Impact of Helminth Infections During Pregnancy on Humoral... | NCT02714348

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

NCT02714348

Sponsor

Centre de Recherche Médicale de Lambaréné

Status

Unknown status

Last Update Posted

Mar 21, 2016Estimated

Enrollment

323Estimated

Phase

Not provided

Conditions

Maternal Infection Affecting Newborn

Interventions

Effect of helminth infection on vaccine immunogenicity

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Sep 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Mar 16, 2016

First Submission Date that Met QC Criteria

Mar 18, 2016

First Posted Date

Mar 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2016

Last Update Posted Date

Mar 21, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Meral Esen, Groupleader immunology and clinical trials, Centre de Recherche Médicale de LambarénéPrincipal Investigator

Lead Sponsor

Centre de Recherche Médicale de LambarénéOTHER

Collaborators

Name	Class
University Hospital Tuebingen	OTHER

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

323Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Effect of helminth infection on vaccine immunogenicity	Other	Observational; immunology

Outcomes Module

Primary Outcomes

Measure	Description	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		12 months of observation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Akim A Adegnika, Md, PhD	Centre de Recherche Médicale de Lambaréné	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Publication

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014201	Trematode Infections

Ancestor Terms

ID	Term
D006373	Helminthiasis
D010272	Parasitic Diseases
D007239	Infections

Browse Leaves

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Browse Branches

Not provided