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Screening study on the prevalence of neutralizing antibodies against adeno-associated virus

Screening study on the prevalence of neutralizing antibodies against adeno-associated virus in serum among populations

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500106694
Enrollment
Unknown
Registered
2025-07-28
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Onset in adolescence

Interventions

Healthy participants without systemic diseases:N/A
Inherited eye disease:N/A

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Healthy participants without systemic diseases: Age 18-60 years;Continuous enrollment until sample size is met;Subjects and their legal guardians are willing and able to participate in additional laboratory examinations as required by the research protocol;Signed and dated informed consent and assent forms as evidence that subjects have been informed of all study-related information;No pathological abnormalities in routine admission examinations including complete blood count, liver function, kidney function, blood glucose, chest X-ray, and abdominal ultrasound;Normal vital signs including blood pressure, pulse, and temperature? 2.Inherited eye disease: Age 18-60 years;Continuous enrollment until sample size is met;Subjects and their legal guardians are willing and able to participate in additional laboratory examinations as required by the research protocol;Signed and dated informed consent and assent forms as evidence that subjects have been informed of all study-related information;No pathological abnormalities in routine admission examinations including complete blood count, liver function, kidney function, blood glucose, chest X-ray, and abdominal ultrasound;Normal vital signs including blood pressure, pulse, and temperature; Confirmed diagnosis of retinitis pigmentosa;

Exclusion criteria

Exclusion criteria: 1.Use of glucocorticoids or systemic immunosuppressants within the past year;Major surgery or trauma history within the past six months;Previous exposure to any gene therapy;Diagnosed with systemic diseases;Presence of diseases potentially associated with AAV infection at the time of blood collection, such as pharyngitis, pneumonia, etc.;Presence of blood-borne pathogen infections, such as HBV, HCV, HIV, etc.

Design outcomes

Primary

MeasureTime frame
Prevalence of neutralizing antibody;

Countries

China

Contacts

Public ContactTong Li

Shanghai General Hospital

019139lt@shgh.cn+86 21 63240090

Outcome results

None listed

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