Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
074679
Study information
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
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
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
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Vaccine immunity, allergic sensitisation, eczema, asthma
Intervention
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.
Intervention type
Biological/Vaccine
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
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.
Overall trial start date
01/12/2005
Overall trial end date
01/12/2015
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
2,500
Participant 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
Recruitment start date
01/12/2005
Recruitment end date
01/12/2015
Locations
Countries of recruitment
Ecuador
Trial participating centre
Instituto de Microbiologia
Quito
N/A
Ecuador
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 074679)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21714922
Publication citations
-
Protocol
Cooper PJ, Chico ME, Guadalupe I, Sandoval CA, Mitre E, Platts-Mills TA, Barreto ML, Rodrigues LC, Strachan DP, Griffin GE, Impact of early life exposures to geohelminth infections on the development of vaccine immunity, allergic sensitization, and allergic inflammatory diseases in children living in tropical Ecuador: the ECUAVIDA birth cohort study., BMC Infect. Dis., 2011, 11, 184, doi: 10.1186/1471-2334-11-184.