Effect of different elimination methods on the prevalence of neutralizing antibodies to AAV

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00021101

Enrollment

Registered

2020-10-19

Start date

2021-06-22

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

AAV seroprevalence in patients with prednisolone, rituximab or plasmapharesis therapy due to various underlying diseases Healthy volunteers

Interventions

Group 1: patients with prednisolone therapy (n=30): 3 times blood sampling: Determination of Neutralizing Antibody Titer (NAbs) against serotypes AAV1, AAV2, AAV5, AAV6, AAV8, AAV9 und AAV10 during ti

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - informed consent -patient should receive therapy with prednisolon or rituximab or plasmapharesis - baseline measurement pre therapy start possible

Exclusion criteria

Exclusion criteria: -no informed consent -no baseline measurement possible pre therapy start

Design outcomes

Primary

Measure	Time frame
Change of Neutralizing Antibody (NAbs) Titer against serotypes AAV1, AAV2, AAV5, AAV6, AAV8, AAV9 und AAV10 during time course of 3 different therapies: blood collections: Group I (prednisolone)/Group II (rituximab): - time point 0 (pre therapy start) -time point 1( 1 week post therapy start) -time point 2 (2-4 weeks post therapy start) Group III (plasmapharesis) -time point 0 (pre plasmapharesis) -time point 1 (post plasmapharesis) control group: blood donors, single blood collection Measurement of titer will be done by ELISA (IgG, IgM) and Transduction Inhibition Assay.	—

Measure

Time frame

Change of Neutralizing Antibody (NAbs) Titer against serotypes AAV1, AAV2, AAV5, AAV6, AAV8, AAV9 und AAV10 during time course of 3 different therapies: blood collections: Group I (prednisolone)/Group II (rituximab): - time point 0 (pre therapy start) -time point 1( 1 week post therapy start) -time point 2 (2-4 weeks post therapy start) Group III (plasmapharesis) -time point 0 (pre plasmapharesis) -time point 1 (post plasmapharesis) control group: blood donors, single blood collection Measurement of titer will be done by ELISA (IgG, IgM) and Transduction Inhibition Assay.

—

Secondary

Measure	Time frame
Cross-reactivity of anti-AAV antibodies	—

Countries

Germany

Contacts

Public ContactWolfgang Miesbach

Hämophiliezentrum, Institut für Transfusionsmedizin, Medizinische Klinik III, Goethe Universitätsklinikum

wolfgang.miesbach@kgu.de06963015051

Outcome results

None listed

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