Diphtheria-Tetanus-acellular Pertussis VaccinesNCT04082299
Immune Response followingTdap Vaccine in Pregnancy
An observational study of Diphtheria-Tetanus-acellular Pertussis Vaccines, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diphtheria-Tetanus-acellular Pertussis Vaccines
- Type of treatment
- Vaccines
- How many people
- 21 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Sep 2019to 19 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant and non pregnant women
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Immune response following Tdap vaccine
Characterization of immune response following Tdap vaccine.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start12 Sep 2019
- Primary completion19 Oct 2023
- Study completion19 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diphtheria-Tetanus-acellular Pertussis VaccinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rinat Gabbay-Benziv, Dr, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082299
- Sponsor's protocol ID
- 0079-19-HYMC
- Status last verified
- May 2025
- First submitted
- 5 Sep 2019
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response Following Tdap Vaccination in Pregnant vs. Non Pregnant Women
- ClinicalTrials.gov ID
- NCT04082299
- Acronym / sponsor ID
- 0079-19-HYMC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant and non pregnant women
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immune response following Tdap vaccine
Time frame: 4 months
Characterization of immune response following Tdap vaccine.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rinat Gabbay-Benziv, Dr principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diphtheria-Tetanus-acellular Pertussis Vaccines, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune response following Tdap vaccine (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.