The optimal timing of vaccination in pregnancy

The optimal timing of vaccination in pregnancy: a multi-dimensional mechanistic approach to measure immune responses in pregnant women - MATIMMUNE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005194-77-BE

Enrollment

Registered

2021-10-05

Start date

2021-10-26

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

humoral and cellular immune responses to pertussis vaccine during pregnancy

Interventions

Trade Name: Triaxis Product Name: Triaxis Pharmaceutical Form: Injection INN or Proposed INN: purified, inactivated diphtheria toxin (DT) Other descriptive name: DIPHTHERIA TOXOID INN or Proposed INN:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Female population older than 18 years. • 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 postvaccination. • Influenza and COVID-19 vaccination during pregnancy (as per Belgian recommendations) is allowed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study is to investigate the impact of timing of vaccination during pregnancy on humoral immune responses in pregnant women at several timepoints during and after pregnancy.;Secondary Objective: In this study we will also investigate: the impact of timing of vaccination during pregnancy on cellular immune responses in pregnant women at several timepoints during and after pregnancy; the impact of timing on vaccination during pregnancy on antibody characteristics that are optimally transferred across the placenta and on transplacental transport efficiency; the impact of maternal Tdap vaccination and timing of maternal Tdap vaccination on breast milk antibody composition at several timepoints postpartum; the impact of vaccination during pregnancy on the mucosal uptake of breast milk IgA antibodies by the infant respiratory and gastrointestinal tract. ;Primary end point(s): To investigate the impact of timing of vaccination during pregnancy on humoral immune responses in pregnant women at several timepoints during pregnancy, at delivery and at several timepoints after delivery.;Timepoint(s) of evaluation of this end point: •During pregnancy: before Tdap vaccination; one month after Tdap vaccination; at an interval of every 4 weeks until delivery occurs •At delivery •After delivery: 2/4/8/12 weeks and 6 months postpartum	—

Measure

Time frame

Main Objective: The main objective of this study is to investigate the impact of timing of vaccination during pregnancy on humoral immune responses in pregnant women at several timepoints during and after pregnancy.;Secondary Objective: In this study we will also investigate: the impact of timing of vaccination during pregnancy on cellular immune responses in pregnant women at several timepoints during and after pregnancy; the impact of timing on vaccination during pregnancy on antibody characteristics that are optimally transferred across the placenta and on transplacental transport efficiency; the impact of maternal Tdap vaccination and timing of maternal Tdap vaccination on breast milk antibody composition at several timepoints postpartum; the impact of vaccination during pregnancy on the mucosal uptake of breast milk IgA antibodies by the infant respiratory and gastrointestinal tract. ;Primary end point(s): To investigate the impact of timing of vaccination during pregnancy on humoral immune responses in pregnant women at several timepoints during pregnancy, at delivery and at several timepoints after delivery.;Timepoint(s) of evaluation of this end point: •During pregnancy: before Tdap vaccination; one month after Tdap vaccination; at an interval of every 4 weeks until delivery occurs •At delivery •After delivery: 2/4/8/12 weeks and 6 months postpartum

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Secondary

Measure	Time frame
Secondary end point(s): • To investigate the impact of timing of vaccination during pregnancy on cellular immune responses in pregnant women at several timepoints during pregnancy (before Tdap vaccination and one month after Tdap vaccination), at delivery and after delivery (6 months postpartum). • To investigate the impact of timing of vaccination during pregnancy on antibody characteristics that are optimally transferred across the placenta and on transplacental transport efficiency. • To investigate the impact of maternal Tdap vaccination and timing of maternal Tdap vaccination on breast milk antibody composition at several timepoints postpartum (<72 hours postpartum, 2/4/8/12 weeks postpartum). • To investigate the impact of vaccination during pregnancy on the mucosal uptake of breast milk IgA antibodies by the infant respiratory and gastrointestinal tract ;Timepoint(s) of evaluation of this end point: • During pregnancy: before Tdap vaccination; one month after Tdap vaccination; at an interval of every 4 weeks until delivery occurs • At delivery • After delivery: 2/4/8/12 weeks and 6 months postpartum	—

Measure

Time frame

Secondary end point(s): • To investigate the impact of timing of vaccination during pregnancy on cellular immune responses in pregnant women at several timepoints during pregnancy (before Tdap vaccination and one month after Tdap vaccination), at delivery and after delivery (6 months postpartum). • To investigate the impact of timing of vaccination during pregnancy on antibody characteristics that are optimally transferred across the placenta and on transplacental transport efficiency. • To investigate the impact of maternal Tdap vaccination and timing of maternal Tdap vaccination on breast milk antibody composition at several timepoints postpartum (<72 hours postpartum, 2/4/8/12 weeks postpartum). • To investigate the impact of vaccination during pregnancy on the mucosal uptake of breast milk IgA antibodies by the infant respiratory and gastrointestinal tract ;Timepoint(s) of evaluation of this end point: • During pregnancy: before Tdap vaccination; one month after Tdap vaccination; at an interval of every 4 weeks until delivery occurs • At delivery • After delivery: 2/4/8/12 weeks and 6 months postpartum

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Countries

Belgium

Contacts

Public ContactKirsten Maertens

University of Antwerp

kirsten.maertens@uantwerpen.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026