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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Actue MeV Infection | Participants have acute MeV infection. |
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| Group 2 - No Actue MeV Infection | Participants do not have acute MeV infection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verorab | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 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 | 5-6 weeks after the first rabies vaccine dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change in healthcare system encounters | Mean number of non-study sick visit healthcare system encounters during the 1-year follow-up. | 1 year following enrollment |
| Change in pre-existing immunity |
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Inclusion Criteria:
Exclusion Criteria:
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Specific study sites within each country will be in areas experiencing measles outbreaks.
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| Name | Affiliation | Role |
|---|---|---|
| Sally Hunsberger, Ph.D. | National Institute of Allergy and Infectious Diseases (NIAID) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Partnership of Clinical Research in Guinea, Partenariat Pour La Recherche Clinique en Guinée (PREGUI) | Conakry | Guinea | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40569945 | Derived | Tchos KF, Ridzon R, Haidara MC, Dabitao D, Akpa E, Camara D, Vallee D, Coulibaly M, Camara S, Aboulhab J, Diakite M, Diarra B, Diarra S, Dicko I, Francis A, Kolie CF, Koropogui M, Lim C, Samake S, Hunsberger S, Sidibe M, Chen RY, Konate I, Doumbia S, Beavogui AH, Shaw-Saliba K. Investigating immune amnesia after measles virus infection in two West African countries: A study protocol. PLoS One. 2025 Jun 26;20(6):e0314828. doi: 10.1371/journal.pone.0314828. eCollection 2025. |
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Blood samples and upper respiratory specimens will be stored for analysis in repositories in each participating country.
Mean change in a panel of antibody levels over 52 weeks as measured by multiplex serological methods and targeted ELISAs for confirmation.
| Week 52 after baseline |
| University Clinical Research Center (UCRC) University of Sciences, Techniques and Technologies of Bamako |
| Bamako |
| Mali |