The Optimal Timing of Vaccination in Pregnancy
ConditionPertussis/Whooping Cough
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorElke Leuridan, MD, PhD
About this trial
The central aim of this study is to investigate the optimal timing of vaccination in pregnant women. Therefore, pregnant women will be vaccinated against pertussis at different timepoints and blood and breast milk samples will be taken at several timepoints. The main objectives are to assess the impact of timing on humoral and cellular immune responses in pregnant women, on antibody characteristics transferred across the placenta and on transplacental transport efficiency. The impact of maternal pertussis vaccination and timing of maternal pertussis vaccination on breastmilk antibody composition will also be investigated, as well as the impact of vaccination during pregnancy on the mucosal uptake of breastmilk IgA antibodies by the infant respiratory and gastrointestinal tract.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ability to provide informed consent.
Willing to be vaccinated with a Tdap vaccine during pregnancy.
Intend to be available for follow-up visits and phone call access until 6 months postpartum.
Influenza and COVID-19 vaccination during pregnancy (as per Belgian recommendations) is allowed.
Disqualifiers
Vaccinated with an aP containing vaccine during the last 5 years
Significant mental illness (e.g. schizophrenia, psychosis, major depression)
Serious underlying immunological condition (e.g. immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection…).
Systemic treatment with immune suppressive medication, including chronic steroid use of > 10 mg prednisone or equivalent.
Trial population
Female pregnant population within Flanders
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Triaxis, Sanofi Pasteur
Biological/Vaccinetetanus, diphtheria, acellular pertussis (aP) (Tdap) vaccine
Treatment groups
96 Participants
are divided into 3 treatment groupsGroup A: Cohort 11 intervention
Group B: Cohort 21 intervention
Group C: Cohort 31 intervention
Trial outcomes
Primary outcomes
1
Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy.
Time frame
Before Tdap vaccination2
Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy.
Time frame
One month after Tdap vaccination3
Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy.
Time frame
At delivery4
Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy.
Time frame
6 months postpartumSecondary outcomes
1
Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy.
Time frame
Before Tdap vaccination2
Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy.
Time frame
One month after Tdap vaccination3
Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy.
Time frame
At delivery4
Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy.
Time frame
6 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Elke Leuridan, MD, PhD
Lead sponsor
Universiteit Antwerpen
Sponsor institution
Université Libre de Bruxelles
Collaborator
Source ClinicalTrials.gov