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

Viruses such as Influenza, Rhinovirus and SARS-CoV-2 cause respiratory tract
infections throughout the general population, affecting elderly and infants
most severely. Annual deaths caused by respiratory viruses are estimated to be
up to 3 million, and medical costs and loss of productivity amount to a
considerable impact on global economy. In temperate regions, incidence of e.g.
Influenza is highly seasonal, with outbreaks generally beginning after
November, and peaks subsiding before April.
Vaccination is the most cost-effective strategy to globally reduce incidence
and mortality of respiratory viruses, though several challenges remain. Major
problems include the necessity to frequently develop a new vaccine for highly
mutagenic viruses such as Influenza, or the limited understanding of the
pathogenicity for viruses such as RSV or SARS-CoV-2. Continuous assessment and
mapping of mutating respiratory viruses is a cornerstone of vaccine
development.
CHDR collaborates with multiple parties involved in the development of vaccines
and therapeutic agents for respiratory viruses. A major contribution to this
development will be the conducting of controlled human infection models (CHIMs)
to evaluate clinical safety and efficacy of vaccines and antivirals. To select
virus stems apt for this model, assessment of circulating respiratory viruses
in The Netherlands is essential; a high immunity in the general population
against the challenge virus would significantly limit the value of a CHIM,
while a low general immunity would increase the risks of major viral outbreaks.
Since for every CHIM individually this consideration is to be made, it is
essential to assess the existing immunity in our population on a regular basis.
This way, this protocol serves as a preparatory study to future vaccine
research at CHDR.

To assess existing background immunity for respiratory virus stems in the
general population.

This protocol describes a cross-sectional investigation of existing immunity
for respiratory virus stems. The blood specimens required for this research
will originate from volunteers recruited for participation of other clinical
trials at CHDR. The total duration of the study for each subject will be a
single visit, being the screening visit for the clinical trial. Screening
visits regularly last no longer than 2 hours. During the visit, subject*s
eligibility for this study will be assessed prior to blood sample collection.

Our aim is to be able to execute this protocol when necessary; 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 per year, with a maximum of including
500 subjects per year; when executed, we intend to collect blood samples within
a short period of time, e.g. 2 weeks, to relieve operational departments of
structural burdens and to minimize the effects of possible new viruses on the
data.

No investigational drug will be administered to the volunteers. The invasive
procedures under this protocol will be restricted to blood sample collection
(venipuncture). The burden for the volunteer related to the study procedures is
limited. Only well-established methods of sample collection will be applied,
with a known and limited risk and no or mild discomfort for the volunteer. In
addition, all collections will be performed by qualified medical staff.