Pertussis Immunization During Pregnancy & HIV Infection

Pregnancy Clinical Trial

Official title:

Impact of HIV Infection and Pregnancy on Humoral Responses to Pertussis Immunization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03519373
• Other study ID #: Pertussis
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• HIV-1-infection
• Immunization; Infection
• Infections
• Pertussis
• Pregnancy
• Whooping Cough

Intervention

Biological:
• TDaP
Tetanus, Diphteria and Acellular Pertussis vaccine (Boostrix)

Locations

Country	Name	City	State
Belgium	CHU Saint-Pierre	Brussels
Belgium	HIS Etterbeek Ixelles	Ixelles

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

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