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Schistosoma Mansoni clinical trials

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NCT ID: NCT06311344 Recruiting - Schistosoma Mansoni Clinical Trials

Filling Key Research Gaps With Clinical Implications in Mansonellosis and Schistosomiasis: a Network Approach

Start date: April 14, 2021
Phase: N/A
Study type: Interventional

This is an experimental, multicenter, non-profit study promoted by the Department of Infectious and Tropical Diseases of the IRCCS (Istituto di Ricerca e Cura a carattere scientifico) Sacro Cuore Don Calabria of Negrar which aims to evaluate the presence of endosymbiont Wolbachia in circulating microfilariae obtained from biological samples of individuals infected with M .perstans and the presence of infection with hybrid Schistosoma species in the population of Schistosoma eggs isolated from biological samples of patients with active schistosomiasis.

NCT ID: NCT05999825 Not yet recruiting - Schistosomiasis Clinical Trials

Sm-p80 Schistosomiasis Challenge Study

Start date: September 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to learn about the Sm-p80 + GLA-SE (Schistoshield®) vaccine in healthy participants who have not had schistosomiasis before. The main questions it aims to answer are: - if the vaccine is safe - if after vaccinated people start producing antibodies - if the vaccine works against schistosomiasis. Participants will receive three vaccines (or placebo) and are then exposed to 20 male Schistosoma cercariae. Afterwards they are treated with praziquantel to cure the infection. Researchers will compare the group vaccinated with Schistoshield® and placebo (fake vaccination) to see if the vaccine has worked.

NCT ID: NCT05085470 Completed - Schistosomiasis Clinical Trials

Repeated Controlled Human Schistosoma Mansoni Infection

Start date: October 29, 2021
Phase: N/A
Study type: Interventional

A group of 24 healthy volunteers are challenged one or three times with 20 male Schistosoma mansoni cercariae to investigate whether this leads to protection and to identify potential correlates of protection

NCT ID: NCT04679831 Completed - Schistosoma Mansoni Clinical Trials

Clinical Evaluation of Ujiplus® Against Schistosoma Mansoni

Start date: May 6, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Schistosomiasis is classified as among the world's neglected tropical diseases (NTD). Morbidity due to Schistosoma mansoni (S. mansoni) is greatest among school-age children who typically have the highest burden of infection. In 2001, World Health Organization (WHO) passed a resolution for large-scale mass drug administration (MDA) using chemotherapy to deworm vulnerable children through school-based programs. While MDA has significantly contributed to reducing the burden of these infections, several concerns still exist over the large-scale use of chemotherapeutic drugs in deworming. The large population of children and the high frequency of dosage may pose a challenge to the sustainability of these programs. Further, the MDAs exert increasing drug pressure on parasite populations, a circumstance that is likely to favor parasite genotypes that can resist chemotherapy. Additionally, the current school-based MDA does not consider child malnutrition a very common malady in African countries. The greatest shortcoming is that currently approved S. mansoni chemotherapeutic treatment, Praziquantel is not recommended for children under six years of age due to its perceived toxicity. This excludes a highly vulnerable group from treatment. The above has called for alternative management options for S. mansoni among school and pre-school age children. The current study seeks to test the feasibility of the use of a nutritional supplement (Ujiplus®), as a potential deworming strategy against S. mansoni. Ujiplus® is a porridge flour fortified with papaya (Carica papaya) seeds extracts. In a previous study (NCT 027-25255), the product was found to have an effect on soil-transmitted helminths among a group of school children with no serious adverse events. We intend to evaluate the efficacy of Ujiplus® when given through school feeding programs and compare the outcome with praziquantel- the recommended MDA agent for deworming school children. The investigators will design and formulate the Ujiplus®, and test it among children in four primary schools in Mbita, Homabay county, Kenya.

NCT ID: NCT03910972 Active, not recruiting - Schistosomiasis Clinical Trials

Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults

Start date: October 7, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The study will recruit up to 290 healthy adult males and non-pregnant females into a two-part clinical trial of a vaccine to protect against schistosomiasis caused by infection with S. mansoni. Two formulations of the Sm-TSP-2 vaccine will be tested: one using Alhydrogel® only, and one using Alhydrogel® plus AP 10-701, each at 3 different doses of antigen: 10mcg, 30mcg, and 100mcg. The first part of the study will be a Phase I dose-escalation safety and immunogenicity study followed by a Phase IIb trial in which a larger number of adults will be enrolled to assess the impact of the vaccine on infection with S. mansoni. The impact of the vaccine on infection with S. haematobium will also be assessed although this will be exploratory given that potential cross-protection against this species is only hypothetical at this point.

NCT ID: NCT03893097 Completed - Schistosoma Mansoni Clinical Trials

Evaluation of Artesunate-mefloquine as a Novel Alternative Treatment for Schistosomiasis in African Children

SchistoSAM
Start date: October 14, 2019
Phase: Phase 3
Study type: Interventional

The SchistoSAM study is an open label, two-arm, individually-randomized controlled trial with a non-inferiority design, conducted in northern Senegal. The study aims at determining if the efficacy of one and of repeated courses of artesunate-mefloquine (AM) is respectively similar to or higher than that of a standard praziquantel (PZQ) treatment. Secondly, the study will assess if novel DNA- and antigen-based diagnostics are more accurate than microscopy in assessing antischistosomal treatment response.

NCT ID: NCT02810613 Withdrawn - Asthma Clinical Trials

Leiden University Medical Center Mini Donor Bank

Start date: May 31, 2016
Phase: N/A
Study type: Observational

(Bio)medical research, particularly immunological, metabolic, transcriptional or biological assays, occasionally require the use of fresh blood (peripheral mononuclear cells) or urine. In order to comply with international guidelines for Good Clinical Practice, the investigators propose to establish a Mini Donor Bank to be able to obtain fresh blood or urine from voluntary donors. Recruitment of volunteers will be a continuous process. Volunteers will consent to occasional blood- or urine donation.

NCT ID: NCT02755324 Completed - Schistosomiasis Clinical Trials

Single-sex Controlled Human Schistosomiasis Infection: Safety and Dose Finding

Start date: October 27, 2016
Phase: N/A
Study type: Interventional

Groups of 3 or 7 volunteers will be exposed to a predetermined number of male Schistosoma mansoni cercariae until 10 volunteers are found infected.

NCT ID: NCT02162875 Completed - Schistosoma Mansoni Clinical Trials

Schistosoma Mansoni in Mwanza Region, Tanzania

SCORE_PAR
Start date: March 2011
Phase: N/A
Study type: Interventional

The objective of this study is to determine the strategy for mass drug administration (MDA) which provides the greatest reductions in prevalence and intensity of Schistosoma mansoni in school-aged children after 4 years of intervention.

NCT ID: NCT01054651 Completed - Schistosoma Mansoni Clinical Trials

A Randomised Trial of Artesunate-sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel for the Treatment of S. Mansoni

Start date: October 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of school children infected with S.mansoni in western Kenya.