Status:
ACTIVE_NOT_RECRUITING
Investigation of Immune Amnesia Following Measles Infection in Select African Regions
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Measles Infection
Eligibility:
All Genders
1-15 years
Brief 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 age...
Detailed Description
This is a prospective, observational, longitudinal study to be conducted in West Africa. Eligible children will be enrolled into 1 of 2 arms: acute MeV infection (cases) or no acute MeV infection (con...
Eligibility Criteria
Inclusion
- 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
- 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 which, in the opinion of the investigator, constitutes a contraindication to participation in this study.
Key Trial Info
Start Date :
January 16 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT06153979
Start Date
January 16 2024
End Date
June 1 2026
Last Update
May 29 2025
Active Locations (2)
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1
Partnership of Clinical Research in Guinea, Partenariat Pour La Recherche Clinique en Guinée (PREGUI)
Conakry, Guinea
2
University Clinical Research Center (UCRC) University of Sciences, Techniques and Technologies of Bamako
Bamako, Mali