Investigation of Immune Amnesia Following Measles Infection in Select African Regions

Last updated: November 21, 2024
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rash

Throat And Tonsil Infections

Memory Problems

Treatment

Verorab

Clinical Study ID

NCT06153979
Measles West Africa 01
  • Ages 1-15
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 1 to 15 years.

  • Ability of the participant's legal or culturally acceptable representative toprovide informed consent.

  • Ability to give assent, as appropriate.

  • Stated willingness of parent/guardian and participant as appropriate, to comply withall 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 skinrash) 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 orskin 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 beoffered if appropriate). If serum measles IgG is negative, participant must bewilling to be vaccinated regardless of prior measles vaccine history to meet thiscriterion.

Exclusion

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 ofprior 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 Design

Total Participants: 256
Treatment Group(s): 1
Primary Treatment: Verorab
Phase:
Study Start date:
January 16, 2024
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

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

    Conakry,
    Guinea

    Active - Recruiting

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

    Bamako,
    Mali

    Active - Recruiting

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