The Optimal Timing of Vaccination in Pregnancy

Launched by ELKE LEURIDAN, MD, PHD · Jun 13, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "The Optimal Timing of Vaccination in Pregnancy," is studying the best time for pregnant women to receive the pertussis (whooping cough) vaccine. Researchers want to understand how the timing of the vaccination affects the mother's immune response, the transfer of antibodies to the baby through the placenta, and the composition of antibodies in breast milk. By doing this, they hope to find out how the vaccine can best protect both mothers and their babies from whooping cough.

To participate in this study, women must be pregnant and willing to receive the Tdap vaccine during their pregnancy. They should be able to provide consent and plan to attend follow-up visits for up to six months after giving birth. Women who have had certain vaccinations in the past five years, have serious health issues, or have had severe reactions to vaccines may not be eligible. Participants can expect to provide blood and breast milk samples at various points during the study, and their involvement will help researchers gain valuable insights into vaccination during pregnancy.

Gender

FEMALE

Eligibility criteria

• 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.