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Umesh D. Parashar - One of the best experts on this subject based on the ideXlab platform.
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Rotavirus Vaccine impact assessment surveillance in India: protocol and methods
BMJ Open, 2019Co-Authors: Nayana P. Nair, Umesh D. Parashar, Samarasimha Reddy N, Sidhartha Giri, Venkata Raghava Mohan, Jacqueline E. Tate, Minesh P. Shah, Rashmi Arora, Mohan D. Gupte, Sanjay MehendaleAbstract:Introduction Rotavirus infection accounts for 39% of under-five diarrhoeal deaths globally and 22% of these deaths occur in India. Introduction of Rotavirus Vaccine in a national immunisation programme is considered to be the most effective intervention in preventing severe Rotavirus disease. In 2016, India introduced an indigenous Rotavirus Vaccine (Rotavac) into the Universal Immunisation Programme in a phased manner. This paper describes the protocol for surveillance to monitor the performance of Rotavirus Vaccine following its introduction into the routine childhood immunisation programme. Methods An active surveillance system was established to identify acute gastroenteritis cases among children less than 5 years of age. For all children enrolled at sentinel sites, case reporting forms are completed and a copy of vaccination record and a stool specimen obtained. The forms and specimens are sent to the referral laboratory for data entry, analysis, testing and storage. Data from sentinel sites in states that have introduced Rotavirus Vaccine into their routine immunisation schedule will be used to determine Rotavirus Vaccine impact and effectiveness. Ethics and dissemination The Institutional Review Board of Christian Medical College, Vellore, and all the site institutional ethics committees approved the project. Results will be disseminated in peer-reviewed journals and with stakeholders of the universal immunisation programme in India.
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Using surveillance and economic data to make informed decisions about Rotavirus Vaccine introduction.
Vaccine, 2018Co-Authors: Adam L. Cohen, Jacqueline E. Tate, Negar Aliabadi, Fatima Serhan, Patrick L.f. Zuber, Umesh D. ParasharAbstract:Abstract While Rotavirus Vaccines are available, safe, and effective, many countries are not yet widely using these Vaccines. Surveillance for Rotavirus disease and potential Vaccine adverse events is critical for country decision making about Rotavirus Vaccine. This special issue shares Rotavirus and intussusception disease surveillance data and Rotavirus Vaccine cost-effectiveness analyses from countries that have yet to introduce Rotavirus Vaccines into their routine infant immunization programs. The studies highlight the substantial burden of Rotavirus disease and the cost-effectiveness of Rotavirus Vaccine in a broad set of countries without Rotavirus Vaccine in their routine immunization programs.
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Global Rotavirus Vaccine introductions and coverage: 2006 – 2016
Human Vaccines & Immunotherapeutics, 2018Co-Authors: Alice J. Abou-nader, Umesh D. Parashar, Jacqueline E. Tate, Molly A. Sauer, A. Duncan Steele, Deborah Atherly, Mathuram Santosham, E. Anthony S. NelsonAbstract:ABSTRACTAn estimated 215,000 children died of Rotavirus infections in 2013, accounting for 37% of diarrhea-related deaths worldwide, 92% of which occurred in low and lower-middle income countries. Since 2009 the World Health Organization (WHO) recommends the use of Rotavirus Vaccines in all national immunization programs. This review compares Rotavirus Vaccine (RV) introductions and Vaccine coverage by region, country income status and Gavi-eligibility from 2006–2016. Gross National Income data from the World Bank and surviving infant population from United Nations Population Division was obtained for 2016. Data from WHO were collected on Rotavirus Vaccine coverage, national immunization schedules, and new Vaccine introductions for 2016 while estimated Rotavirus deaths were collected for 2013, the last year of available WHO data. As of December 2016, the majority of countries (57%, 110/194) had not introduced universal Rotavirus Vaccine despite WHO's 2009 recommendation to do so. Countries in the WHO Afri...
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potential for a booster dose of Rotavirus Vaccine to further reduce diarrhea mortality
Vaccine, 2017Co-Authors: Eleanor Burnett, Benjamin A. Lopman, Umesh D. ParasharAbstract:Concern has grown that children vaccinated against Rotavirus in developing countries may be vulnerable to Rotavirus diarrhea in the second year of life due to waning immunity. Adding a booster dose of Rotavirus Vaccine at 9 or 12 months of age with measles Vaccine has been suggested as a strategy to address this. We evaluated the hypothetical potential benefits of a booster dose on reduction of Rotavirus mortality. The projected number of deaths averted were calculated using national level full series vaccination coverage, estimated national Rotavirus deaths by week of age, and VE at <12 months of age and ≥12 months of age derived from the published literature. We assumed three functional forms of waning based on the VE estimates: stepwise, linear, and logarithmic. We modeled three potential boosting scenarios: (a) reduced VE waning in the second year of life by 50%, (b) reestablished second year of life VE to the levels in the first year of life, and (c) boosted first year VE by 50% of the difference between VE in the first and second years. To express uncertainty resulting from the parameters, each of the nine models were run 1000 times using a random sample of input values. Across all WHO regions, with the stepwise models we estimated a median of 9800 (95%CI: 9400, 10,200), 19,600 (95%CI: 18,800, 20,400), and 29,400 (95%CI: 28,200, 30,700) additional Rotavirus deaths averted in the reduced VE waning, reestablished VE, and boosted VE scenarios. These estimates were highly sensitive to the assumed functional form of waning with approximately 65–80% fewer deaths averted if immunity waned in a linear or logarithmic fashion compared to the stepwise model. While these projections will benefit from improved input data points, our results inform consideration of booster doses of Rotavirus Vaccine.
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Potential for a booster dose of Rotavirus Vaccine to further reduce diarrhea mortality.
Vaccine, 2017Co-Authors: Eleanor Burnett, Benjamin A. Lopman, Umesh D. ParasharAbstract:Concern has grown that children vaccinated against Rotavirus in developing countries may be vulnerable to Rotavirus diarrhea in the second year of life due to waning immunity. Adding a booster dose of Rotavirus Vaccine at 9 or 12 months of age with measles Vaccine has been suggested as a strategy to address this. We evaluated the hypothetical potential benefits of a booster dose on reduction of Rotavirus mortality. The projected number of deaths averted were calculated using national level full series vaccination coverage, estimated national Rotavirus deaths by week of age, and VE at
Richard L Ward - One of the best experts on this subject based on the ideXlab platform.
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live attenuated human Rotavirus Vaccine rix4414 provides clinical protection in infants against Rotavirus strains with and without shared g and p genotypes integrated analysis of randomized controlled trials
Pediatric Infectious Disease Journal, 2009Co-Authors: Alain Bouckenooghe, Richard L Ward, Paul Gillard, Serge Debrus, Brigitte CheuvartAbstract:Background:The 2-dose, oral live attenuated human G1P[8] Rotavirus Vaccine (RIX4414) is highly effective against Rotavirus gastroenteritis caused by circulating G1 and non-G1 types. An integrated analysis on Vaccine efficacy was undertaken to obtain more precise estimates of the overall protective e
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Why does the world need another Rotavirus Vaccine
Therapeutics and Clinical Risk Management, 2008Co-Authors: Richard L Ward, Monica M Mcneal, A. Duncan SteeleAbstract:A “Meeting on Upstream Rotavirus Vaccines and Emerging Vaccine Producers” was held at the World Health Organization in Geneva, Switzerland on March 28–30, 2006. The purpose was to discuss, evaluate, and weigh the importance of additional Rotavirus Vaccine candidates following the successful international licensure of Rotavirus Vaccines by two major pharmaceutical companies (GlaxoSmithKline and Merck) that had been in development for many years. Both licensed Vaccines are composed of live Rotaviruses that are delivered orally as have been all candidate Rotavirus Vaccines evaluated in humans. Each is built on the experience gained with previous candidates whose development had either been discontinued or, in the case of the previously licensed rhesus Rotavirus reassortant Vaccine (Rotashield), was withdrawn by its manufacturer after the discovery of a rare association with intussusception. Although which alternative candidate Vaccines should be supported for development and where this should be done are controversial topics, there was general agreement expressed at the Geneva meeting that further development of alternative candidates is a high priority. This development will help insure that the most safe, effective and economic Vaccines are available to children in Third World nations where the vast majority of the >600,000 deaths due to Rotavirus occur each year. This review is intended to provide the history and present status of Rotavirus Vaccines as well as a perspective on the future development of candidate Vaccines as a means of promulgating plans suggested at the Geneva meeting.
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effects of the potency and composition of the multivalent human bovine wc3 reassortant Rotavirus Vaccine on efficacy safety and immunogenicity in healthy infants
Vaccine, 2006Co-Authors: Timo Vesikari, Paul A. Offit, Aino Karvonen, Michelle G Goveia, Michael J Dallas, Richard L Ward, Fred H Clark, Daniel J Distefano, Florian Schodel, James E DrummondAbstract:Abstract Background Rotavirus gastroenteritis, which causes substantial infant mortality and morbidity worldwide, is a Vaccine-preventable disease. The purpose of this study was to evaluate different compositions and potencies (Vaccine virus titers) of a live multivalent human-bovine (WC3) reassortant Rotavirus Vaccine in order to select the potency and composition of the Vaccine for further development. Methods The efficacy, safety, and immunogenicity of a G1, G2, G3, G4, and P1A pentavalent composition at three different potencies, a G1, G2, G3, G4 quadrivalent composition, and a P1A monovalent composition of an oral human-bovine (WC3) reassortant Rotavirus Vaccine were compared in a blinded, placebo-controlled trial conducted between 1998 and 2001 enrolling 1946 healthy Finnish infants 2–8 months of age. Results All potencies of the pentavalent and quadrivalent Vaccines were efficacious (58–74%) against wild-type Rotavirus gastroenteritis of any severity and 100% protective against severe Rotavirus disease caused by Vaccine G-serotypes through the first Rotavirus season post-vaccination. The monovalent P1A Vaccine was 53% efficacious against moderate-and-severe Rotavirus gastroenteritis. Protection against Rotavirus gastroenteritis of any severity was demonstrated through two and three Rotavirus seasons for all Vaccine compositions. After the third dose, the percentage of infants with ≥3-fold rise in baseline serum neutralizing antibody titers against G1 ranged from 62% to 86% for recipients of the pentavalent Vaccine, depending on the potency. The incidence of fever, irritability, vomiting, and diarrhea did not significantly differ between Vaccine and placebo groups. A 7-month-old male developed intussusception 9 days after the first dose of the low-potency pentavalent Vaccine. Conclusions Based on the results of this trial, a pentavalent composition (G1, G2, G3, G4, and P1A) of human-bovine (WC3) reassortant Rotavirus Vaccine with a potency similar to that of the middle-potency pentavalent Vaccine (∼8 × 10 6 plaque-forming units/dose) was selected for further development.
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second year follow up evaluation of live attenuated human Rotavirus Vaccine 89 12 in healthy infants
The Journal of Infectious Diseases, 2002Co-Authors: David I. Bernstein, Keith S. Reisinger, David Allen Sack, Edward P Rothstein, Richard L WardAbstract:Rotavirus Vaccine development is a high priority. The association between the tetravalent rhesus-human reassortant Rotavirus Vaccine and intussusception has increased the need to develop new Vaccines. In a small efficacy trial, the human Rotavirus Vaccine 89-12 recently has been shown to be safe and effective; 184 of the 215 healthy infants initially enrolled in this trial were followed for a second year. Vaccine efficacy during the second year was 59% ( ). For the 2 years of observation, Vaccine efficacy was 76% against Rotavirus gasP p .047 troenteritis, 83% against severe Rotavirus gastroenteritis, and 100% against Rotavirus illnesses requiring medical intervention ( for each). These encouraging results have led to conP ! .001 tinued evaluation, in several countries, of a Vaccine candidate derived from strain 89-12.
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efficacy of live attenuated human Rotavirus Vaccine 89 12 in infants a randomised placebo controlled trial
The Lancet, 1999Co-Authors: David I. Bernstein, Keith S. Reisinger, David Allen Sack, Edward P Rothstein, Vicki E Smith, Donna Osullivan, Dale R Spriggs, Richard L WardAbstract:Summary Background Rotavirus is the most common cause of severe, dehydrating diarrhoea in infants worldwide. We assessed the safety, immunogenicity, and efficacy of a live, oral human Rotavirus Vaccine, 89–12, in US children in a randomised, placebo-controlled, double-blind multicentre trial. Methods 215 healthy infants were enrolled, of whom 213 were given two doses of 89–12 (containing 1×10 5 plaque-forming units) or placebo, and 213 were followed up through one Rotavirus season. The frequency of side-effects was compared for 7 days after each dose of Vaccine. Immune responses to Rotavirus were assessed by serum and stool IgA, and by serum 89–12 neutralising titres. The primary outcome variable (protection from Rotavirus disease) was evaluated by comparing the frequencies of Rotavirus gastroenteritis in an intention-to-treat analysis. Findings Adverse reactions were mild. Low-grade fever (≥38·1°C) after the first dose was the only side-effect significantly more common in the Vaccine group than in the placebo group (21 [19%] vs 5 [5%], p=0·001). An immune response to Vaccine was detected in 94·4% of Vaccinees. Rotavirus disease occurred in 18 of 107 placebo recipients and two of 108 Vaccine recipients (Vaccine efficacy 89·0% [95% Cl 65·4–94·5]). Ten infants in the placebo group but none in the Vaccine group were presented for medical care. Interpretation The 89–12 Rotavirus Vaccine was safe and immunogenic and provided a high degree of protection against Rotavirus disease. Further investigations of this Vaccine are needed to confirm these findings in other settings.
David I. Bernstein - One of the best experts on this subject based on the ideXlab platform.
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second year follow up evaluation of live attenuated human Rotavirus Vaccine 89 12 in healthy infants
The Journal of Infectious Diseases, 2002Co-Authors: David I. Bernstein, Keith S. Reisinger, David Allen Sack, Edward P Rothstein, Richard L WardAbstract:Rotavirus Vaccine development is a high priority. The association between the tetravalent rhesus-human reassortant Rotavirus Vaccine and intussusception has increased the need to develop new Vaccines. In a small efficacy trial, the human Rotavirus Vaccine 89-12 recently has been shown to be safe and effective; 184 of the 215 healthy infants initially enrolled in this trial were followed for a second year. Vaccine efficacy during the second year was 59% ( ). For the 2 years of observation, Vaccine efficacy was 76% against Rotavirus gasP p .047 troenteritis, 83% against severe Rotavirus gastroenteritis, and 100% against Rotavirus illnesses requiring medical intervention ( for each). These encouraging results have led to conP ! .001 tinued evaluation, in several countries, of a Vaccine candidate derived from strain 89-12.
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Rotavirus Vaccine
BioDrugs, 2000Co-Authors: David I. BernsteinAbstract:Rotavirus is the most important cause of severe gastroenteritis in infants and children worldwide. Efforts to develop a Vaccine have concentrated on live oral Vaccines, especially with attenuated animal viruses. Because studies with rhesus monkey Rotavirus and bovine Rotavirus RIT 4237 or WC3 were inconsistent, reassortant rhesus and bovine Vaccines have been developed that include the gene encoding the neutralising protein, VP7, of several human strains. These efforts culminated in the licensure of a tetravalent rhesus Rotavirus Vaccine, in 1998. Subsequent reports linking vaccination to intussusception, however, led to withdrawal of this Vaccine. Trials, nevertheless, continue with an oral bovine reassortant Vaccine and an attenuated human strain, 89-12. Other strategies in preclinical development include the use of virus-like particles, DNA Vaccines and subunit Vaccines given by mucosal and nonmucosal routes.
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efficacy of live attenuated human Rotavirus Vaccine 89 12 in infants a randomised placebo controlled trial
The Lancet, 1999Co-Authors: David I. Bernstein, Keith S. Reisinger, David Allen Sack, Edward P Rothstein, Vicki E Smith, Donna Osullivan, Dale R Spriggs, Richard L WardAbstract:Summary Background Rotavirus is the most common cause of severe, dehydrating diarrhoea in infants worldwide. We assessed the safety, immunogenicity, and efficacy of a live, oral human Rotavirus Vaccine, 89–12, in US children in a randomised, placebo-controlled, double-blind multicentre trial. Methods 215 healthy infants were enrolled, of whom 213 were given two doses of 89–12 (containing 1×10 5 plaque-forming units) or placebo, and 213 were followed up through one Rotavirus season. The frequency of side-effects was compared for 7 days after each dose of Vaccine. Immune responses to Rotavirus were assessed by serum and stool IgA, and by serum 89–12 neutralising titres. The primary outcome variable (protection from Rotavirus disease) was evaluated by comparing the frequencies of Rotavirus gastroenteritis in an intention-to-treat analysis. Findings Adverse reactions were mild. Low-grade fever (≥38·1°C) after the first dose was the only side-effect significantly more common in the Vaccine group than in the placebo group (21 [19%] vs 5 [5%], p=0·001). An immune response to Vaccine was detected in 94·4% of Vaccinees. Rotavirus disease occurred in 18 of 107 placebo recipients and two of 108 Vaccine recipients (Vaccine efficacy 89·0% [95% Cl 65·4–94·5]). Ten infants in the placebo group but none in the Vaccine group were presented for medical care. Interpretation The 89–12 Rotavirus Vaccine was safe and immunogenic and provided a high degree of protection against Rotavirus disease. Further investigations of this Vaccine are needed to confirm these findings in other settings.
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safety and immunogenicity of live attenuated human Rotavirus Vaccine 89 12
Vaccine, 1998Co-Authors: David I. Bernstein, Vicki E Smith, Dale R Spriggs, James R Sherwood, Gilbert M Schiff, Donna S Sander, Donna Defeudis, Richard L WardAbstract:Abstract The safety and immunogenicity of an orally administered live human Rotavirus Vaccine candidate (89-12), attenuated by 33 passages in monkey kidney cells, were evaluated in placebo-controlled trials in adults, children and infants. This strain was selected because natural infections with 89-12-like Rotaviruses provided 100% protection over two years. The initial evaluations in adults, seropositive children and nine infants indicated that the Vaccine was safe. Two doses of Vaccine (10 5 p.f.u. dose −1 ) or placebo were then given to 42 infants, aged from 6 to 26 weeks. No significant difference in side effects was seen. Seroconversion was demonstrated in 19 of 20 previously uninfected Vaccine recipients, but ≥4-fold rises in 89-12 neutralizing antibody titers were detected in only seven subjects. Intestinal IgA responses were detected in 15 subjects. This attenuated human Rotavirus was safe and immunogenic and should be further evaluated as a Vaccine candidate.
Timo Vesikari - One of the best experts on this subject based on the ideXlab platform.
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Norovirus gastroenteritis in young children receiving human Rotavirus Vaccine
Scandinavian Journal of Infectious Diseases, 2010Co-Authors: Shang-qin Zeng, Anne Halkosalo, Marjo Salminen, Evelin D. Szakal, Aino Karvonen, Timo VesikariAbstract:AbstractWe explored whether human Rotavirus Vaccine had any efficacy against norovirus (NV)-associated gastroenteritis in young children. In an efficacy trial of Rotavirus Vaccine, 405 infants were immunized with a human Rotavirus Vaccine or placebo at a ratio of 2:1, and prospectively followed for acute gastroenteritis (AGE) from approximately 2 months to 2 y of age. Multiplex real-time reverse transcription polymerase chain reaction (Mrt RT-PCR) assays were used for detection and quantitation of NVs of genogroup I (GI) and genogroup II (GII) in stool specimens. NVs were detected in 155 (32%) of 485 episodes of AGE. Of these, NV was the only gastroenteritis virus detected in the stools in 142 (29%) episodes. GI and GII NVs were found in 12% and 88% of the cases, respectively. NV as the only gastroenteritis virus was detected in 36% of the infants in the Rotavirus Vaccine group and 27% in the placebo group. The clinical severity of NV-associated AGE in the Vaccine and placebo recipients was not different....
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rotateq a pentavalent Rotavirus Vaccine efficacy and safety among infants in europe
Vaccine, 2009Co-Authors: Timo Vesikari, Aino Karvonen, Penny M Heaton, Robbin F Itzler, Tiina Korhonen, Pierre Van Damme, Ulrich Behre, Gianni Bona, Leif Gothefors, Michael J DallasAbstract:A pentavalent human-bovine reassortant oral Rotavirus Vaccine, RotaTeq, was evaluated among nearly 70,000 infants in the Rotavirus Efficacy and Safety Trial (REST), of which 30,523 were from Europe. All infants were followed for serious adverse events as well as hospitalizations and emergency department (ED) visits. All adverse events, health care utilization, and RVGE regardless of severity were evaluated in the clinical efficacy cohort (N=2686) in Finland. RotaTeq was 98.3% (95% CI, 90.2-100%) and 68.0% (95% CI 60.3-74.4%) efficacious against severe Rotavirus gastroenteritis (RVGE) and all RVGE due to any serotype for two Rotavirus seasons post-vaccination. The combined rate of hospitalizations and ED visits due to RVGE of any serotype was reduced by 94.5% (95% CI, 91.3-96.8%) for up to 2 years after vaccination. There were no statistically significant differences between RotaTeq and placebo for any of the safety outcomes. In Europe, RotaTeq was highly efficacious and well tolerated.
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efficacy immunogenicity and safety of a pentavalent human bovine wc3 reassortant Rotavirus Vaccine at the end of shelf life
Pediatrics, 2007Co-Authors: Stan L. Block, Timo Vesikari, Michelle G Goveia, Stephen B Rivers, Ben A Adeyi, Michael J Dallas, Jeffrey Bauder, John W Boslego, Penny M HeatonAbstract:BACKGROUND.Rotavirus is the leading cause of dehydrating acute gastroenteritis in infants worldwide. Previous studies of a live pentavalent human-bovine reassortant Rotavirus Vaccine have shown it to be efficacious across a range of potencies. OBJECTIVE.Our goal was to evaluate the efficacy, immunogenicity, and safety of pentavalent Rotavirus Vaccine at the end of shelf life in healthy infants. PATIENTS AND METHODS.During 2002‐2004, 1312 healthy infants 6 to 12 weeks old from the United States (47%) and Finland (53%) were randomly assigned to receive 3 oral doses of Vaccine (Vaccine at 1.1 10 7 infectious U per dose) or placebo 4 to 10 weeks apart. Infants were to be followed for acute gastroenteritis through 1 Rotavirus season after vaccination and for adverse events postvaccination. RESULTS.Three doses of pentavalent Rotavirus Vaccine at the end of shelf life demonstrated efficacy against Rotavirus gastroenteritis caused by human G-serotypes included in the Vaccine (G1‐G4). Efficacy against severe Rotavirus gastroenteritis was 100%, and efficacy against any Rotavirus gastroenteritis regardless of severity was 72.5%. A threefold rise in G1 serum neutralizing was observed in 57% and in anti-Rotavirus immunoglobulin A in 96% of pentavalent Rotavirus Vaccine recipients. No statistically significant increase in vomiting, diarrhea, or irritability was observed among pentavalent Rotavirus Vaccine recipients compared with placebo recipients within the 7-day period from each dose. A statistically significant increase in fevers (100.5°F, rectal equivalent) was observed among pentavalent Rotavirus Vaccine recipients compared with placebo recipients after dose 1. CONCLUSIONS.This pentavalent human-bovine Rotavirus Vaccine was generally well tolerated, efficacious, and immunogenic at the end of shelf life.
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effects of the potency and composition of the multivalent human bovine wc3 reassortant Rotavirus Vaccine on efficacy safety and immunogenicity in healthy infants
Vaccine, 2006Co-Authors: Timo Vesikari, Paul A. Offit, Aino Karvonen, Michelle G Goveia, Michael J Dallas, Richard L Ward, Fred H Clark, Daniel J Distefano, Florian Schodel, James E DrummondAbstract:Abstract Background Rotavirus gastroenteritis, which causes substantial infant mortality and morbidity worldwide, is a Vaccine-preventable disease. The purpose of this study was to evaluate different compositions and potencies (Vaccine virus titers) of a live multivalent human-bovine (WC3) reassortant Rotavirus Vaccine in order to select the potency and composition of the Vaccine for further development. Methods The efficacy, safety, and immunogenicity of a G1, G2, G3, G4, and P1A pentavalent composition at three different potencies, a G1, G2, G3, G4 quadrivalent composition, and a P1A monovalent composition of an oral human-bovine (WC3) reassortant Rotavirus Vaccine were compared in a blinded, placebo-controlled trial conducted between 1998 and 2001 enrolling 1946 healthy Finnish infants 2–8 months of age. Results All potencies of the pentavalent and quadrivalent Vaccines were efficacious (58–74%) against wild-type Rotavirus gastroenteritis of any severity and 100% protective against severe Rotavirus disease caused by Vaccine G-serotypes through the first Rotavirus season post-vaccination. The monovalent P1A Vaccine was 53% efficacious against moderate-and-severe Rotavirus gastroenteritis. Protection against Rotavirus gastroenteritis of any severity was demonstrated through two and three Rotavirus seasons for all Vaccine compositions. After the third dose, the percentage of infants with ≥3-fold rise in baseline serum neutralizing antibody titers against G1 ranged from 62% to 86% for recipients of the pentavalent Vaccine, depending on the potency. The incidence of fever, irritability, vomiting, and diarrhea did not significantly differ between Vaccine and placebo groups. A 7-month-old male developed intussusception 9 days after the first dose of the low-potency pentavalent Vaccine. Conclusions Based on the results of this trial, a pentavalent composition (G1, G2, G3, G4, and P1A) of human-bovine (WC3) reassortant Rotavirus Vaccine with a potency similar to that of the middle-potency pentavalent Vaccine (∼8 × 10 6 plaque-forming units/dose) was selected for further development.
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a Rotavirus Vaccine for prophylaxis of infants against Rotavirus gastroenteritis
Pediatric Infectious Disease Journal, 2004Co-Authors: Timo Vesikari, Alexandre Da Costa Linhares, Belen Salinas, Irene Perezschael, Guillermo M Ruizpalacios, Maria De Lourdes Guerrero, Kong Boo Phua, Andree Delem, K HardtAbstract:The need for safe and effective Vaccines to reduce morbidity and mortality caused by Rotavirus gastroenteritis in children is well-known. A live attenuated monovalent Rotavirus Vaccine (Rotarix) containing human Rotavirus strain RIX4414 of G1P1A P{8} specificity is being developed to meet the global need. An overview of RIX4414 trials in developed and developing settings is presented for 3 selected trials conducted in Finland (pilot study) Latin America (Brazil Mexico and Venezuela) and Singapore involving 5024 infants. The Vaccine was well-tolerated with no increase in any solicited symptoms as compared with the placebo. After 2 doses 61–91% of vaccinated infants developed Rotavirus-specific IgA antibodies. There was no interference with immunogenicity of coadministered routine pediatric Vaccines. Rotarix significantly reduced Rotavirus gastroenteritis episodes and Rotavirusrelated hospitalizations in vaccinated infants compared with placebo recipients (P < 0.05). Vaccine efficacy was observed against severe Rotavirus gastroenteritis caused by G1 and non-G1 types including the emerging G9 type (P < 0.05) in Latin America. These results show prospects for widespread use of Rotarix to reduce Rotavirus disease burden and warrant continued worldwide evaluation. (authors)
Jacqueline E. Tate - One of the best experts on this subject based on the ideXlab platform.
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Rotavirus Vaccine impact assessment surveillance in India: protocol and methods
BMJ Open, 2019Co-Authors: Nayana P. Nair, Umesh D. Parashar, Samarasimha Reddy N, Sidhartha Giri, Venkata Raghava Mohan, Jacqueline E. Tate, Minesh P. Shah, Rashmi Arora, Mohan D. Gupte, Sanjay MehendaleAbstract:Introduction Rotavirus infection accounts for 39% of under-five diarrhoeal deaths globally and 22% of these deaths occur in India. Introduction of Rotavirus Vaccine in a national immunisation programme is considered to be the most effective intervention in preventing severe Rotavirus disease. In 2016, India introduced an indigenous Rotavirus Vaccine (Rotavac) into the Universal Immunisation Programme in a phased manner. This paper describes the protocol for surveillance to monitor the performance of Rotavirus Vaccine following its introduction into the routine childhood immunisation programme. Methods An active surveillance system was established to identify acute gastroenteritis cases among children less than 5 years of age. For all children enrolled at sentinel sites, case reporting forms are completed and a copy of vaccination record and a stool specimen obtained. The forms and specimens are sent to the referral laboratory for data entry, analysis, testing and storage. Data from sentinel sites in states that have introduced Rotavirus Vaccine into their routine immunisation schedule will be used to determine Rotavirus Vaccine impact and effectiveness. Ethics and dissemination The Institutional Review Board of Christian Medical College, Vellore, and all the site institutional ethics committees approved the project. Results will be disseminated in peer-reviewed journals and with stakeholders of the universal immunisation programme in India.
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Using surveillance and economic data to make informed decisions about Rotavirus Vaccine introduction.
Vaccine, 2018Co-Authors: Adam L. Cohen, Jacqueline E. Tate, Negar Aliabadi, Fatima Serhan, Patrick L.f. Zuber, Umesh D. ParasharAbstract:Abstract While Rotavirus Vaccines are available, safe, and effective, many countries are not yet widely using these Vaccines. Surveillance for Rotavirus disease and potential Vaccine adverse events is critical for country decision making about Rotavirus Vaccine. This special issue shares Rotavirus and intussusception disease surveillance data and Rotavirus Vaccine cost-effectiveness analyses from countries that have yet to introduce Rotavirus Vaccines into their routine infant immunization programs. The studies highlight the substantial burden of Rotavirus disease and the cost-effectiveness of Rotavirus Vaccine in a broad set of countries without Rotavirus Vaccine in their routine immunization programs.
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Global Rotavirus Vaccine introductions and coverage: 2006 – 2016
Human Vaccines & Immunotherapeutics, 2018Co-Authors: Alice J. Abou-nader, Umesh D. Parashar, Jacqueline E. Tate, Molly A. Sauer, A. Duncan Steele, Deborah Atherly, Mathuram Santosham, E. Anthony S. NelsonAbstract:ABSTRACTAn estimated 215,000 children died of Rotavirus infections in 2013, accounting for 37% of diarrhea-related deaths worldwide, 92% of which occurred in low and lower-middle income countries. Since 2009 the World Health Organization (WHO) recommends the use of Rotavirus Vaccines in all national immunization programs. This review compares Rotavirus Vaccine (RV) introductions and Vaccine coverage by region, country income status and Gavi-eligibility from 2006–2016. Gross National Income data from the World Bank and surviving infant population from United Nations Population Division was obtained for 2016. Data from WHO were collected on Rotavirus Vaccine coverage, national immunization schedules, and new Vaccine introductions for 2016 while estimated Rotavirus deaths were collected for 2013, the last year of available WHO data. As of December 2016, the majority of countries (57%, 110/194) had not introduced universal Rotavirus Vaccine despite WHO's 2009 recommendation to do so. Countries in the WHO Afri...
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Impact of Rotavirus Vaccine on Rotavirus diarrhoea in countries of East and Southern Africa
Vaccine, 2017Co-Authors: Goitom Weldegebriel, Umesh D. Parashar, Jason M. Mwenda, Jethro M. Chakauya, Fussum Daniel, Balcha Masresha, Jacqueline E. TateAbstract:Abstract Background Established in 2006 with four countries conducting hospital-based Rotavirus surveillance, the African Rotavirus surveillance network has expanded over subsequent years. By 2015, 14 countries in the World Health Organization (WHO) East and Southern Africa sub-region (Eritrea, Ethiopia, Kenya, Lesotho, Madagascar, Mauritius, Namibia, Rwanda, Seychelles, Swaziland, Tanzania, Uganda, Zambia and Zimbabwe) were participating in the Rotavirus surveillance network coordinated by WHO. We monitored the proportion of Rotavirus diarrhoea among children under five years of age who were hospitalized for diarrhoea in the sentinel hospitals from 2010 to 2015 among countries that introduced Rotavirus Vaccine during or before 2013 (Rwanda, Tanzania, Zambia and Ethiopia) and compared with the other countries in the network. Methods Children under the age of five years hospitalized due to acute diarrhoea were enrolled into the sentinel surveillance system and had stool samples collected and tested for Rotavirus antigens by enzyme immunoassay. We described trends in Rotavirus positivity among tested stool samples before and after Rotavirus Vaccine introduction. Results In countries that introduced Rotavirus Vaccine by 2013 (Rwanda, Tanzania, Zambia and Ethiopia), average Rotavirus Vaccine coverage from 2010 to 2015 improved from 0% in 2010 and 2011, 13% in 2012, 46% in 2013, 83% in 2014 to 90% in 2015. Annual average Rotavirus positivity from 2010 to 2015 was 35%, 33%, 38%, 28%, 27%, and 19%, respectively. In countries that introduced Rotavirus Vaccine after 2013 or had not introduced by 2015, average Rotavirus Vaccine coverage was 0% in 2010–2013, 13% in 2014 and 51% in 2015. In these countries, Rotavirus positivity was 44% in 2010, 32% in 2011, 33% in 2012, 41% in 2013, 40% in 2014 and 25% in 2015. Conclusion Countries that introduced Rotavirus Vaccine by 2013 had a lower proportion of Rotavirus positive hospitalizations in 2013–2015 as compared to those that had not introduced Rotavirus Vaccine by 2013. The decrease in Rotavirus positivity was inversely related to increase in Rotavirus Vaccine coverage showing impact of Rotavirus Vaccines.
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intussusception rates before and after the introduction of Rotavirus Vaccine
Pediatrics, 2016Co-Authors: Jacqueline E. Tate, Margaret M Cortese, Claudia Angelica Steiner, Umesh D. ParasharAbstract:BACKGROUND: Recent US studies have identified a small increased risk of intussusception after Rotavirus vaccination, mainly after the first dose. We examined trends in intussusception hospitalizations before (2000–2005) and after (2007–2013) Rotavirus Vaccine introduction to assess whether this observed temporal risk translates into more hospitalized cases at the population level. METHODS: Intussusception hospitalizations in children RESULTS: No consistent change in intussusception hospitalization rates was observed among all children CONCLUSIONS: The increase in the intussusception hospitalization rate in children 8 to 11 weeks when the majority of first doses of Vaccine are given is consistent with recent US postlicensure studies. Given the magnitude of declines in Rotavirus disease compared with this small increase in intussusception, the benefits of Rotavirus vaccination outweigh the increase risk of intussusception.
