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.
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 (controls) as assessed using upper respiratory specimens and blood samples. Blood samples will be collected at screening/enrollment (Day 0) and follow-up visits on Day 14, Week 13, and Week 52, and tested for humoral and cellular immune responses to endemic pathogens to determine changes in antibody diversity and antibody secreting cells (ASCs). All children in each arm will receive rabies vaccination (standard 3-dose series given as pre-exposure prophylaxis \[PrEP\]), with the first dose randomized to either Week 8 or Week 47 after enrollment. Biological samples will be collected after vaccination to assess if the immune stimulus (rabies vaccine) response differs: 1) between children with and without MeV infection, and 2) based on the timing of the receipt of the rabies vaccine.
Study Type
OBSERVATIONAL
Enrollment
256
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.
Partnership of Clinical Research in Guinea, Partenariat Pour La Recherche Clinique en Guinée (PREGUI)
Conakry, Guinea
University Clinical Research Center (UCRC) University of Sciences, Techniques and Technologies of Bamako
Bamako, Mali
Change in pre-existing immunity
Mean change in a panel of antibody levels over 13 weeks as measured by multiplex serological methods and targeted ELISAs for confirmation.
Time frame: Week 13 after baseline
Effect of MeV infection on immune response to a controlled immune stimulus (rabies vaccination)
Proportion of subjects with rabies virus neutralizing antibodies (RVNA) titer ≥ 0.5 IU/mL as measured by rapid fluorescent focus inhibition test
Time frame: 14 days after last PrEP regimen vaccination
Effect of MeV infection on immune response to a controlled immune stimulus
Proportion of subjects with an RVNA titer ≥ lower limit of quantification
Time frame: 5-6 weeks after the first rabies vaccine dose
Effect of MeV infection on immune response to a controlled immune stimulus
Geometric mean RVNA titer
Time frame: 5-6 weeks after the first rabies vaccine dose
Change in healthcare system encounters
Mean number of non-study sick visit healthcare system encounters during the 1-year follow-up.
Time frame: 1 year following enrollment
Change in pre-existing immunity
Mean change in a panel of antibody levels over 52 weeks as measured by multiplex serological methods and targeted ELISAs for confirmation.
Time frame: Week 52 after baseline
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