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

Ethical protocol for blood sampling from healthy adult volunteers for research on risk mitigation of immunogenicity of Nanobodies®

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46694886
Enrollment
300
Registered
2015-07-01
Start date
2015-07-01
Completion date
Unknown
Last updated
2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Blood sampling (up to 450 ml). Nothing is administered.

Sponsors

Vrije Universiteit Brussel
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Good general health 2. Aged 18-65

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026