Impact of Helminth Infections During Pregnancy on Humoral Vaccine Immunogenicity in Infants (NCT02714348) | Clinical Trial Compass
UnknownNot Applicable
Impact of Helminth Infections During Pregnancy on Humoral Vaccine Immunogenicity in Infants
323 participantsStarted 2014-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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