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Pertussis Immunization During Pregnancy & HIV Infection

NCT ID: NCT03519373

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-06-01

Brief Summary

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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.

Detailed Description

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Despite the growing importance of maternal immunization in the control of infectious pathogens in early life, the impact of pregnancy on vaccine immunogenicity remains poorly understood. Evidence suggests that pregnancy may influence the quality of the antibody response to vaccines. Pregnancy is associated with modifications in the glycosylation profile of immunoglobulins G (IgG). Different patterns of glycosylation are associated with differential regulation of the effector functions of IgG such as antibody-dependent cell cytotoxicity, complement activation or antibody dependent phagocytosis. Whether similar modifications affect vaccine-induced IgG in pregnant women is unknown.

HIV infection is associated with important alterations in B cells and antibodies. Although antiretroviral therapy partly corrects the proportions of memory B cells (MBC) subsets, it does not restore B cell responses to vaccines, measured as seroconversion rates and antibody persistence. Reduced IgG responses to vaccines have been observed in HIV-infected pregnant women but the impact of HIV on the quality of vaccine-induced IgG has not been reported. On the other hand, HIV infection in pregnancy has a strong impact on the transfer of maternal IgG to the newborn, possibly as a consequence of hypergammaglobulinemia and immune activation.

The investigators will:

1. Assess the respective impact of pregnancy and HIV infection on the magnitude and quality of B cell and antibody responses to pertussis immunization with the TDaP vaccine.
2. Assess the impact of HIV infection and of the timing of maternal immunization on the transplacental transfer and on the quality of pertussis-specific IgG in the newborn.

Conditions

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Immunization; Infection Pertussis HIV-1-infection Pregnancy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PER001

HIV 1-infected pregnant women

TDaP

Intervention Type BIOLOGICAL

Tetanus, Diphteria and Acellular Pertussis vaccine (Boostrix)

PER002

HIV 1-uninfected pregnant women

TDaP

Intervention Type BIOLOGICAL

Tetanus, Diphteria and Acellular Pertussis vaccine (Boostrix)

PER003

HIV 1-uninfected non-pregnant women

TDaP

Intervention Type BIOLOGICAL

Tetanus, Diphteria and Acellular Pertussis vaccine (Boostrix)

Interventions

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TDaP

Tetanus, Diphteria and Acellular Pertussis vaccine (Boostrix)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role lead

Responsible Party

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Nicolas Dauby

M.D. Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolas Dauby, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Saint Pierre

Locations

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CHU Saint-Pierre

Brussels, , Belgium

Site Status

HIS Etterbeek Ixelles

Ixelles-Elsene, , Belgium

Site Status

Countries

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Belgium

References

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Taton M, Willems F, Widomski C, Martin C, Jiang Y, Renard K, Cogan A, Necsoi C, Ackerman ME, Marchant A, Dauby N. Impact of pregnancy on polyfunctional IgG and memory B cell responses to Tdap immunization. Vaccine. 2023 Jun 19;41(27):4009-4018. doi: 10.1016/j.vaccine.2023.05.035. Epub 2023 May 25.

Reference Type DERIVED
PMID: 37244810 (View on PubMed)

Other Identifiers

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Pertussis

Identifier Type: -

Identifier Source: org_study_id