CompletedNot Applicable

Pertussis Immunization During Pregnancy & HIV Infection

Belgium135 participantsStarted 2017-03-01

Plain-language summary

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.

Who can participate

Age range18 Years – 60 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pertussis-specific antibodies GMC after immunization

Timeframe: 7-10 days, 30 days and at delivery for pregnant women

Transplacental transfer of pertussis-specific antibodies

Timeframe: Birth

Trial details

NCT IDNCT03519373

SponsorCentre Hospitalier Universitaire Saint Pierre

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-06-01

View on ClinicalTrials.gov More Immunization; Infection trials