Clinical trial

Investigation of Immune Amnesia Following Measles Infection in Select African Regions

Name
Measles West Africa 01
Description
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.
Trial arms
Trial start
2024-01-16
Estimated PCD
2025-06-01
Trial end
2025-06-01
Status
Recruiting
Treatment
Verorab
Participants in each group will receive rabies vaccination (standard 3-dose series given as PrEP), with the first dose randomized to either Week 8 or Week 47 after enrollment.
Arms:
Group 1 - Actue MeV Infection, Group 2 - No Actue MeV Infection
Size
256
Primary endpoint
Change in pre-existing immunity
Week 13 after baseline
Effect of MeV infection on immune response to a controlled immune stimulus (rabies vaccination)
14 days after last PrEP regimen vaccination
Effect of MeV infection on immune response to a controlled immune stimulus
5-6 weeks after the first rabies vaccine dose
Effect of MeV infection on immune response to a controlled immune stimulus
5-6 weeks after the first rabies vaccine dose
Eligibility criteria
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 which, in the opinion of the investigator, constitutes a contraindication to participation in this study.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples and upper respiratory specimens will be stored for analysis in repositories in each participating country.'}, 'enrollmentInfo': {'count': 256, 'type': 'ESTIMATED'}}
Updated at
2024-03-08

1 organization

1 product

1 indication

Product
Verorab
Indication
Measles