BACKGROUND:Rotavirus results in more diarrhoea-related deaths in children under five years than any other single agent in countries with high childhood mortality. It is also a common cause of diarrhoea-related hospital admissions in countries with low childhood mortality. Rotavirus vaccines that have been prequalified by the World Health Organization (WHO) include a monovalent vaccine (RV1; Rotarix, GlaxoSmithKline), a pentavalent vaccine (RV5; RotaTeq, Merck), and, more recently, another monovalent vaccine (Rotavac, Bharat Biotech). OBJECTIVES:To evaluate rotavirus vaccines prequalified by the WHO (RV1, RV5, and Rotavac) for their efficacy and safety in children. SEARCH METHODS:On 4 April 2018 we searched MEDLINE (via PubMed), the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (published in the Cochrane Library), Embase, LILACS, and BIOSIS. We also searched the WHO ICTRP, ClinicalTrials.gov, clinical trial reports from manufacturers' websites, and reference lists of included studies and relevant systematic reviews. SELECTION CRITERIA:We selected randomized controlled trials (RCTs) in children comparing rotavirus vaccines prequalified for use by the WHO versus placebo or no intervention. DATA COLLECTION AND ANALYSIS:Two review authors independently assessed trial eligibility and assessed risks of bias. One review author extracted data and a second author cross-checked them. We combined dichotomous data using the risk ratio (RR) and 95% confidence interval (CI). We stratified the analysis by country mortality rate and used GRADE to evaluate evidence certainty. MAIN RESULTS:Fifty-five trials met the inclusion criteria and enrolled a total of 216,480 participants. Thirty-six trials (119,114 participants) assessed RV1, 15 trials (88,934 participants) RV5, and four trials (8432 participants) Rotavac. RV1 Children vaccinated and followed up the first year of life In low-mortality countries, RV1 prevents 84% of severe rotavirus diarrhoea cases (RR 0.16, 95% CI 0.09 to 0.26; 43,779 participants, 7 trials; high-certainty evidence), and probably prevents 41% of cases of severe all-cause diarrhoea (RR 0.59, 95% CI 0.47 to 0.74; 28,051 participants, 3 trials; moderate-certainty evidence). In high-mortality countries, RV1 prevents 63% of severe rotavirus diarrhoea cases (RR 0.37, 95% CI 0.23 to 0.60; 6114 participants, 3 trials; high-certainty evidence), and 27% of severe all-cause diarrhoea cases (RR 0.73, 95% CI 0.56 to 0.95; 5639 participants, 2 trials; high-certainty evidence). Children vaccinated and followed up for two years In low-mortality countries, RV1 prevents 82% of severe rotavirus diarrhoea cases (RR 0.18, 95% CI 0.14 to 0.23; 36,002 participants, 9 trials; high-certainty evidence), and probably prevents 37% of severe all-cause diarrhoea episodes (rate ratio 0.63, 95% CI 0.56 to 0.71; 39,091 participants, 2 trials; moderate-certainty evidence). In high-mortality countries RV1 probably prevents 35% of severe rotavirus diarrhoea cases (RR 0.65, 95% CI 0.51 to 0.83; 13,768 participants, 2 trials; high-certainty evidence), and 17% of severe all-cause diarrhoea cases (RR 0.83, 95% CI 0.72 to 0.96; 2764 participants, 1 trial; moderate-certainty evidence). No increased risk of serious adverse events (SAE) was detected (RR 0.88 95% CI 0.83 to 0.93; high-certainty evidence). There were 30 cases of intussusception reported in 53,032 children after RV1 vaccination and 28 cases in 44,214 children after placebo or no intervention (RR 0.70, 95% CI 0.46 to 1.05; low-certainty evidence). RV5 Children vaccinated and followed up the first year of life In low-mortality countries, RV5 probably prevents 92% of severe rotavirus diarrhoea cases (RR 0.08, 95% CI 0.03 to 0.22; 4132 participants, 5 trials; moderate-certainty evidence). We did not identify studies reporting on severe all-cause diarrhoea in low-mortality countries. In high-mortality countries, RV5 prevents 57% of severe rotavirus diarrhoea (RR 0.43, 95% CI 0.29 to 0.62; 5916 participants, 2 trials; high-certainty evidence), but there is probably little or no difference between vaccine and placebo for severe all-cause diarrhoea (RR 0.80, 95% CI 0.58 to 1.11; 1 trial, 4085 participants; moderate-certainty evidence). Children vaccinated and followed up for two years In low-mortality countries, RV5 prevents 82% of severe rotavirus diarrhoea cases (RR 0.18, 95% CI 0.08 to 0.39; 7318 participants, 4 trials; moderate-certainty evidence). We did not identify studies reporting on severe all-cause diarrhoea in low-mortality countries. In high-mortality countries, RV5 prevents 41% of severe rotavirus diarrhoea cases (RR 0.59, 95% CI 0.43 to 0.82; 5885 participants, 2 trials; high-certainty evidence), and 15% of severe all-cause diarrhoea cases (RR 0.85, 95% CI 0.75 to 0.98; 5977 participants, 2 trials; high-certainty evidence). No increased risk of serious adverse events (SAE) was detected (RR 0.93 95% CI 0.86 to 1.01; moderate to high-certainty evidence). There were 16 cases of intussusception in 43,629 children after RV5 vaccination and 20 cases in 41,866 children after placebo (RR 0.77, 95% CI 0.41 to 1.45; low-certainty evidence). Rotavac Children vaccinated and followed up the first year of life Rotavac has not been assessed in any RCT in countries with low child mortality. In India, a high-mortality country, Rotavac probably prevents 57% of severe rotavirus diarrhoea cases (RR 0.43, 95% CI 0.30 to 0.60; 6799 participants, moderate-certainty evidence); the trial did not report on severe all-cause diarrhoea at one-year follow-up. Children vaccinated and followed up for two years Rotavac probably prevents 54% of severe rotavirus diarrhoea cases in India (RR 0.46, 95% CI 0.35 to 0.60; 6541 participants, 1 trial; moderate-certainty evidence), and 16% of severe all-cause diarrhoea cases (RR 0.84, 95% CI 0.71 to 0.98; 6799 participants, 1 trial; moderate-certainty evidence). No increased risk of serious adverse events (SAE) was detected (RR 0.93 95% CI 0.85 to 1.02; moderate-certainty evidence). There were eight cases of intussusception in 5764 children after Rotavac vaccination and three cases in 2818 children after placebo (RR 1.33, 95% CI 0.35 to 5.02; very low-certainty evidence). There was insufficient evidence of an effect on mortality from any rotavirus vaccine (198,381 participants, 44 trials; low- to very low-certainty evidence), as the trials were not powered to detect an effect at this endpoint. AUTHORS' CONCLUSIONS:RV1, RV5, and Rotavac prevent episodes of rotavirus diarrhoea. Whilst the relative effect estimate is smaller in high-mortality than in low-mortality countries, there is a greater number of episodes prevented in these settings as the baseline risk is much higher. We found no increased risk of serious adverse events.

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Vaccines for preventing rotavirus diarrhoea: vaccines in use

Purpose of reviewAs of 2019, four rotavirus vaccines have been prequalified by the WHO for use worldwide. This review highlights current knowledge regarding rotavirus vaccines available, and provides a brief summary of the rotavirus vaccine pipeline.Recent findingsData generated from use of currentl

Current and new rotavirus vaccines

Subnational mapping of under-5 and neonatal mortality trends in India: the Global Burden of Disease Study 2000–17

Summary Background The duration of protection offered by rotavirus vaccines varies across the world, and this variation is important to understanding and predicting the effects of the vaccines. There is now a large body of evidence on the efficacy of live oral rotavirus vaccines in different settings, but these data have never been synthesised to obtain robust estimates of efficacy by duration of follow-up. Our aim is to estimate the efficacy of live oral rotavirus vaccines at each point during follow-up and by mortality stratum. Methods In our meta-regression study, we identified all randomised controlled trials of rotavirus vaccines published until April 4, 2018, using the results of a Cochrane systematic review, and cross checked these studies against those identified by another systematic review. We excluded trials that were based on special populations, trials without an infant schedule, and trials without clear reporting of numbers of enrolled infants and events in different periods of follow-up. For all reported periods of follow-up, we extracted the mean duration of follow-up (time since administration of the final dose of rotavirus vaccination), the number of enrolled infants, and case counts for rotavirus-positive severe gastroenteritis in both non-vaccinated and vaccinated groups. We used a Bayesian hierarchical Poisson meta-regression model to estimate the pooled cumulative vaccine efficacy (VE) and its waning with time for three mortality strata. We then converted these VE estimates into instantaneous VE (iVE). Findings In settings with low mortality (15 observations), iVE pooled for infant schedules of Rotarix and RotaTeq was 98% (95% credibility interval 93–100) 2 weeks following the final dose of vaccination and 94% (87–98) after 12 months. In medium-mortality settings (11 observations), equivalent estimates were 82% (74–92) after 2 weeks and 77% (67–84) after 12 months. In settings with high mortality (24 observations), there were five different vaccines with observation points for infant schedules. The pooled iVE was 66% (48–81) after 2 weeks of follow-up and 44% (27–59) after 12 months. Interpretation Rotavirus vaccine efficacy is lower and wanes more rapidly in high-mortality settings than in low-mortality settings, but the earlier peak age of disease in high-mortality settings means that live oral rotavirus vaccines are still likely to provide substantial benefit. Funding Bill & Melinda Gates Foundation.

Efficacy of live oral rotavirus vaccines by duration of follow-up: a meta-regression of randomised controlled trials.

Rotavirus is the leading cause of diarrheal death among children   65% of children had at least one rotavirus diarrhea illness by 5 years of age and rotavirus accounted for > 40% of all-cause diarrhea hospitalizations globally. Two live, oral rotavirus vaccines have been implemented nationally in > 100 countries since 2006 and their use has substantially reduced the burden of severe diarrheal illness in all settings. Vaccine efficacy and effectiveness estimates suggest there is a gradient in vaccine performance between low child-mortality countries (> 90%) and medium and high child-mortality countries (57–75%). Additionally, an increased risk of intussusception (~ 1–6 per 100,000 vaccinated infants) following vaccination has been documented in some countries, but this is outweighed by the large benefits of vaccination. Two additional live, oral rotavirus vaccines were recently licensed and these have improved on some programmatic limitations of earlier vaccines, such as heat stability, cost, and cold-chain footprint. Non-replicating rotavirus vaccines that are parenterally administered are in clinical testing, and these have the potential to reduce the performance differential and safety concerns associated with live oral rotavirus vaccines.

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Rotavirus Vaccines: Effectiveness, Safety, and Future Directions.

Background: Young people, more than any other age group, have been adversely affected by globalization, violence, advances in information and communication technology and the HIV/AIDS epidemic. The objective of the study was to assess the knowledge and epidemiological determinants related to HIV-AIDS among the youth in the urban slum. Methods: This was a cross-sectional study conducted in Malvani slum area of Mumbai among 540 youth between 15 to 24 years of age. Two stage systematic random sampling method was used with individual household being the sampling unit. Results: Almost everybody had heard of HIV/AIDS. 21.5% participants had comprehensive knowledge about HIV AIDS. There were many misconceptions about how HIV-AIDS can spread. 57% thought that HIV-AIDS could spread by kissing, 22.7% said that HIV-AIDS could spread by sharing belongings. 36.8% thought that HIV- AIDS could spread through urine while 62.6% thought HIV- AIDS to be spread by saliva. 23.9% said that withdrawing penis before ejaculation could prevent HIV-AIDS and that there was no need to use condoms in that case. The predictors for comprehensive knowledge of HIV-AIDS in study participants were religion, education and per capita income. Conclusion: Although almost everybody had heard of HIV/AIDS, only around 21% had correct and comprehensive knowledge about HIV-AIDS. This reflects a massive gap that needs to be bridged, as awareness becomes the first step for initiating the behavior change process.

http://imsear.hellis.org/bitstream/123456789/175551/1/ijcmph2015v2n3p293.pdf

Youth and human immunodeficiency virus infection and acquired immune deficiency syndrome: a cross-sectional study from a slum in Mumbai -

Background: According to the World Health Organization, there were 10.4 million cases of tuberculosis (TB) in 2017 and 1.8 million deaths. The highest prevalence is in Asia, where China, India, Bangladesh, Indonesia, and Pakistan collectively make up over 50% of the global burden. India ranks second in the total number of patients who have diabetes. While the national prevalence of diabetes mellitus in India is estimated at 7.3%, it is higher at 11.2% in urban regions. Objectives: The aim is to determine the association of pulmonary TB with diabetes and anemia. Materials and Methods: A hospital-based cross-sectional study was conducted at a tertiary care rural hospital in central India. The study population was recruited from the DOTS center in the hospital. Complete blood count and blood sugar were carried out. Results: Among 162 patients, 31 were TB-positive. Anemic patients were more significantly at higher odds (odds ratio [OR]=15.18, 95% confidence interval [CI]=3.5, 66.2) of having TB than non-anemic patients. Similarly, diabetic individuals had higher odds (OR=2.3, 95% CI=0.64, 8.1) than non-diabetic individuals for TB, but this association was not statistically significant. Conclusion: In this study, we found a significant association between anemia and TB. Also, there is a probable association between diabetes and TB. So, we suggest that every TB patient be screened for anemia and diabetes.

Association of tuberculosis with diabetes and anemia: A hospital-based cross-sectional study from central India

Abstract Background We estimated the incidence of Japanese encephalitis (JE) and acute encephalitis syndrome (AES) following routine immunization with the live-attenuated SA 14-14-2 JE vaccine. Methods We implemented enhanced surveillance of AES and JE hospitalizations in endemic districts in Maharashtra and Telangana States during 2015–2016 and 2018–2020. We estimated incidence and compared differences in the incidence of JE and AES between two states, and vaccinated and unvaccinated districts during two study periods. We also considered secondary data from public health services to understand long-term trends from 2007 to 2020. Results The annual AES incidence rate of 2.25 cases per 100,000 children in Maharashtra during 2018–2020 was significantly lower than 3.36 cases per 100,000 children during 2015–2016. The six JE-vaccinated districts in Maharashtra had significantly lower incidence rates during 2018–2020 (2.03, 95% CI 1.73–2.37) than in 2015–16 (3.26, 2.86–3.70). In addition, the incidence of both JE and AES in two unvaccinated districts was higher than in the vaccinated districts in Maharashtra. Telangana had a lower incidence of both JE and AES than Maharashtra. The AES incidence rate of 0.95 (0.77–1.17) during 2018–2020 in Telangana was significantly lower than 1.67 (1.41–1.97) during 2015–2016. Conclusions The annual incidence rate of Japanese encephalitis was &lt; 1 case per 100,000 children. It indicated accelerated control of Japanese encephalitis after routine immunization. However, the annual incidence of acute encephalitis syndrome was still &gt; 1 case per 100,000 children. It highlights the need for improving surveillance and evaluating the impacts of vaccination. 

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Incidence of Japanese Encephalitis and Acute Encephalitis Syndrome Hospitalizations in the Medium-Endemic Region in Central India

The role of Accredited Social Health Activist (ASHA) the key worker is primely surrounded to be mainly a link-worker or facilitator, a community health worker, and a social activist under National Rural Health Mission (NRHM). This study was conducted to study the workload and work pattern of ASHAs and identify the causes for improving work. This was an observational cross-sectional study conducted using a time-motion study as the tool among seventeen ASHAs from two primary health centers (PHC) in central India for four months. An ASHA’s work pattern and workload were studied by constructing a 24-h recall. An focus group discussion (FGD) was conducted with the ASHAs to identify the factors affecting their effective functioning, after which content analysis was done. It was observed that activities under National programs consumed most of the time of ASHAs, followed by Maternal-Child Health (MCH) activities and Register maintenance. There was no homogenous work distribution among ASHAs. In content analysis, 30 concepts were categorized into four themes (responses from villages- an important drive, work pressure, survey a double-edged sword, demands of ASHAs). We conclude that the ASHAs are overburdened, and hence, not effectively utilizing their role as social activists. Clarity about job responsibilities, training, support, and coordination among seniors, frontiers trust-building can improve their work efficiency. 

“We are working for seven days a week” :Time motion study of accredited social health activists from central India

Introduction The ProSPoNS trial is a multicentre, double-blind, placebo-controlled trial to evaluate the role of probiotics in prevention of neonatal sepsis. The present protocol describes the data and methodology for the cost utility of the probiotic intervention alongside the controlled trial. Methods and analysis A societal perspective will be adopted in the economic evaluation. Direct medical and non-medical costs associated with neonatal sepsis and its treatment would be ascertained in both the intervention and the control arm. Intervention costs will be facilitated through primary data collection and programme budgetary records. Treatment cost for neonatal sepsis and associated conditions will be accessed from Indian national costing database estimating healthcare system costs. A cost–utility design will be employed with outcome as incremental cost per disability-adjusted life year averted. Considering a time-horizon of 6 months, trial estimates will be extrapolated to model the cost and consequences among high-risk neonatal population in India. A discount rate of 3% will be used. Impact of uncertainties present in analysis will be addressed through both deterministic and probabilistic sensitivity analysis. Ethics and dissemination Has been obtained from EC of the six participating sites (MGIMS Wardha, KEM Pune, JIPMER Puducherry, AIPH, Bhubaneswar, LHMC New Delhi, SMC Meerut) as well as from the ERC of LSTM, UK. A peer-reviewed article will be published after completion of the study. Findings will be disseminated to the community of the study sites, with academic bodies and policymakers. Registration The protocol has been approved by the regulatory authority (Central Drugs Standards Control Organisation; CDSCO) in India (CT-NOC No. CT/NOC/17/2019 dated 1 March 2019). The ProSPoNS trial is registered at the Clinical Trial Registry of India (CTRI). Registered on 16 May 2019. Trial registration number CTRI/2019/05/019197; Clinical Trial Registry.

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Study protocol for economic evaluation of probiotic intervention for prevention of neonatal sepsis in 0–2-month old low-birth weight infants in India: the ProSPoNS trial

Abhishek V Raut

Papers

Youth and human immunodeficiency virus infection and acquired immune deficiency syndrome: a cross-sectional study from a slum in Mumbai -

Association of tuberculosis with diabetes and anemia: A hospital-based cross-sectional study from central India

Incidence of Japanese Encephalitis and Acute Encephalitis Syndrome Hospitalizations in the Medium-Endemic Region in Central India

“We are working for seven days a week” :Time motion study of accredited social health activists from central India

Study protocol for economic evaluation of probiotic intervention for prevention of neonatal sepsis in 0–2-month old low-birth weight infants in India: the ProSPoNS trial