Vaccine immunity, allergic sensitisation, eczema, asthma Not Applicable Immunisation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Neonate born within the previous 14 days 2. Gestational age of at least 34 weeks 3. At least one stool sample collected during third trimester of pregnancy 4. The mother lives within the geographic limits of the District of Quininde, Esmeraldas Province 5. The mother plans to live within the District of Quininde, Esmeraldas Province for at least 3 years 6. The mother's household is accessible
Exclusion criteria
Exclusion criteria: 1. Neonate of greater than 14 days age 2. Gestational age less than 34 weeks 3. No stool sample collected during third trimester of pregnancy 4. The mother does not live within the geographic limits of the District of Quininde, Esmeraldas Province 5. The mother does not plan to live within the District of Quininde, Esmeraldas Province for at least 3 years 6. The mother's household is not easily accessible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Vaccine immunity: protective levels of antibodies to rotavirus, Hemophilus influenzae type B, hepatitis B virus, OPV serotype 3, and tetanus toxoid 2. Allergic sensitization: allergen skin test reactivity to at least one aeroallergen tested 3. Eczema: at least one presentation with eczema by 3 years of age 4. Asthma: Asthma diagnosed at 5 years of age | — |
Secondary
| Measure | Time frame |
|---|---|
| Studies of intermediate immunological mechanisms that mediate exposure-outcome effects including: 1. Immune homeostasis: measured by spontaneous IL-10 in whole blood 2. Immune regulation/suppression - IL-10 to tetanus toxoid (TT), tuberculin (PPD), Ascaris lumbricoides or Dermatophagoides pteronyssinus 3. Th2 polarization - ratio of IL-5 to IFN-g TT, PPD or Staphylococcus enterotoxin B 4. Pro-inflammatory responses - IL-8 to endotoxin These responses will be measured at 2, 3, or 5 years depending on the relevant exposure-outcome association. | — |
Countries
Ecuador