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

2024-518692-56-00 Therapeutic use (Phase IV) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruitment pending
Participants planned 96
Countries 1
Sites 1

Pregnant

To assess the impact of timing of pertussis vaccination in pregnancy on humoral and cellular immune responses in pregnant women, at delivery and postpartum.

Key facts

Sponsor
University Of Antwerp
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Female
Therapeutic area
Phenomena and Processes [G] - Immune system processes [G12], Diseases [C] - Respiratory Tract Diseases [C08]
Decision date (initial)
2024-10-24
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2024-518692-56-00
EudraCT number
2021-005194-77
ClinicalTrials.gov
NCT06466629

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

To assess the impact of timing of pertussis vaccination in pregnancy on humoral and cellular immune responses in pregnant women, at delivery and postpartum.

Conditions and MedDRA coding

Pregnant

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Ability to provide informed consent.
  2. Willing to be vaccinated with a Tdap vaccine during pregnancy.
  3. Intend to be available for follow-up visits and phone call access until 6 months postpartum.
  4. Influenza and COVID-19 vaccination during pregnancy (as per Belgian recommendations) is allowed.

Exclusion criteria 7

  1. Vaccinated with an aP containing vaccine during the last 5 years.
  2. Significant mental illness (e.g. schizophrenia, psychosis, major depression).
  3. Serious underlying immunological condition (e.g. immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection…).
  4. Systemic treatment with immune suppressive medication, including chronic steroid use of > 10 mg prednisone or equivalent.
  5. Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
  6. Previous severe reaction to any vaccine
  7. High risk for serious obstetrical complications.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Measurement of antibody levels and functional antibody characteristics in maternal blood with Tdap vaccination at different timings in pregnancy (measurement at baseline, after Tdap vaccination, at delivery and 6 months postpartum).

Secondary endpoints 3

  1. Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy (measurement at baseline, after Tdap vaccination, at delivery and 6 months postpartum).
  2. 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.
  3. Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in breastmilk 6 months postpartum after Tdap vaccination at different timings in pregnancy.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Triaxis, suspensie voor injectie in een voorgevulde spuit. Difterie, tetanus, kinkhoest (acellulaire component) vaccin (geadsorbeerd, gereduceerde antigen(en)inhoud)

PRD10244951 · Product

Active substance
Diphtheria Toxoid
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INJECTION
Max daily dose
1 ml millilitre(s)
Max total dose
1 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AJ52 — PERTUSSIS, PURIFIED ANTIGEN, COMBINATIONS WITH TOXOIDS
Marketing authorisation
RVG130536
MA holder
SANOFI PASTEUR EUROPE
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Of Antwerp

7 Total trials 4 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
University Of Antwerp
Address
Drie Eikenstraat 663
City
Edegem
Postcode
2650
Country
Belgium

Scientific contact point

Organisation
University Of Antwerp
Contact name
Kirsten Maertens

Public contact point

Organisation
University Of Antwerp
Contact name
Kirsten Maertens

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Authorised, recruitment pending 96 1
Rest of world — 0 —

Investigational sites

Belgium

1 site · Authorised, recruitment pending
University Of Antwerp
VAXINFECTIO, Drie Eikenstraat 663, 2650, Edegem

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Protocol versie110321 1
Recruitment arrangements (for publication) patientrecruitmentprocedure_final 1
Subject information and informed consent form (for publication) NL IC information MATIMMUNE version 5 1
Summary of Product Characteristics (SmPC) (for publication) Triaxis_SuPC 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-11 Belgium Acceptable
2024-10-23
 2024-10-24