Plain English Summary
Background and study aims
Nanobodies® are a recently discovered class of proteins, which show great therapeutic and diagnostic potential in diseases such as cancer. They have many advantages over classical biotherapeutics (engineered biological products), but since Nanobodies originate from camelid animals (e.g. camels and alpacas) there is a risk of unwanted side effects, particularly immune system responses, when used in humans. These responses may drastically limit how effective the therapy is, and in certain cases can even be very harmful for the patient. The aim of this study is to investigate the cause of unwanted immune system reactions to Nanobodies. Specifically, this study will examine the non-human (camelid) aspects of the Nanobodies protein, production side-products and formulation to analyse the main steps responsible for inducing an immune response in humans. This will be done by taking blood samples from healthy volunteers, which will then be analysed in the laboratory to isolate specific, highly sensitive cells that are known to be critical in initiating an immune system response.
Who can participate?
Healthy adults aged 18-65.
What does the study involve?
All participants are asked to give a blood sample.
What are the possible benefits and risks of participating?
The results of this study will be used to generate safer and more efficient Nanobodies, resulting in healthier patients and reduced health costs.
Where is the study run from?
1. Free University of Brussels (Vrije Universiteit Brussel) (Belgium)
2. University Hospital Brussels (Universitair Ziekenhuis Brussel) (Belgium)
When is the study starting and how long is it expected to run for?
July 2015 to June 2018
Who is funding the study?
Free University of Brussels (Vrije Universiteit Brussel) (Belgium)
Who is the main contact?
Dr C Ackaert
Trial website
Contact information
Type
Scientific
Primary contact
Dr Chloé Ackaert
ORCID ID
http://orcid.org/0000-0001-9145-2931
Contact details
VUB
Building E
8th Floor
Pleinlaan 2
Elsene
1050
Belgium
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Ethical protocol for blood sampling from healthy adult volunteers for research on risk mitigation of immunogenicity of Nanobodies®
Acronym
Study hypothesis
Rationale of the study: to determine immunogenic regions in the sequence of Nanobodies to be able to change these regions to generate more safe and less immunogenic Nanobodies.
Ethics approval
Ethics Committee of the University Hospital Brussels (UZ Brussel), Belgium - submission planned for 05/06/2015.
Study design
Single-centre trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
GP practices
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
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.
Intervention
Blood sampling (up to 450 ml). Nothing is administered.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
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 measures
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.
Overall trial start date
01/07/2015
Overall trial end date
30/06/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Good general health
2. Aged 18-65
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
300
Participant 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
Recruitment start date
01/07/2015
Recruitment end date
01/06/2018
Locations
Countries of recruitment
Belgium
Trial participating centre
Free University of Brussels (Vrije Universiteit Brussel)
Boulevard de la Plaine 2
Elsene
1050
Belgium
Trial participating centre
University Hospital Brussels (Universitair Ziekenhuis Brussel)
Avenue du Laerbeek 101
Jette
1090
Belgium
Funders
Funder type
University/education
Funder name
Free University of Brussels (Vrije Universiteit Brussel)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication 1: Response of dendritic cells to Nanobodies: planned beginning 2016
Publication 2: Response of T cells to Nanobodies: planned end 2016
Publication 3: Optimised sequence of Nanobodies with reduced immunogenicity: planned half 2018
Intention to publish date
01/01/2016
Participant level data
Other
Results - basic reporting
Publication summary