Condition category
Not Applicable
Date applied
01/06/2015
Date assigned
01/07/2015
Last edited
28/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Sponsor information

Organisation

Vrije Universiteit Brussel

Sponsor details

Pleinlaan 2
Elsene
1050
Belgium

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes