Rotavirus Vaccine Trials in International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) and Future Use of the Vaccine in Bangladesh.
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ABSTRACT:
SUBMITTER: Zaman K
PROVIDER: S-EPMC8687083 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Secretor status controls mucosal histo-blood group antigen expression and is associated with susceptibility to rotavirus (RV) diarrhea, with nonsecretors less susceptible to symptomatic infection. The role of breast milk secretor status on oral live-attenuated RV vaccine response in breastfed infants has not been explored. In a monovalent G1P[8] RV vaccine (Rotarix) trial in Bangladesh, RV-specific plasma immunoglobulin A antibody seroconversion rates were higher among infants of maternal nonsecretors (39%) than infants of maternal secretors (23%; P = .001). Maternal status remained a significant predictor when correcting for infant status (P = .002). Maternal secretor status should be considered when interpreting oral RV vaccine responses in low- and middle-income settings. Clinical Trials Registration. NCT01375647.
| S-EPMC8561252 | biostudies-literature
Project description:Plague is one of the world's most lethal human diseases caused by Yersinia pestis, a Gram-negative bacterium. Despite overwhelming studies for many years worldwide, there is no safe and effective vaccine against this fatal disease. Inhalation of Y. pestis bacilli causes pneumonic plague, a fast growing and deadly dangerous disease. F1/LcrV-based vaccines failed to provide adequate protection in African green monkey model in spite of providing protection in mice and cynomolgus macaques. There is still no explanation for this inconsistent efficacy, and scientists leg behind to search reliable correlate assays for immune protection. These paucities are the main barriers to improve the effectiveness of plague vaccine. In the present scenario, one has to pay special attention to elicit strong cellular immune response in developing a next-generation vaccine against plague. Here, we review the scientific contributions and existing progress in developing subunit vaccines, the role of molecular adjuvants; DNA vaccines; live delivery platforms; and attenuated vaccines developed to counteract virulent strains of Y. pestis.
| S-EPMC5155008 | biostudies-literature
Project description:Soon after its identification, norovirus (NoV) has been indicated as one of the most common causes of outbreaks of acute gastroenteritis (AGE) and sporadic acute diarrhea episodes in subjects of any age. In 2016 the World Health Organization stated that the development of a NoV vaccine should be considered an absolute priority. Unfortunately, the development of an effective NoV vaccine has proven extremely difficult, and only in recent years, some preparations have been tested in humans in advanced clinical trials. In this paper, reasons that justify efforts to develop a NoV vaccine, difficulties encountered during NoV vaccine development, and NoV vaccine candidates will be discussed. In recent years, identification of some NoV antigens that alone or in combination with other viral antigens can induce a potentially protective immune response has led to the development of a large series of preparations that seem capable of coping with the problems related to NoV infection. Epidemiological and immunological studies have shown that multivalent vaccines, including both GI and GII NoV, are the only solution to induce sufficiently broad protection. However, even if the road to formulation of an effective and safe NoV vaccine seems to be definitively traced, many problems still need to be solved before the total burden of NoV infections can be adequately controlled. Whether currently available vaccines are able to protect against all the heterologous NoV strains and the variants of the most common serotypes that frequently emerge and cause outbreaks must be defined. Moreover, as performed clinical trials have mainly enrolled adults, it is mandatory to know whether vaccines are effective in all age groups, including younger children. Finally, we must know the immune response of immunocompromised patients and the duration of protection induced by NoV vaccines. Only when all these problems have been solved will it be possible to establish an effective immunization schedule against NoV infection and calculate whether systematic vaccination can be cost effective.
| S-EPMC7358258 | biostudies-literature
Project description:Clinical trials of the human rotavirus vaccine Rotarix™ (RV1) have demonstrated significant reductions in severe rotavirus gastroenteritis (RVGE) in children worldwide. However, no correlate of vaccine efficacy (VE) has yet been established. This paper presents 2 analyses which aimed to investigate whether serum anti-RV IgA measured by ELISA 1 or 2 mo post-vaccination can serve as a correlate of efficacy against RVGE: (1) In a large Phase III efficacy trial (Rota-037), the Prentice criteria for surrogate endpoints was applied to anti-RV IgA seropositivity 1 mo post-vaccination. These criteria determine whether a significant vaccine group effect can be predicted from the surrogate, namely seropositivity (anti-RV IgA concentration>20 U/mL); (2) Among other GSK-sponsored RV1 VE studies, 8 studies which assessed immunogenicity at 1 or 2 mo post-vaccination in all or a sub-cohort of enrolled subjects and had at least 10 RVGE episodes were included in a meta-analysis to measure the regression between clinical VE and VE predicted from immunogenicity (VE1). In Rota-037, anti-RV IgA seropositivity post-vaccination was associated with a lower incidence of any or severe RVGE, however, the proportion of vaccine group effect explained by seropositivity was only 43.6% and 32.7% respectively. This low proportion was due to the vaccine group effect observed in seronegative subjects. In the meta-analysis, the slope of the regression between clinical VE and VE1 was statistically significant. These two independent analyses support the hypothesis that post-vaccination anti-RV IgA seropositivity (antibody concentration ≥20 U/mL) may serve as a useful correlate of efficacy in clinical trials of RV1 vaccines.
| S-EPMC4185910 | biostudies-literature
Project description:Trivalent oral poliovirus vaccine (OPV) is known to interfere with monovalent rotavirus vaccine (RV1) immunogenicity. The interference caused by bivalent and monovalent OPV formulations, which will be increasingly used globally in coming years, has not been examined. We conducted a post hoc analysis to assess the effect of coadministration of different OPV formulations on RV1 immunogenicity.Healthy infants in Matlab, Bangladesh, were randomized to receive 3 doses of monovalent OPV type 1 or bivalent OPV types 1 and 3 at either 6, 8, and 10 or 6, 10, and 14 weeks of age or trivalent OPV at 6, 10, and 14 weeks of age. All infants received 2 doses of RV1 at about 6 and 10 weeks of age. Concomitant administration was defined as RV1 and OPV given on the same day; staggered administration as RV1 and OPV given ?1 day apart. Rotavirus seroconversion was defined as a 4-fold rise in immunoglobulin A titer from before the first RV1 dose to ?3 weeks after the second RV1 dose.There were no significant differences in baseline RV1 immunogenicity among the 409 infants included in the final analysis. Infants who received RV1 and OPV concomitantly, regardless of OPV formulation, were less likely to seroconvert (47%; 95% confidence interval, 39%-54%) than those who received both vaccines staggered ?1 day (63%; 57%-70%; P < .001). For staggered administration, we found no evidence that the interval between RV1 and OPV administration affected RV1 immunogenicity.Coadministration of monovalent, bivalent, or trivalent OPV seems to lower RV1 immunogenicity.NCT01633216.
| S-EPMC4755336 | biostudies-literature
Project description:BackgroundRotavirus vaccines are now globally recommended by the World Health Organization (WHO), but in early 2009 WHO's Strategic Advisory Group of Experts on Immunization reviewed available data and concluded that there was no evidence for the efficacy or effectiveness of a two-dose schedule of the human rotavirus vaccine (HRV; Rotarix) given early at 6 and 10 wk of age. Additionally, the effectiveness of programmatic rotavirus vaccination, including possible indirect effects, has not been assessed in low-resource populations in Asia.Methods and findingsIn Bangladesh, we cluster-randomized (1:1) 142 villages of the Matlab Health and Demographic Surveillance System to include two doses of HRV with the standard infant vaccines at 6 and 10 wk of age or to provide standard infant vaccines without HRV. The study was initiated November 1, 2008, and surveillance was conducted concurrently at Matlab Diarrhoea Hospital and two community treatment centers to identify children less than 2 y of age presenting with acute rotavirus diarrhea (ARD) through March 31, 2011. Laboratory confirmation was made by enzyme immunoassay detection of rotavirus antigen in stool specimens. Overall effectiveness of the HRV vaccination program (primary objective) was measured by comparing the incidence rate of ARD among all children age-eligible for vaccination in villages where HRV was introduced to that among such children in villages where HRV was not introduced. Total effectiveness among vaccinees and indirect effectiveness were also evaluated. In all, 6,527 infants were age-eligible for vaccination in 71 HRV villages, and 5,791 in 71 non-HRV villages. In HRV villages, 4,808 (73.7%) infants received at least one dose of HRV. The incidence rate of ARD was 4.10 cases per 100 person-years in non-HRV villages compared to 2.8 per 100 person-years in HRV villages, indicating an overall effectiveness of 29.0% (95% CI, 11.3% to 43.1%). The total effectiveness of HRV against ARD among vaccinees was 41.4% (95% CI, 23.2% to 55.2%). The point estimate for total effectiveness was higher against ARD during the first year of life than during the second (45.2% versus 28.9%), but estimates for the second year of life lacked precision and did not reach statistical significance. Indirect effects were not detected. To check for bias in presentation to treatment facilities, we evaluated the effectiveness of HRV against acute diarrhea associated with enterotoxigenic Escherichia coli; it was 4.0% (95% CI, -46.5% to 37.1%), indicating that bias likely was not introduced. Thirteen serious adverse events were identified among recipients of HRV, but none were considered related to receipt of study vaccine. The main limitation of this study is that it was an open-label study with an observed-only control group (no placebo).ConclusionsThe two-dose HRV rotavirus vaccination program significantly reduced medically attended ARD in this low-resource population in Asia. Protection among vaccinees was similar to that in other low-resource settings. In low-resource populations with high rotavirus incidence, large-scale vaccination across a wide population may be required to obtain the full benefit of rotavirus vaccination, including indirect effects.Trial registrationClinicalTrials.gov NCT00737503.
| S-EPMC5395158 | biostudies-literature
Project description: Not available
| S-EPMC7744161 | biostudies-literature
Project description:Impact of the gut microbiome and metabolome on the peripheral immune response in non-alcoholic fatty liver disease related hepatocellular carcinoma
| PRJNA647523 | ENA
Project description:Large-scale deployment of COVID-19 vaccines will seriously affect the ongoing phases 2 and 3 randomised placebo-controlled trials assessing SARS-CoV-2 vaccine candidates. The effect will be particularly acute in high-income countries where the entire adult or older population could be vaccinated by late 2021. Regrettably, only a small proportion of the population in many low-income and middle-income countries will have access to available vaccines. Sponsors of COVID-19 vaccine candidates currently in phase 2 or initiating phase 3 trials in 2021 should consider continuing the research in countries with limited affordability and availability of COVID-19 vaccines. Several ethical principles must be implemented to ensure the equitable, non-exploitative, and respectful conduct of trials in resource-poor settings. Once sufficient knowledge on the immunogenicity response to COVID-19 vaccines is acquired, non-inferiority immunogenicity trials-comparing the immune response of a vaccine candidate to that of an authorised vaccine-would probably be the most common trial design. Until then, placebo-controlled, double-blind, crossover trials will continue to play a role in the development of new vaccine candidates. WHO or the Council for International Organizations of Medical Sciences should define an ethical framework for the requirements and benefits for trial participants and host communities in resource-poor settings that should require commitment from all vaccine candidate sponsors from high-income countries.
| S-EPMC8131060 | biostudies-literature
Project description:BACKGROUND:Although smokeless tobacco (SLT) use is prevalent in South Asian countries including Bangladesh, information about the pattern and correlates of SLT use is scarce. This study described the pattern and predictors of SLT use among Bangladeshi adults. METHODS:The data for this study were derived from the International Tobacco Control Policy Evaluation Bangladesh (ITC BD) Survey, a prospective cohort survey of a nationally representative sample of smokers and non-smokers, conducted during November 2011 and May 2012. The study included 5522 adults aged 15 or above. We used multiple logistic regression models to identify predictors of SLT use. RESULTS:Of the respondents (N?=?5522), 20% were SLT users. In general, SLT use was significantly higher among women, the illiterate and residents of the Dhaka slums or non-tribal/non-border areas outside Dhaka; SLT use increased with age. Several attitudinal factors were also associated with SLT use. Multivariable logistic regression analyses revealed several predictors of SLT use: being female (OR?=?1.96, 95% confidence interval, CI: 1.18-3.24), an increasing age, being a resident of a Dhaka slum (OR?=?5.86; 95% CI: 3.73-9.21) or non-tribal/non-border areas outside Dhaka (OR?=?3.42; 95% CI: 1.94-6.03), being illiterate (OR?=?3.37; 95% CI: 1.99-5.71), holding positive opinion towards societal approval of SLT use (OR?=?5.84; 95% CI: 3.38-10.09), holding positive opinion towards SLT use by women (OR?=?2.63; 95% CI: 1.53-4.54), believing that SLT is addictive (OR?=?2.96; 95% CI: 1.51-5.81), and believing SLT is less harmful than bidi (OR?=?2.22; 95% CI: 1.36-3.62). CONCLUSION:The findings suggest that coordinated efforts of governmental and non-governmental organizations, targeting both smoked tobacco and SLT use reduction and cessation, could be modified to reach each level of population including those who are marginalized, female, less educated and elderly. As most tobacco control programs in Bangladesh target mainly cigarette or bidi smoking, coordinated programs are needed that will also include SLT use within the tobacco control policy and prevention strategies.
| S-EPMC4090160 | biostudies-literature