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Respiratory virus background immunity assessment

Seasonal assessment of existing immunity for respiratory viruses in healthy volunteers to facilitate targeted vaccine development – a preparatory study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN15445591
Enrollment
3500
Registered
2024-02-21
Start date
2023-09-23
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Viral infection, respiratory tract infections Infections and Infestations

Interventions

In this trial, serum samples from healthy volunteers will be collected for analysis. Serum will be collected from subjects that are already planned to visit CHDR for screening or follow-up for a diffe
when the planned screening or follow-up date for the other trial they participate in falls within the study period of this trial, subjects will be asked consent for the additional blood donation. Part
for example, when a scientific question emerges regarding existing immunity, or for the selection of a virus strain for a controlled human infection model. This protocol may be executed multiple times

Sponsors

Centre for Human Drug Research
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years and in good health; the upper age limit could be lowered for different executions of this protocol, but will never exceed 75 years 2. Good health, based upon the results of medical history 3. Subject has signed informed consent

Exclusion criteria

Exclusion criteria: 1. Evidence of immunodeficiency in medical history 2. Prior use of immunosuppressive medication (systemic glucocorticoids 6 months prior to inclusion or any other systemic immunosuppressive medication at any time), immunoglobulins or systemic antiviral therapy)

Design outcomes

Primary

MeasureTime frame
Assess existing background immunity for respiratory virus stems in the general population using laboratory assessments containing, but not limited to: 1. Hemagglutination inhibiton assay (HAI) titre for selected viral stems, for influenza 2. Microneutralization assay (MN) titre for selected viral stems 3. (Neutralizing) IgG & IgA titre for selected viral stems Serum will be collected from subjects that are already planned to visit CHDR for screening or follow-up for a different study.

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

Netherlands

Contacts

Public ContactVictor Cnossen
clintrials@chdr.nl+31 715246400

Outcome results

None listed

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