Clinical Trials Logo
  1. Home
  2. Schistosomiasis
  3. NCT01154049

Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis

Schistosomiasis Clinical Trial

Official title:
Phase 1 Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis

Clinical Trial Summary

This is a phase I, open-label, single arm trial, which aims to assess the safety of the vaccine prepared sm14 in healthy subjects. The product immunogenicity will be evaluated by conducting serology (anti-sm14 antibodies) and testing of cellular response to the antigen by the method ELI-SPOT. Each participant will remain in the study for approximately 4 months. The total study duration is 10 months, considering a period of 6 months for inclusion. Will be included in the study subjects male and female, between 18 and 49 years, that manifest their will to participate in the research by signing an Informed Consent Form. Eligible population for the study are subjects who do not present at screening significant changes in renal, cardiac and liver functions, complete blood count, clotting, present no acute or chronic illnesses, are not in the chronic use of any medication, do not have HIV infection or other immunodeficiency. Pregnant or breastfeeding women will not be included. Volunteers will receive three doses of vaccine prepared sm14, in doses containing 50 mcg of the antigen, associated with adjuvant GLA-SE at a dose of 10 mcg, with an interval of 30 days between each application. Twenty volunteers will be included in the study. This is a convenience sample, established for the first test of the product in humans, for the initial safety assessment.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01154049
Study type Interventional
Source Oswaldo Cruz Foundation
Contact
Status Completed
Phase Phase 1
Start date March 2011
Completion date April 2014
View Details
See also
  Status Clinical Trial Phase
Completed NCT04115072 - Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study Phase 2/Phase 3
Not yet recruiting NCT05999825 - Sm-p80 Schistosomiasis Challenge Study Phase 2
Completed NCT00463931 - Using Community-Based Volunteers to Reach Non-Enrolled School Aged Children Through Community-Directed Treatment of Schistosomiasis in School-Aged Children in Rural Northern Ghana N/A
Completed NCT00215267 - The Effect of Praziquantel Treatment on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria, Uganda N/A
Completed NCT00276224 - Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia N/A
Completed NCT03845140 - L-PZQ ODT in Schistosoma Infected Children Phase 3
Completed NCT01512277 - Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis Phase 1
Active, not recruiting NCT03910972 - Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults Phase 1/Phase 2
Completed NCT05085470 - Repeated Controlled Human Schistosoma Mansoni Infection N/A
Completed NCT02755324 - Single-sex Controlled Human Schistosomiasis Infection: Safety and Dose Finding N/A
Recruiting NCT05868005 - Delivering a Multi-disease Screening Tool to Migrant Populations N/A
Active, not recruiting NCT01869465 - Evaluation of Strategies for Improved Uptake of Preventive Treatment for Intestinal Schistosomiasis N/A
Completed NCT01553552 - Schistosomiasis Effect on Response to Vaccines, Anaemia and Nutritional Status of Children of Northern Senegal N/A
Recruiting NCT04589390 - Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension Phase 2
Completed NCT02868385 - Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST) Phase 3
Recruiting NCT05762393 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar Phase 1
Not yet recruiting NCT06182176 - Effectiveness and Cost-effectiveness of Integrated Model for Malaria and Helminth Control N/A
Completed NCT05292391 - Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults Phase 1
Completed NCT03110757 - A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel)(R) With or Without AP 10-701 for Intestinal Schistosomiasis in Healthy Exposed Adults Phase 1
Active, not recruiting NCT05354258 - Feasibility and Safety of Combining Anti-malarial With Deworming Drugs in African Children N/A