Maternal Determinants of Infant Immunity to Pertussis

Launched by CENTRE HOSPITALIER UNIVERSITAIRE SAINT PIERRE · May 3, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Maternal Determinants of Infant Immunity to Pertussis," is studying how vaccines given to pregnant women affect the immunity of their infants against whooping cough (pertussis). The goal is to learn more about how well these vaccines work, how antibodies (the body's defense against infections) are passed from mothers to their babies, and how infants respond to vaccines themselves. Researchers will look at blood samples and breastmilk to understand the immune responses before and after the mothers receive the vaccine.

To participate in this trial, women aged 18 to 45 who are either pregnant or not pregnant and eligible for the Tdap vaccine can join. Infants aged 2 to 3 months born to mothers who have or have not received the vaccine may also be included. However, there are some health conditions, like serious infections or certain medical treatments, that may prevent someone from joining. Participants can expect to provide blood samples and possibly breastmilk, which will help researchers gather important information about how maternal vaccination influences infant immunity.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • For non-pregnant \& pregnant women Age between 18 and 45 years Eligible for Tdap vaccination
• • For infants Born to mothers vaccinated or not with Tdap Vaccinated with hexavalent vaccine Age between 2 and 3 months
• Exclusion Criteria:
• • For pregnant and non-pregnant women
• • Inability to understand the nature and extent of the study and the procedures required
• • Grade III/IV anemia,
• • Acute infection at the time of immunization
• • Chronic infections such as Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection, acute toxoplasmosis
• • Current or recent use of immunosuppressive drugs
• • Active neoplasia
• • Other vaccine(s) administered at the same time as Tdap vaccination (wash out of 4 weeks after others vaccinations and 28 days after Tdap vaccination )
• • For pregnant women
• • Risk of premature delivery or intrauterine growth retardation
• • Twin or triplet pregnancies
• • For non-pregnant women Last Tdap vaccination \< 12 months before
• For infants:
• • Infants born before 35 weeks of gestation
• • Birthweight below 2.5 kg,
• • Severe neonatal distress
• • Serious congenital abnormalities or congenital infection.