Approved Clinical Trials This page provides a searchable list of all clinical trial research protocols that have been reviewed and approved by the Uganda National Council for Science and Technology (UNCST).
Search By Approval Date:
Clear Filter Total: 302
Name Title Study Sites Nationality Approval Date Expiry Date Sample Size Target Population Sponsors Field of Science/Classification Trial Type Research Type  
Julius Okuni Boniface
ID: UNCST-2019-R000963
 A MULTI-COUNTRY, SINGLE-BLINDED, PHASE 2 STUDY TO EVALUATE RAPID DETECTION SYSTEMS OF SARS-COV-2
REFNo: HS1425ES

1. To determine the clinical sensitivity of the test assays compared to the real-time RT-PCR-based method.
2. To determine the specificity of the test assays compared to the real-time RT-PCR-based method.

 Kampala, Mulago
 Uganda 2021-06-16 2024-06-16 500 The age group will be adults from 18 years and above. The samples will be collected from archives at the Biorepository in the Department of Immunology and Molecular Biology, Makerere University. The samples will be from people from patients that had compl EDCTP Medical and Health Sciences Clinical Trial Non-degree Award
Musa Sekikubo
ID: UNCST-2021-R014010
 A multi-Centre, randomised, placebo controlled, double-blind, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine (GBS-NN/NN2) in women who are pregnant and living with HIV and women who are pregnant and do not have HIV
REFNo: HS1390ES

Objectives
Primary Objectives:
Safety:
To evaluate the safety and tolerability of the GBS-NN/NN2 vaccine in women living with HIV and women without HIV and their newborn babies from vaccination up to delivery/birth.
Immunological:
To compare the transfer rate of vaccine- specific immunoglobulin G (IgG) antibody concentrations from the mother to the baby at birth in women living with HIV with the transfer rate in women without HIV. This endpoint will be used to determine the sample size calculation.
Secondary Objectives
Safety: The safety and tolerability of the GBS-NN/NN2 vaccine in the mother and baby over the first 6 months post-partum, as assessed at 6 months of age.
Immunological: The secondary immunological objectives are:
• To compare IgG antibody responses, specific to the GBS-NN/NN2 vaccine, induced by the first and second vaccine doses over time in pregnant women living with HIV and pregnant women without HIV.
• To evaluate the concentration of IgG antibodies specific for the GBS-NN/NN2 vaccine up to 6 months post-delivery in the mother and baby in women with and without HIV.
• To determine the concentrations of vaccine specific IgG to GBS-NN/NN2 in cord blood at delivery in babies born to women with and without HIV.
Exploratory Objectives
• To compare between groups the isotype composition of the vaccine specific antibodies; in particular IgG and IgA as well as their subclasses, i.e. IgG1-4, IgA1 and IgA2 in maternal and cord blood.
• To compare between groups the vaccine specific IgG antibodies to Rib, Alp1, Alp2 and AlpC, GBS-NN and GBS-NN2 in maternal and cord blood.
• To compare between groups the functional activity of vaccine specific antibodies from cord blood in an opsonophagocytic killing assay (OPkA) and other in vitro assays in selected samples.

 Kampala, Kawempe
 Uganda 2021-06-08 2024-06-08 50 HIV negative and HIV positive pregnant women aged 18 to 40 years attending Kawempe national referral Hospital MINERVAX AS Medical and Health Sciences Clinical Trial Non-degree Award
View Sort By:

Our Partners