The Optimal Timing of Vaccination in Pregnancy

Pertussis/Whooping Cough Clinical Trial

— MATIMMUNE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06466629
• Other study ID #: cev005
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2024
• Source: Universiteit Antwerpen
• Contact: Kirsten Maertens
• Phone: +32496717845
• Email: kirsten.maertens[@]uantwerpen.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: April 30, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pertussis/Whooping Cough
• Whooping Cough

Intervention

Biological:
• Triaxis, Sanofi Pasteur
tetanus, diphtheria, acellular pertussis (aP) (Tdap) vaccine

Locations

Country	Name	City	State
Belgium	Vaccinopolis	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
Elke Leuridan, MD, PhD	Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy.		Before Tdap vaccination
Secondary	Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy.		One month after Tdap vaccination
Secondary	Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy.		At delivery
Secondary	Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy.		6 months postpartum
Secondary	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
Secondary	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