Investigation of Immune Amnesia Following Measles Infection in Select African Regions

NCT ID: NCT06153979

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 256 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-16
• Study Completion Date: 2026-06-30

Brief 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

Measles Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1 - Actue MeV Infection

Participants have acute MeV infection.

Verorab

Intervention Type: 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.

Group 2 - No Actue MeV Infection

Participants do not have acute MeV infection.

Verorab

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sally Hunsberger, Ph.D.

Role: STUDY_DIRECTOR

National Institute of Allergy and Infectious Diseases (NIAID)

Locations

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

Countries

Guinea; Mali

References

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.

Reference Type: DERIVED

PMID: 40569945 (View on PubMed)

Other Identifiers

Measles West Africa 01

Identifier Type: -

Identifier Source: org_study_id