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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Kampala,
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Uganda |
2024-06-05 17:42:17 |
2027-06-05 |
100 |
Individuals with or without HIV, 18 years or older male or female (any tribe) with bacteriologically confirmed rifampicin-susceptible pulmonary TB receiving locally provided SOC TB treatment. Enrollment of participants living with HIV will be capped at 20% in each group. |
National Institute of Allergy and Infectious Diseases |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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ERIC WOBUDEYA
ID: UNCST-2019-R001047
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Shortened RegiMen for Drug-susceptIbLE TB in Children
REFNo: HS4030ES
Primary
1. To determine if an 8-week HPZM regimen in children with presumed drug-susceptible TB disease has non-inferior efficacy to 8-weeks of HRZ(E) plus 8- or 16-weeks of HR(E) for achieving treatment success.
2. To evaluate the safety of the 8-week HPZM regimen in comparison to the 16- or 24- week HRZ(E) regimen among children with and without HIV.
Secondary
1. To evaluate the tolerability of the 8-week HPZM regimen in comparison to the 16- or 24- week HRZ(E) regimen among children with and without HIV.
2. To determine the weight-banded dosing of rifapentine and moxifloxacin taken as part of the HPZM regimen.
3. To evaluate the palatability and acceptability of the 8-week HPZM regimen in comparison to the 16- or 24-week HRZ(E) regimen among children with and without HIV.
4. To evaluate adherence to the 8-week HPZM regimen in comparison to the 16- or 24- week HRZ(E) regimen among children with and without HIV.
5. To evaluate clinical and laboratory characteristics and drug exposures associated with unsuccessful treatment outcomes (treatment failure or death).
6. To evaluate the cost and cost-effectiveness of the 8-week HPZM regimen relative to the 16- or 24-week HRZ(E) standard of care regimen, using a societal approach.
Exploratory
1. To characterize rifapentine and moxifloxacin PK parameters in malnourished children.
2. To evaluate the effect of rifapentine or rifampin, taken as part of the HPZM or HRZ(E) regimen, on the PK of dolutegravir.
3. To evaluate virologic control (less than 200 copies/mL) at 24- and 48-weeks among children with HIV taking a dolutegravir-based ARV treatment regimen co-administered with either HPZM or HRZ(E).
4. To collect and store biospecimens from consented participants for the purpose of future TB research.
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Kampala, mulago
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Uganda |
2024-05-31 18:02:19 |
2027-05-31 |
150 |
Children less than 10 years of age |
Johns Hopkins University |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Adoke Yeka
ID: UNCST-2021-R004300
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A randomized, open-label, multicenter study to compare efficacy, safety and tolerability of KLU156 with Coartem® in the treatment of uncomplicated Plasmodium falciparum malaria in adults and children ≥ 5 kg body weight followed by an Extension phase with repeated KLU156 treatment.
REFNo: HS3732ES
This study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for three days in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated P.Falciparum malaria (with or without other plasmodium spp. co-infection). In the Extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 will be assessed for a maximum of two years in patients who did not experience early treatment failure(ETF), who did not experience any study treatment-related SAE (Serious Adverse Event) previously and who gave informed consent to participate in the Extension phase.
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Tororo, Tororo
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Uganda |
2024-05-29 9:37:35 |
2027-05-29 |
1500 |
male and female patients’ ≥ 5 kg body weight and ≥ 2 months of age will be randomized in the study |
Novartis |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Jane Achan Edwin
ID: UNCST-2023-R005498
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Evaluation of the protective efficacy of a spatial repellent to reduce malaria prevalence in Uganda: Study protocol for a cluster-randomized double-blinded control trial: The Mossie-GO trial
REFNo: HS4196ES
The study’s primary objective is to demonstrate and quantify the protective efficacy (PE) of Mossie-GO, an active spatial repellent system disseminating transfluthrin, in reducing the prevalence of malaria infection in children ≤ 5 years of age.
The study’s secondary objective is to measure the impact of the intervention on entomological correlates of transmission including vector densities and host seeking behaviour. Insecticide resistance in the local mosquito population will also be explored.
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Buikwe, N/A
Jinja, N/A
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Uganda |
2024-05-23 14:23:11 |
2027-05-23 |
5600 |
The population will include children less than 5 years of age living in selected households in the selected villages. We will include children of both sexes and of all tribes in the selected villages. |
AFRICA POWER |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Josephine Najjuma Nambi
ID: UNCST-2021-R013717
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Developing and testing a simulation-based intervention to improve stroke nursing care in Mbarara Regional Referral Hospital
REFNo: HS3535ES
6. Pilot test the simulation-based nursing intervention for feasibility, acceptability, functionality, quality of life, and preliminary health outcomes among stroke patients at MRRH. ,5. Develop a simulation-based stroke training packet/intervention for nurses to improve stroke care and management at Mbarara Regional Referral Hospital,4. Explore the barriers and facilitators for stroke management, and training among health care professionals at Mbarara Regional Referral Hospital ,The general objective of the study is to develop and pilot a simulation-based stroke intervention to improve stroke management at MRRH ,
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Mbarara, Kyamugorani
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Uganda |
2024-05-07 13:49:58 |
2027-05-07 |
168 |
Age 18-100, Both male and Female and all tribes |
Self-sponsored |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
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