Francis Kiweewa
ID: UNCST-2020-R014929
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A Global Multi-Center, Randomized, Blinded, Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) for the Prevention of COVID-19 in Participants Aged 18 Years and Older
REFNo: HS2476ES
The objective of this study is to evaluate the effectiveness, safety, and the ability of the study vaccine to provoke an immune response in your body against COVID-19. This study is necessary because the COVID-19 epidemic poses a significant global health challenge, and a large number of effective vaccines are still needed for the future.
A total of approximately 34,000 participants like you from around the world, such as Africa and Asia will participate in this study. The entire study will last approximately 20 months, and your participation will last approximately at least 17 months. (The exact duration of your participation in the study may depend on the specific situation of the study. Please consult your study doctor at that time.)
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Wakiso,
Kampala,
Lira,
Tororo,
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Uganda |
2022-09-28 14:10:52 |
2025-09-28 |
234 |
Adults aged 18 years and older of all sexes.
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AIM Vaccine Co., Ltd, AIM Innovation Biotechnology (Shanghai) Co., Ltd, LiveRNA Therapeutics Inc. & Ningbo Rongan Biological Pharmaceutical Co., Ltd |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Byamah Mutamba Brian
ID: UNCST-2022-R011124
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Strengthening Care in collaborAtion with People with lived Experience of psychosis in Uganda (SCAPE-U
REFNo: HS2327ES
General objective
To assess the impact of SCAPE-U on individual, family members’ and health system outcomes, and evaluate trial procedures to determine the optimal design for a future fully-powered cluster randomised controlled trial (RCT).
Specific objectives
1. To assess the feasibility and acceptability of SCAPE-U from the perspective of people with lived experience of psychosis, their family members and primary and community care providers.
2. To demonstrate proof-of-concept for the benefit of SCAPE-U for service users (i.e., patients with psychosis receiving primary care services) and their families, including changes in psychosis symptoms, quality of life, frequency of hospitalization and the potential impacts on family members.
3. To determine changes in health systems outcomes in terms of primary care provider knowledge, attitudes, competency in psychosis diagnosis and management, as well as accuracy of diagnosis and fidelity to treatment guidelines in actual care settings.
4. To evaluate trial procedures, including costing, recruitment and retention, and data collection protocols, to determine the optimal design for a future fully-powered cluster RCT
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Kampala, All parishes
Wakiso, All parishes
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Uganda |
2022-09-21 21:32:50 |
2025-09-21 |
120 persons diagnosed with Psychosis |
There will be five categories of participants in this study:
Persons with lived experience of psychosis (SCAPE-U facilitators) – Approximately 10-20 people with lived experience of psychosis will be recruited from prior YouBelong Uganda programs to be trained in PhotoVoice as SCAPE-U facilitators in the SCAPE-U arm. These people with lived experience of psychosis will require a diagnosis of a psychotic disorder confirmed by a mental health professional (psychiatric clinical officer or psychiatrist). Mental health professionals will be required to evaluate PLWP for any health or functional impairment that could jeopardize their safe participation as well as seek their consent. Currently participating in treatment (taking antipsychotics, receiving psychosocial support, or both) is not an exclusion criterion. We plan to draw SCAPE-U facilitators from YouBelongHome beneficiaries. The YBH intervention comprises two unique phases: 1) a pre-discharge assessment which provides a detailed description of an individual’s general health and mental health history; individual goals and aspirations; a social demography of the individual and his/her family with particular emphasis on potential barriers to and supports for individual and family well-being; and the education and awareness level of the local community in mental health; this first phase is completed in a 2 to 3 weeks and 2) the second phase is the post-discharge community-based strengthening, informed by the pre-discharge assessment, that focuses on both empowering the family as an active agent in the returned person’s recovery and connecting the person with SMI and family to the support of friends, extended family, community, and work. This phase includes both face to face and phone engagements over a 12-week period. In response to the COVID-19 pandemic, YBU has modified the pre and post discharge process from a 16 week to a 5-week intervention, to allow for a higher rate of return and resettlement of patients, while ensuring that those patients in need of complex mental health and psychosocial care still receive the unmodified YBH pre and post discharge version of care.
They will meet the following selection criteria: a) completion of the YBH program, b) confirmed diagnosis of a primary psychotic disorder (e.g., schizophrenia) by a psychiatrist or PCO, c) provision of informed consent, d) fluency in the local language (Luganda), e) good functioning with respect to performance of daily chores, engagement with family members, comprehension and community participation as assessed by the YBH team, and f) a supportive family member. We will also maintain professional conduct guidelines to monitor experience of clients during home visits and other interactions.
Primary care providers – Primary care providers who have been selected by the in-charge of the health facility to participate in the study, will be trained in mental health service delivery with the mhGAP-IG. Two providers will be selected per facility and there are no exclusion criteria, for an estimated 70 primary care providers per arm. At the primary care provider level, all primary care providers being trained in mental health services will be eligible for participation.
Community health workers – Five community health workers (VHTs) who are affiliated to the health facilities where PHWs receive training in mhGAP and have been selected by the in-charge of the health facility to participate in the study.
Service users (main intended beneficiaries) – The primary intended beneficiaries of study interventions are patients receiving treatment for psychoses. At the patient level, any patient presenting to HC-II, III, or IV receiving a diagnosis of psychosis from primary care providers will be eligible for participation in this study. The goal is to have 60 patients per arm for the two arms (120 patients total). At the patient level, any patient presenting to HC-II, III, or IV receiving a diagnosis of psychosis from primary care providers will be eligible for participation in this study. Service user inclusion criteria: 1. Persons diagnosed with psychosis at a primary health care facility in Kampala/Wakiso District; 2. Ability of the patient or responsible surrogate to consent to study enrolment and procedures; 3. Persons eligible for outpatient management of psychosis. Exclusion criteria will be 1. Persons diagnosed with psychosis requiring inpatient management/services; and 2. Persons for whom consent for participation in the study cannot be obtained.
Family members of service users – At least one primary carer to a participating service user will be identified in order to collect outcome data from the carer
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Wellcome Trust, UK |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Henry Ssenyondo
ID:
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Maternal Antibody in Milk After Group B Streptococcus Vaccination in Uganda: MAMA study
REFNo: HS1986ES
General Objective
• To determine the concentration of antibody transferred in breastmilk following vaccination with Group B Streptococcal vaccine
Specific Objectives
• To determine the anti-GBS (anti-Alp1N, Alp2N, AlpCN and RibN) Immunoglobulin A (IgA) concentrations in the colostrum of women following vaccination with a GBS-containing vaccine or placebo in pregnancy.
• To determine the total IgA and Immunoglobulin G (IgG) concentrations in the colostrum and breastmilk of women at less than 48 hours, 28 (+/-4 days) and 56 (+/- 6 days) days after delivery following vaccination with a GBS-containing vaccine or placebo in pregnancy.
• To determine the anti-GBS (antiAlp1N, Alp2N, AlpCN and RibN) IgA concentrations in the breastmilk of women at 28 (+/-4 days) and 56 (+/- 6 days) days after delivery following vaccination with a GBS-containing vaccine in pregnancy.
• To determine the anti-GBS (antiAlp1N, Alp2N, AlpCN and RibN) IgG concentrations in the colostrum and breastmilk of women at less than 48 hours, 28 (+/-4 days) and 56 (+/- 6 days) days after delivery following vaccination with a GBS-containing vaccine in pregnancy.
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Kampala, Kawempe Central
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Uganda |
2022-09-21 21:13:49 |
2025-09-21 |
50 |
Women
18 to 40 years
All tribes |
Makerere University |
Medical and Health Sciences |
Clinical Trial |
Degree Award |
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Eugene Ruzagira
ID: UNCST-2023-R008282
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A phase Ib study to assess the safety and immunogenicity of a recombinant adenovirus-based vaccine against plague in Uganda
REFNo: HS2387ES
Primary
To investigate safety and tolerability of 5 x 1010 VP of the proposed ChAdOx1 Plague vaccine in healthy African adults aged 18 to 49 residing in Uganda, when given as one or two dose(s) intramuscularly with different prime-boost intervals
Secondary
To determine the immunogenicity of 5 x 1010 VP of the proposed ChAdOx1 Plague vaccine, in healthy African adults aged 18 to 49 years residing in Uganda when given as one or two dose(s) intramuscularly with different prime-boost intervals.
Tertiary
Exploratory immunogenicity assays to determine the immunogenicity of 5 x 1010 VP of the proposed ChAdOx1 Plague vaccine, in healthy African adults aged 18 to 49 years residing in Uganda when given as one or two dose(s) intramuscularly with different prime-boost intervals.
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Masaka, KATWE
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Uganda |
2022-09-12 18:28:42 |
2025-09-12 |
36 |
Healthy male or female African adults aged 18-49 years, inclusive. Inclusion and exclusion criteria are as follows:
Inclusion Criteria
• Willing and able to give informed consent for participation in the trial.
• Male or female aged between 18-49 years inclusive at enrolment (first vaccination visit, V1)
• In good health as determined by
o Medical history (as determined by verbal medical history)
o Physical examination
o Clinical judgment of the investigators
• Female participants of childbearing potential must be willing to ensure that they use effective contraception during the trial and for 3 months after the last vaccination.
• Female participants of childbearing potential must have a negative pregnancy test on the day(s) of screening and vaccination.
• Able to attend the scheduled visits and to comply with all study procedures
• Agrees to refrain from donating blood for the duration of the trial
• Clinically acceptable baseline screening results (includes vital signs, physical examination, urinalysis, and laboratory results)
• In the Investigator’s opinion, is able and willing to comply with all trial requirements.
Exclusion Criteria
The participant may not be enrolled in the study if any of the following apply:
• Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
• History of significant organ/system disease that could interfere with trial conduct or completion. This includes a known history of significant disease in the following:
o Cardiovascular disease including congenital heart disease, previous myocardial infarction, valvular heart disease (or history of rheumatic fever), previous bacterial endocarditis, history of cardiac surgery (including pacemaker insertion), personal or family history of cardiomyopathy or sudden adult death
o Respiratory disease such as uncontrolled asthma and chronic obstructive pulmonary disease
o Endocrine disorders such as diabetes mellitus and Addison’s disease
o Significant renal or bladder disease
o Biliary tract disease
o Gastro-intestinal disease such as inflammatory bowel disease, major abdominal surgery within the last two years, coeliac disease and liver disease (including hepatitis B or C infection)
o Neurological disease such as seizures and myasthenia gravis
o Haematological problems such as coagulation problems or anaemia (haemoglobin < 12.5g/dL for females and < 13.5 g/dL and for males)
o Metabolic disease such as glucose-6-phosphate dehydrogenase deficiency
o Psychiatric illness requiring hospitalisation or depression if severity is deemed clinically significant by the study Investigators
o Known or suspected drug and/or alcohol misuse
o Non-benign cancer, except squamous cell or basal cell carcinoma of the skin and cervical carcinoma in situ
• Any other significant disease or disorder which, in the opinion of the Investigator, could:
o Put the participant at risk because of participation in the trial
o Influence the result of the trial
o Impair the participant’s ability to participate in the trial
• History of allergy to a vaccine or any component of the vaccines used in this study
• History of anaphylaxis
• Have any known or suspected impairment or alteration of immune function, resulting from, for example:
o Congenital or acquired immunodeficiency
o Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition
o Autoimmune disease
o Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy (including for more than 7 days consecutively within the previous 3 months).
• Receipt of immunoglobulins or any blood product transfusion within 3 months prior to enrolment
• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial
• Weight <50kg or a body mass index (BMI) greater than 35kg/m2.
• Known history of previous occurrence of disease caused by Y. pestis or receipt of a vaccine against plague
• Current active participation in another research study involving an investigational product (including receipt of an IMP within last 30 days) or where involvement in this study could impact the results
• It is not in the best interest of the volunteer to participate in the trial, in the opinion of the Investigator.
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University of Oxford |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Gorretti Nassali
ID:
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A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTOR?POSITIVE, HER2 NEGATIVE EARLY BREAST CANCER
REFNo: HS2133ES
Primary objective:
To demonstrate superiority of giredestrant over the control treatment
Secondary objectives:
1. To evaluate the efficacy of giredestrant compared with TPC
2. To evaluate the safety of giredestrant compared with TPC
3. To characterize giredestrant pharrmacokinetics (PK)
4. To evaluate health status utility scores of participants treated with giredestrant compared with TPC
5. To evaluate the efficacy of giredestrant compared with TPC
6. To evaluate the tolerability of giredestrant compared with TPC
7. To identify and/or evaluate biomarkers that are predictive of response to giredestrant
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Kampala, mulago
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Uganda |
2022-09-06 14:14:37 |
2025-09-06 |
Approximately 4700 participants will be screened to achieve random assignment in 1:1 ratio to study treatment of 4100 randomized participants for an estimated total of 2050 randomized participants per |
Approximately 4100 participants with medium- and high-risk Stage I?III histologically confirmed ER? and HER2? EBC will be enrolled during the global enrollment phase of this study. After completion of the global enrollment phase, additional participants |
F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 4070 Basel, Switzerland |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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