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	https://doi.org/10.1186/ISRCTN41239086
Secondary identifying numbers	074679

Submission date: 30/04/2010
Registration date: 04/05/2010
Last edited: 27/10/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Philip Cooper
Scientific

Instituto de Microbiologia
Universidad san Francisco de Quito
Via interoceaniaca S/N
Cumbaya
Quito
N/A
Ecuador

Study information

Study design	Observational; prospective birth cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	ECUAVIDA
Study objectives	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(s)	Ethics Committee of Hospital Pedro Vicente Maldonado, Pichincha Province, Ecuador, 13/06/2005
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 study start date	01/12/2005
Completion date	01/12/2015

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	2,500
Key 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
Key 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
Date of first enrolment	01/12/2005
Date of final enrolment	01/12/2015

Locations

Countries of recruitment

Ecuador

Study participating centre

Universidad san Francisco de Quito

Quito
N/A
Ecuador

Sponsor information

Ecuadorian Foundation for Health Research (Fundacion Ecuatoriana Para Investigacion en Salud) (Ecuador)
Research organisation

Gaspar de Villaroel y Shyris
Quito
NA
Ecuador

Funders

Funder type

Charity

Wellcome Trust (grant ref: 074679)
Private sector organisation / International organizations

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	29/06/2011		Yes	No
Results article	results	15/06/2016		Yes	No
Results article		01/03/2021	22/03/2021	Yes	No
Results article	childhood wheeze cross-sectional analysis	30/11/2020	27/10/2021	Yes	No

Editorial Notes

27/10/2021: Publication reference added.
22/03/2021: Publication reference added.
23/03/2016: Publication reference added.