Viral infections
Conditions
Interventions
None listed
Sponsors
RIVM
Eligibility
Age
No minimum to 64 Years
Inclusion criteria
Inclusion criteria: Pregnant women over 18 years of age. Women with no findings related to the health of the foetus at the 20-week ultrasound.
Exclusion criteria
Exclusion criteria: For the mother:Repeated usage of certain immunosuppressive or immune modulating medication during pregnancy, such as biologicals (for example anti-TNF-a) or corticosteroid treatment. Examples of steroid treatments are: receipt of any high-dose (= 20 mg of prednisone daily or equivalent) steroid treatment. The use of hydrocortisone as a substitution therapy in case a participant does not produce sufficient amounts is allowed. Daily corticosteroids (for example locally, incl. inhaled steroids), is also acceptable. Known or suspected immunological disorder or immune deficiency including but not limited to HIV. Known or suspected bleeding disorder. For the infant:Premature infants born before 37 weeks gestational age. Known or suspected serious underlying condition that can interfere with the results or outcome of the study. Such as, but not limited to, certain chromosomal abnormalities or craniofacial abnormalities (such as Trisomy 21 or schisis), known or suspected immunodeficiency disease, seizure disorder or cancer. Repeated usage of certain immunosuppressive or immune modulating medication, such as biologicals (for example anti-TNF-a) or corticosteroid treatment. Examples of steroid treatments are: receipt of any high-dose (= 20 mg of prednisone daily or equivalent) steroid treatment. The use of hydrocortisone as a substitution therapy in case a participant does not produce sufficient amounts is allowed. Daily corticosteroids (for example locally, incl. inhaled steroids), is also acceptable.If the infant is diagnosed with an immunological disorder. If the infant is diagnosed with a bleeding disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterize the developmental trajectory of the immune system during the first 15 months of life in generally healthy infants and identify key factors involved, with the goal of informing strategies to optimize protection against infectious diseases in infancy and later in life.Identify factors, such as presence of (maternal) antibodies, infant exposome (questionnaire data), gut-and respiratory microbiome and other external factors that are associated with the development of the infants’ immune system in the form of differences in blood cell composition. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Cellular immune profiles, including all major innate and adaptive immune cell populations, at 2, 6, 12, and 15 months of age. • Antibodies specific for least one of the components in the DTaP-IPV-Hib-HBV and/or the MMR-vaccine in cord blood. • Vaccine-specific antibody levels (against at least one of the components of the DTaP-IPV-Hib-HBV-vaccine) at 6 and 15 months of age. • Cellular responses specific for at least one of the components of the DTaP-IPV-Hib-HBV-vaccine at 15 months of age. • Vaccine-specific antibody levels (against at least one of the components of the MMR-vaccine) in plasma at 15 months of age. • Cellular responses specific for at least one of the components of the MMR-vaccine at 15 months of age. • Vaccine-specific antibody levels (against at least one of the components of the DTaP-IPV-Hib-HBV-vaccine) in the upper respiratory tract (MLF samples) at 4, 6, 14 and 15 months of age. • Microbiome profile in the upper respiratory tract (MLF samples) at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14 and 15 months of age. • Microbiome profile in the upper respiratory tract (MLF samples) at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14 and 15 months of age. • Immune markers in the upper respiratory tract (MLF samples) at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14 and 15 months of age. • Data from respiratory symptom diary. • Gut microbiome profile at day 0 (meconium), day 1, day 2, day 7 and day 14 of age, months 1, 6 and 12 • Vaccine-specific antibody levels (against at least one of the components of the DTaP-IPV-Hib-HBV-vaccine) at 6 and 15 months of life. | — |
Countries
Netherlands
Contacts
Public ContactI.M. Slits
RIVM
Outcome results
None listed