The effect of pertussis vaccination during pregnancy on the immune response after infant and childhood vaccinations in term and preterm infants.
Conditions
Interventions
Trade Name: Tetravac
Product Name: Tetravac
Pharmaceutical Form: Suspension for injection
Trade Name: Hexyon
Product Name: Hexyon
Pharmaceutical Form: Suspension for injection
Trade Name: Boostrix
P
Sponsors
University of Antwerp
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The effect of vaccination during pregnancy on the amount of pertussis specific antibodies (Pertussis Toxin (anti-PT), Filamentous Haemagglutinin (anti-FHA) and pertactin (anti-PRN)) in both women and offspring will be measured in 4 different cohorts: vaccinated and non-vaccinated women with either term and preterm born infants. ;Secondary Objective: What is the functionality of the IgG against Pertussis Toxin (anti-PT), Filamentous Haemagglutinin (anti-FHA) and pertactin (anti-PRN), in women at delivery, in children at birth and before and after vaccination. What are the concentrations of SIgA and IgG (both specific against pertussis toxin antigen as well as total IgA and IgG) in breast milk. What type of T cell response, Th1, Th2 and Th17 directed, is present before and after pertussis vaccination. ;Primary end point(s): To assess whether there is a difference in humoral immune response in the presence of vaccine-induced maternal antibodies in term and preterm infants before and after vaccination.;Timepoint(s) of evaluation of this end point: 01/2015: Start practical organization, ethical approval of the study and recruiting willing participants. After informed consent is obtained both the mother and her newborn infant are followed-up. 7/2017: End of recruitment. Conduct of mother and infant follow-up. 01/2019: Finalizing mother-infant follow-up, humoral immunity testing. 09/2020: Statistical analysis of the results. Deliver papers for peer review and formulate possible updated recommendations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess whether there is a difference in the functionality of the humoral and cellular immune response in the presence of vaccine- induced maternal antibodies in term and preterm infants before and after vaccination. Differences in breastmilk composition after term and preterm delivery in the presence of maternal antibodies will be determined.;Timepoint(s) of evaluation of this end point: 01/2015: Start practical organization, ethical approval of the study and recruiting willing participants. After informed consent is obtained both the mother and her newborn infant are followed-up. Cellular immunity testing performed on fresh blood samples. 7/2017: End of recruitment. Conduct of mother and infant follow-up and cellular immunity testing. 01/2019: Finalizing mother-infant follow-up and cellular immunity testing. Start breastmilk antibody testing. 10/2020: Statistical analysis of the results. Deliver papers for peer review and formulate possible updated recommendations. 05/2021 Humoral functionality testing 12/2021: Statistical analysis of the humoral functionality results. Deliver papers for peer review and formulate possible updated recommendations. | — |
Countries
Belgium
Contacts
Public ContactKirsten Maertens
University of Antwerp
Outcome results
None listed