PAULA NJERU
ID:
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Utility of An Epilepsy Self-Management And Resilience Technical (SMART) APP for Adolescents and Young Adults
REFNo: HS3799ES
To identify specific improvements for the APP that will make it more useful for AWE and young adults.,To understand aspects of the APP that AWE and young adults derive the greatest benefit from.,To understand the perspectives of adolescents and young adults with epilepsy about using the SMART APP. ,To characterize the experiences of adolescents and young adults with epilepsy while using the SMART APP, pinpoint the essential elements of the APP that adolescents and young adults with epilepsy find most advantageous, and propose specific enhancements to further improve the APP,
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Kenya |
2024-06-05 17:45:41 |
2027-06-05 |
Medical and Health Sciences |
Non-Clinical Trial |
Non-degree Award |
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Cissy Kityo
ID: UNCST-2021-R013663
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A Phase 2a/2b Study Evaluating Safety, Immunogenicity, and Therapeutic Efficacy of ID93 + GLA-SE Vaccination in Participants with Rifampicin-Susceptible Pulmonary TB
REFNo: HS3834ES
1.2 Secondary Objectives 1.2.1 Phase 2a and 2b: To evaluate the proportion of participants with a quantifiable RS ratio after therapeutic vaccination with ID93 + GLA-SE compared to placebo. 1.2.2 Phase 2a: To evaluate the kinetics of cellular immunogenicity of ID93 + GLA-SE through 12 months post second dose of study product. 1.2.3 Phase 2a: To evaluate the kinetics of humoral immunogenicity of ID93 + GLA-SE through 12 months post second dose of study product. 1.2.4 Phase 2a: To evaluate innate immune changes in response to ID93 + GLA-SE through 2 weeks post second dose of study product. 1.2.5 Phase 2b: To compare therapeutic vaccination with ID93 + GLA-SE, to placebo, with respect to the proportion of participants with TB-related unfavorable outcomes at 540 days after study entry, which is approximately 18 months after start of TB treatment, in subgroups defined by: Hard-to-treat phenotype and not hard-to-treat phenotype, where hard-to-treat phenotype is defined as smear Grade ?3 and cavitary disease on chest radiograph at TB diagnosis.1.3 Exploratory Objectives 1.3.1 Phase 2a: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to: • The safety and immunogenicity of ID93 + GLA-SE in participants living with and without HIV. • The quantitative RS ratio at time points relative to vaccination and TB treatment as indicated in the Schedule of Evaluations (SOE). • The magnitude and quality of immune responses with respect to the composition of the intestinal microbiota. 1.3.2 Phase 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to the proportion of participants with TB-related unfavorable outcomes at 540 days after study entry, which is approximately 18 months after start of TB treatment, adjusted for • Pharmacokinetics (PK) assessments of first-line TB drugs (exposure) during TB treatment as per the SOE. • Levels of participant adherence to standard of care (SOC) TB treatment measured using self-reporting and urine acetyl-isoniazid (AcINH) from start to end of TB treatment. 1.3.3 Phase 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to the proportion of participants with TB-related unfavorable outcomes at 540 days after study entry, which is approximately 18 months after start of TB treatment, stratified by bacterial burden at start of TB treatment. 1.3.4 Phase 2a and 2b: To develop the composite predictive model of TB drug response by using measures of adherence, drug exposure (PK), immune response, gut microbiota, and participant phenotype. 1.3.5 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to proportion of participants with sputum culture conversion at baseline at time of randomization and at Step 2, Days 30, 120, and 150, which are approximately 2, 5, and 6 months after start of TB treatment. 1.3.6 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to cumulative relapse from end of TB treatment up to end of study follow-up, that is, Step 2, Days 420, 450, 480, and 510, for Groups 1, 2, 3 (&5), and 4 (&5), respectively. 1.3.7 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to lung function and health-related quality of life, as measured by spirometry and the St. George’s Respiratory Questionnaire. 1.3.8 Phase 2a and 2b: To compare the within-person change in lung function tests over time from the first dose of therapeutic vaccination with ID93 + GLA-SE to placebo. 1.3.9 Phase 2a and 2b: To compare therapeutic vaccination with ID93 + GLA-SE to placebo, with respect to resolution of transcriptomic biomarkers of TB disease. 1.3.10 Phase 2b: To identify correlates of protection for unfavorable TB outcomes. 1.3.11 Phase 2b: To estimate the effect of the vaccine on the proportion of participants with TB-related unfavorable outcomes among participants living with and without HIV. 1.3.12 Phase 2a and 2b: To conduct analyses related to furthering the understanding of TB, HIV, immunology, vaccines, and clinical trial conduct.,1.1 Primary Objectives 1.1.1 Phase 2a and 2b: To evaluate safety of a two-dose ID93 + GLA-SE vaccine regimen administered 60 days apart on Step 2, Days 0 and 60, with TB treatment administered, at approximately: 1.1.1.1 Months 4 and 6 after start of TB treatment (Group 1) 1.1.1.2 Months 3 and 5 after start of TB treatment (Group 2) 1.1.1.3 Months 2 and 4 after start of TB treatment (Group 3 and Group 5, if this vaccination schedule is adopted for Group 5) 1.1.1.4 Months 1 and 3 after start of TB treatment (Group 4 and Group 5, if this vaccination schedule is adopted for Group 5) 1.1.2 Phase 2a and 2b: To determine if therapeutic vaccination with ID93 + GLA-SE will increase the magnitude of vaccine-specific cellular responses compared to placebo at 2 weeks post second dose of study product. 1.1.3 Phase 2b: To estimate the effect of the vaccine on the proportion of participants with TB-related unfavorable outcomes (treatment failure, TB recurrence, or death due to TB) at Day 540 after study entry, which is approximately 18 months after start of TB treatment (Group 5 combined with either Group 3 or Group 4, depending on which vaccination schedule is selected for Group 5).,
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Uganda |
2024-06-05 17:42:17 |
2027-06-05 |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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