Monovalent Human Rotavirus Vaccine Research Articles

Effect of childhood rotavirus vaccination on community rotavirus prevalence in rural Ecuador, 2008-13.

Although live attenuated monovalent human rotavirus vaccine (Rotarix) efficacy has been characterized through randomized studies, its effectiveness, especially in non-clinical settings, is less clear. In this study, we estimate the impact of childhood Rotarix® vaccination on community rotavirus prevalence. We analyse 10 years of serial population-based diarrhoea case-control study, which also included testing for rotavirus infection (n = 3430), and 29 months of all-cause diarrhoea active surveillance from a child cohort (n = 376) from rural Ecuador during a period in which Rotarix vaccination was introduced. We use weighted logistic regression from the case-control data to assess changes in community rotavirus prevalence (both symptomatic and asymptomatic) and all-cause diarrhoea after the vaccine was introduced. We also assess changes in all-cause diarrhoea rates in the child cohort (born 2008-13) using Cox regression, comparing time to first all-cause diarrhoea case by vaccine status. Overall, vaccine introduction among age-eligible children was associated with a 82.9% reduction [95% confidence interval (CI): 49.4%, 94.2%] in prevalence of rotavirus in participants without diarrhoea symptoms and a 46.0% reduction (95% CI: 6.2%, 68.9%) in prevalence of rotavirus infection among participants experiencing diarrhoea. Whereas all age groups benefited, this reduction was strongest among the youngest age groups. For young children, prevalence of symptomatic diarrhoea also decreased in the post-vaccine period in both the case-control study (reduction in prevalence for children <1 year of age = 69.3%, 95% CI: 8.7%, 89.7%) and the cohort study (reduction in hazard for receipt of two Rotarix doses among children aged 0.5-2 years = 57.1%, 95% CI: 16.6, 77.9%). Rotarix vaccination may suppress transmission, including asymptomatic transmission, in low- and middle-income settings. It was highly effective among children in a rural community setting and provides population-level benefits through indirect protection among adults.

Infrequent Transmission of Monovalent Human Rotavirus Vaccine Virus to Household Contacts of Vaccinated Infants in Malawi.

Horizontal transmission of rotavirus vaccine virus may contribute to indirect effects of rotavirus vaccine, but data are lacking from low-income countries. Serial stool samples were obtained from Malawian infants who received 2 doses of monovalent human rotavirus vaccine (RV1) (days 4, 6, 8, and 10 after vaccination) and from their household contacts (8–10 days after vaccine). RV1 vaccine virus in stool was detected using semiquantitative real-time reverse-transcription polymerase chain reaction. RV1 fecal shedding was detected in 41 of 60 vaccinated infants (68%) and in 2 of 147 household contacts (1.4%). Horizontal transmission of vaccine virus within households is unlikely to make a major contribution to RV1 indirect effects in Malawi.

Evaluation of Intussusception after Monovalent Rotavirus Vaccination in Africa

BackgroundPostlicensure evaluations have identified an association between rotavirus vaccination and intussusception in several high- and middle-income countries. We assessed the association between monovalent human rotavirus vaccine and intussusception in lower-income sub-Saharan African countries.MethodsUsing active surveillance, we enrolled patients from seven countries (Ethiopia, Ghana, Kenya, Malawi, Tanzania, Zambia, and Zimbabwe) who had intussusception that met international (Brighton Collaboration level 1) criteria. Rotavirus vaccination status was confirmed by review of the vaccine card or clinic records. The risk of intussusception within 1 to 7 days and 8 to 21 days after vaccination among infants 28 to 245 days of age was assessed by means of the self-controlled case-series method.ResultsData on 717 infants who had intussusception and confirmed vaccination status were analyzed. One case occurred in the 1 to 7 days after dose 1, and 6 cases occurred in the 8 to 21 days after dose 1. Five cases and 16 cases occurred in the 1 to 7 days and 8 to 21 days, respectively, after dose 2. The risk of intussusception in the 1 to 7 days after dose 1 was not higher than the background risk of intussusception (relative incidence [i.e., the incidence during the risk window vs. all other times], 0.25; 95% confidence interval [CI], <0.001 to 1.16); findings were similar for the 1 to 7 days after dose 2 (relative incidence, 0.76; 95% CI, 0.16 to 1.87). In addition, the risk of intussusception in the 8 to 21 days or 1 to 21 days after either dose was not found to be higher than the background risk.ConclusionsThe risk of intussusception after administration of monovalent human rotavirus vaccine was not higher than the background risk of intussusception in seven lower-income sub-Saharan African countries. (Funded by the GAVI Alliance through the CDC Foundation.)

Trends in diarrhea hospitalizations among infants at three hospitals in Tanzania before and after rotavirus vaccine introduction

BackgroundThe Tanzania Ministry of Health introduced monovalent human rotavirus vaccine in January 2013, to be administered at ages 6 and 10 weeks. Data suggest there was high vaccine uptake. We used hospital ward registers from 3 hospitals to examine trends in diarrhea hospitalizations among infants before and after vaccine introduction. MethodsWard registers from Dodoma Regional Referral Hospital (Central Tanzania), and two hospitals in Mbeya (Southwest area), Mbeya Zonal Referral Hospital and Mbalizi Hospital, were used to tally admissions for diarrhea among children by age group, month and year. Rotavirus surveillance had started at these hospitals in early 2013; the proportion of infants enrolled and rotavirus-EIA positive were examined by month to determine peak periods of rotavirus disease post-vaccine introduction. ResultsRegisters were available for 2–4 prevaccine years and 2–3 post introduction years. At Dodoma Regional Referral Hospital, compared with the mean of 2011 and 2012, diarrhea hospitalizations among infants were 26% lower in 2015 and 58% lower in 2016. The diarrhea peak shifted later in the year first by 1 and then by 2–3 months from prevaccine. At the Mbeya hospitals, the number of diarrhea admissions in prevaccine period varied substantially by year. At Mbeya Referral Hospital, diarrhea hospitalizations among infants were lower by 25–37% in 2014 and 11–26% in 2015, while at Mbalizi Hospital, these hospitalizations were 4% lower in 2014 and 14% higher in 2015. Rotavirus testing data demonstrated a lowering of the prevaccine peak, a shift in timing of the peak months and indicated that other diarrheal peaks in post-introduction years were not due to rotavirus. ConclusionsIn this ecological evaluation, total diarrhea hospitalizations among infants were lower (≥25% lower in ≥1 year) following introduction in 2 of 3 hospitals. There are challenges in using ward registers to ascertain possible impact of rotavirus vaccine introduction on trends in hospitalizations for treatment of all diarrheal illness.

Validation of current procedural terminology codes for rotavirus vaccination among infants in two commercially insured US populations

We validated procedure codes used in health insurance claims for reimbursement of rotavirus vaccination by comparing claims for monovalent live-attenuated human rotavirus vaccine (RV1) and live, oral pentavalent rotavirus vaccine (RV5) to medical records. Using administrative data from two commercially insured United States populations, we randomly sampled vaccination claims for RV1 and RV5 from a cohort of infants aged less than 1 year from an ongoing post-licensure safety study of rotavirus vaccines. The codes for RV1 and RV5 found in claims were confirmed through medical record review. The positive predictive value (PPV) of the Current Procedural Terminology codes for RV1 and RV5 was calculated as the number of medical record-confirmed vaccinations divided by the number of medical records obtained. Medical record review confirmed 92 of 104 RV1 vaccination claims (PPV: 88.5%; 95% CI: 80.7-93.9%) and 98 of 113 RV5 vaccination claims (PPV: 86.7%; 95% CI: 79.1-92.4%). Among the 217 medical records abstracted, only three (1.4%) of vaccinations were misclassified in claims-all were RV5 misclassified as RV1. The medical records corresponding to 9 RV1 and 15 RV5 claims contained insufficient information to classify the type of rotavirus vaccine. Misclassification of rotavirus vaccines is infrequent within claims. The PPVs reported here are conservative estimates as those with insufficient information in the medical records were assumed to be incorrectly coded in the claims. Copyright © 2016 John Wiley & Sons, Ltd.

Impact of Rotavirus Vaccination on Hospitalizations and Deaths From Childhood Gastroenteritis in Botswana.

A monovalent human rotavirus vaccine (RV1) was introduced in Botswana in July 2012. We assessed the impact of RV1 vaccination on childhood gastroenteritis-related hospitalizations and deaths in 2013 and 2014. We obtained data from registers of 4 hospitals in Botswana on hospitalizations and deaths from gastroenteritis, regardless of cause, among children <5 years of age. Gastroenteritis hospitalizations and deaths during the prevaccine period (January 2009-December 2012) were compared to the postvaccine period (January 2013-December 2014). Vaccine coverage was estimated from data collected through a concurrent vaccine effectiveness study at the same hospitals. By December 2014, coverage with ≥1 dose of RV1 was an estimated 90% among infants <1 year of age and 76% among children 12-23 months of age. In the prevaccine period, the annual median number of gastroenteritis-related hospitalizations in children <5 years of age was 1212, and of gastroenteritis-related deaths in children <2 years of age was 77. In the postvaccine period, gastroenteritis-related hospitalizations decreased by 23% (95% confidence interval [CI], 16%-29%) to 937, and gastroenteritis-related deaths decreased by 22% (95% CI, -9% to 44%) to 60. Declines were most prominent during the rotavirus season (May-October) and among infants <1 year of age, with reductions of 43% (95% CI, 34%-51%) in gastroenteritis hospitalizations and 48% (95% CI, 11%-69%) in gastroenteritis deaths. Following introduction of RV1 into the national immunization program, significant declines in hospitalizations and deaths from gastroenteritis were observed among children in Botswana, suggestive of the beneficial public health impact of rotavirus vaccination.

Reassuring safety information for monovalent rotavirus vaccine

Rotavirus vaccines (RVs) are remarkably effective in averting this previously inescapable cause of gastroenteritis in young children. The benefit of RVs in developing countries primarily are saving lives, and in developed countries they are preventing hospitalizations. Since the implementation of pentavalent human-bovine reassortant vaccine (RV5) and monovalent human vaccine (RV1) in multiple countries, it has become apparent that both vaccines are associated with a small but measurable increase in cases of intussusception following immunization, especially in the first week and especially after the first dose. The rate of vaccine-associated intussusception has varied by country and likely is related to existing differences in rates of nonvaccine associated intussusception, as well as diet, maternal antibodies, and prevalence of enteropathogens – to name just a few. Young age, when intussusception is uncommon and when some maternal antibody to rotavirus is still present, is thought to be protective against RV-associated intussusception. The vast safety studies leading to licensure of RVs entered only young infants. Recommendation in the US is that the first dose of RV vaccination should be given at 2 months of age routinely and vaccination should be initiated only if the infant is 14 weeks and 6 days of age or younger. The study from Singapore reported in this issue of The Journal adds further data from a geographic area with higher incidence of background intussusception, a slightly older age at first dose, and dominant use of RV1 compared with the US. The analysis of cases and timing of intussusception in infants who received RV1 versus unimmunized infants suggests that a program achieving 90% vaccine coverage would prevent 71% of rotavirus hospitalizations, require 340 infants to be immunized to prevent one hospitalization, and would result in one excess intussusception hospitalization for every 64 668 infants immunized. These data, in this setting, are reassuring to the conclusion that the benefits of RVs far outweigh risk. Article page 163▶ Intussusception and Monovalent Rotavirus Vaccination in Singapore: Self-Controlled Case Series and Risk-Benefit StudyThe Journal of PediatricsVol. 167Issue 1PreviewTo investigate the association between monovalent human rotavirus vaccine (RV1) and intussusception among Asian infants and the impact of older age of vaccination. To perform risk-benefit analysis of RV1 vaccination programs in Singapore. Full-Text PDF

Rotavirus strain surveillance for three years following the introduction of rotavirus vaccine into Belém, Brazil.

The monovalent human rotavirus (RV) vaccine, RIX4414 (Rotarix™, GlaxoSmithKline Biologicals) was introduced into Brazil's Expanded Program on Immunization in March 2006. One year after vaccine introduction, the G2P[4] strain was found to be predominant, with an apparent extinction of many non-G2 strains. This study investigated the diversity of circulating strains in the three years following RIX4414 introduction. Between May 2008 and May 2011, stool samples were collected from children aged ≥12 weeks who were hospitalized for severe lab confirmed RV-gastroenteritis (≥3 liquid or semi-liquid motions over a 24-h period for <14 days, requiring ≥1 overnight hospital stay and intravenous rehydration therapy) in Belém, Brazil. RV-gastroenteritis was detected by ELISA and the G- and P-types were determined by RT-PCR assays. During the first year of surveillance nucleotide sequencing was used for typing those samples not previously typed by RT-PCR. A total of 1,726 of 10,030 severe gastroentertis hospitalizations (17.2%) were due to severe RVGE. G2P[4] was detected in 57.2% of circulating strains over the whole study period, however it predominated during the first 20 months from May 2008 to January 2009. G1P[8] increased in the last part of the study period from May 2010 to May 2011 and represented 36.6% (112/306) of the circulating strains. G2P[4] was the predominant RV strain circulating during the first 20 months of the study, followed by G1P[8]. These findings probably reflect a natural fluctuation in RV strains over time, rather than a vaccine-induced selective pressure.

Intussusception and Monovalent Rotavirus Vaccination in Singapore: Self-Controlled Case Series and Risk-Benefit Study

To investigate the association between monovalent human rotavirus vaccine (RV1) and intussusception among Asian infants and the impact of older age of vaccination. To perform risk-benefit analysis of RV1 vaccination programs in Singapore. We performed a self-controlled case series by extracting intussusception cases in infants aged <12 months from hospital databases (2005-2012) and with vaccination histories from a national immunization registry. Relative incidences were calculated by comparing incidence during defined risk periods after vaccination with times outside these periods. In the risk benefit analysis, we estimated excess intussusception hospitalization in relation to the number of infants vaccinated for hypothetical vaccination coverage scenarios. There were 86 infants hospitalized with intussusception; 20 cases had received at least 1 dose of RV1. Nearly all (19) had received their first dose at age >12 weeks old. The age-adjusted relative incidence of intussusception in the 1- to 7-day period post dose one was 8.36 (95% CI 2.42-28.96). Of all childhood hospitalizations because of rotavirus, 71% (570 cases) could be prevented with 90% vaccination coverage. There would be approximately 1 excess intussusception case per 65,000 infants vaccinated. Risk of intussusception increases about 8-fold during 1-7 days after receipt of first dose RV1 in infants of Chinese, Malay, and Indian ethnicity in Singapore, Asia. High vaccine coverage program in Singapore would be beneficial with only a low risk of excess intussusception. The relative risk of intussusception post-RV1 vaccination is not higher in Asia despite differences in background intussusception incidence compared with US and Australia, or older age of vaccination.

Impact of high coverage of monovalent human rotavirus vaccine on Emergency Department presentations for rotavirus gastroenteritis

IntroductionAustralia was one of the first countries to introduce nationally funded rotavirus vaccination. The program has had a substantial impact on both rotavirus and all-cause acute gastroenteritis (AGE) hospitalisations and rotavirus laboratory tests. Evidence for an impact on Emergency Department (ED) presentations is limited. This study assessed changes in ED presentations for rotavirus in children aged <5 years in New South Wales, Australia, following introduction of monovalent human rotavirus vaccine (RV1, Rotarix®, GlaxoSmithKline Australia Pty Ltd., Victoria, Australia). MethodA time series analysis to examine trends in total non-admitted ED presentations for all-cause AGE and in the rotavirus-attributable fraction using data on rotavirus positive laboratory tests. ResultsA decline in the rate of non-admitted ED presentations for all-cause AGE was observed for all ages, being most notable in 1 year old children. Compared with the pre-vaccination period, we estimated the average weekly rate was lower across the first 4.5 years of the program for both all-cause AGE (18.3%; 70.5 versus 57.5 per 100,000 population) and rotavirus attributable (55.4%; 17.3 versus 7.7 per 100,000 population) presentations. In the fourth year of the program, estimated annual rotavirus attributable presentations were 77% lower than the pre-vaccination annual mean (996 versus 4300 per year). ConclusionThe program was associated with a substantial decline in rotavirus attributable non-admitted AGE presentations to ED among children aged <5 years.

Effectiveness of a monovalent rotavirus vaccine in infants in Malawi after programmatic roll-out: an observational and case-control study

SummaryBackgroundRotavirus is the main cause of severe acute gastroenteritis in children in Africa. Monovalent human rotavirus vaccine (RV1) was added into Malawi's infant immunisation schedule on Oct 29, 2012. We aimed to assess the impact and effectiveness of RV1 on rotavirus gastroenteritis in the 2 years after introduction.MethodsFrom Jan 1, 2012, to June 30, 2014, we recruited children younger than 5 years who were admitted into Queen Elizabeth Central Hospital, Blantyre, Malawi, with acute gastroenteritis. We assessed stool samples from these children for presence of rotavirus with use of ELISA and we genotyped rotaviruses with use of RT-PCR. We compared rotavirus detection rates in stool samples and incidence of hospital admittance for rotavirus in children from Jan 1 to June 30, in the year before vaccination (2012) with the same months in the 2 years after vaccination was introduced (2013 and 2014). In the case-control portion of our study, we recruited eligible rotavirus-positive children from the surveillance platform and calculated vaccine effectiveness (one minus the odds ratio of vaccination) by comparing infants with rotavirus gastroenteritis with infants who tested negative for rotavirus, and with community age-matched and neighbourhood-matched controls.FindingsWe enrolled 1431 children, from whom we obtained 1417 stool samples (99%). We detected rotavirus in 79 of 157 infants (50%) before the vaccine, compared with 57 of 219 (40%) and 52 of 170 (31%) in successive calendar years after vaccine introduction (p=0·0002). In the first half of 2012, incidence of rotavirus hospital admission was 269 per 100 000 infants compared with 284 in the same months of 2013 (rise of 5·8%, 95% CI −23·1 to 45·4; p=0·73) and 153 in these months in 2014 (a reduction from the prevaccine period of 43·2%, 18·0–60·7; p=0·003). We recruited 118 vaccine-eligible rotavirus cases (median age 8·9 months; IQR 6·6–11·1), 317 rotavirus-test-negative controls (9·4 months; 6·9–11·9), and 380 community controls (8·8 months; 6·5–11·1). Vaccine effectiveness for two doses of RV1 in rotavirus-negative individuals was 64% (95% CI 24–83) and community controls was 63% (23–83). The point estimate of effectiveness was higher against genotype G1 than against G2 and G12.InterpretationRoutine use of RV1 reduced hospital admissions for several genotypes of rotavirus in children younger than 5 years, especially in infants younger than 1 year. Our data support introduction of rotavirus vaccination at the WHO recommended schedule, with continuing surveillance in high-mortality countries.FundingWellcome Trust, GlaxoSmithKline Biologicals.

Effectiveness of monovalent human rotavirus vaccine against admission to hospital for acute rotavirus diarrhoea in South African children: a case-control study

The effectiveness of the rotavirus vaccine under conditions of routine use in an African setting with a high prevalence of HIV infection needs to be established. We assessed the vaccine effectiveness of monovalent human rotavirus vaccine in preventing admission to hospital for acute rotavirus diarrhoea, after its introduction at age 6 and 14 weeks into South Africa's national immunisation programme. This case-control study was done at seven hospitals in South Africa between April 19, 2010, and Oct 31, 2012. The hospitals were located in a range of urban, peri-urban, and rural settings, with varying rates of population HIV infection. Cases were children aged from 18 weeks to 23 months who were age-eligible to have received at least one dose of the human rotavirus vaccine (ie, those born after June 14, 2009) admitted to hospital with laboratory-confirmed acute rotavirus diarrhoea, and the primary control group was children admitted to hospital with diarrhoea testing negative for rotavirus. A second control group comprised children admitted to a subset of three of the seven hospitals with respiratory illness. The primary endpoint was adjusted vaccine effectiveness (1 - adjusted odds ratio × 100%) in children aged from 18 weeks to 23 months and was calculated by unconditional logistic regression. This study is registered on the South African National Clinical Trial Register, number DOH-27-0512-3247. Of 540 rotavirus-positive cases, 278 children (52%) received two doses, 126 (23%) one dose, and 136 (25%) no doses of human rotavirus vaccine, compared with 1434 rotavirus-negative controls of whom 856 (60%) received two doses, 334 (23%) one dose, and 244 (17%) no doses. Adjusted vaccine effectiveness using rotavirus-negative controls was 57% (95% CI 40-68) for two doses and 40% (16-57) for one dose; estimates were similar when respiratory controls were used as the control group. Adjusted vaccine effectiveness for two doses was similar between age groups 18 weeks-11 months (54%, 95% CI 32-68) and 12-23 months (61%, 35-77), and was similar in HIV-exposed-uninfected (64%, 95% CI 34-80) and HIV-unexposed-uninfected children (54%, 31-69). Human rotavirus vaccine provided sustained protection against admission to hospital for acute rotavirus diarrhoea during the first and second years of life. This finding is encouraging and establishes the public health value of rotavirus vaccine in an African setting, especially as rotavirus vaccines are introduced into an increasing number of African countries. GAVI Alliance (with support from PATH).

Indian Academy of Pediatrics (IAP) recommended immunization schedule for children aged 0 through 18 years--India, 2014 and updates on immunization.

There is a need to review/revise recommendations about existing vaccines in light of recent developments in the field of vaccinology. Following an IAP ACVIP meeting on April 19 and 20, 2014, a draft of revised recommendations for the year 2014 and updates on certain vaccine formulations was prepared and circulated among the meeting participants to arrive at a consensus. To review and revise recommendations for 2014 Immunization timetable for pediatricians in office practice and issue statements on certain new and existing vaccine formulations. The major changes in the 2014 Immunization Timetable include two doses of MMR vaccine at 9 and 15 months of age, single dose recommendation for administration of live attenuated H2 strain hepatitis A vaccine, inclusion of two new situations in high-risk category of children in context with pre-exposure prophylaxis of rabies, creation of a new slot at 9-12 months of age for typhoid conjugate vaccine for primary immunization, and recommendation of two doses of human papilloma virus vaccines with a minimum interval of 6 months between doses for primary schedule of adolescent/preadolescent girls aged 9-14 years. There would not be any change to the committee's last year's (2013) recommendations on pertussis vaccination and administration schedule of monovalent human rotavirus vaccine. There is no need of providing additional doses of whole-cell pertussis vaccine to children who have earlier completed their primary schedule with acellular pertussis vaccine-containing products. A brief update on the new Indian Rotavirus vaccine, 116E is also provided. The committee has reviewed and offered its recommendations on the currently available pentavalent vaccine (DTwP+Hib+Hepatitis-B) combinations in Indian market. The comments and footnotes for several vaccines are also updated and revised.

Indian Academy of Pediatrics (IAP) recommended immunization schedule for children aged 0 through 18 years — India, 2013 and updates on immunization

There is a need to review/revise recommendations about existing vaccines in light of recent developments in the field of vaccinology where new developments are taking place regularly at short intervals. Following an IAP ACVIP meeting on 3rd and 4th August, 2013, a draft of revised recommendations for the year 2013 and updates on certain new vaccine formulations was prepared and circulated among the meeting participants to arrive at a consensus. To review and revise recommendations for 2013 Immunization timetable for pediatricians in office practice and issue statements on new vaccine formulations. The major change in the 2013 Immunization timetable was made in the recommendations pertaining to pertussis immunization. Taking in to the consideration of recent outbreaks of pertussis in many industrialized countries using acellular pertussis (aP) vaccines and subsequent finding of faster waning of the same in comparison to whole-cell pertussis (wP) vaccines and superior priming with wP vaccines than aP vaccines, the committee has now recommended wP vaccines for the primary series of infant vaccination. Guidelines are now also issued on the preference/selection of a particular aP vaccine in case it is not feasible to use wP vaccine, and use of Tdap vaccine during pregnancy. The administration schedule of monovalent human rotavirus vaccine, RV1 has been revised to 10 and 14 weeks from existing 6 and 10 weeks. Recommendation is made for the need of booster dose of live attenuated SA-14-14-2 JE vaccine. Updates and recommendations are issued on new typhoid conjugate vaccine, inactivated vero-cell culture derived SA-14-14-2 JE vaccine, inactivated vero-cell derived Kolar strain, 821564XY JE vaccine, and new meningococcal conjugate vaccines. This year the recommended immunization schedule with range for persons aged 0 through 18 years is being published together instead of two separate schedules. A subcategory of general instruction is added in footnotes. The comments and footnotes for several vaccines are revised and separate instructions for routine vaccination and catch-up vaccination are added in the footnotes section wherever applicable.

Development of Neutralizing Monoclonal Antibodies Against VP4 of Rotavirus CC0812-1

The G10P[15] rotavirus CC0812-1 isolated from a diarrheal woman in Wuhan, China, in 2008 is phylogenetically close to the Lanzhou lamb rotavirus (LLR) of a monovalent human rotavirus vaccine produced by the Lanzhou Institute of Biological Products, China, and rotavirus Lamb-NT. This rotavirus can be used as the backbone of the attenuated rotavirus reassortant as a rotavirus vaccine candidate. In this study, rotavirus CC0812-1 was purified from the culture supernatant of CC0812-1-infected MA104 cells and used as antigen to immunize BALB/c mice. Four hybridoma clones were developed secreting antibodies that reacted with CC0812-1, designated as 1B1, 1B8, 1F11, and 1G10, respectively. Western blot analysis indicated that the four monoclonal antibodies (MAbs) were all specific for VP4 of rotavirus CC0812-1. Isotyping revealed that MAbs 1B1, 1B8, and 1G10 belonged to the IgM class, while MAb 1F11 belonged to the IgG1 subclass. A neutralization test demonstrated that the four MAbs all had the capacity to neutralize rotavirus CC0812-1. The neutralizing titers of the BALB/c mice ascites were 1:2048, 1:1024, 1:512, and 1:512 for MAbs 1B1, 1B8, 1F11, and 1G10, respectively.

Frequently asked questions on monovalent human rotavirus vaccine (Rotarix)® available in India

Frequently asked questions on monovalent human rotavirus vaccine (Rotarix)® available in India

Prevention and treatment of viral diarrhea in pediatrics

Diarrhea is the second largest cause of mortality worldwide in children from the perinatal period to the age of 5 years. Rotavirus has been the most commonly identified viral cause of diarrhea in children. Norovirus is now recognized as the second most common viral pathogen. Adenovirus, astrovirus and sapovirus are the other major viral causes of pediatric gastroenteritis. Strategies for prevention include basic hygiene, optimization of nutrition and, ultimately, vaccination. Two new vaccines have recently been licensed for the prevention of rotavirus, the monovalent human rotavirus vaccine (Rotarix™) and the pentavalent bovine–human reassortant vaccine (RotaTeq®). These vaccines have already dramatically decreased the morbidity associated with rotavirus in countries where they are widely used. Efforts to develop a norovirus vaccine face substantial hurdles. Treatment of the viral pathogens is primarily limited to symptomatic measures.

Rotavirus vaccines: an overview.

Rotavirus infection is the most common cause of severe diarrhea disease in infants and young children worldwide and continues to have a major global impact on childhood morbidity and mortality. Vaccination is the only control measure likely to have a significant impact on the incidence of severe dehydrating rotavirus disease. In 1999, a highly efficacious rotavirus vaccine licensed in the United States, RotaShield, was withdrawn from the market after 14 months because of its association with intussusception. Two new live, oral, attenuated rotavirus vaccines were licensed in 2006: the pentavalent bovine-human reassortant vaccine (RotaTeq) and the monovalent human rotavirus vaccine (Rotarix). Both vaccines have demonstrated very good safety and efficacy profiles in large clinical trials in western industrialized countries and in Latin America. Careful surveillance has not revealed any increased risk of intussusception in the vaccinated groups with either vaccine. The new rotavirus vaccines are now introduced for routine use in a number of industrialized and developing countries. These new safe and effective rotavirus vaccines offer the best hope of reducing the toll of acute rotavirus gastroenteritis in both developed and developing countries.

Rotavirus vaccines: entering a new stage of deployment

Rotavirus is the single most important cause of severe diarrhoea in infants and young children. This review provides updated information concerning three rotavirus vaccines that are being evaluated and introduced globally. Two large, phase III clinical trials, each involving more than 60,000 infants in both developing and developed countries, demonstrated that both RotaTeq (Merck & Co., Whitehouse Station, New Jersey, USA), the pentavalent human-bovine reassortant vaccine, and Rotarix (GlaxoSmithKine Biologicals, Rixensart, Belgium), the monovalent live-attenuated human rotavirus vaccine, are safe with respect to intussusception when the first dose is administered between 6 and 12 weeks of age, and that both vaccines are 90-95% efficacious in preventing severe rotavirus gastroenteritis including hospitalization. The bovine (UK)-human rotavirus reassortant tetravalent (BRV-TV) vaccine, developed at the National Institutes of Health (USA), was licensed for local production in several developing countries. Rotavirus vaccines are entering a new stage of deployment toward the goal of reducing morbidity and mortality attributed to rotavirus infection in developing countries, and hospitalizations and emergency visits caused by rotavirus in developed countries. High vaccine prices appear to offset cost savings, and may make policymakers even in wealthy countries hesitate to introduce a rotavirus vaccine into their childhood immunization programmes.

A short report on the highlights of world-wide development of RIX4414: a North American experience: Comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine (RIX4414) in infants in the United States and Canada

This randomized, double-blind trial conducted in the US and Canada was conducted to compare the safety and immunogenicity of two dosages of live attenuated oral monovalent G1 human rotavirus (HRV) vaccine administered orally at a 2-month interval concomitantly with routine childhood vaccines to healthy infants 5–15 weeks of age. No SAEs considered related to vaccine were reported. The incidence of solicited symptoms was similar among treatment groups during the 15-day post-vaccination surveillance periods. No significant difference in vaccine take after 2 doses (88.0% in high dose group and 81.5% in low dose group) was seen between vaccine groups. Two doses of either dosage level of HRV vaccine administered concurrently with routine childhood vaccines to healthy infants were well tolerated and elicited excellent vaccine takes.