TDaP (Tetanus, Diphtheria, acellular Pertussis) immunization during pregnancy results in an augmentation of maternal antibodies, which are in turn transferred from the mother to fetus and offer additional protection to the newborn infant during the first months of life. The role of these high maternal antibodies levels on the infant’s immune responses after vaccination will be assessed in term and preterm infants (the MAMA study).

Phase 1

• Conditions: The effect of pertussis vaccination during pregnancy on the immune response after infant and childhood vaccinations in term and preterm infants.; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2020-003466-39-BE
• Lead Sponsor: niversity of Antwerp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-29
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

I.Female population older than 18 Years
II.Women in the vaccinated cohort: received a pertussis containing vaccine (paper-proven) during pregnancy within the present Belgian recommendation. They will not receive the vaccine within the study.
III.Women in the unvaccinated cohorts: received no pertussis containing vaccine at least 5 year before study entrance, but can receive a vaccine in postpartal period. The cocoon strategy has to be taken into account in the analysis of breast milk samples.
IV.Intend to be available for follow-up visits and phone call access through 16 months following delivery.
V.Willing to have infant immunized with hexavalent vaccine according to the general Belgian schedule.
VI.Influenza vaccination during pregnancy is allowed.
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria for women (limited since premature delivery is usually the result of serious events):
Pregnant women who meet any exclusion criteria at baseline will be excluded from the study.
I. Significant mental illness (e.g. schizophrenia, psychosis, major depression)
II. Serious underlying immunological condition (e.g. immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection)
III. Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
IV. Receipt of a blood product or experimental medicine within 4 weeks prior to delivery or prior to blood sampling. Exclusion for 1 time point is possible after blood transfusion, with reboot of the study 1 month after transfusion.
Exclusion criteria for children:
I. No signed informed consent from both parents.
II. Severe reactions to any vaccine.
III. Serious underlying medical condition (e.g., genetic disorder (eg Down syndrome), immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection, lung/heart disease, liver/kidney disease, chronic or recurrent infections).
IV. Children suffering from primary humoral immune disorders (B cell related): severe X linked agammaglobulinaemia, CVID (Common variable immunodeficiency, late onset agammaglobulnaemia) and SAD (specific antibody deficiency); suffering from primary cellular immune deficiencies (T cell related): SCID (Severe combined immune deficiency syndrome), CID, hyper IGM syndrome, di George's syndrome and others;
suffering from disorders in phagocytosis and chemotaxis (CGD, Schwach Diamond syndrome) and disorders from the complement cascade.
V. In addition, children on immunodepressive medication and with hemato-oncologic disorders will be excluded. All these children can receive the inactivated pertussis vaccines, but will respond different from the normal population to vaccination.
VI. Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
VII. Receipt of a blood product 1 month prior to blood sampling. Exclusion for 1 time point is possible after blood transfusion, with reboot of the study 1 month after transfusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified