Annet Nanvubya
ID: UNCST-2025-R015525
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Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern version 1.0 16-05-2021.
REFNo: HS1677ES
Primary Objectives
The primary objectives of this study are to determine the following:
• To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19
• To assess vaccine efficacy (VE) of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk for severe COVID-19
• To assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19
Secondary Objectives
The secondary objectives of this study are to evaluate the following:
• Durability of VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 through the final study visit (Month 12 post-dose 1) in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against SARS-CoV-2 infection defined by nucleocapsid protein seroconversion regardless of symptomology in volunteers with no previous COVID-19
• VE of COVID-19 mRNA vaccine against asymptomatic SARS-CoV-2 infection defined by nucleocapsid protein seroconversion without prior occurrence of the symptomatic COVID-19 primary endpoint in volunteers with no previous COVID-19
• Post -vaccination immune response markers as correlates of risk of COVID-19 and as correlates protection against COVID-19
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in all participants regardless of baseline SARS-CoV-2 status
gestational age)
Exploratory Objectives
The exploratory objectives of this study are to:
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 by baseline HIV infection status in volunteers with no previous COVID-19 and in all volunteers regardless of previous COVID-19 status
• VE of COVID-19 mRNA vaccine against COVID-19 and against severe COVID-19 by neutralization phenotype and Spike sequence features of acquired SARS-CoV-2 viruses (sieve analysis), including VE against the B.1.351/501Y.V2 variant and VE against all other variants combined in volunteers with no previous COVID-19 and in all volunteers regardless previous COVID-19 status
• VE of COVID-19 mRNA vaccine against COVID-19 and severe COVID-19 in volunteers with previous COVID-19
• Relative rate of COVID-19 and severe COVID-19 in placebo recipients with previous COVID-19 compared to vaccine recipients with no previous COVID-19
• Assess T-cell responses in placebo recipients who develop COVID-19 compared to vaccine recipients who develop symptomatic COVID-19
• Assess incidence of adverse birth outcomes among pregnant persons enrolled in the trial
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Wakiso, Division A and B
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Uganda |
2021-08-20 |
2024-08-20 |
14,000 |
This study will enroll participants who meet one or more of the following criteria:
1) Age > 40, who have at least one comorbidity known to be associated with severe COVID-19,
2) women age 18 years or older who are pregnant, and
3) HIV-1-infected indiv |
South African Medical Research Council(SAMRC) Cape Town, South Africa |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Eun Seok Kim
ID:
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Cross-sectional prevalence study of schistosomiasis and soil-transmitted helminthiasis with nested open-label randomised controlled study of evaluating the impact of fatty meal co-administration and double-dosing on albendazole effectiveness against hookworm infection among school-aged children in Mayuge district: Implications for Mayuge NTDs Elimination (MANE) Project
REFNo: HS1411ES
Objective 1: To determine the effect of albendazole administration with a fatty meal such as avocado, versus albendazole administration without a fatty meal, on hookworm cure rate and egg reduction rate.
Objective 2: To determine the effectiveness of dual-dose (400mg/day, two consecutive days) versus single-dose (400mg) albendazole treatment regimens on hookworm cure rate and egg reduction rate.
Objective 3: To identify and evaluate environmental, social and cultural variables affecting hookworm infection, and cure rate and egg reduction rate of albendazole against hookworm.
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Mayuge, All parish
,
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South Korea |
2021-08-16 |
2024-08-16 |
1650 |
Age: P4 and P5 grade students (approximately 9-10 years old)
Sex: an approximately equal number of both male and female
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Korea International Cooperation Agency (KOICA) |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
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Violet Korutaro
ID: UNCST-2019-R000618
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IMPAACT 2017: Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents. Short title: ‘MOCHA’ (More Options for Children and Adolescents), DAIDS # 30070, IND # 138,754
REFNo: HS1512ES
To assess the safety of CAB LA + RPV LA through Week 24 in HIV-infected, virologically suppressed adolescents,To confirm the doses for oral CAB followed by injectable CAB LA in HIV-infected, virologically suppressed adolescents by evaluating: Safety and multiple dose PK of oral CAB through Week 4, Safety and multiple dose PK of CAB LA through Week 16, and to confirm doses for injectable RPV LA in HIV-infected, virologically suppressed adolescents by evaluating safety and multiple dose PK of RPV LA through Week 16,To confirm the dose and evaluate the safety, tolerability, acceptability, and pharmacokinetics (PK) of oral cabotegravir (CAB), long-acting injectable cabotegravir (CAB LA), and long-acting injectable rilpivirine (RPV LA) in virologically suppressed HIVâ€1 infected children and adolescents aged 12 to <18 years.,
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Kampala, Kisenyi
Kampala, Mulago
Kampala, Kawaala
Kampala, Naguru
Kampala, Kitebi
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Uganda |
2021-08-16 |
2024-08-16 |
155 |
This study will be conducted in Kampala among HIVâ€1 infected children and adolescents, 12 to <18 years of age, who are virologically suppressed on stable cART consisting of 2 or more drugs from 2 or more classes of antiretroviral. These potential partic |
National Institute of Allergy and Infectious Diseases |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Jonathan Kayondo
ID: UNCST-2021-R008325
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Multi-Centre, Prospective, Evaluation for Matrix equivalence of capillary whole blood finger-stick and fresh and frozen venous whole blood with the NxTekâ„¢ Malaria Pf Plus Rapid Test Device and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test Device for the Detection of Plasmodium Infections in Patients with Symptoms Suggestive of Malaria within the Lab and its intended use environment for CE IVDR.
REFNo: HS1587ES
This trial is part of the R&D Verification and Validation studies, to provide clinical matrix equivalence evaluation to support the conformity assessment procedure for the use of fingerstick and venous whole blood samples with Abbott’s NxTek™ Malaria Pf Plus and NxTek™ Malaria Pf/Pv Plus Rapid Test Devices, as performed by professional users, in accordance with WHO PQ TSS-3, WHO PQ Dossier, EU 2017/7461.
Primary Objective: Matrix Equivalence
To assess the matrix equivalence of:
a. Fresh CWBFS and Fresh VWB
b. Frozen VWB and Fresh VWB
when used with the NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ Malaria Pf Plus by laboratory professionals (from hereon referred to as Lab operators) in a laboratory environment to support CE IVDR certification.
The test results of the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using a VWB sample, will be evaluated against the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using CWBFS sample from the same participant. In summary: Fresh CWBFS vs. Fresh VWB*. Likewise, the test results of the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using VWB samples that have been exposed to 1x Freeze/Thaw cycle will be evaluated against the NxTekâ„¢ Malaria Pf Plus and NxTekâ„¢ Malaria Pf/Pv Plus Rapid Test using fresh VWB samples from the same participant. In summary: Frozen VWB vs. Fresh VWB*
*indicates: Where Fresh VWB will be the comparator sample type.
The data obtained will be used in the application for CE IVDR certification and WHO PQ. Paired CWBFS and VWB samples will be taken from the same individuals for testing on both NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ Malaria Pf Plus RDTs.
Secondary Objective: Intended Users within the Intended Use Environment
Malaria RDTs are used outside of the laboratory for near patient testing (NPT)* by non laboratory healthcare workers with limited training. Thus the secondary objective of this study is to assess the perfromance of the NxTekâ„¢ Malaria Pf/Pv Plus and NxTekâ„¢ Malaria Pf Plus results when used in its intended environment (NPT setting) by intended users (non laboratory healthcare workers with limited training) using CWBFS as the sample type.*see NPT definition Section 4.2-4.3 of protocol (or below sections on trial operator types and trial envitronment types).
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Kanungu, Market Cell
Wakiso, Maganjo
Wakiso, Central Ward
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Uganda |
2021-08-16 |
2024-08-16 |
Section 5.2 of Protocol: Two arms- each kit minimum 90 Pf Positives, 26 Pv Positives, 116 Negatives |
All comers, febrile symptomatic patients of both sexes aged 15 years and above suspected of having malaria and seeking standard medical care at the sites. |
Abbott Diagnostics Korea Inc. |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Rhoda Wanyenze
ID: UNCST-2021-R013352
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PILOT OF A NETWORK-DRIVEN, ADVOCACY INTERVENTION TO PROMOTE CERVICAL CANCER SCREENING IN UGANDA (PHASE 3)
REFNo: HS1633ES
The proposed intervention development study seeks to improve cervical cancer screening in Uganda by engaging and training local public health researchers and program implementers, and empowering women living with cervical cancer risk (WLCCR), defined as women who have ever received CC screening procedures, to advocate for CC screening and early treatment among women in their social networks.
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Namayingo, Buyinja
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Uganda |
2021-08-16 |
2024-08-16 |
40 index participants; 120 social network members |
This study represents phase 3 of the study that was earlier registered with UNCST. During this phase, we will aim to enroll women living with cervical cancer risk (hereafter referred to as the 'index participants'), defined as women who have ever been scr |
Glenn Wagner (RAND Corporation, USA) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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