Understanding how maternal vaccination affects infant immunity to pertussis
Maternal Determinants of Infant Immunity to Pertussis
PHASE4 · Centre Hospitalier Universitaire Saint Pierre · NCT05856396
This study is trying to see how getting vaccinated against whooping cough during pregnancy affects the immunity of newborns and how well antibodies are passed from mothers to their babies.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 2 Months to 45 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Saint Pierre (other) |
| Locations | 1 site (Brussels) |
| Trial ID | NCT05856396 on ClinicalTrials.gov |
What this trial studies
This project aims to identify the factors that influence antibody-mediated immunity in infants whose mothers are vaccinated against pertussis during pregnancy. It will assess the quality of antibody responses in both pregnant and non-pregnant women, the transfer of maternal antibodies to newborns, and the immune responses in infants. A systems biology approach will be employed to analyze blood and breastmilk samples at various stages, providing insights into the immune correlates of vaccination. The study will involve 40 non-pregnant and 80 pregnant women, along with infants aged 2-3 months.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 18-45 eligible for Tdap vaccination and their infants aged 2-3 months.
Not a fit: Patients with chronic infections, severe anemia, or those on immunosuppressive drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how maternal vaccination impacts infant immunity, potentially leading to improved vaccination strategies.
How similar studies have performed: Other studies have shown promise in understanding maternal vaccination effects, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brussels
- CHU Saint-Pierre — Brussels, Belgium (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vaccination, Infection, Maternal-Fetal Relations, Pertussis, Immunoglobulins