Clinical trial NCT04082299: Immune Response followingTdap Vaccine in Pregnancy
Official title: Immune Response Following Tdap Vaccination in Pregnant vs. Non Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diphtheria-Tetanus-acellular Pertussis Vaccines
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-09-09
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant and non pregnant women

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.

Eligibility 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.

Primary outcomes:
measure: Immune response following Tdap vaccine
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe medical center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Rinat Gabbay-Benziv, Dr
role: PRINCIPAL_INVESTIGATOR
References: