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临床试验/NCT03519373
NCT03519373已完成不适用

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

Centre Hospitalier Universitaire Saint Pierre2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2017年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
135
试验地点
2
主要终点
Pertussis-specific antibodies GMC after immunization

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

PER001

HIV 1-infected pregnant women

干预措施: TDaP (Biological)

PER002

HIV 1-uninfected pregnant women

干预措施: TDaP (Biological)

PER003

HIV 1-uninfected non-pregnant women

干预措施: TDaP (Biological)

结局指标

主要结局

Pertussis-specific antibodies GMC after immunization

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

Anti-Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and pertactin (PRN) specific antibodies levels

Transplacental transfer of pertussis-specific antibodies

时间窗: Birth

Anti-PT, FHA and PRN specific antibodies levels transfer ratio

次要结局

  • Pertussis-specific memory B cells quantification & phenotype(7-10 days, 30 days and at delivery for pregnant women)
  • Pertussis-specific antibodies glycosylation profiles(7-10 days, 30 days and at delivery for pregnant women)

研究者

发起方
Centre Hospitalier Universitaire Saint Pierre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolas Dauby

M.D. Ph.D.

Centre Hospitalier Universitaire Saint Pierre

研究点 (2)

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