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| Name | Class |
|---|---|
| Université Libre de Bruxelles | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Pregnant women vaccinated with Tdap vaccine between 16-18 weeks of gestation |
| |
| Cohort 2 | Pregnant women vaccinated with Tdap vaccine between 25-27 weeks of gestation |
| |
| Cohort 3 | Pregnant women vaccinated with Tdap vaccine between 34-36 weeks of gestation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triaxis, Sanofi Pasteur | Biological | tetanus, diphtheria, acellular pertussis (aP) (Tdap) vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy. | Before Tdap vaccination | |
| Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy. | One month after Tdap vaccination | |
| Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy. | At delivery | |
| Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy. | 6 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy. | Before Tdap vaccination | |
| Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy. |
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Inclusion Criteria:
Exclusion Criteria:
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Female pregnant population within Flanders
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kirsten Maertens | Contact | +32496717845 | kirsten.maertens@uantwerpen.be | |
| Elke Leuridan | Contact | 032652885 | elke.leuridan@uantwerpen.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vaccinopolis | Recruiting | Edegem | Antwerp | 2650 | Belgium |
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| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C509326 | adacel |
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Serum, Cord blood, breast milk
| One month after Tdap vaccination |
| Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy. | At delivery |
| Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy. | 6 months postpartum |
| Measurement of antibody levels in cord blood at delivery after Tdap vaccination at different timings in pregnancy to calculate the transport of antibodies across the placenta | At delivery |
| Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in breastmilk after Tdap vaccination at different timings in pregnancy. | 6 months postpartum |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |