Victoria Nankabirwa
ID: UNCST-2021-R011871
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A multicenter, phase III, double-blind, randomised, active-controlled study to evaluate the efficacy and safety of VPM1002 in comparison to BCG in prevention of Mycobacterium tuberculosis infection in newborn infants
REFNo: HS838ES
Primary objectives
1. To demonstrate that VPM1002 is non-inferior to BCG SII in providing protection against incident Mtb infection
2. To demonstrate that vaccination with VPM1002 is superior to BCG SII in providing protection against incident Mtb infection
Secondary objectives
1. To compare the safety and tolerability profile of VPM1002 and BCG SII administered as a single dose to newborn infants
2. To compare the protective efficacy of VPM1002 versus BCG SII against TB disease
3. To compare the protective efficacy of VPM1002 versus BCG SII against sustained Mtb infection
Exploratory objectives
1. To evaluate the immunological response to vaccination with a single dose of VPM1002 compared to BCG SII in a subset (immunogenicity cohort) of HIV-exposed and HIV-unexposed newborn infants in terms of the following parameters:
o Concentration of Interferon (IFN)-γ in the supernatant after antigen re-stimulation as determined by ELISA
o CD4+ and CD8+ T-cells after antigen stimulation as determined by Fluorescence-activated cell staining/Intracellular cytokine staining (FACS/ICS)
o Transcriptomics
o Antibody production
2. To evaluate occurrence of QuantiFERON® Gold Plus In-tube test (QFT) conversion, where conversion is defined using alternative QFT thresholds (e.g. > 4 IU/ml); and sustained QFT conversion, where sustained conversion is defined as QFT ≥ 4IU /ml maintained for approximately 6 months following initial QFT conversion, compared across trial arms in all participants.
3. To determine the mortality rate in children receiving VPM1002 compared to BCG SII
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Uganda |
2020-10-14 |
2023-10-14 |
Medical and Health Sciences |
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Non-degree Award |
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Victoria Nankabirwa
ID: UNCST-2021-R011871
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SARS-CoV-2 infection and COVID-19 in women and their infants in Kampala, Uganda
REFNo: HS915ES
Overall aim
To describe how the COVID-19 epidemic and Uganda's countermeasures affect women and their newborns, especially newborns of HIV-1 positive mothers, and to test whether BCG vaccination offers protection against SARS-CoV-2 infection and COVID-19.
Specific objectives
1. To investigate if BCG vaccination of HIV-1 exposed infants at birth or at 14 weeks of age protects them against SARS-CoV-2 infection and COVID-19 until 14 weeks of age or against COVID-19 between 15 and 52 weeks of age, respectively.
2. To estimate the evolving prevalence of SARS-CoV-2 infection and of COVID-19 among HIV-1 positive as well as among HIV-1 negative women who have recently given birth, and describe their association with hospitalization on the day of birth, complications during delivery, low birth weight, and other adverse outcomes
3. To estimate the evolving 14-week cumulative incidence of SARS-CoV-2 infection and of COVID-19 among mothers and babies, and evaluate whether maternal HIV-1 infection affects maternal and infant risk of developing COVID-19 of varying severity
4. To evaluate the impact of wide-ranging preventive measures to control COVID-19 on women giving birth during the epidemic, their children, and their families
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Uganda |
2020-10-14 |
2023-10-14 |
Medical and Health Sciences |
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Non-degree Award |
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Emanuel Peter L
ID:
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Development of Standardized Herbal Formulation: Synergy between Momordica charantia, Aloe vera and Abelmoschus esculentus for Glycemic Control
REFNo: NS119ES
Objectives
1. To establish ethnomedical use of M. charantia and A. esculentus among indigenous community in Tanzania.
2.To establish physicochemical and stability parameters of freeze dried aqueous extracts of the three plant species separately in pre-formulation studies.
3. To evaluate efficacy of combined freeze dried extracts in different ratios of doses of M. charantia, A. esculentus and A. vera in vivo.
4. To establish safety profile of best optimal dose combination of M. charantia, A. esculentus and A. vera on healthy Wistar female rats.
5. To design a solid pharmaceutical dosage form of the optimal dose combination and evaluate its stability, safety and efficacy in vivo.
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Tanzania |
2020-10-12 |
2023-10-12 |
Natural Sciences |
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Degree Award |
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Christine Aanyu
ID:
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EQUITABLE MATERNAL CARE FOR WOMEN WITH DISABILITY (EMeralD) STUDY
REFNo: HS722ES
1) Specific Aim 1. Conduct an analysis of disability, pregnancy and birth outcomes, and maternal health care utilization data for pregnant women with disabilities in Uganda.
2) Specific Aim 2. Understand the needs and perceptions of pregnant women with disabilities and identify availability of, and barriers to accessing, maternal health care services.
3) Specific Aim 3. Formulate and develop a model for disability-friendly services for pregnant women.
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Uganda |
2020-10-07 |
2023-10-07 |
Medical and Health Sciences |
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Non-degree Award |
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David Serwadda -
ID:
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Characterizing community exposure to SARS-CoV-2 in Uganda, and assessing biological determinants of virus spread
REFNo: HS878ES
1.Assess the diagnostic sensitivity and specificity of the CoronaChekTM rapid COVID-19 IgM/IgG lateral flow test (CoronaChekTM by Hangzhou Biotest Biotech Co Ltd) for anti- SARS-CoV-2 antibodies detection in Uganda.
2.Conduct enhanced surveillance of COVID19-like symptoms in the context of an existing population cohort and assess the predictive value of prevailing symptoms for COVID-19 exposure based on rapid serological testing in this region.
3.Determine rates of sero-reactivity/positivity among key health care workers at high-volume health centers III and IV and also among PCR-negative contacts of confirmed COVID-19 cases in the region.
4.Explore ‘prior importation of COVID-19 infection in Ugandaâ€/ pre-existing sero-reactivity (may due to ‘related’ coronavirus strains/shared epitopes) in purposively selected archived sera, prioritizing from truck drivers and commercial sex workers that was collected before the lockdown in Uganda / Rakai region.
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Uganda |
2020-10-06 |
2023-10-06 |
Medical and Health Sciences |
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Non-degree Award |
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