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Impact of Helminth Infections During Pregnancy on Humoral Vaccine Immunogenicity in Infants

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ClinicalTrials.gov Identifier: NCT02714348
Recruitment Status : Unknown
Verified March 2016 by Meral Esen, Centre de Recherche Médicale de Lambaréné.
Recruitment status was:  Active, not recruiting
First Posted : March 21, 2016
Last Update Posted : March 21, 2016
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by (Responsible Party):
Meral Esen, Centre de Recherche Médicale de Lambaréné

Brief Summary:

Helminth infection is associated with low vaccine immunogenicity. Pregnant women are particularly sensitive to helminth infection.

Since most vaccines are given shortly after birth, an effect of parasites on infant immunogenicity is of particular concern. Therefore, within this study the investigators aim to investigate if maternal infection influences vaccine immunogenicity in the newborn.


Condition or disease Intervention/treatment
Maternal Infection Affecting Newborn Other: Effect of helminth infection on vaccine immunogenicity

Detailed Description:
There is evidence that helminth infections during pregnancy affect the immune system of the mother and the unborn child. As a consequence, the antimicrobial- immune and vaccine- response of the infant may be deficient. The aim of the present study is to measure the influence of maternal helminth infection (schistosomal, filarial and intestinal helminth infection) on vaccine immunogenicity of their infants. The main focus is on immune responses of infants to vaccine antigens given as part of the expanded program on immunization (EPI) in Gabon at an age when infants are unlikely to be infected with helminths and are immunologically primed by their intrauterine life. The objective is to investigate if and which species of helminths during pregnancy have an effect on any of the EPI vaccine-induced immune responses.

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Study Type : Observational
Estimated Enrollment : 323 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Helminth Infections During Pregnancy on Humoral Vaccine Immunogenicity in Infants
Study Start Date : February 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Effect of helminth infection on vaccine immunogenicity
    Observational; immunology


Primary Outcome Measures :
  1. Difference in Immunoglobulin G (IgG) concentration against EPI vaccine Ags of infants born to helminth infected mothers and non infected mothers at the age of nine months and 12 months [ Time Frame: 12 months of observation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women and their infants from Lambaréné and surroundings (Gabon)
Criteria

Inclusion Criteria:

  • Signed informed consent form (ICF) by the participant aged 18 years or older or by a legal major representative and the participant
  • Willingness to deliver in one of the two maternities in the study area
  • Willingness and ability to comply with study protocol for the duration of the trial
  • Willingness to give blood for the examinations and to provide samples for helminth assessment (stool, urine, blood)

Exclusion Criteria:

  • Known chronic diseases (diabetes, TB, HIV, HCV or HBV infection); these will be assessed on a regular basis at given examinations during pregnancy
  • Withdrawal of consent
  • Poor general health (including a hemoglobin level out of local reference range)
  • Signs of symptoms of helminth infection which needs immediate treatment of the mother
  • Planned migration from the area

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714348


Sponsors and Collaborators
Centre de Recherche Médicale de Lambaréné
University Hospital Tuebingen
Investigators
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Study Director: Akim A Adegnika, Md, PhD Centre de Recherche Médicale de Lambaréné
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Responsible Party: Meral Esen, Groupleader immunology and clinical trials, Centre de Recherche Médicale de Lambaréné
ClinicalTrials.gov Identifier: NCT02714348    
Other Study ID Numbers: HelmVacc_II
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: March 21, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication
Keywords provided by Meral Esen, Centre de Recherche Médicale de Lambaréné:
Helminth infection
Vaccination
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Helminthiasis
Parasitic Diseases