In this research study we will look whether in the blood of patients who were recently infected with the coronavirus (SARS-CoV-2), antibodies can be found that neutralise the virus. We will produce those antibodies. With the produced antibodies we…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Generate human antibodies with high affinity for SARS-CoV-2, which are
neutralizing and cross-reactive against older SARS-Cov viruses, and that target
a broad spectrum of epitopes, spread across the viral proteome. Antibodies
should preferentially enhance each other's efficacy with regard to virus
neutralization. Potent antibodies will be either developed into a product, or
offered for licensing to a pharmaceutical party that will continue the path
towards the market.
2. Establish a set of IP-protected protocols and procedures as a workflow that
rapidly yields monoclonal antibody molecules in response to emerging pathogens.
Secondary outcome
-
Background summary
It is known that in patients who are infected with the corona virus, antibodies
arise that can stop the virus infection or can reduce the virus infection
significantly. By producing these antibodies at large scale, and applying them
to people who are recently infected, we can fight the virus efficiently.
Study objective
In this research study we will look whether in the blood of patients who were
recently infected with the coronavirus (SARS-CoV-2), antibodies can be found
that neutralise the virus. We will produce those antibodies. With the produced
antibodies we will make a medicine that will eliminate or strongly reduce the
effect of the virus on patients.
Study design
- Bloodsampling. The researcher takes each time max 6 tubes of blood max 50 ml.
- Antibody characterisation. We will analyse which antibodies against
SARS-CoV-2 are in your blood.
- Isolation of B cells. If you have the proper antibodies against SARS-CoV-2 in
your blood we will isolate RNA from the B-cells in your blood. B cells are
those cells that produce antibodies. We will use the RNA to determine the exact
composition of the antibodies so they can be produced.
- Isolate antibodies from the plasma. We will try to directly isolate a small
quantity of antibodies from your blood. We will determine the composition of
those antibodies with Mass-spectrometry. The is a modern technique to analyse
proteins. This will be done so these antibodies can also be produced.
Study burden and risks
The risks associated with venipuncture by a trained professional are
negligible. Phlebotomists that will assist in this study are qualified
professionals assigned by lnnatoss. Risks associated with drawing blood include
pain, bruising, light-headedness, and, on extremely rare occasions, infection.
The burden of participation will be limited. Each visit will last up to
approximately 15 minutes. There will be no other procedures or follow-up
required after the specimens are obtained.
Kloosterstraat 9, RE21
Oss 5349 AB
NL
Kloosterstraat 9, RE21
Oss 5349 AB
NL
Listed location countries
Age
Inclusion criteria
- Over 18 years of age
- Positive PCR in the previous 2 months and/or
- Vaccinated against SARS-CoV-2
- Devoid of symptoms associated with an active SARS-CoV-2 infection
Exclusion criteria
- Individuals who cannot or are not willing to consent.
- Individuals who are undergoing an immunosuppressive treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76229.028.21 |