Status:

COMPLETED

Immune Response followingTdap Vaccine in Pregnancy

Lead Sponsor:

Hillel Yaffe Medical Center

Conditions:

Diphtheria-Tetanus-acellular Pertussis Vaccines

Eligibility:

FEMALE

18-45 years

Brief Summary

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.

Detailed Description

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 poten...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    September 12 2019

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    October 19 2023

    Estimated Enrollment :

    21 Patients enrolled

    Trial Details

    Trial ID

    NCT04082299

    Start Date

    September 12 2019

    End Date

    October 19 2023

    Last Update

    May 9 2025

    Active Locations (1)

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    Hillel Yaffe medical center

    Hadera, Israel, 3810101