Our primary objective is to evaluate non-inferiority of anti-Pertussis Toxin (PT) IgG in term infants at 2m of age born of mothers having received a pertussis vaccine between 20-24w Gestational Age (GA) compared to a reference anti-PT IgG at 2m of…
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Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serum IgG antibody levels against vaccine antigen PT in preterm and term
infants at 2 months of age, before start of infant vaccination.
Secondary outcome
- The IgG antibody concentration against pertussis toxin (PT), pertactin (Prn)
filamentous hemagglutinin (FHA), tetanus and diphtheria in the mother at
delivery.
- The IgG antibody concentration against PT, Prn, FHA, tetanus and diphtheria
in the infant at birth (cord blood).
- The IgG antibody concentration against Prn, FHA, tetanus and diphtheria in
the infant at 2m of age.
- The decay in IgG antibody concentration against PT, Prn, FHA, tetanus and
diphtheria in infants from birth until 2 months of age.
- The ratio between maternal GMCs and infant GMCs at birth.
- Frequency of local and systemic adverse events occurring within 7 days after
vaccination during pregnancy.
- Frequency of systemic events, occurring in the week before the maternal
vaccination.
- Frequency of determinants of acceptance of 2nd trimester pertussis
vaccination.
- Determinants of women*s attitude towards maternal pertussis vaccination
between 20-24w GA.
Background summary
Pertussis has resurged worldwide. Current epidemiology shows that very young
infants do not profit from the currently used vaccination schedules and remain
at highest risk for severe pertussis disease and even death. Therefore, a
growing number of countries implemented 3rd trimester maternal pertussis
vaccination. Through trans-placental transport of pertussis specific
antibodies, infants are protected in the first months of life. Data have shown
that this intervention is 91% effective in preventing pertussis in young
infants and 95% effective in preventing death due to pertussis. However, data
also show that preterm infants profit less from 3rd trimester pertussis
vaccination, probably due to insufficient time for antibody transfer. At the
same time, preterm infants are overrepresented in pertussis notifications and
hospitalisations. Some countries have implemented 2nd trimester pertussis
vaccination, with good immunogenicity data. In contrast, another study showed
that 2nd trimester pertussis vaccination is less effective in preventing infant
pertussis than 3rd trimester immunisation. Therefore, it is important to gain
more insight into second trimester maternal pertussis vaccination. In the
Netherlands, maternal pertussis vaccination will be implemented late 2019 and
probably will be offered from 22 week gestational age onwards.
Study objective
Our primary objective is to evaluate non-inferiority of anti-Pertussis Toxin
(PT) IgG in term infants at 2m of age born of mothers having received a
pertussis vaccine between 20-24w Gestational Age (GA) compared to a reference
anti-PT IgG at 2m of age in a historical control group of term infants born of
mothers who were vaccinated between 30-32w GA. Likewise, we aim to assess
non-inferiority of anti-PT IgG in preterm infants at 2m of age born of mothers
having received a pertussis vaccine between 20-24w GA compared to the 20 IU/ml
anti-PT IgG cut-off used in many immunogenicity studies.
Study design
We will set up a prospective cohort study of pregnant women with follow up of
their infants up to 2 months of age. The study consists of two parts. The first
part aims to study acceptance of 2nd trimester pertussis vaccination and the
relation between determinants and actual behavior, i.e. acceptance of
vaccination. Women who actually received a 2nd trimester pertussis vaccination
will be asked to also participate in the second study part, i.e. the
immunogenicity part.
Intervention
Pregnant woman can choose to receive a single dose of Boostrix vaccine between
week 20 and 24 of pregnancy
Study burden and risks
Available data on the use of Tdap in pregnant women does not suggest any
elevated frequency or unusual patterns of adverse events in pregnant women who
received Tdap.
One heel/finger stick blood collections of 100 µl will be performed in the
mother after delivery and in the infant at 2m of age. The burden and risk is
considered low. It might be painful but only for a few seconds.
One cord blood sample will be collected from all participating infants at
birth.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
1. 18 years or older , 2. Being pregnant , 3. Having an antenatal appointment
with a midwife or obstetrician in the 1st trimester of pregnancy , 4. Signed
informed consent , 5. Parents who are willing to adhere to the protocol and
perform all planned visits and, sample collections for themselves and their
newborn child (only relevant for the immunogenicity part
Exclusion criteria
1. All women with one or more missing inclusion criteria, 2. History of having
received a pertussis containing vaccination in the past 2 years. , 3. History
of having had pertussis disease in the past 5 years., 4. Known or suspected
serious underlying condition that can interfere with the results, of the study
such as but not limited to cancer, autoimmune disease, immunodeficiency,
seizure disorder or significant psychiatric illness., 5. Receipt of any
high-dose (>=20 mg of prednisone daily or equivalent) daily corticosteroids
within 2 weeks of study entry (inhaled or other local steroids are acceptable)
with exception of corticosteroids to enhance maturation of fetal lungs in case
of imminent early delivery., 6. Receipt of other immune modulating medication,
for instance biologicals., 7. Receipt of blood products or immunoglobulins,
within three months of study entry, (Rhesus negative women who receive
anti-rhesus (D)- immunoglobulin will not be, excluded from the study)., 8.
Presence of bleeding disorder., 9. Having experienced a previous severe adverse
reaction to any vaccine., 10. Receipt of any vaccine(s) within 2 weeks of study
vaccine (except influenza, vaccine which may be given concomitantly).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-002976-41-NL |
| CCMO | NL66966.000.18 |
| OMON | NL-OMON21026 |