Condition category
Not Applicable
Date applied
30/04/2010
Date assigned
04/05/2010
Last edited
26/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Philip Cooper

ORCID ID

Contact details

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

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

Sponsor information

Organisation

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

Sponsor details

Gaspar de Villaroel y Shyris
Quito
NA
Ecuador

Sponsor type

Research organisation

Website

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

  1. 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.

Additional files

Editorial Notes