Maternal Determinants of Infant Immunity to Pertussis

NCT05856396 | Completed Phase 4

• 1 other identifier: B0762022220909
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of the project is to identify the determinants of antibody-mediated immunity in infants born to mothers immunized during pregnancy. Using maternal pertussis immunization as a model, the project will identify key predictors and potential determinants of vaccine responses in pregnant women, of the transfer of maternal antibodies to the newborn and of vaccine responses in infants. A systems biology approach will be used to delineate pre-vaccination and post-vaccination cellular and molecular correlates of the immune response to pertussis immunization in peripheral blood and in breastmilk.

Conditions

Vaccination; Infection; Maternal-Fetal Relations; Pertussis; Immunoglobulins

Outcome Measures

Primary Outcomes (2)

• IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA)

  IgG titers specific to Bordetella Pertussis Antigens will be assessed by ELISA: * in women (pregnant and non-pregnant) at 28 days post vaccination * in infants (from unvaccinated mothers and mothers vaccinated during pregnancy) at 28 days post third vaccine dose

  Day 28 post-vaccination

• IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA)

  IgG titers specific to Bordetella Pertussis Antigens will be assessed by ELISA: * in women vaccinated during pregnancy, at delivery * in umbilical cord blood of infants born to mothers vaccinated during pregnancy

  At delivery

Secondary Outcomes (2)

• IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA)

  up to 9 month after vaccination

• CD4+ T cell frequencies specific to Bordetella Pertussis Antigens by flow cytometry

  up to 9 month after vaccination

Study Arms (4)

Pregnant women

ACTIVE COMPARATOR

Pregnant women will receive one dose of Pertussis-containing vaccine during pregnancy.

Biological: Triaxis® (Pertussis-containing vaccine)

Non pregnant women

ACTIVE COMPARATOR

Non-Pregnant women will receive one dose of Pertussis-containing vaccine.

Biological: Triaxis® (Pertussis-containing vaccine)

Infants born to Tdap-vaccinated mothers

ACTIVE COMPARATOR

Infants whose mothers have been immunized during pregnancy with Tdap vaccine. Infants will receive three doses of Pertussis-containing vaccine (with 28 days interval starting at two months of age).

Biological: Vaxelis® (Pertussis-containing vaccine)

Infants born to non Tdap-vaccinated mothers

ACTIVE COMPARATOR

Infants whose mothers have not been immunized during pregnancy with Tdap vaccine. Infants will receive three doses of Pertussis-containing vaccine (with 28 days interval starting at two months of age).

Biological: Vaxelis® (Pertussis-containing vaccine)

Interventions

Triaxis® (Pertussis-containing vaccine) BIOLOGICAL

Triaxis® (Pertussis-containing vaccine) will be administered: * in non-pregnant women presenting to the Travel and Vaccine clinic for pertussis immunization only or hospital member staff requiring Tetanus Toxoid (TT)-booster immunisation * in Pregnant women between 16 and 29 weeks of gestation.

Non pregnant women; Pregnant women

Vaxelis® (Pertussis-containing vaccine) BIOLOGICAL

Vaxelis® (Hexavalent vaccine) will be proposed in infants at 8, 12 and 16 weeks of life.

Infants born to Tdap-vaccinated mothers; Infants born to non Tdap-vaccinated mothers

Eligibility Criteria

• Age: 2 Months - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• For non-pregnant \& pregnant women Age between 18 and 45 years Eligible for Tdap vaccination
• For infants Born to mothers vaccinated or not with Tdap Vaccinated with hexavalent vaccine Age between 2 and 3 months

You may not qualify if:

• For pregnant and non-pregnant women
• Inability to understand the nature and extent of the study and the procedures required
• Grade III/IV anemia,
• Acute infection at the time of immunization
• Chronic infections such as Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection, acute toxoplasmosis
• Current or recent use of immunosuppressive drugs
• Active neoplasia
• Other vaccine(s) administered at the same time as Tdap vaccination (wash out of 4 weeks after others vaccinations and 28 days after Tdap vaccination )
• For pregnant women
• Risk of premature delivery or intrauterine growth retardation
• Twin or triplet pregnancies
• For non-pregnant women Last Tdap vaccination \< 12 months before
• For infants:
• Infants born before 35 weeks of gestation
• Birthweight below 2.5 kg,

Sponsors & Collaborators

• Université Libre de Bruxelles: collaborator
• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU Saint-Pierre

Brussels, 1000, Belgium

Location

Related Publications (7)

• Marchant A, Sadarangani M, Garand M, Dauby N, Verhasselt V, Pereira L, Bjornson G, Jones CE, Halperin SA, Edwards KM, Heath P, Openshaw PJ, Scheifele DW, Kollmann TR. Maternal immunisation: collaborating with mother nature. Lancet Infect Dis. 2017 Jul;17(7):e197-e208. doi: 10.1016/S1473-3099(17)30229-3. Epub 2017 Apr 19.

  PMID: 28433705 BACKGROUND

• Gunn BM, Alter G. Modulating Antibody Functionality in Infectious Disease and Vaccination. Trends Mol Med. 2016 Nov;22(11):969-982. doi: 10.1016/j.molmed.2016.09.002. Epub 2016 Oct 15.

  PMID: 27756530 BACKGROUND

• Jennewein MF, Alter G. The Immunoregulatory Roles of Antibody Glycosylation. Trends Immunol. 2017 May;38(5):358-372. doi: 10.1016/j.it.2017.02.004. Epub 2017 Apr 3.

  PMID: 28385520 BACKGROUND

• Jennewein MF, Abu-Raya B, Jiang Y, Alter G, Marchant A. Transfer of maternal immunity and programming of the newborn immune system. Semin Immunopathol. 2017 Nov;39(6):605-613. doi: 10.1007/s00281-017-0653-x. Epub 2017 Oct 2.

  PMID: 28971246 BACKGROUND

• Jennewein MF, Goldfarb I, Dolatshahi S, Cosgrove C, Noelette FJ, Krykbaeva M, Das J, Sarkar A, Gorman MJ, Fischinger S, Boudreau CM, Brown J, Cooperrider JH, Aneja J, Suscovich TJ, Graham BS, Lauer GM, Goetghebuer T, Marchant A, Lauffenburger D, Kim AY, Riley LE, Alter G. Fc Glycan-Mediated Regulation of Placental Antibody Transfer. Cell. 2019 Jun 27;178(1):202-215.e14. doi: 10.1016/j.cell.2019.05.044. Epub 2019 Jun 13.

  PMID: 31204102 BACKGROUND

• Jennewein MF, Kosikova M, Noelette FJ, Radvak P, Boudreau CM, Campbell JD, Chen WH, Xie H, Alter G, Pasetti MF. Functional and structural modifications of influenza antibodies during pregnancy. iScience. 2022 Mar 16;25(4):104088. doi: 10.1016/j.isci.2022.104088. eCollection 2022 Apr 15.

  PMID: 35402869 BACKGROUND

• Tsang JS. Utilizing population variation, vaccination, and systems biology to study human immunology. Trends Immunol. 2015 Aug;36(8):479-93. doi: 10.1016/j.it.2015.06.005. Epub 2015 Jul 14.

  PMID: 26187853 BACKGROUND

MeSH Terms

Conditions

Infections; Whooping Cough

Interventions

adacel; Vaxelis

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Respiratory Tract Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers analyzing the immunological outcomes will be blinded to the groups of the subjects (pregnant vs non pregnant ; infants)
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinic

Model Details: * Non pregnant and pregnant women will be recruited in parallel * Infants born to Tdap vaccinated-mothers (enrolled or not in the study) or not vaccinated mothers will be recruited

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: May 12, 2023
• Study Start: September 12, 2023
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

BE (1)