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

March 18, 2016 updated by: Meral Esen, Centre de Recherche Médicale de Lambaréné

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

323

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women and their infants from Lambaréné and surroundings (Gabon)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months of observation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de Recherche Médicale de Lambaréné

Collaborators

University Hospital Tuebingen

Investigators

  • Study Director: Akim A Adegnika, Md, PhD, Centre de Recherche Médicale de Lambaréné

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

March 16, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (Estimate)

March 21, 2016

Study Record Updates

Last Update Posted (Estimate)

March 21, 2016

Last Update Submitted That Met QC Criteria

March 18, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HelmVacc_II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publication

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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