The primary objective of the proposed study is to isolate and characterize neutralizing Lassa-specific monoclonal antibodies from LASV recovered individuals.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Neutralization potency and breadth of monoclonal antibodies derived from LASV
individuals who have recovered from LASV infection as assayed in neutralization
assays using lentiviral vectors pseudo-typed with Lassa GP protein
Secondary outcome
- Percentage Lassa GP positive memory B cells as assayed by FACS (clonality)
using Lassa GP protein labelled in different colors
- Sequence screening of the most promising LASV monoclonal antibodies
Background summary
Lassa Virus (LASV) is an Old-World Arenavirus and the causative agent of Lassa
fever, a viral hemorrhagic fever that is endemic in parts of West Africa.
Recent years have seen several outbreaks of Lassa fever with high mortality
rates. The LASV also belongs to the highly pathogenic Risk Group 4 (RG4)
viruses that may be used as biological warfare or terrorism agents. Recent
animal studies demonstrated that administration of neutralizing antibodies
(NAbs) isolated from people previously infected with LASV conferred 100%
protection against a LASV challenge (1-3). Monoclonal antibodies (MAbs) have
been successfully employed to prevent and treat viral infections such as
SARS-CoV-2, RSV, Ebola, influenza and rabies in clinical phase testing and in
addition, MAbs have an excellent safety record. We hypothesize that the
isolation and characterization of LASV-specific antibodies will provide an
avenue for the development of targeted prevention and treatment of LASV
hemorrhagic fever.
Study objective
The primary objective of the proposed study is to isolate and characterize
neutralizing Lassa-specific monoclonal antibodies from LASV recovered
individuals.
Study design
- Observational study with 5 healthy volunteers in 5 years time
- Participants are recruited by Prof. Grobusch in the Tropencentrum of the
Amsterdam UMC
- we will conduct a medical history and physical examination and obtain
information regarding results of previous Lassa Virus infection
- we will perform a one timepoint blood withdrawal via venapuncture
Study burden and risks
The main adverse reactions related to phlebotomy are hematomas, a slightly
increased risk of infection and vasovagal complaints or vasovagal collapse.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Written informed consent to store samples and perform genetic testing.
- Age >= 18 years
- Individuals who have experienced PCR proven LASV infection and minimally 4
weeks post-infection
Exclusion criteria
- Mental disorder that in the view of the investigator would interfere with
adherence to the treatment or the study procedures, or the decision to
participate in the study.
- Immunosuppressive medication or other diseases associated with
immunodeficiency.
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 | NL83461.018.22 |