The Optimal Timing of Vaccination in Pregnancy (MATIMMUNE)

The Optimal Timing of Vaccination in Pregnancy: a Multi-dimensional Mechanistic Approach to Measure Immune Responses in Pregnant Women

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.

Study Overview

• Status: Recruiting
• Conditions: Pertussis/Whooping Cough
• Intervention / Treatment: Biological: Triaxis, Sanofi Pasteur

• Study Type: Observational
• Enrollment (Estimated): 96

Contacts and Locations

• Study Contact: Name: Kirsten Maertens; Phone Number: +32496717845; Email: kirsten.maertens@uantwerpen.be
• Study Contact Backup: Name: Elke Leuridan; Phone Number: 032652885; Email: elke.leuridan@uantwerpen.be

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • Vaccinopolis
      • Contact: Kirsten Maertens; Phone Number: 0496717845; Email: kirsten.maertens@uantwerpen.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Female pregnant population within Flanders

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Pregnant women vaccinated with Tdap vaccine between 16-18 weeks of gestation	Biological: Triaxis, Sanofi Pasteur; tetanus, diphtheria, acellular pertussis (aP) (Tdap) vaccine
Cohort 2; Pregnant women vaccinated with Tdap vaccine between 25-27 weeks of gestation	Biological: Triaxis, Sanofi Pasteur; tetanus, diphtheria, acellular pertussis (aP) (Tdap) vaccine
Cohort 3; Pregnant women vaccinated with Tdap vaccine between 34-36 weeks of gestation	Biological: Triaxis, Sanofi Pasteur; tetanus, diphtheria, acellular pertussis (aP) (Tdap) vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Elke Leuridan, MD, PhD
• Collaborators: Université Libre de Bruxelles

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Whooping Cough
• Other Study ID Numbers: cev005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No