Investigation of Immune Amnesia Following Measles Infection in Select African Regions

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.

Study Overview

• Status: Completed
• Conditions: Measles Infection
• Intervention / Treatment: Biological: Verorab

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.

• Study Type: Observational
• Enrollment (Actual): 264

Contacts and Locations

Study Locations

• Guinea
  • Conakry, Guinea
    • Partnership of Clinical Research in Guinea, Partenariat Pour La Recherche Clinique en Guinée (PREGUI)
• Mali
  • Bamako, Mali
    • University Clinical Research Center (UCRC) University of Sciences, Techniques and Technologies of Bamako

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Specific study sites within each country will be in areas experiencing measles outbreaks.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 - Actue MeV Infection; Participants have acute MeV infection.	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.
Group 2 - No Actue MeV Infection; Participants do not have acute MeV infection.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Johns Hopkins University
• Investigators: Study Director: Sally Hunsberger, Ph.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Actual): April 16, 2026
• Study Completion (Actual): April 16, 2026

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathologic Processes; Disease Attributes; RNA Virus Infections; Virus Diseases; Neurobehavioral Manifestations; Neurocognitive Disorders; Paramyxoviridae Infections; Mononegavirales Infections; Morbillivirus Infections; Memory Disorders; Infections; Communicable Diseases; Measles; Amnesia
• Other Study ID Numbers: Measles West Africa 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No