Investigation of Immune Amnesia Following Measles Infection in Select African Regions (NCT06153979) | Clinical Trial Compass
CompletedNot Applicable
Investigation of Immune Amnesia Following Measles Infection in Select African Regions
Guinea, Mali264 participantsStarted 2024-01-16
Plain-language summary
The goal of this observational study is to investigate the effects of measles virus (MeV) infection on pre-existing immunity, vaccine response, and susceptibility to subsequent illness in children aged 1-15 either with or without acute MeV infection.
Who can participate
Age range
1 Year – 15 Years
Sex
ALL
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:
* Aged 1 to 15 years.
* Ability of the participant's legal or culturally acceptable representative to provide informed consent.
* Ability to give assent, as appropriate.
* Stated willingness of parent/guardian and participant as appropriate, to comply with all study procedures.
* Willingness to receive rabies vaccine.
* Meet the criteria for assignment to Group 1 or Group 2, as follows:
* Group 1, cases (acute MeV infection):
* Clinical signs and symptoms suggestive of acute MeV infection (Koplik spots or skin rash) AND
* Laboratory confirmed measles:
* Upper respiratory specimen (swab) PCR for measles positive, OR
* Serum IgM for measles positive.
* Group 2, controls (no acute MeV infection):
* No clinical signs and symptoms suggestive of acute MeV infection (Koplik spots or skin rash) AND
* Upper respiratory specimen (swab) PCR negative for MeV AND
* Serum measles IgM negative AND
* Serum measles IgG positive and previously vaccinated for measles (2nd dose will be offered if appropriate). If serum measles IgG is negative, participant must be willing to be vaccinated regardless of prior measles vaccine history to meet this criterion.
Exclusion Criteria:
* HIV infection or any other immunosuppressive condition or medications.
* Pregnant or lactating.
* History of prior measles or immunologic evidence of prior measles in the absence of prior measles vaccination.
* Severe anemia, defined as hemoglobin less than 8 g/dL.
* Any acute or chronic condition whi…
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
Change in pre-existing immunity
Timeframe: Week 13 after baseline
2
Effect of MeV infection on immune response to a controlled immune stimulus (rabies vaccination)
Timeframe: 14 days after last PrEP regimen vaccination
3
Effect of MeV infection on immune response to a controlled immune stimulus
Timeframe: 5-6 weeks after the first rabies vaccine dose
4
Effect of MeV infection on immune response to a controlled immune stimulus
Timeframe: 5-6 weeks after the first rabies vaccine dose
Trial details
NCT IDNCT06153979
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)