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OpenTrials
Completed

NCT Number: NCT04082299

Immune Response followingTdap Vaccine in Pregnancy

Pregnancy involves changes in immune response. The investigators aim to evaluate the immune response to Tdap in pregnancy in comparison to non pregnant women usig proteomics and gene sequencing.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Hillel Yaffe medical center

Hadera, 3810101, Israel

About this study

Many vaccine-preventable diseases, like influenza, pertussis, and tetanus cause substantial morbidity and mortality in pregnant women, newborns and infants. Immunization during pregnancy has the potential to provide protection to the newborn and infant by the transplacental transfer of vaccine-specific maternal antibodies. However, the immunobiology underlying immunization during pregnancy, that leads to the protection of the newborn are not understood. Current vaccine formulations were designed for and tested in non-pregnant populations; yet substantial immune modulations take place during different stages of pregnancy and potentially can impact the humoral response following maternal immunization. The investigators thus have insufficient data on quantity and quality of the immune response during pregnancy and how this relates to immunity provided from the mother to the newborn. First, The investigators hypothesize that the nature and breadth of the humoral immune response following vaccination differs in pregnant and non-pregnant vaccinees. Next, The investigators hypothesize that the vaccine-specific antibodies that cross the placenta, comprise distinct repertoire features thus, the placenta functions as a differential barrier for antibody transfer. To test these hypotheses, The investigators will use proteomic and genomic/transcriptomic measurements of antibody repertoires in the maternal and cord blood compartments. The measurements will be based on antibody clonal diversity/frequency, V(D)J germline usage and SHM, where we expect to find changes in i) vaccine-specific B cell frequency, antibody clonal diversity, germline usage and SHM in pregnant women and ii) distinct repertoire features in the transplacental vaccine-specific antibody compartment compared the maternal compartment. The investigators will utilize deep sequencing and proteomic technologies to provide, for the first time, insight into the immunobiology of a promising intervention aimed to prevent early life infectious morbidity and mortality and establish new research avenues for vaccine research in vulnerable populations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for pregnant women (cohort 1):

  • age between 18-45 years
  • pregnant women who expected to have Tdap vaccine
  • Informed Consent Form signature

Inclusion criteria

for non pregnant women (cohort 2):

  • age between 18-45 years
  • non pregnant women who expected to have Tdap vaccine
  • Informed Consent Form signature

Exclusion criteria

(cohort 1 and 2):

  • any background immune diseases- autoimmune conditions or cancer.
  • women who take immunosuppressive/ immunomodulatory medications
  • a patient has received Tdap vaccine in 6 months prior to study entry.
  • no will to signed the Informed Consent Form.

Treatment and study plan

Primary outcomes

  1. Immune response following Tdap vaccine

    Time frame: 4 months

    Characterization of immune response following Tdap vaccine.

Sponsors and collaborators

Lead sponsor

Hillel Yaffe Medical Center

Other Gov

Registry information

Official study title

Immune Response Following Tdap Vaccination in Pregnant vs. Non Pregnant Women

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 9, 2019
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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