|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
8 January 2018 |
|
Main ID: |
NCT03041766 |
|
Date of registration:
|
16/11/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Study of Safety and Immune Response of the Sm14 Vaccine in Adults of Endemic Regions
|
|
Scientific title:
|
Safety and Immunogenicity Evaluation of the Vaccine Candidate Sm14 in Combination With the Adjuvant Glucopyranosyl Lipid A (GLA-SE) in Adults Living in Endemic Regions for S. Mansoni and S. Haematobium in Senegal. A Comparative, Randomized, Open-label Trial |
|
Date of first enrolment:
|
December 6, 2016 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03041766 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Senegal
| | | | | | | |
|
Contacts
|
|
Name:
|
Gilles RIVEAU, PharmD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS) |
|
|
Name:
|
Doudou DIOP, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS) |
|
|
Name:
|
Miriam Tendler, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Oswaldo Cruz Foundation |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Adults, male, 18 to 49 years old (inclusive) at the time of inclusion.
- Living in one of selected villages in Saint-Louis Region (Senegal).
- Free of obvious/severe health problems except schistosomiasis, as established by
clinical examination and blood analysis, i.e. hematological exams, liver and renal
function tests.
- Written informed consent to participate obtained
- Treated with 40mg/kg Praziquantel (PZQ) before inclusion (W-5 to W-4 before the first
injection) in case of infection with S. mansoni and S. haematobium
- Residence in the area during the period of the study.
Exclusion Criteria:
- Adult who does not respond to one of the inclusion criteria
- Current or previous chronic administration (defined as more than 14 days) of
immunosuppressive drugs or other immuno-modifying drugs.
- Known hypersensitivity to any component in the Sm14 vaccine or history of allergic
disease.
- Knowledge of non-infectious chronic disease
- Acute disease at time of enrollment.
- Other conditions which in opinion of the PI may potentially represent a danger for the
patient to be enrolled.
- Non residence in the study area or intent to move during the study period
Age minimum:
18 Years
Age maximum:
49 Years
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Schistosomiasis
|
|
Intervention(s)
|
|
Biological: Sm14
|
|
Drug: GLA-SE solution
|
|
Primary Outcome(s)
|
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
[Time Frame: D30-D37: within 7 days of the administration of the second dose]
|
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
[Time Frame: D60-67 : within 7 days of the administration of the third dose]
|
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
[Time Frame: within 7 days of the administration of the first dose]
|
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
[Time Frame: D120 : four months after the first injection]
|
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
[Time Frame: D90 : three months after the first injection]
|
|
Secondary Outcome(s)
|
|
Qualitative and quantitative assessment of the Immunogenicity
[Time Frame: 60 days after the first administration]
|
|
Qualitative and quantitative assessment of the Immunogenicity
[Time Frame: 90 days after the first administration]
|
|
Qualitative and quantitative assessment of the Immunogenicity
[Time Frame: 120 days after the first administration]
|
|
Qualitative and quantitative assessment of the Immunogenicity
[Time Frame: Day of first administration]
|
|
Qualitative and quantitative assessment of the Immunogenicity
[Time Frame: 30 days after the first administration]
|
|
Secondary ID(s)
|
|
Sm14-2a-Sn
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|