|
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:
|
ISRCTN |
|
Last refreshed on:
|
29 November 2021 |
|
Main ID: |
ISRCTN46694886 |
|
Date of registration:
|
01/07/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Ethical protocol for blood sampling from healthy adult volunteers for research on the immune answer towards biotherapeutic drugs in development
|
|
Scientific title:
|
Ethical protocol for blood sampling from healthy adult volunteers for research on risk mitigation of immunogenicity of Nanobodies® |
|
Date of first enrolment:
|
01/07/2015 |
|
Target sample size:
|
300 |
|
Recruitment status: |
Completed |
|
URL:
|
https://www.isrctn.com/ISRCTN46694886 |
|
Study type:
|
Interventional |
|
Study design:
|
Single-centre trial (Other)
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Belgium
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Chloé
Ackaert |
|
Address:
|
VUB, Building E, 8th Floor
Pleinlaan 2
1050
Elsene
Belgium |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
1. Good general health
2. Aged 18-65
Exclusion criteria:
1. Pregnant (in case of doubt, a test will be taken) or envisages a pregnancy in the near future
2. History of significant inconvenience with blood sampling
3. High risk for HIV, HBV or HCV
4. Has received blood or blood products in the last 6 months
5. Has received any therapeutic treatment that influences the immune system
6. Presence of acute or chronic infection or disease
7. Currently taking drugs, except for contraceptives
8. Associated with the current study
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Blood sampling from healthy, adult volunteers for isolation of peripheral blood mononuclear cells (PBMCs) for in vitro analysis of the human immune response towards Nanobodies.
Not Applicable
|
|
Intervention(s)
|
|
Blood sampling (up to 450 ml). Nothing is administered.
|
|
Primary Outcome(s)
|
|
T cell proliferation and differentiation in vitro as surrogate marker for the in vivo development of anti-drug antibody formation, measured 1-2 weeks after blood sampling.
|
|
Secondary Outcome(s)
|
|
Immunogenic regions of the Nanobodies are identified and mutated, and the resulting new Nanobodies are tested once again for immunogenicity. Measurements are carried out 2.5 years after blood sampling.
|
|
Source(s) of Monetary Support
|
|
Free University of Brussels (Vrije Universiteit Brussel)
|
|
Ethics review
|
Status:
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
30/06/2018 |
|
URL:
|
|
|
|