Clinical Trials Directory

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

TypeNameDescription
BIOLOGICALVerorabParticipants 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.