The SILVER study aims to give insight into the half-life of maternally acquired antibodies in preterms and the foetus to mother transfer function. These findings have implications for understanding infectious disease susceptibility, vaccine…
ID
Source
Brief title
Condition
- Other condition
- Viral infectious disorders
Synonym
Health condition
prematuriteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. To measure maternal naturally occurring neutralizing RSV antibody levels at
birth as function of gestational age, and
2. To quantify transplacental antibody transfer ratios of RSV-specific
antibodies in preterm babies depending on their gestational age group and
compared to ratios obtained in term neonates
Secondary outcome
1. SILVER describes post-partum half-life of maternally acquired RSV-specific
antibodies in preterm and full-term neonates. Preterm and full-term
neonates will be followed up after birth to capture the decrease in
maternally acquired RSV-specific antibodies in their first weeks of life. The
SILVER study will describe the half-life of maternally acquired
RSV-specific antibodies in neonates in relation to their gestational age,
repeated
blood-draws during hospitalization and health status and comorbidities.
2. SILVER will describe the health of the placenta in relation to antibody
transfer.
3. SILVER will describe the correlation between RSV seasonality (using local
public health surveillance data from RIVM) and observed antibodies of
pregnant woman.
Background summary
Respiratory syncytial virus (RSV) infection is an important cause of
hospitalization and death in children younger than 5 years. A vaccine against
RSV infection is expected to become available in the next 5-10 years. Next to
the degree to which a vaccine will boost levels of maternal protective
antibodies and the degree to which these RSV antibodies are transported
trans-placental to the foetus, the success of a maternal RSV vaccination
strategy will also be defined by the half-life of vaccine-induced maternally
acquired antibodies after birth.
Given the complex health conditions of premature babies including, but not
limited to repeated blood-draws during their hospitalization, it is conceivable
that there is a more rapid decrease of antibodies during this period of time
leading to increased risk of RSV infection.
Study objective
The SILVER study aims to give insight into the half-life of maternally acquired
antibodies in preterms and the foetus to mother transfer function. These
findings have implications for understanding infectious disease susceptibility,
vaccine development, and vaccine scheduling in premature neonates.
Study design
SILVER is a cross-sectional prospective seroepidemiologic study. At birth
neonatal blood specimen from both pre-term and term neonates as well as
maternal blood sample will be scavenged from standard of care specimens and/or
by taking additional capillary blood samples, in addition to a the collection
of placental specimens. We will collect clinical and demographical
characteristics of the mother and foetus pairs to use as covariates in our
model. In the second part, the babies will be followed-up up to 8 weeks to
measure antibody level decrease.
Study burden and risks
Risks and burdens for study subjects are considered to be minimal. No safety
issues are expected due to the set-up and nature of the study.
There are no direct or indirect benefits for the participants. Burden for the
participant is minimal, as only a small amount of blood volume is required and
the sampling can be performed quickly and easily.
Lundlaan 6
Utrecht 3584 EA
NL
Lundlaan 6
Utrecht 3584 EA
NL
Listed location countries
Age
Inclusion criteria
1. Women >=18 years of age and pregnant.
2. Woman with hospitalization at the WKZ hospital due to imminent labor from
240/7 weeks of gestation.
3. Both parent(s)/legal guardian(s) must be willing to adhere to the protocol
and sign informed consent. A signature from the mother is sufficient in case
consent from the father cannot be obtained.
4. The maternal participant must be willing to accept maternal blood specimen
collection and neonate specimens collection and relevant clinical and medical
history data collection.
Exclusion criteria
There are no exclusion criteria for the study. If mothers have a medical
diagnosis or pregnancy-related condition that is suspected to impact the
transplacental transfer rate, these confounding variables (comorbidities) will
be documented and accounted for in the analyses.
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 | NL79793.041.21 |