Pertussis Clinical Trial
— MADI-02Official title:
Maternal Determinants of Infant Immunity to Pertussis
Verified date | May 2023 |
Source | Centre Hospitalier Universitaire Saint Pierre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Months to 45 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 3 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, - Severe neonatal distress - Serious congenital abnormalities or congenital infection. |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU Saint-Pierre | Brussels |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Saint Pierre | Université Libre de Bruxelles |
Belgium,
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. — View Citation
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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 pregnant women (PW): at day of vaccination , day 7 post-vaccination, week 6 and 12 post-delivery in non-pregnant women (non PW): at day of vaccination, day 7 and Month 5 post-vaccination in infants (from unvaccinated mothers and mothers vaccinated during pregnancy) at day of first and third vaccine dose |
up to 9 month after vaccination | |
Secondary | CD4+ T cell frequencies specific to Bordetella Pertussis Antigens by flow cytometry | The percentage of CD4+ T cells expressing any of the following biomarkers (CD154, Interferon gamma, IL-2) in response to in vitro stimulation with Bordetella Pertussis Antigens will be measured by flow cytometry:
i. in pregnant and non-pregnant women: at day of vaccination, and day 28 post vaccination ii. in infants (from unvaccinated mothers and mothers vaccinated during pregnancy) at day of first vaccine dose and 28 days after third vaccine dose |
up to 9 month after vaccination |
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