevention & control , Rotavirus Infections/veterinary , Rotavirus Infections/immunology , Rotavirus Infections/virology , Rotavirus Vaccines/immunology , Rotavirus Vaccines/administration & dosage , Swine , Swine Diseases/prevention & control , Swine Diseases/virology , Swine Diseases/immunology , Vaccination , Vaccines, Subunit/immunology , Vaccines, Subunit/administration & dosage , Vaccines, Synthetic/immunology , Vaccines, Synthetic/administration & dosage
12.
Hum Vaccin Immunother ; 20(1): 2324538, 2024 Dec 31.
Article in English | MEDLINE | ID: mdl-38509699

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.


Subject(s)
Poliomyelitis , Poliovirus , Rotavirus Vaccines , Humans , Infant , Antibodies, Neutralizing , Antibodies, Viral , China , Immunogenicity, Vaccine , Poliomyelitis/prevention & control , Poliovirus Vaccine, Inactivated , Poliovirus Vaccine, Oral , Vaccines, Attenuated
13.
Arch Virol ; 169(3): 72, 2024 Mar 08.
Article in English | MEDLINE | ID: mdl-38459213

ABSTRACT

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.


Subject(s)
Gastroenteritis , Rotavirus Infections , Rotavirus Vaccines , Rotavirus , Child , Female , Humans , Child, Preschool , Gastroenteritis/prevention & control , Antibodies, Viral , Vaccination , Immunoglobulin A , Immunoglobulin G , Vaccines, Attenuated
14.
Front Public Health ; 12: 1356932, 2024.
Article in English | MEDLINE | ID: mdl-38463163

ABSTRACT

Introduction: Rotavirus-associated diarrheal diseases significantly burden healthcare systems, particularly affecting infants under five years. Both Rotarix™ (RV1) and RotaTeq™ (RV5) vaccines have been effective but have distinct application schedules and limited interchangeability data. This study aims to provide evidence on the immunogenicity, reactogenicity, and safety of mixed RV1-RV5 schedules compared to their standard counterparts. Methods: This randomized, double-blind study evaluated the non-inferiority in terms of immunogenicity of mixed rotavirus vaccine schedules compared to standard RV1 and RV5 schedules in a cohort of 1,498 healthy infants aged 6 to 10 weeks. Participants were randomly assigned to one of seven groups receiving various combinations of RV1, and RV5. Standard RV1 and RV5 schedules served as controls of immunogenicity, reactogenicity, and safety analysis. IgA antibody levels were measured from blood samples collected before the first dose and one month after the third dose. Non-inferiority was concluded if the reduction in seroresponse rate in the mixed schemes, compared to the standard highest responding scheme, did not exceed the non-inferiority margin of -0.10. Reactogenicity traits and adverse events were monitored for 30 days after each vaccination and analyzed on the entire cohort. Results: Out of the initial cohort, 1,365 infants completed the study. Immunogenicity analysis included 1,014 infants, considering IgA antibody titers ≥20 U/mL as seropositive. Mixed vaccine schedules demonstrated non-inferiority to standard schedules, with no significant differences in immunogenic response. Safety profiles were comparable across all groups, with no increased incidence of serious adverse events or intussusception. Conclusion: The study confirms that mixed rotavirus vaccine schedules are non-inferior to standard RV1 and RV5 regimens in terms of immunogenicity and safety. This finding supports the flexibility of rotavirus vaccination strategies, particularly in contexts of vaccine shortage or logistic constraints. These results contribute to the global effort to optimize rotavirus vaccination programs for broader and more effective pediatric coverage.Clinical trial registration: ClinicalTrials.gov, NCT02193061.


Subject(s)
Rotavirus Infections , Rotavirus Vaccines , Humans , Infant , Diarrhea/virology , Immunoglobulin A , Rotavirus Infections/complications , Rotavirus Infections/prevention & control , Rotavirus Vaccines/adverse effects , Double-Blind Method
16.
Viruses ; 16(3)2024 03 07.
Article in English | MEDLINE | ID: mdl-38543776

ABSTRACT

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.


Subject(s)
Gastroenteritis , Rotavirus Infections , Rotavirus Vaccines , Rotavirus , Humans , Animals , Swine , Reverse Genetics , Ohio , Universities , Rotavirus Infections/prevention & control , Rotavirus Infections/veterinary , Gastroenteritis/prevention & control , Gastroenteritis/veterinary
17.
Viruses ; 16(3)2024 03 12.
Article in English | MEDLINE | ID: mdl-38543803

ABSTRACT

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.


Subject(s)
Gastroenteritis , Rotavirus Infections , Rotavirus Vaccines , Rotavirus , Animals , Mice , Child , Humans , Child, Preschool , Rotavirus/genetics , Prospective Studies , Antibodies, Viral , Vaccines, Synthetic/genetics , Gastroenteritis/prevention & control , Rotavirus Vaccines/genetics
18.
Hum Vaccin Immunother ; 20(1): 2322202, 2024 Dec 31.
Article in English | MEDLINE | ID: mdl-38478958

ABSTRACT

Rotavirus (RV) vaccines were first introduced in 2011 and adopted for universal vaccination in 2020 in Japan. However, the effectiveness of RV vaccines after being adopted for universal vaccination in 2020 has not been reported. Because of the easy accessibility of clinics in Japan, many children are not usually hospitalized for RV gastroenteritis (RVGE). Therefore, in order to evaluate the impact of the RV vaccine since 2008, we investigated the incidence of hospitalization for RVGE as well as the frequency of children aged < 5 years who received medical treatment for severe RVGE at clinics in Shibata City, Japan. The RV vaccine coverage rate was 94.0% (1,046/1,113) in Shibata City after universal vaccination in 2020; this was a significant increase from previous rates. The incidence per 1000 person - years for RVGE hospitalization and severe RVGE at clinics were significantly higher among children aged < 3 years than in previous time periods. The incidence in children with all acute gastroenteritis (AGE) decreased significantly after universal vaccination during the COVID-19 pandemic. The proportion of severe RVGE among all AGE cases also decreased significantly after universal vaccination among children aged < 3 years (0.0%) and those aged 3-4 years (0.6%). There were significant differences in the distribution of RV genotypes isolated from the feces of children with RVGE between different eras divided by RV vaccination rates, especially G1P[8], which was the major genotype before it recently almost disappeared. Further studies are warranted to assess the impact of the COVID-19 pandemic.


Subject(s)
COVID-19 , Gastroenteritis , Rotavirus Infections , Rotavirus Vaccines , Rotavirus , Child , Humans , Infant , Incidence , Japan/epidemiology , Pandemics , Gastroenteritis/epidemiology , Gastroenteritis/prevention & control , Rotavirus Infections/epidemiology , Rotavirus Infections/prevention & control , Vaccination , Hospitalization , COVID-19/epidemiology
19.
BMC Public Health ; 24(1): 770, 2024 Mar 12.
Article in English | MEDLINE | ID: mdl-38475736

ABSTRACT

INTRODUCTION: The 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. METHODS: We 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. RESULTS: A 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. CONCLUSIONS: Consistent 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.


Subject(s)
Rotavirus Infections , Rotavirus Vaccines , Rotavirus , Child , Female , Humans , Infant , Child, Preschool , Cross-Sectional Studies , Rotavirus Infections/prevention & control , Vaccination , Italy
20.
Vaccine ; 42(7): 1534-1541, 2024 Mar 07.
Article in English | MEDLINE | ID: mdl-38331661

ABSTRACT

INTRODUCTION: Botswana had a resurgent diarrhea outbreak in 2018, mainly affecting children under five years old. Botswana introduced rotavirus vaccine (RotarixTM) into the national immunization programme in July 2012. Official rotavirus vaccine coverage estimates averaged 77.2% over the five years following introduction. MATERIALS AND METHODS: The outbreak was investigated using multiple data sources, including stool laboratory testing, immunization data review, water assessment, and vaccine storage assessment. We reviewed official reports of the routine immunization data from 2013 to 2017 and compared district-level rotavirus vaccine coverage with district-level attack rates during the outbreak. RESULTS: During the outbreak, a total of 228 stool samples were tested at the national health laboratory and 152 (67%) of the specimens were positive for rotavirus. A portion of adequate samples (80) were selected for referral to the Regional Reference Lab. The laboratory testing of 80 samples at the Regional Reference Laboratory in South Africa showed that 91% of the stool samples were positive for rotavirus, and the dominant strain 47/80 (58.7%) was G3P[8]. The immunization data showed that rotavirus vaccine coverage varied widely among districts, and there was no correlation between districts with high attack rates and those with low immunization coverage. Water assessment showed that some water sources were contaminated with E Coli. There was no problem with vaccine storage. CONCLUSION: The outbreak was caused by rotavirus G3P[8], a strain that was not common in the country prior to the outbreak. Despite the significant pressure and anxiety that outbreaks cause, the number of diarrhea cases and deaths were less compared to pre-vaccine era due to the impact of vaccination. This highlights the need for continuous implementation of high impact child survival interventions.


Subject(s)
Rotavirus Infections , Rotavirus Vaccines , Rotavirus , Child, Preschool , Humans , Infant , Botswana/epidemiology , Diarrhea/epidemiology , Diarrhea/prevention & control , Disease Outbreaks , Escherichia coli , Feces , Genotype , Rotavirus Infections/epidemiology , Rotavirus Infections/prevention & control , Water
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