Image

The Optimal Timing of Vaccination in Pregnancy

Recruiting
18 years of age
Female
Phase N/A

Powered by AI

Overview

The central aim of this study is to investigate the optimal timing of vaccination in pregnant women. Therefore, pregnant women will be vaccinated against pertussis at different timepoints and blood and breast milk samples will be taken at several timepoints. The main objectives are to assess the impact of timing on humoral and cellular immune responses in pregnant women, on antibody characteristics transferred across the placenta and on transplacental transport efficiency. The impact of maternal pertussis vaccination and timing of maternal pertussis vaccination on breastmilk antibody composition will also be investigated, as well as the impact of vaccination during pregnancy on the mucosal uptake of breastmilk IgA antibodies by the infant respiratory and gastrointestinal tract.

Eligibility

Inclusion Criteria:

  • Ability to provide informed consent.
  • Willing to be vaccinated with a Tdap vaccine during pregnancy.
  • Intend to be available for follow-up visits and phone call access until 6 months postpartum.
  • Influenza and COVID-19 vaccination during pregnancy (as per Belgian recommendations) is allowed.

Exclusion Criteria:

  • Vaccinated with an aP containing vaccine during the last 5 years
  • Significant mental illness (e.g. schizophrenia, psychosis, major depression)
  • Serious underlying immunological condition (e.g. immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection…).
  • Systemic treatment with immune suppressive medication, including chronic steroid use of > 10 mg prednisone or equivalent.
  • Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
  • Previous severe reaction to any vaccine
  • High risk for serious obstetrical complications.

Study details

Pertussis/Whooping Cough

NCT06466629

Elke Leuridan, MD, PhD

24 June 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.