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| 2. |
- Qadri, F., et al.
(author)
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Safety and immunogenicity of the oral, inactivated, enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi children and infants: a double-blind, randomised, placebo-controlled phase 1/2 trial
- 2020
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In: Lancet Infectious Diseases. - : Elsevier BV. - 1473-3099. ; 20:2, s. 208-219
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Journal article (peer-reviewed)abstract
- Background Enterotoxigenic Escherichia coil causes diarrhoea, leading to substantial mortality and morbidity in children, but no specific vaccine exists. This trial tested an oral, inactivated, enterotoxigenic E coli vaccine (ETVAX), which has been previously shown to be safe and highly immuongenic in Swedish and Bangladeshi adults. We tested the safety and immunogenicity of ETVAX, consisting of four E coli strains overexpressing the most prevalent colonisation factors (CFA/I, CS3, CSS, and CS6) and a toxoid (LCTBA) administered with or without a double-mutant heat-labile enterotoxin (dmLT) as an adjuvant, in Bangladeshi children. Methods We did a randomised, double-blind, placebo-controlled, dose-escalation, age-descending, phase 1/2 trial in Dhaka, Bangladesh. Healthy children in one of three age groups (24-59 months, 12-23 months, and 6-11 months) were eligible. Children were randomly assigned with block randomisation to receive either ETVAX, with or without dmLT, or placebo. ETVAX (half [5.5 x 10(10) cells], quarter [2.5 x 10(10) cells], or eighth [1.25 x 10(10) cells] adult dose), with or without dmLT adjuvant (2.5 mu g, 5.0 mu g, or 10.0 mu g), or placebo were administered orally in two doses 2 weeks apart. Investigators and participants were masked to treatment allocation. The primary endpoint was safety and tolerability, assessed in all children who received at least one dose of vaccine. Antibody responses to vaccine antigens, defined as at least a two-times increase in antibody levels between baseline and post-immunisation, were assessed as secondary endpoints. This trial is registered with ClinicalTrials.gov , NCT02531802. Findings Between Dec 7, 2015, and Jan 10, 2017, we screened 1500 children across the three age groups, of whom 430 were enrolled and randomly assigned to the different treatment groups (130 aged 24-59 months, 100 aged 12-23 months, and 200 aged 6-11 months). All participants received at least one dose of vaccine. No solicited adverse events occurred that were greater than moderate in severity, and most were mild. The most common solicited event was vomiting (ten [8%] of 130 patients aged 24-59 months, 13 [13%] of 100 aged 12-23 months, and 29 115%1 of 200 aged 6-11 months; mostly of mild severity), which appeared related to dose and age. The addition of dmLT did not modify the safety profile. Three serious adverse events occurred but they were not considered related to the study drug. Mucosal IgA antibody responses in lymphocyte secretions were detected against all primary vaccine antigens (CFA/I, CS3, CSS, CS6, and the LCTBA toxoid) in most participants in the two older age groups, whereas such responses to four of the five antigens were less frequent and of lower magnitude in infants aged 6-11 months than in older children. Faecal secretory IgA immune responses were recorded against all vaccine antigens in infants aged 6-11 months. 78 (56%) of 139 infants aged 6-11 months who were vaccinated developed mucosal responses against at least three of the vaccine antigens versus 14 (29%) of 49 of the infants given placebo. Addition of the adjuvant dmLT enhanced the magnitude, breadth, and kinetics (based on number of responders after the first dose of vaccine) of immune responses in infants. Interpretation The encouraging safety and immunogenicity of ETVAX and benefit of dmLT adjuvant in young children support its further assessment for protective efficacy in children in enterotoxigenic E coli-endemic areas. Copyright (C) 2019 The Author(s). Published by Elsevier Ltd.
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- Al-Mamun, F., et al.
(author)
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Sleep duration during the COVID-19 pandemic in Bangladesh : A GIS-based large sample survey study
- 2023
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In: Scientific Reports. - : Springer. - 2045-2322. ; 13:1
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Journal article (peer-reviewed)abstract
- Although several studies have been conducted in Bangladesh regarding sleep problems during the COVID-19 pandemic, none have utilized a large nationwide sample or presented their findings based on nationwide geographical distribution. Therefore, the aim of the present study was to explore the total sleep duration, night-time sleep, and daily naptime and their associated factors as well as geographic information system (GIS) distribution. A cross-sectional survey was carried out among 9730 people in April 2020, including questions relating to socio-demographic variables, behavioral and health factors, lockdown, depression, suicidal ideation, night sleep duration, and naptime duration. Descriptive and inferential statistics, both linear and multivariate regression, and spatial distribution were performed using Microsoft Excel, SPSS, Stata, and ArcGIS software. The results indicated that 64.7% reported sleeping 7–9 h a night, while 29.6% slept less than 7 h nightly, and 5.7% slept more than 9 h nightly. 43.7% reported 30–60 min of daily nap duration, whereas 20.9% napped for more than 1 h daily. Significant predictors of total daily sleep duration were being aged 18–25 years, being unemployed, being married, self-isolating 4 days or more, economic hardship, and depression. For nap duration, being aged 18–25 years, retired, a smoker, and a social media user were at relatively higher risk. The GIS distribution showed that regional division areas with high COVID-19 exposure had higher rates of non-normal sleep duration. Sleep duration showed a regional heterogeneity across the regional divisions of the country that exhibited significant associations with a multitude of socioeconomic and health factors.
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- Mamun, M. A., et al.
(author)
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The COVID-19 pandemic and serious psychological consequences in Bangladesh : A population-based nationwide study
- 2021
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In: Journal of Affective Disorders. - : Elsevier. - 0165-0327 .- 1573-2517. ; 279, s. 462-472
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Journal article (peer-reviewed)abstract
- Background: As with other countries worldwide, lockdown measures during the COVID-19 outbreak in Bangladesh were sudden and unexpected, and have the capacity to elicit serious psychological consequences. The present study examined the psychological consequences of COVID-19 in Bangladesh during the lockdown period.Methods: A nationwide online cross-sectional survey study recruited 10,067 individuals covering all 64 districts in Bangladesh via social media (April 1-10, 2020). The survey comprised questions concerning socio-demographics, knowledge of COVID-19, behavior towards COVID-19, fear of COVID-19, insomnia, depression, and suicidal ideation. Logistic regression and structural equation modeling (SEM) analyses were performed to identify the risk factors depression and suicidal ideation. Geographical information system (GIS)-based spatial analysis was used to identify district-wise susceptibility to depression and suicidal ideation.Findings: The prevalence rate of depression and suicidal ideation related to COVID-19 was 33% and 5%%. Common risk factors for suicidal ideation and depression included being young, being female, being a cigarette smoker, having comorbid diseases, having high scores on the Fear COVID-19 Scale, and having insomnia symptoms. GIS-based maps detected high depression and suicidal ideation in the capital of Bangladesh and the districts near the capital as well as coastal areas where COVID-19 prevalence was high, as compared with districts with no reported cases. Limitations: Self-reported scales and cross-sectional design of the study.Conclusion: COVID-19 is associated with major psychological impact across Bangladesh, underlining the need of strategically located psychological support measures and improved access to mental health services, especially among women and younger people.
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- Chowdhury, F., et al.
(author)
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A phase I/II study to evaluate safety, tolerability and immunogenicity of Hillchol®, an inactivated single Hikojima strain based oral cholera vaccine, in a sequentially age descending population in Bangladesh
- 2021
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In: Vaccine. - : Elsevier BV. - 0264-410X. ; 39:32, s. 4450-4457
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Journal article (peer-reviewed)abstract
- Background: The World Health Organization (WHO) recommends the use of oral cholera vaccines (OCVs) as part of an integrated control program, both in highly endemic settings and during cholera epidemics. The available and internationally recommended WHO-prequalified OCVs (Dukoral, Shanchol, Euvichol) contain multiple heat and formalin-killed V. cholerae strains of Inaba and Ogawa serotypes. MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd. in technical collaboration with University of Gothenburg, Sweden has developed a new single strain OCV, Hillchol. This vaccine consists of formaldehyde-inactivated whole cell El Tor V. cholerae O1 bacteria engineered into the Hikojima serotype for stable expression of both the Ogawa (AB) and Inaba (AC) LPS antigens on the bacterial surface. We evaluated the safety and immunogenicity of this novel and potentially much less expensive OCV in comparison with Shanchol. Methods: We conducted a randomized, non-inferiority, age-descending clinical trial of OCV (Hillchol vs. Shanchol) in the Mirpur area of Dhaka city from July 2016 to May 2017. This study was carried out in three different age cohorts (1–<5, 5–17 and ≥18 years old). Two doses of vaccine were given at 14 days intervals to 560 healthy participants. Findings: No serious adverse events were reported. There were no significant differences in the rates of adverse events between the test vaccine (Hillchol) and the comparator (Shanchol) group. Serum vibriocidal antibody responses in all age groups combined were comparable for all the O1 Ogawa (59% vs. 67%; 90% CI of difference: −14.55, −0.84) and Inaba (70% vs. 71%; 90% CI of difference: −7.24, 5.77) serotypes, showing that the Hillchol vaccine was non-inferior to Shanchol. This new vaccine was also non-inferior to Shanchol in the different age strata. Conclusion: The safety and immunogenicity profile of the new OCV Hillchol is comparable to Shanchol in persons residing in a cholera-endemic setting. ClinicalTrials.gov number: NCT02823899. © 2021
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- Svennerholm, Ann-Mari, 1947, et al.
(author)
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Induction of mucosal and systemic immune responses against the common O78 antigen of an oral inactivated ETEC vaccine in Bangladeshi children and infants
- 2022
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In: Vaccine. - : Elsevier BV. - 0264-410X. ; 40:2, s. 380-389
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Journal article (peer-reviewed)abstract
- We tested an oral enterotoxigenic Escherichia coli (ETEC) vaccine, ETVAX, consisting of inactivated E. coli overexpressing the most prevalent ETEC colonization factors (CFs) and a toxoid (LCTBA), in Bangladeshi children for capacity to induce mucosal and plasma immune responses against O78 lipopolysaccharide (LPS) expressed on the vaccine strains. The vaccine was given +/- double-mutant heat-labile toxin (dmLT) adjuvant. We evaluated the impact of dmLT on anti-O78 LPS immune responses and whether such responses can predict responses against the CFs as a marker for vaccine "take". Two fractionated doses of ETVAX +/- different amounts of dmLT were administered biweekly to groups of children 24-59 (n = 125), 12-23 (n = 97) and 6-11 (n = 158) months of age. Immune responses were evaluated in antibody in lymphocyte supernatants (ALS), fecal extracts and plasma. ALS IgA responses against O78 LPS were induced in 44-49% of the children aged 12-59 months. The magnitudes of the ALS responses were significantly higher in children receiving a half-dose (5 x 10(10) bacteria) of ETVAX +/- dmLT than in placebo recipients. <10% of the vaccinees aged 6-11 months mounted ALS responses against O78 LPS. However, 49% of the infants developed fecal secretory IgA responses which were significantly more frequent in those receiving a quarter-dose (2.5 x 10(10) bacteria) of vaccine + dmLT (62%) compared to a quarter-dose alone (36%). Plasma IgA antibody responses were induced in 80% of older children and 36% of infants. The frequencies of O78 LPS responses in plasma and feces were comparable or higher than against the vaccine CFs in infants. Our findings show that ETVAX induced mucosal and systemic immune responses against O78 LPS in all age groups and that dmLT improved intestinal immune responses among infants. These observations may have implications for more successful use of other oral vaccines based on O antigens in children. (C) 2021 Published by Elsevier Ltd.
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