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Immune Response followingTdap Vaccine in Pregnancy

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ClinicalTrials.gov Identifier: NCT04082299
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

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.

Condition or disease
Diphtheria-Tetanus-acellular Pertussis Vaccines

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 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: Immune Response Following Tdap Vaccination in Pregnant vs. Non Pregnant Women
Actual Study Start Date : September 12, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Pregnant women
pregnant women expected to be vaccinate with Tdap vaccine during their 3th trimester
Non pregnant women
Non pregnant women expected to be vaccinate with Tdap vaccine



Primary Outcome Measures :
  1. Immune response following Tdap vaccine [ Time Frame: 4 months ]
    Characterization of immune response following Tdap vaccine.


Biospecimen Retention:   Samples Without DNA
Peripheral blood for Immunoglobulin G analysis, umbilical blood and mother milk.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
pregnant and non pregnant women
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082299


Contacts
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Contact: Rinat Gabbay-Benziv, Dr +972-4-7744602 rinatg@hymc.gov.il
Contact: Yariv Wine, PhD +972-3-6408723 yariv.wine@gmail.com

Locations
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Israel
Hillel Yaffe medical center Recruiting
Hadera, Israel, 3810101
Contact: Osnat Palgi, Bsc    +972-4-7744602    osnatp@hymc.gov.il   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Rinat Gabbay-Benziv, Dr Hillel Yaffe Medical Center
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT04082299    
Other Study ID Numbers: 0079-19-HYMC
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diphtheria
Bacterial Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections