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Impact of maternal and infant geohelminth infections on atopy and vaccine immunity in infants living in rural tropical region of Ecuador [Impacto de las infecciones con geohelmintos en madres embarazadas e infantes sobre atopia e inmunidad a vacunas en infantes que viven en zonas rurales tropicales del Ecuador]
ISRCTN ISRCTN41239086
DOI 10.1186/ISRCTN41239086
ClinicalTrials.gov identifier
EudraCT number
Public title Impact of maternal and infant geohelminth infections on atopy and vaccine immunity in infants living in rural tropical region of Ecuador [Impacto de las infecciones con geohelmintos en madres embarazadas e infantes sobre atopia e inmunidad a vacunas en infantes que viven en zonas rurales tropicales del Ecuador]
Scientific title Impact of maternal and infant geohelminth infections on atopy and vaccine immunity in infants living in rural tropical region of Ecuador: a prospective birth cohort following up newborns to 5 years of age
Acronym ECUAVIDA
Serial number at source 074679
Study hypothesis Exposure to maternal geohelminth infections and infant geohelminth infections within the first 2 years of life:
1. Suppresses immune responses to childhood vaccines
2. Suppresses aeroallergen skin test reactivity
3. Protects against the development of eczema and asthma
Lay summary Not provided at time of registration
Ethics approval Ethics Committee of Hospital Pedro Vicente Maldonado, Pichincha Province, Ecuador, approved on the 13th June 2005
Study design Observational; prospective birth cohort study
Countries of recruitment Ecuador
Disease/condition/study domain Vaccine immunity, allergic sensitisation, eczema, asthma
Participants - 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
Participants - 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
Anticipated start date 01/12/2005
Anticipated end date 01/12/2015
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 2,500
Interventions The primary exposures are maternal geohelminth infections and infant infections during the first 2 years of life. Stool samples are collected during pregnancy or at the time of birth to determine maternal infection status and at 3, 7, 13, 18, and 24 months to determine infant infection status. Stool samples are examined using a combination of methods including modified Kato-Katz method, formol-ether concentration, and carbon-coproculture. Observations for measurement of differences are made at 7, 13, 24, 36, and 60 months of age. Follow-up of all participants will be to 5 years of age.
Primary outcome measure(s) 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 outcome measure(s) 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.
Sources of funding The Wellcome Trust (UK) (grant ref: 074679)
Trial website
Publications 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21714922
Contact name Dr  Philip  Cooper
  Address Instituto de Microbiologia
Universidad san Francisco de Quito
Via interoceaniaca S/N
Cumbaya
  City/town Quito
  Zip/Postcode N/A
  Country Ecuador
Sponsor Ecuadorian Foundation for Health Research (Fundacion Ecuatoriana Para Investigacion en Salud) (Ecuador)
  Address Gaspar de Villaroel y Shyris
  City/town Quito
  Zip/Postcode NA
  Country Ecuador
Date applied 30/04/2010
Last edited 26/02/2013
Date ISRCTN assigned 04/05/2010
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