Ethical protocol for blood sampling from healthy adult volunteers for research on the immune answer towards biotherapeutic drugs in development

ISRCTN ISRCTN46694886
DOI https://doi.org/10.1186/ISRCTN46694886
Secondary identifying numbers N/A
Submission date
01/06/2015
Registration date
01/07/2015
Last edited
18/11/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Chloé Ackaert
Scientific

VUB, Building E, 8th Floor
Pleinlaan 2
Elsene
1050
Belgium

ORCiD logoORCID ID 0000-0001-9145-2931

Study information

Study designSingle-centre trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)GP practice
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleEthical protocol for blood sampling from healthy adult volunteers for research on risk mitigation of immunogenicity of Nanobodies®
Study objectivesRationale 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(s)Ethics Committee of the University Hospital Brussels (UZ Brussel), Belgium - submission planned for 05/06/2015.
Health condition(s) or problem(s) studiedBlood sampling from healthy, adult volunteers for isolation of peripheral blood mononuclear cells (PBMCs) for in vitro analysis of the human immune response towards Nanobodies.
InterventionBlood sampling (up to 450 ml). Nothing is administered.
Intervention typeProcedure/Surgery
Primary outcome measureT 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 measuresImmunogenic 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 study start date01/07/2015
Completion date30/06/2018

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants300
Key inclusion criteria1. Good general health
2. Aged 18-65
Key exclusion criteria1. 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
Date of first enrolment01/07/2015
Date of final enrolment01/06/2018

Locations

Countries of recruitment

  • Belgium

Study participating centres

Free University of Brussels (Vrije Universiteit Brussel)
Boulevard de la Plaine 2
Elsene
1050
Belgium
University Hospital Brussels (Universitair Ziekenhuis Brussel)
Avenue du Laerbeek 101
Jette
1090
Belgium

Sponsor information

Vrije Universiteit Brussel
University/education

Pleinlaan 2
Elsene
1050
Belgium

ROR logo "ROR" https://ror.org/006e5kg04

Funders

Funder type

University/education

Free University of Brussels (Vrije Universiteit Brussel)

No information available

Results and Publications

Intention to publish date01/01/2016
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPublication 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
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 09/03/2021 18/11/2021 Yes No

Editorial Notes

18/11/2021: Publication reference added.