Maternal Infection Affecting NewbornNCT02714348
Impact of Helminth Infections During Pregnancy on Humoral Vaccine Immunogenicity in Infants
An observational study of Maternal Infection Affecting Newborn, run by Centre de Recherche Médicale de Lambaréné.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Infection Affecting Newborn
- What is being tested?
- Effect of helminth infection on vaccine immunogenicity
- Type of treatment
- Vaccines
- How many people
- 323 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women and their infants from Lambaréné and surroundings (Gabon)
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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.
- Conditions
- Maternal Infection Affecting Newborn
- Being tested
- Effect of helminth infection on vaccine immunogenicity
- Keywords
- Helminth infection, Vaccination
- Medical subject headings
- Trematode Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of helminth infection on vaccine immunogenicityOther
Observational; immunology
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startFeb 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Infection Affecting NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 323 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche Médicale de Lambaréné
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Principal investigator, Meral Esen, Centre de Recherche Médicale de Lambaréné
- Investigators
- Akim A Adegnika, Md, PhD, Study director, Centre de Recherche Médicale de Lambaréné
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714348
- Sponsor's protocol ID
- HelmVacc_II
- Status last verified
- Mar 2016
- First submitted
- 16 Mar 2016
- Last updated
- 21 Mar 2016
- Results posted
- No
- Individual data sharing
- Yes: Publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Helminth Infections During Pregnancy on Humoral Vaccine Immunogenicity in Infants
- ClinicalTrials.gov ID
- NCT02714348
- Acronym / sponsor ID
- HelmVacc_II
- Conditions
- Maternal Infection Affecting Newborn
- Keywords
- Helminth infection, Vaccination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- Centre de Recherche Médicale de LambarénéUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- Feb 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women and their infants from Lambaréné and surroundings (Gabon)
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effect of helminth infection on vaccine immunogenicityObservational; immunology | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
- Individual participant dataSharing planned: Yes. Publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akim A Adegnika, Md, PhD study director
Centre de Recherche Médicale de Lambaréné
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Infection Affecting Newborn, run by Centre de Recherche Médicale de Lambaréné.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2016.