Research with human participants

Overview of medical research in the Netherlands

The role of pregnancy on susceptibility and antibody dependent enhancement of immune cells for Zika virus infection

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The aim of this study is to determine whether white blood cells from pregnant women are more susceptible to infection with the Zika virus compared to white blood cells from non-pregnant women. We do this by collecting two tubes of blood from…

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Viral infectious disorders
Study type
Observational invasive

ID

NL-OMON50935

Source

ToetsingOnline

Brief title

Zika virus and pregnancy

Condition

  • Viral infectious disorders
  • Foetal complications

Synonym

Zika virus

Research involving

Human

Sponsors and support

Primary sponsor :
Erasmus MC, Universitair Medisch Centrum Rotterdam
Source(s) of monetary or material Support :
ZonMW

Intervention

Keyword :
Antibody dependent enhancement of infection, Pregnancy, Zika virus

Outcome measures

Primary outcome

The main endpoints of this study are the ZIKV titers measured in the

supernatant of infected PBMCs as well as the percentage of PBMCs that are

infected with ZIKV.

Secondary outcome

The secondary endpoints of this study are the cytokines detected in the

supernatant of infected PBMCs from pregnant women and non pregnant women.

Background summary

In 2015/2016 there was a major outbreak of the Zika virus in South America.
This virus is transmitted by mosquitoes and is currently not found in the
Netherlands. An infection with the Zika virus during pregnancy can lead to
congenital birth defects. It is currently unclear how the Zika virus is
transmitted from mother to child and what risk factors are for this
transmission.

Study objective

The aim of this study is to determine whether white blood cells from pregnant
women are more susceptible to infection with the Zika virus compared to white
blood cells from non-pregnant women. We do this by collecting two tubes of
blood from participants in this study and by examining whether the white blood
cells isolated from the blood can become infected with the Zika virus.

Study design

Cross-sectional study

Study burden and risks

There is no benefit in participating this study, the burden and the risk of the
intervention in this study (venapuncture) is negligible.

Public
Erasmus MC, Universitair Medisch Centrum Rotterdam

Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Scientific
Erasmus MC, Universitair Medisch Centrum Rotterdam

Doctor Molewaterplein 40
Rotterdam 3015GD
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Pregnancy

Exclusion criteria

Pregnancy complications

Design

Study type :
Observational invasive
Intervention model
:
Other
Allocation :
Non-randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Basic science

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
40
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

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 NL76727.078.21