Pertussis Immunization During Pregnancy & HIV Infection

Brief Title

Pertussis Immunization During Pregnancy & HIV Infection

Official Title

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

Brief 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.
    

Detailed 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.
    

Study Type

Observational

Primary Outcome

Pertussis-specific antibodies GMC after immunization

Secondary Outcome

 Pertussis-specific memory B cells quantification & phenotype

Condition

Immunization; Infection

Intervention

TDaP

Study Arms / Comparison Groups

 PER001

Description:  HIV 1-infected pregnant women

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

120

Start Date

March 1, 2017

Completion Date

September 1, 2019

Primary Completion Date

June 1, 2019

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Nicolas Dauby, M.D. Ph.D., 3225354130, [email protected]

Location Countries

Belgium

Location Countries

Belgium

NCT ID

NCT03519373

Organization ID

Pertussis

Responsible Party

Principal Investigator

Study Sponsor

Centre Hospitalier Universitaire Saint Pierre

Study Sponsor

Nicolas Dauby, M.D. Ph.D., Principal Investigator, Centre Hospitalier Universitaire Saint Pierre

Verification Date

May 2018