CClinicalTrials.gg
Status unknownNCT02714348Updated Mar 21, 2016

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

An observational study in Maternal Infection Affecting Newborn, sponsored by Centre de Recherche Médicale de Lambaréné. Status unknown. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-21.

Sponsored by Centre de Recherche Médicale de Lambaréné · Observational

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
323
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Maternal Infection Affecting Newborn

Keywords

  • Helminth infection
  • Vaccination
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 323 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Centre de Recherche Médicale de Lambaréné is the lead sponsor of 16 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
323 participants (estimated)
Patient registry
No

Interventions

  • OtherEffect of helminth infection on vaccine immunogenicity

    Observational; immunology

06

What researchers measure

Primary outcomes

  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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Publication

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02714348
Lead sponsor
Centre de Recherche Médicale de Lambaréné
Collaborators
University Hospital Tuebingen
Responsible party
Meral Esen (Groupleader immunology and clinical trials, Centre de Recherche Médicale de Lambaréné) — Principal investigator
First posted
Mar 21, 2016
Start date
Feb 2014
Primary completion
Sep 2016 (estimated)
Completion
Sep 2016 (estimated)
Last update
Mar 21, 2016

Study contacts

Akim A Adegnika, Md, PhD
study director · Centre de Recherche Médicale de Lambaréné
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion