The Optimal Timing of Vaccination in Pregnancy

NCT06466629 | Recruiting

• 1 other identifier: cev005
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pertussis/Whooping Cough

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (6)

• 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.

  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

Study Arms (3)

Cohort 1

Pregnant women vaccinated with Tdap vaccine between 16-18 weeks of gestation

Biological: Triaxis, Sanofi Pasteur

Cohort 2

Pregnant women vaccinated with Tdap vaccine between 25-27 weeks of gestation

Biological: Triaxis, Sanofi Pasteur

Cohort 3

Pregnant women vaccinated with Tdap vaccine between 34-36 weeks of gestation

Biological: Triaxis, Sanofi Pasteur

Interventions

Triaxis, Sanofi Pasteur BIOLOGICAL

tetanus, diphtheria, acellular pertussis (aP) (Tdap) vaccine

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female pregnant population within Flanders

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
• Previous severe reaction to any vaccine
• High risk for serious obstetrical complications.

Sponsors & Collaborators

• Elke Leuridan, MD, PhD: lead
• Université Libre de Bruxelles: collaborator

Study Sites (1)

Vaccinopolis

Edegem, Antwerp, 2650, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Cord blood, breast milk

MeSH Terms

Conditions

Whooping Cough

Interventions

adacel

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Central Study Contacts

Kirsten Maertens

CONTACT

+32496717845; kirsten.maertens@uantwerpen.be

Elke Leuridan

CONTACT

032652885; elke.leuridan@uantwerpen.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: June 20, 2024
• Study Start: July 1, 2021
• Primary Completion: October 31, 2024
• Study Completion: April 30, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

BE (1)