Investigation of Immune Amnesia Following Measles Infection in Select African Regions

NCT06153979 | Active Not Recruiting

• 1 other identifier: Measles West Africa 01
• Study Type: observational
• Target: 256
• Locations: 2 countries
• Sites: 2

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.

Conditions

Measles Infection

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Change in healthcare system encounters

  1 year following enrollment

• Change in pre-existing immunity

  Week 52 after baseline

Study Arms (2)

Group 1 - Actue MeV Infection

Participants have acute MeV infection.

Biological: Verorab

Group 2 - No Actue MeV Infection

Participants do not have acute MeV infection.

Biological: Verorab

Interventions

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.

Group 1 - Actue MeV Infection; Group 2 - No Actue MeV Infection

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Johns Hopkins University: collaborator

Study Sites (2)

Partnership of Clinical Research in Guinea, Partenariat Pour La Recherche Clinique en Guinée (PREGUI)

Conakry, Guinea

Location

University Clinical Research Center (UCRC) University of Sciences, Techniques and Technologies of Bamako

Bamako, Mali

Location

Related Publications (1)

• 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.

  PMID: 40569945 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and upper respiratory specimens will be stored for analysis in repositories in each participating country.

Study Officials

• Sally Hunsberger, Ph.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: December 1, 2023
• Study Start: January 16, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1); MA (1)