Pertussis/Whooping CoughMATIMMUNENCT06466629
The Optimal Timing of Vaccination in Pregnancy
An observational study of Pertussis/Whooping Cough, run by Elke Leuridan, MD, PhD at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pertussis/Whooping Cough
- What is being tested?
- Triaxis, Sanofi Pasteur
- Type of treatment
- Vaccines
- How many people
- 96 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2021to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female pregnant population within Flanders
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Vaccinopolis
Edegem, Antwerp, 2650
Kirsten Maertens, 0496717845, kirsten.maertens@uantwerpen.be
About this study
Official title: 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.
- Conditions
- Pertussis/Whooping Cough
- Being tested
- Triaxis, Sanofi Pasteur
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triaxis, Sanofi PasteurBiological
tetanus, diphtheria, acellular pertussis (aP) (Tdap) vaccine
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Pregnant women vaccinated with Tdap vaccine between 16-18 weeks of gestation Receives: Biological: Triaxis, Sanofi Pasteur | |
| Cohort 2 | Pregnant women vaccinated with Tdap vaccine between 25-27 weeks of gestation Receives: Biological: Triaxis, Sanofi Pasteur | |
| Cohort 3 | Pregnant women vaccinated with Tdap vaccine between 34-36 weeks of gestation Receives: Biological: Triaxis, Sanofi Pasteur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before Tdap vaccination
Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy.
Measured: One month after Tdap vaccination
Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy.
Measured: At delivery
Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy.
Measured: 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
Measured: At delivery
Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in breastmilk after Tdap vaccination at different timings in pregnancy.
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start1 Jul 2021
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertussis/Whooping CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elke Leuridan, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Responsible party
- Sponsor-investigator, Elke Leuridan, MD, PhD, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466629
- Sponsor's protocol ID
- cev005
- Acronym
- MATIMMUNE
- Status last verified
- Jun 2024
- First submitted
- 16 Nov 2022
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Timing of Vaccination in Pregnancy: a Multi-dimensional Mechanistic Approach to Measure Immune Responses in Pregnant Women
- ClinicalTrials.gov ID
- NCT06466629
- Acronym / sponsor ID
- MATIMMUNE / cev005
- Conditions
- Pertussis/Whooping Cough
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Elke Leuridan, MD, PhDUniversity, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Biological: Triaxis, Sanofi PasteurPregnant women vaccinated with Tdap vaccine between 16-18 weeks of gestation |
| Cohort 2 | – | Biological: Triaxis, Sanofi PasteurPregnant women vaccinated with Tdap vaccine between 25-27 weeks of gestation |
| Cohort 3 | – | Biological: Triaxis, Sanofi PasteurPregnant women vaccinated with Tdap vaccine between 34-36 weeks of gestation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female pregnant population within Flanders
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triaxis, Sanofi Pasteurtetanus, diphtheria, acellular pertussis (aP) (Tdap) vaccine | Biological | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months postpartum
6 secondary outcomes
Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy.
Time frame: Before Tdap vaccination
Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy.
Time frame: One month after Tdap vaccination
Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy.
Time frame: At delivery
Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy.
Time frame: 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
Time frame: At delivery
Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in breastmilk after Tdap vaccination at different timings in pregnancy.
Time frame: 6 months postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis/Whooping Cough, run by Elke Leuridan, MD, PhD at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kirsten Maertens (+32496717845, kirsten.maertens@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy. (time frame: Before Tdap vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.