Immune Response followingTdap Vaccine in Pregnancy

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

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.

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Rinat Gabbay-Benziv, Dr; Phone Number: +972-4-7744602; Email: rinatg@hymc.gov.il
• Study Contact Backup: Name: Yariv Wine, PhD; Phone Number: +972-3-6408723; Email: yariv.wine@gmail.com

Study Locations

• Israel
  • Hadera, Israel, 3810101
    • Recruiting
    • Hillel Yaffe Medical Center
    • Contact: Osnat Palgi, Bsc; Phone Number: +972-4-7744602; Email: osnatp@hymc.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

pregnant and non pregnant women

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune response following Tdap vaccine	Characterization of immune response following Tdap vaccine.	4 months

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center
• Investigators: Principal Investigator: Rinat Gabbay-Benziv, Dr, Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2019
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Corynebacterium Infections; Diphtheria
• Other Study ID Numbers: 0079-19-HYMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No