Pregnancy Clinical Trial
Official title:
Impact of HIV Infection and Pregnancy on Humoral Responses to Pertussis Immunization
NCT number | NCT03519373 |
Other study ID # | Pertussis |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2017 |
Est. completion date | June 1, 2019 |
Verified date | September 2022 |
Source | Centre Hospitalier Universitaire Saint Pierre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The impact of chronic HIV infection and pregnancy on different aspects of the humoral response to pertussis immunization with the TDaP vaccine will be studied. The parameters will be measured in 3 groups (HIV-infected pregnant, HIV-uninfected pregnant and HIV-uninfected non pregnant) at different time points before and after immunization (7-10 days, 30 days and at delivery). The transfer ratio and the quality of maternal antibodies will be studied in cord blood.
Status | Completed |
Enrollment | 135 |
Est. completion date | June 1, 2019 |
Est. primary completion date | June 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Age over 18 - HIV-infected or uninfected pregnant women in their second/third trimester with an indication of TDaP vaccination - Non pregnant HIV negative women (having a negative HIV test in the last 6 months or at screening) with an indication of TDaP vaccination Exclusion Criteria: - Grade III/IV anemia - Active bacterial infection - Opportunistic infection (Tuberculosis, CMV, toxoplasmosis, etc) - Inability to understand the nature and extent of the study and the procedures required - Current or recent use of immunosuppressive drugs (corticosteroids, anti-TNF, methotrexate, etc) - Active neoplasia |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU Saint-Pierre | Brussels | |
Belgium | HIS Etterbeek Ixelles | Ixelles |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Saint Pierre |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pertussis-specific antibodies GMC after immunization | Anti-Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and pertactin (PRN) specific antibodies levels | 7-10 days, 30 days and at delivery for pregnant women | |
Primary | Transplacental transfer of pertussis-specific antibodies | Anti-PT, FHA and PRN specific antibodies levels transfer ratio | Birth | |
Secondary | Pertussis-specific memory B cells quantification & phenotype | PT, FHA and PRN-specific memory B cells numbers assessed by ELISPOT assay & Flow Cytometry | 7-10 days, 30 days and at delivery for pregnant women | |
Secondary | Pertussis-specific antibodies glycosylation profiles | Anti-PT, FHA and PRN specific antibodies profiles | 7-10 days, 30 days and at delivery for pregnant women |
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