Immune Response followingTdap Vaccine in Pregnancy

NCT ID: NCT04082299

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-12
• Study Completion Date: 2023-10-19

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 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.

Conditions

Diphtheria-Tetanus-acellular Pertussis Vaccines

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pregnant women

pregnant women expected to be vaccinate with Tdap vaccine during their 3th trimester

No interventions assigned to this group

Non pregnant women

Non pregnant women expected to be vaccinate with Tdap vaccine

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rinat Gabbay-Benziv, Dr

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

Hillel Yaffe medical center

Hadera, , Israel

Countries

Israel

Other Identifiers

0079-19-HYMC

Identifier Type: -

Identifier Source: org_study_id