Trials / Active Not Recruiting
Active Not RecruitingNCT06153979
Investigation of Immune Amnesia Following Measles Infection in Select African Regions
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 256 (estimated)
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID) · NIH
- Sex
- All
- Age
- 1 Year – 15 Years
- Healthy volunteers
- Accepted
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.
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 (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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 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. |
Timeline
- Start date
- 2024-01-16
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2023-12-01
- Last updated
- 2025-05-29
Locations
2 sites across 2 countries: Guinea, Mali
Source: ClinicalTrials.gov record NCT06153979. Inclusion in this directory is not an endorsement.